SUZHOU, China, and ROCKVILLE, Md., Nov. 3, 2023 /PRNewswire/ — Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that results from multiple clinical studies of the company’s novel drug candidate, olverembatinib, have been selected for presentations, including two Oral Reports, at the 65th American Society of Hematology (ASH) Annual Meeting. Being selected for Oral Reports at the ASH Annual Meeting for the sixth consecutive year underscores the significant interest in the drug by the global hematology community. This year, results from multiple clinical studies on two of Ascentage Pharma’s lead drug candidates (olverembatinib and lisaftoclax) have been selected for presentations at the ASH Annual Meeting.

As a potential best-in-class drug, olverembatinib has broad therapeutic potential for the treatment of multiple solid tumors and hematologic malignancies. Currently, olverembatinib is being jointly commercialized by Ascentage Pharma and Innovent Biologics. Through an Oral Report at this year’s ASH Annual Meeting, Ascentage Pharma will present the latest results from a randomized, controlled registrational Phase II study in patients with first- and second-generation tyrosine kinase inhibitor (TKI)-resistant chronic myeloid leukemia in the chronic-phase (CML-CP), led by Prof. Xiaojun Huang and Prof. Qian Jiang, from the Institute of Hematology of the Peking University People’s Hospital. These data show that, in patients with CML-CP who were resistant/intolerant to TKIs, olverembatinib demonstrated statistically significant and clinically meaningful improvement in event-free survival (EFS), compared with the best available therapy (BAT), meeting the primary endpoint of the study.

The other Oral Report featuring early results from a Phase II study of olverembatinib combined with venetoclax and reduced-intensity chemotherapy in treatment-naïve patients with Ph+ ALL, led by Prof. Xiaoyuan Gong of the Institute of Hematology and Blood Diseases Hospital, the Chinese Academy of Medical Sciences

Also at this year’s ASH Annual Meeting, Ascentage Pharma will release updated results from a US study of olverembatinib in a Poster Presentation. These data demonstrate the favorable potential clinical benefit of olverembatinib monotherapy and combination regimens in patients with heavily pretreated CML or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and show the drug’s therapeutic effect in patients who had failed prior treatment with ponatinib or asciminib, further demonstrating the drug’s potential as a new treatment option to patients with CML or Ph+ ALL worldwide.

In addition, multiple studies of olverembatinib were also selected for Poster Presentations, including one featuring a case series study of liposome mitoxantrone combined with venetoclax, homoharringtonine, and olverembatinib (the MVHO regimen) in pediatric patients with refractory or recurrent acute myeloid leukemia (AML), carried out by a team of investigators including Wenting Hu and Prof. Shuhong Shen of the Department of Hematology & Oncology, Shanghai Children’s Medical Center of Shanghai Jiao Tong University School of Medicine (see the table below for details).

The ASH Annual Meeting is one of the largest gatherings of the international hematology community, bringing together the latest and most cutting-edge scientific research in the pathogenesis and clinical treatment of hematologic diseases. The 65th ASH Annual Meeting will take place on December 9-12, 2023, local time, both online and in-person in San Diego, CA (United States).

"This is the sixth consecutive year for the updated clinical data of olverembatinib to be accepted for presentation at the ASH Annual Meeting, a new record for the drug," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "This year, results from multiple studies of olverembatinib have been selected for presentations, including two Oral Reports, at the meeting. This indicates the global hematology community’s strong recognition of olverembatinib, a global best-in-class drug. The large body of clinical data we are bringing to this year’s ASH Annual Meeting underscores our broad progress in new drug discovery and clinical development. Moving forward, we will continue to expeditiously advance our clinical development programs globally for the benefit of patients in China and around the world."

Studies of Ascentage Pharma’s Drug Candidates to be presented at ASH 2023

Drug Candidate

Title

PI/Presenter

Institution

Abstract#

Format

Olverembatinib

（HQP1351）

Olverembatinib (HQP1351) Demonstrates Efficacy Vs. Best Available Therapy (BAT) in Patients (Pts) with Tyrosine Kinase Inhibitor (TKI)-Resistant Chronic Myeloid Leukemia Chronic-Phase (CML-CP) in a Registrational Randomized Phase 2 Study

Qian Jiang

Xiaojun Huang

The Peking University People’s Hospital

#869

Oral Report

Olverembatinib Combined with Venetoclax and Reduced-Intensity Chemotherapy for Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: Early results from a phase II study

Xiaoyuan Gong

Institute of Hematology and Blood Diseases Hospital, the Chinese Academy of Medical Sciences

#827

Oral Report

Update of Olverembatinib (HQP1351) Overcoming Ponatinib and/or Asciminib Resistance in Patients (Pts) with Heavily Pretreated/Refractory Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

Elias Jabbour

Hagop Kantarjian

MD Anderson Cancer Center

#1798

Poster

Presentation

Combination of Liposome Mitoxantrone, Venetoclax, Homoharringtonine, and Olverembatinib (HQP1351) (MVHO) in Pediatric Patients with Refractory or Recurrent Acute Myeloid Leukemia (AML): Case Series

Wenting Hu

Shuhong Shen

Department of Hematology & Oncology, Shanghai Children’s Medical Center of Shanghai Jiao Tong University School of Medicine

#2840

Poster

Presentation

Combination of Olverembatinib and VP Regimen As First-Line Therapy for Adult Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Gaixiang Xu

Jie Jin

The First Affiliated Hospital, Zhejiang University School of Medicine

#4205

Poster

Presentation

Olverembatinib(HQP1351)-Based Therapy in Adults with Relapsed or Refractory Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Advanced Chronic Myeloid Leukemia: Results of the Real-Life Study

Na Xu

Nanfang Hospital of Southern Medical University

#4538

Poster

Presentation

Frontline Combination of 3 Generation TKI Olverembatinib and Blinatumomab for Ph+/Phlike ALL Patients

Hongsheng Zhou

Nanfang Hospital of Southern Medical University

#1504

Poster

Presentation

Lisaftoclax

APG-2575

Updated Efficacy and Safety Results of Lisaftoclax (APG-2575) in Patients (pts) with Heavily Pretreated Chronic Lymphocytic Leukemia (CLL): Pool Analysis of Two Clinical Trials

Keshu Zhou

Jianyong Li

Jianxiang Wang

Henan Cancer Hospital,

Jiangsu Province Hospital

Institute of Hematology and Blood Diseases Hospital, the Chinese Academy of Medical Sciences

#1900

Poster

Presentation

Safety and Efficacy of Lisaftoclax (APG-2575), a Novel BCL-2 Inhibitor (BCL-2i), in Relapsed or Refractory (R/R) or Treatment-Naïve (TN) Patients (Pts) with Acute Myeloid leukemia (AML), Myelodysplastic Syndrome (MDS), or Other Myeloid Neoplasms

Huafeng Wang

Jie Jin

The First Affiliated Hospital, Zhejiang University School of Medicine

#2925

Poster

Presentation

First Report on the Effects of Lisaftoclax (APG-2575） in Combination with Novel Therapeutic Regimens in Patients with Relapsed or Refractory Multiple Myeloma (R/R MM） or Immunoglobulin Light-Chain (Amyloid Light-Chain [AL]） Amyloidosis

Sikander Ailawadhi

Asher A. Chanan-Khan

Mayo Clinic

#2016

Poster

Presentation

Abtracts on olverembatinib presented at the 2023 ASH Annual Meeting are as follows (for details on the abstracts featuring lisaftoclax, please refer to a separate press release published at the same time):

Olverembatinib (HQP1351) Demonstrates Efficacy Vs. Best Available Therapy (BAT) in Patients (Pts) with Tyrosine Kinase Inhibitor (TKI)-Resistant Chronic Myeloid Leukemia Chronic-Phase (CML-CP) in a Registrational Randomized Phase 2 Study

Format: Oral Report
Abstract: #869
Session: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Novel Therapeutic Approaches
Time: December 11, 2023, Monday, 3:45 PM (Pacific Time) / December 12, 2023, Tuesday, 7:45 AM (Beijing Time)

Highlights:

This is a multicenter, randomized, registrational Phase II study designed to assess the efficacy and safety of olverembatinib compared with the BAT in patients with CML-CP. As of April 30, 2023, a total of 144 patients were enrolled, of whom 69.4% were male and 30.6% were female. The median (range) age of these patients was 49.0 (18-77) years. A total of 96 patients were treated with olverembatinib, and 48 patients were treated with BAT. The median (range) duration of follow-up for the olverembatinib and BAT arms were 12.67 (0.0-40.9) months and 2.94 (0.0-40.4) months, respectively. 66 (45.8%) patients had ≥1 BCR::ABL1 mutations, and 39 (27.1%) had the "gatekeeper" BCR::ABL1T315I mutation, which confers resistance against all first- and second-generation tyrosine kinase inhibitors (TKIs). A total of 97 patients discontinued therapies (56 [58.3%] from the olverembatinib arm, 41 [85.4%] from the BAT arm) due to disease progression, treatment failure, adverse events (AEs), consent withdrawal, poor compliance, or death. Safety results: 82/96 (85.4%) patients receiving olverembatinib and 31/46 (67.4%) patients receiving BAT experienced grade≥3 AEs. AEs with an incidence >20% included thrombocytopenia; leukopenia; anemia; neutropenia; elevated creatine phosphokinase (CPK), alanine aminotransferase (ALT), and aspartate aminotransferase (AST); and hypertriglyceridemia. Serious AEs (SAEs) with an incidence >5% included thrombocytopenia. Common AEs (≥10%) that led to discontinuation, dose reduction, or treatment withdrawal were thrombocytopenia, neutropenia, and leukopenia. Efficacy results: Data showed that, in patients with CML-CP resistant/intolerant to prior treatment with TKIs, the olverembatinib arm, compared with the BAT arm, achieved statistically significant improvement in event-free survival (EFS), therefore meeting the primary endpoint of the study. The median (range) EFS was 21.22 (95% CI: 10.15 to not reached) months in the olverembatinib arm compared to 2.86 (95% CI 2.53-4.73) months in the BAT arm. Compared with the BAT control arm, olverembatinib reduced the risk of events by 65%. In the olverembatinib arm, the estimated EFS at 6, 12, and 24 months was 73% (95% CI, 62.5-81.0), 58.7% (95% CI, 47.5-68.2), and 46.9% (95% CI, 35.9-57.2), respectively. In the BAT group, it was 32.6% (95% CI,19.7-46.2), 26.1% (95% CI, 14.5-39.3), and 16.9% (95% CI, 7.7-29.2) at 6, 12 and 24 months, respectively. Neither the olverembatinib nor the BAT arm reached the median overall survival (OS). As of the data cutoff date, 34 (71%) patients in the BAT control arm were crossed-over to be treated with olverembatinib after reaching the EFS endpoint. The olverembatinib arm showed significantly better efficacy and higher response rates than the BAT control arm. Conclusions: Olverembatinib was observed to be better tolerated and more effective than BAT in patients with CML-CP resistant or intolerant to first- and second-generation TKIs.

Update of Olverembatinib (HQP1351) Overcoming Ponatinib and/or Asciminib Resistance in Patients (Pts) with Heavily Pretreated/Refractory Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

Format: Poster Presentation

Abstract: #1798

Session: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster I

Time: December 9, 2023, Saturday, 5:30 PM – 7:30 PM (Pacific Time) / December 10, 2023, Sunday, 9:30 AM – 11:30 AM (Beijing Time)

Highlights

Olverembatinib, a novel, potent BCR::ABL1 tyrosine kinase inhibitor (TKI), has shown strong antitumor activity in patients with CML and Ph+ ALL. This abstract reports on the safety, efficacy, and pharmacokinetics (PK) of olverembatinib in patients with CML and Ph+ ALL outside China, particularly in patients previously treated with third-generation TKI ponatinib and/or allosteric STAMP inhibitor asciminib. Methods: Olverembatinib was administered orally once every other day (QOD) in 28-day cycles. In the monotherapy cohort, patients were enrolled after treatment failures on at least 2 prior TKIs and randomized to receive olverembatinib QOD at 30, 40, or 50 mg. In the combination cohort, patients with Ph+ B-cell precursor ALL (BCP ALL) or lymphoid CML-BP (CML-LBP) resistant to at least 1 TKI were enrolled and administered olverembatinib (30 or 40 mg) QOD in combination with blinatumomab. As of June 30, 2023, 76 patients were enrolled, including 57 with CML-CP and 19 with advanced Ph+ leukemia. The median (range) age was 54.5 (21-80) years and 56.6% of patients were male.11 (14.5%), 23 (30.3%) and 39 (51.3%) patients had received 2, 3, and ≥4 TKIs, respectively. A total of 52.6% of patients were previously treated with ponatinib, of whom 67.5% were resistant and 25.0% were intolerant to the drug, and 7.5% of patients failed for other reasons. A total of 27.6% of patients were previously treated with asciminib, of whom 71.4% were resistant and 19.1% were intolerant to the agent, and 9.5% failed for other reasons. At baseline, 32% of patients had T315I mutations, 38% had hypertension, and 17.1% had other cardiovascular comorbidities. The median (range) duration of treatment was 24.1 (0-134) weeks. PK analysis showed that western patients had a PK profile similar to historical data on Chinese patients. Safety results: 12 patients with CML-CP and 7 with advanced Ph+ leukemia discontinued treatment for reasons including AEs (n=4), disease progression (n=7), and other reasons (n=8). A total of 54 (83.1%) patients experienced treatment-related AEs (TRAEs) of any grade after receiving olverembatinib. Grade ≥3 AEs occurring in ≥3 patients (≥ 4.6% incidence) included thrombocytopenia (17%), neutropenia (13.8%), elevated blood creatine phosphokinase (13.8%), leukopenia (7.7%), anemia (4.6%), and elevated lipase (4.6%). 10 (15.4%) patients experienced olverembatinib treatment-related serious AEs (SAEs). 2 (3.1%) patients discontinued the study due to TRAEs, and no TRAE-related deaths were reported. Efficacy results:
Among 50 efficacy-evaluable patients with CML-CP, 57% (25/44) achieved a complete cytogenetic response (CCyR), 43% (21/49) achieved a major molecular response (MMR), and efficacy continued to improve over time. The rate of MMR in patients with CML-CP treated for 6 months and 12 months was 66% and 88%, respectively. At 24 months, the rate of progression-free survival (PFS) was 75% (95% CI: 56.1-86.7) and the OS was 97.6% (95% CI: 90.8-99.4). Among patients whose disease failed ≥4 prior TKIs, CCyR and MMR rates were 57% (13/23) and 42% (11/26), respectively; In patients with CML-CP harboring the T315I mutation, CCyR and MMR rates were 60% (9/15) and 44% (7/16), respectively; In patients without the T315I mutation, CCyR and MMR rates were 55% (16/29) and 42% (14/33), respectively; In patients who had failed treatment with ponatinib, CCyR and MMR rates were 53% (8/15) and 38% (6/16), respectively; In patients who had failed treatment with asciminib, CCyR and MMR rates were 43% (3/7) and 38% (3/8), respectively. Among the 8 patients who were resistant/intolerant to both ponatinib and asciminib, 2 achieved MMR.

Among the 13 efficacy-evaluable patients with advanced Ph+ leukemia, 3 (23%) achieved MMR, of whom 1 patient harbored the T315I mutation and 2 were T315I mutation negative and resistant to ponatinib.

In the combination cohort, 2 patients with Ph+ BCP ALL received olverembatinib 30 mg QOD in combination with blinatumomab. Both patients achieved CCyR and 1 achieved negative minimal residual disease (MRD) status after 1 treatment cycle. Conclusions: Olverembatinib alone or combined with blinatumomab was efficacious and well tolerated in heavily pretreated patients with CML or Ph+ ALL. The efficacy of olverembatinib was not affected by prior exposure to ponatinib or asciminib, and the status of the T315I mutation. Olverembatinib may provide an effective treatment option for patients with CML or Ph+ ALL who have failed 2 or more TKIs.

Olverembatinib Combined with Venetoclax and Reduced-Intensity Chemotherapy for Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: Early results from a phase II study

Format: Oral Report
Abstract: #827
Session: 614. Acute Lymphoblastic Leukemia: Therapies, Excluding Transplantation and Cellular Immunotherapies: Optimal Frontline Treatment for ALL
Time: December 11, 2023, Monday; 3:45 PM (Pacific Time) / December 12, 2023, Tuesday; 7:45 AM (Beijing Time)

Highlights:

Background: The combination of olverembatinib (HQP1351), a novel third-generation tyrosine kinase inhibitors (TKIs), with venetoclax generated high response rates in patients with relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph ALL). However, the efficacy and safety of these two agents-based regimens as frontline treatment remains unknown. Methods: This is a single-arm phase II study (NCT05594784) that enrolled patients (pts) ≥ 14 years (yrs) of age with newly diagnosed Ph+ ALL. Pts were treated with a combination of venetoclax (100 mg d1, 200 mg d2, 400 mg d3-28), olverembatinib 40 mg once every continuously other day, vincristine 1.4 mg/m2 (maximum dose 2 mg) on day 1, 8, 15, 22, and prednisone 60 mg/m2 on day 1-14; 40 mg/m2 on day 15-28 in cycle 1. In cycle 2-3, oral treatment with venetoclax 400 mg × 7 days, olverembatinib once every other day continuously and prednisone 60 mg/m × 7 days were administrated. Cycles were repeated every 28 days. During cycle 1, The dose of olverembatinib was reduced to 30 mg once every other day for pts achieving a complete molecular response (CMR). The primary endpoint of this study was the CMR rate at 3 months. CMR was defined as undetectable BCR:ABL1 transcripts by using the RT-PCR method with sensitivity of 0.001%. MMR was defined as more than 3-log reduction of BCR:ABL1 transcripts. From August 2022 to April 2023, a total of 31 pts were enrolled. All pts completed 3 cycles of treatment and could be assessed for the primary endpoint. The data cutoff date was July 25, 2023 with a median follow-up time of 5.8 months. The median age was 40 years (range, 20-66 years) and males accounted for 58.1%. Twenty-three pts (74.2%) expressed the p190 transcript and 8 pts (25.8%) expressed the p210 transcript. The median expression level of BCR:ABL1 was 96.33% (range, 70.79%-175.39%). Efficacy results: All patients achieved CR at the end of cycle 1 and no TLS or treatment-related deaths occurred. Molecular response at the end of cycle 1 was CMR in 17 patients (54.8%), and MMR in 8 (25.8%). Molecular response at 3 months was CMR in 19 patients (61.3%) and MMR in 10 (32.3%). No patients developed relapses or deaths at the last follow-up. Safety results: The regimen was well-tolerated and safe. Most side effects were grade 1-2. The demand for transfusion and the incidence of infections significantly decreased compared to our historic data. No patient discontinued olverembatinib or venetoclax due to toxicity. Conclusions: The combination of olverembatinib and venetoclax with reduced-intensity chemotherapy is a safe and effective regimen in patients with newly diagnosed Ph ALL. The regimen results in high rates of CMR in the absence of intensive chemotherapy or immunotherapy.

Combination of Liposome Mitoxantrone, Venetoclax, Homoharringtonine, and Olverembatinib (HQP1351) (MVHO) in Pediatric Patients with Refractory or Recurrent Acute Myeloid Leukemia (AML): Case Series

Format: Poster Presentation
Abstract: #2840
Session: 613. Acute Myeloid Leukemias: Clinical and Epidemiological: Poster II
Time: December 10, 2023, Sunday, 6:00 PM – 8:00 PM (Pacific Time) / December 11, 2023, Monday, 10:00 AM – 12:00 PM (Beijing Time)

Highlights:

Background: AML accounts for up to 25% of all pediatric acute leukemia cases. Although the OS in pediatric AML has increased to approximately 70% in recent years because of enhanced risk stratification and therapeutics, approximately 30% of patients experience relapse, and 5% to 10% die because of disease complications or untoward medication effects. Hence, pediatric AML continues to represent an unmet medical need. This study investigated the safety and efficacy of the MVHO therapy in pediatric patients with refractory or relapsed AML. Methods: The study enrolled patients with recurrent or newly diagnosed AML with poor prognosis secondary to related molecular abnormalities, including NUP98 rearrangements, FUS-ERG, CBFA2T3-GLIS2, and del(7/7q), who did not achieve complete remission (CR) after first-line induction therapy (i.e., DA, DAE, DAH, MAG, and CLAG). Patients were administered the MVHO regimen, which included 1 dose of liposome mitoxantrone at 8 mg/m2; venetoclax at 300 to 350 mg/m2 once daily on days (D) 1 through 7 (with dose escalation if high tumor burden); homoharringtonine at 2 mg/m2 once daily on D1 through 7; and olverembatinib at 20-30 mg/m2 every other day on D1, 3, 5, and 7. The remission rate after 1 cycle (28-35 days, depending on hematopoietic recovery), overall response rate, recurrence rate, EFS, hematologic toxicity, and infection rate of the MVHO protocol were evaluated. A total of 18 patients were enrolled (9 boys and 9 girls), with a median (range) age of 7.3 (4 months-13 years) years, and underwent a total of 27 cycles of the MVHO therapy. Half of the patients underwent 1 cycle and the other half underwent 2 cycles. Per French-American-British (FAB) classification criteria, patients had myelodysplastic syndrome (n = 2); mixed-phenotype acute leukemia (n = 2); and AML subtypes M7 (n = 4), M2 (n = 4), M5 (n = 4), M4 (n = 1), and M0 (n = 1). Efficacy results: The median (range) follow-up time was 131 (26-256) days. The objective response rate (CR + complete remission with incomplete hematological recovery [Cri] + partial response) was 83.3%, and the remission rate (CR + Cri) after 1 cycle was 72.2%. A total of 8 patients were minimum residual disease negative. For the 6 patients with relapsed AML, the remission rate after 1 cycle was 66.7%. A total of 3 patients discontinued because of no response or disease progression, and 12 patients underwent hematopoietic stem cell transplantation, after which 1 patient relapsed. The rate of recurrence was 6.7% (1/15). The 8-month mean (± SD) EFS was 60.1% (± 19%) and the OS was 100%. Safety results: Among the 26 cycles of treatment evaluated for toxicity, there were no associated fatal infections or bleeding events. Prophylactic levofloxacin and posaconazole were administered orally (or intravenously administered anti-infection treatment in the case of infection) during myelosuppression in each cycle. No breakthrough infection was observed in 5 of 26 cycles of MVHO. There was 1 case of septic shock, and the incidence of grade ≥ 3 infection was 80.7%, which included pneumonia and bloodstream infections. Common grade 4 TRAEs were neutropenia, which was experienced by 100% of patients, and grade 4 thrombocytopenia, which was experienced by 46.1% of patients. Platelets did not decrease to below 100,000/μL after 5 of 26 cycles of MVHO treatment. Conclusions: MVHO therapy was effective and reasonably well tolerated in pediatric patients with refractory or recurrent AML, suggesting that it may comprise a suitable first-line treatment option for pediatric patients with AML.

* Olverembatinib is an investigational drug that has not been approved for any indication outside the Chinese mainland

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK.

Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of 9 clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, Europe, and China. Ascentage Pharma has been designated for multiple Major National R&D Projects, including five Major New Drug Projects, one New Drug Incubator status, four Innovative Drug Programs, and one Major Project for the Prevention and Treatment of Infectious Diseases.

Olverembatinib, the company’s core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company’s first approved product, has been granted Priority Review Designations and Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug had been included into the China 2022 National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU. To date, Ascentage Pharma has obtained a total of 16 ODDs, 2 FTDs, and 2 Rare Pediatric Disease (RPD) Designations from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company’s investigational drug candidates.

Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships with numerous renowned biotechnology and pharmaceutical companies and research institutes such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, Dana-Farber Cancer Institute, MSD, and AstraZeneca. The company has built a talented team with global experience in the discovery and development of innovative drugs and is setting up its world-class commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.

Forward-Looking Statements

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

Source : ASH 2023 | For the Sixth Consecutive Year, Results from Multiple Clinical Studies of Olverembatinib Have Been Selected for Presentations, Including Two Oral Reports, at the 2023 ASH Annual Meeting

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SUZHOU, China, and ROCKVILLE, Md., Nov. 3, 2023 /PRNewswire/ — Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that results from three clinical studies of lisaftoclax (APG-2575), a key candidate drug in the Company’s pipeline, have been selected for presentations at the 65th American Society of Hematology (ASH) Annual Meeting, marking the second consecutive year in which clinical results of lisaftoclax were selected. This year, results from multiple clinical studies on two of Ascentage Pharma’s lead drug candidates (olverembatinib and lisaftoclax) have been selected for presentations at the ASH Annual Meeting.

Developed by Ascentage Pharma, lisaftoclax is an orally available Bcl-2 inhibitor with a wide therapeutic window in multiple hematologic malignancies and solid tumors. The investigational clinical data of lisaftoclax in patients with chronic lymphocytic leukemia (CLL), to be presented at the ASH Annual Meeting this year, once again demonstrate the drug’s efficacy and favorable tolerability in patients with CLL who were heavily pretreated and had prior exposure to BTK inhibitors. In two other abstracts on lisaftoclax, results were disclosed from clinical studies of the drug as a single agent and in combination regimens in multiple hematologic malignancies, including relapsed/refractory (R/R) multiple myeloma (MM) and acute myeloid leukemia (AML).

The ASH Annual Meeting is one of the largest gatherings of the international hematology community, bringing together the latest and most cutting-edge scientific research in the pathogenesis and clinical treatment of hematologic diseases. The 65th ASH Annual Meeting will take place on December 9-12, 2023, both online and in-person, in San Diego, CA (United States).

"Lisaftoclax is the first Bcl-2 inhibitor in China and the second globally that has demonstrated promising efficacy. Clinical results to be presented at the ASH Annual Meeting this year further validate the drug’s potential as an alternative treatment option for a number of hematologic malignancies, including R/R CLL," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "In addition, we will also present data of a few more clinical studies that will underscore our broad progress in new drug discovery and clinical development. Moving forward, we will continue to expeditiously advance our clinical development programs globally for the benefit of patients in China and around the world."

Studies of Ascentage Pharma’s Drug Candidates to be presented at ASH 2023.

Drug Candidate

Title

PI/Presenter

Institution

Abstract#

Format

Olverembatinib

（HQP1351）

Olverembatinib (HQP1351) Demonstrates Efficacy Vs. Best Available Therapy (BAT) in Patients (Pts) with Tyrosine Kinase Inhibitor (TKI)-Resistant Chronic Myeloid Leukemia Chronic-Phase (CML-CP) in a Registrational Randomized Phase 2 Study

Qian Jiang

Xiaojun Huang

The Peking University People’s Hospital

#869

Oral Report

Olverembatinib Combined with Venetoclax and Reduced-Intensity Chemotherapy for Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: Early results from a phase II study

Xiaoyuan Gong

Institute of Hematology and Blood Diseases Hospital, the Chinese Academy of Medical Sciences

#827

Oral Report

Update of Olverembatinib (HQP1351) Overcoming Ponatinib and/or Asciminib Resistance in Patients (Pts) with Heavily Pretreated/Refractory Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

Elias Jabbour

Hagop Kantarjian

MD Anderson Cancer Center

#1798

Poster

Presentation

Combination of Liposome Mitoxantrone, Venetoclax, Homoharringtonine, and Olverembatinib (HQP1351) (MVHO) in Pediatric Patients with Refractory or Recurrent Acute Myeloid Leukemia (AML): Case Series

Wenting Hu

Shuhong Shen

Department of Hematology & Oncology, Shanghai Children’s Medical Center of Shanghai Jiao Tong University School of Medicine

#2840

Poster

Presentation

Combination of Olverembatinib and VP Regimen As First-Line Therapy for Adult Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Gaixiang Xu

Jie Jin

The First Affiliated Hospital, Zhejiang University School of Medicine

#4205

Poster

Presentation

Olverembatinib(HQP1351)-Based Therapy in Adults with Relapsed or Refractory Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Advanced Chronic Myeloid Leukemia: Results of the Real-Life Study

Na Xu

Nanfang Hospital of Southern Medical University

#4538

Poster

Presentation

Frontline Combination of 3 Generation TKI Olverembatinib and Blinatumomab for Ph+/Phlike ALL Patients

Hongsheng Zhou

Nanfang Hospital of Southern Medical University

#1504

Poster

Presentation

Lisaftoclax

APG-2575

Updated Efficacy and Safety Results of Lisaftoclax (APG-2575) in Patients (pts) with Heavily Pretreated Chronic Lymphocytic Leukemia (CLL): Pool Analysis of Two Clinical Trials

Keshu Zhou

Jianyong Li

Jianxiang Wang

Henan Cancer Hospital,

Jiangsu Province Hospital

Institute of Hematology and Blood Diseases Hospital, the Chinese Academy of Medical Sciences

#1900

Poster

Presentation

Safety and Efficacy of Lisaftoclax (APG-2575), a Novel BCL-2 Inhibitor (BCL-2i), in Relapsed or Refractory (R/R) or Treatment-Naïve (TN) Patients (Pts) with Acute Myeloid leukemia (AML), Myelodysplastic Syndrome (MDS), or Other Myeloid Neoplasms

Huafeng Wang

Jie Jin

The First Affiliated Hospital, Zhejiang University School of Medicine

#2925

Poster

Presentation

First Report on the Effects of Lisaftoclax (APG-2575） in Combination with Novel Therapeutic Regimens in Patients with Relapsed or Refractory Multiple Myeloma (R/R MM） or Immunoglobulin Light-Chain (Amyloid Light-Chain [AL]） Amyloidosis

Sikander Ailawadhi

Asher A. Chanan-Khan

Mayo Clinic

#2016

Poster

Presentation

The abstracts of lisaftoclax presented at the 2023 ASH Annual Meeting are as follows (for details on the abstracts featuring olverembatinib, please refer to a separate press release published at the same time):

Updated Efficacy and Safety Results of Lisaftoclax (APG-2575) in Patients (pts) with Heavily Pretreated Chronic Lymphocytic Leukemia (CLL): Pool Analysis of Two Clinical Trials

Format: Poster Presentation
Abstract: #1900
Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I
Time: Saturday, December 9, 2023, 5:30 PM – 7:30 PM (Pacific Time) / Sunday, December 10, 2023, 9:30 AM – 11:30 AM (Beijing Time)

Highlights:

This abstract reported updated data from long-term follow-ups in two Phase 1b/2 studies of lisaftoclax (APG-2575-CN001 [NCT03913949] and APG-2575-CC101 [NCT04494503]) in patients with CLL.

In the 2 studies, lisaftoclax was administered orally once daily in 28-day cycles, in 100 mg, 200 mg, 400 mg, 600 mg, and 800 mg dose cohorts. Under close monitoring for prevention and early detection of tumor lysis syndrome (TLS), patients were treated (with a daily dose ramp-up schedule) until disease progression, intolerable toxicity, death, or any other reason for termination.

As of April 27, 2023, a total of 47 patients with CLL were enrolled. The median (range) duration of follow-up was 14.06 (0.70-30.2) months. The median (range) age was 58 (34-80) years. At enrolment, 53.2% of patients were in Rai stage III/IV, and 48.9% of patients were in Binet stage C. 44.7% of patients had received ≥3 lines of treatment; 66.0% of patients had received ≥2 lines of treatment; 23.4% of patients were treated with Bruton tyrosine kinase inhibitors (BTKis); and 55.3% were treated with a CD20 monoclonal antibody. 68.1% (32) of patients discontinued the study due to disease progression (51.1%), consent withdrawal (6.4%), adverse events (AEs) (2.1%), investigator’s decision (2.1%), poor compliance (2.1%), protocol deviation (2.1%), and other reasons (2.1%).

The overall response rate (ORR) in patients with CLL was 73.3% (33/45), and the complete response (CR)/incomplete hematological recovery (Cri) rate was 24.4% (11/45).

In total, 76.6% (36) of patients experienced grade ≥3 treatment-emergent adverse events (TEAEs); 27.7% (13) experienced serious AEs (SAEs). Treatment-related adverse events (TRAEs) were observed in 95.7% (45) of patients, of whom 68.1% (32) experienced grade ≥3 TRAEs and 14.9% (7) experienced SAEs. One incident of TLS was reported.

Conclusions: Lisaftoclax demonstrated significant efficacy and favorable tolerability in patients with CLL who were heavily pretreated and had prior exposure to BTKis.

Safety and Efficacy of Lisaftoclax (APG-2575), a Novel BCL-2 Inhibitor (BCL-2i), in Relapsed or Refractory (R/R) or Treatment-Naïve (TN) Patients (Pts) with Acute Myeloid leukemia (AML), Myelodysplastic Syndrome (MDS), or Other Myeloid Neoplasms

Format: Poster Presentation
Abstract: #2925
Session: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II
Time: December 10, 2023, Sunday, 6:00 PM – 8:00 PM (Pacific Time) / December 11, 2023, Monday, 10:00 AM – 12:00 PM (Beijing Time)

Highlights:

This multicenter, open-label, Phase 1 study in China evaluated the efficacy and safety of lisaftoclax alone or combined with azacitidine (AZA) or homoharringtonine (HHT) in patients with treatment-naïve or R/R AML, MDS, or other myeloid neoplasms.

Trial design:
In part one, lisaftoclax as a single agent was orally administered once daily at 200, 400, 600, or 800 mg, using a "3+3" dose escalation design. In part two, patients with R/R AML, mixed-phenotype acute leukemia (MPAL), blastic plasmacytoid dendritic cell neoplasm (BPDCN), or chronic myelomonocytic leukemia (CMML) were enrolled in Cohorts A, B, and C; while patients with higher-risk MDS were enrolled in Cohort D; and older or chemotherapy-ineligible (unfit) patients with treatment-naïve AML were enrolled in Cohort E. Lisaftoclax was administered orally once daily in 28-day cycles (or 14-day cycles for patients with MDS). A daily ramp-up schedule was adopted to prevent TLS. Cohort A was treated with lisaftoclax combined with low-dose HHT (1 mg daily on days [d] 1-14); Cohort B was treated with lisaftoclax combined with standard-dose HHT (2 mg/m2 daily on d1-7); Cohort C, D, E were treated with lisaftoclax combined with AZA (75 mg/m2 daily on d1-7). Dose-limiting toxicity (DLT) was assessed during the first cycle.

As of July 19, 2023, a total of 115 patients were enrolled, including 89 patients with AML (64 R/R; 25 TN older/unfit), 22 with MDS (7 R/R MDS; 15 TN MDS), 2 MPAL, 1 CMML, and 1 BPDCN. A total of 13 patients received lisaftoclax monotherapy and 102 patients received combination regimens.

Efficacy results: In patients treated with lisaftoclax monotherapy, the ORR and composite remission rate (CRc=complete remission [CR] + CR with incomplete blood count recovery [CRi]) were each 8.3% (1/12). Lisaftoclax at 600 mg and 800 mg were chosen as exploratory doses for combination therapies. Among the 21 efficacy evaluable patients with TN AML in Cohort E, the ORR and CRc were 71.4% and 47.6%, respectively. Among the 36 efficacy evaluable patients with R/R AML or myeloid neoplasm in Cohort C, the ORR and CRc were 75.0% and 44.4%, respectively. The progression-free survival (PFS) was 10.22 months. Among patients in Cohort B, the ORR and CRc were both 75.0%. Among patients in Cohort D, the ORR was 70.0%, the CR/marrow CR rate was 60.0%。

Safety results: Common TEAEs included hematologic toxicity, electrolyte imbalances, and diarrhea. No TLS was reported during the study and dose-limiting toxicities (DLTs; pneumonia, respiratory failure, and heart failure) were observed in 1 patient in Cohort C. 13 patients who received lisaftoclax monotherapy experienced TEAEs and grade ≥3 TEAEs, and 4 (30.8%) patients experienced SAEs. In patients treated with lisaftoclax combined with HHT, 12 (85.7%) experienced TEAEs and grade ≥3 TEAEs, and 2 (14.3%) experienced SAEs. In the 75 patients treated with lisaftoclax combined with AZA, 100% of patients experienced TEAEs, including 55 (73.3%) who experienced grade ≥3 TEAEs and 18 (24.0%) SAEs.

Increased systemic exposure of lisaftoclax was discerned as the dosage escalated from 200 mg to 800 mg. Compared to lisaftoclax monotherapy, no significant difference was observed in the pharmacokinetic profile of lisaftoclax combined with AZA or HHT.

Conclusions: Lisaftoclax, in monotherapy or combination regimens, showed encouraging efficacy and favorable tolerability profiles in patients with R/R AML or MDS and older/unfit patients with TN AML.

First Report on the Effects of Lisaftoclax (APG-2575） in Combination with Novel Therapeutic Regimens in Patients with Relapsed or Refractory Multiple Myeloma (R/R MM） or Immunoglobulin Light-Chain (Amyloid Light-Chain [AL]） Amyloidosis

Format: Poster Presentation
Abstract: #2016
Session: 653. Multiple Myeloma: Prospective Therapeutic Trials: Poster I
Time: December 9, 2023, Saturday, 5:30 PM – 7:30 PM (Pacific Time) / December 10, 2023, Sunday, 9:30 AM – 11:30 AM (Beijing Time)

Highlights:

This multicenter study was designed to evaluate the safety and efficacy of lisaftoclax combination regimens in patients with R/R MM or R/R AL amyloidosis. This study has three treatment arms that included Arm A: lisaftoclax combined with pomalidomide and dexamethasone in patients with R/R MM; Arm B: lisaftoclax combined with daratumumab, lenalidomide, and dexamethasone in patients with R/R MM; and Arm C: lisaftoclax combined with pomalidomide and dexamethasone in patients with R/R amyloidosis. Lisaftoclax was administered orally once daily (QD) at 5 dose levels (400 mg, 600 mg, 800 mg, 1,000 mg, and 1,200 mg) without ramp-up in 28-day cycles. Pomalidomide, daratumumab, and lenalidomide were administered per label use. Dexamethasone 40 mg (20 mg for patients aged >75 years) was administered on Days 1, 8, 15, and 22 of 28-day cycles. As of July 3, 2023, a total of 30 patients were enrolled. Among them, 22, 3, and 5 patients were enrolled into Arms A, B, and C, respectively. 66.7% of patients were male and the median (range) age was 70.5 (24-88) years. All patients were previously exposed to multiple lines of treatment, with a median (range) line of prior therapies of 4 (1-19). 18 patients were triple-class-exposed, including 7 who had received pomalidomide and 3 who harbored the t(11;14) chromosomal abnormality. Safety results: A total of 19 patients experienced lisaftoclax treatment related AEs, including nausea (16.7%), neutropenia (16.7%); thrombocytopenia, leukopenia, abdominal distension, constipation, or diarrhea (6.7% each). A total of 7 patients experienced grade ≥3 TRAEs, including neutropenia (10.0%), febrile neutropenia (3.3%), iron deficiency anemia (3.3%), thrombocytopenia (3.3%), prolonged electrocardiogram QT interval (3.3%), and acute kidney injury (3.3%). Two patients experienced lisaftoclax-related SAEs, including 1 acute kidney injury and 1 febrile neutropenia. Efficacy results: In Arm A, 21 patients with R/R MM were efficacy evaluable, with an ORR (partial response [PR] + very good partial response [VGPR]) of 66.7%. In Arm B, 1 patient with R/R MM achieved PR and another achieved VGPR. In Arm C, 3 patients with R/R amyloidosis achieved a hematologic VGPR. The ORR was 60% and 1 patient experience organ function improvement. Conclusions: Lisaftoclax combination regimens were well tolerated and demonstrated potent antitumor activity in patients with R/R MM and R/R amyloidosis.

* Lisaftoclax (APG-2575) is an investigational drug that has not been approved in any country and region.

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK.

Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of 9 clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, Europe, and China. Ascentage Pharma has been designated for multiple Major National R&D Projects, including five Major New Drug Projects, one New Drug Incubator status, four Innovative Drug Programs, and one Major Project for the Prevention and Treatment of Infectious Diseases.

Olverembatinib, the company’s core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company’s first approved product, has been granted Priority Review Designations and Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug had been included into the China 2022 National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU. To date, Ascentage Pharma has obtained a total of 16 ODDs, 2 FTDs, and 2 Rare Pediatric Disease (RPD) Designations from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company’s investigational drug candidates.

Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships with numerous renowned biotechnology and pharmaceutical companies and research institutes such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, Dana-Farber Cancer Institute, MSD, and AstraZeneca. The company has built a talented team with global experience in the discovery and development of innovative drugs and is setting up its world-class commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.

Forward-Looking Statements

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

Source : ASH 2023 | Ascentage Pharma to Present Results from Three Clinical Studies of Bcl-2 Inhibitor Lisaftoclax (APG-2575), Including the First Data in AML and MM

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PASIG, Philippines, Nov. 3, 2023 /PRNewswire/ — Banking Innovation trailblazer Union Bank of the Philippines (UnionBank) recently achieved another first in the industry after securing a Certificate of Authority from the Bangko Sentral ng Pilipinas (BSP) to operate as a virtual asset service provider (VASP). This makes UnionBank the first and only universal bank in the Philippines, licensed to offer virtual asset exchange services. UnionBank celebrated the landmark achievement during the ceremonial presentation of the license to UnionBankers last September 27 at UnionBank Plaza in Pasig City.

Unveiling the VASP license from the BSP: UnionBank Chief Financial Officer, Manuel R. Lozano; UnionDigital CEO and President, Henry R. Aguda; UnionBank President and CEO, Edwin R. Bautista; UnionBank Emerging Technology Group Head, Catherine Anne B. Casas; UnionBank Vice Chairman, Dr. Justo A. Ortiz; UnionBank Chief Technology and Operations Officer, Dennis D. Omila; UnionBank Treasurer and Head of Global Markets, Johnson L. Sia; UnionBank Chief Cross-Sell Officer, Antonio Sebastian T. Corro

With the VASP license, UnionBank will be able to tap into new markets and opportunities, explore new ways of addressing evolving client needs like never before, and remain at the forefront of technological advancements ensuring its competitiveness in the digital financial space. Together with its commitment to innovation, regulatory compliance, and customer-centricity, the license enables the Bank to become more future-ready, ready to serve and lead in an evolving financial landscape.

The adoption of blockchain technology has been integral to UnionBank’s future-proofing strategy, and the Bank has been actively exploring potential use cases, including cryptocurrencies, to adapt to evolving customer needs and financial trends. In 2019, the Bank launched the country’s first bank-operated, two-way virtual currency ATM located in its digital branch "The ARK" in Makati City, which allows users to buy and sell cryptocurrencies.

Drawing upon the insights gained from the virtual asset ecosystem, the Bank can discover additional applications for blockchain technology that extend beyond virtual assets.  Through exploring various possibilities such as tokenized collaterals, tokenized deposits, and the implementation of tokenization in trade finance and supply chain financing, blockchain technology has the potential to revolutionize customary banking processes, thereby bolstering efficiency, transparency, and accessibility.

"This is a testament to the pioneering effort of the [Emerging Technology] team and the spirit of innovation by UnionBank," said UnionDigital Bank President and CEO Henry Aguda during the ceremony. "Strategically, this will pay off in the next coming years especially when a lot of investors are going into blockchain and tokenization."

"With this license, we’re ready to once again break molds, set trends, and rewrite the rules," said UnionBank Senior Vice President and Head of Emerging Technology Group Cathy Casas. "This is exactly what innovation is about—pushing boundaries, venturing into the unknown, courageously stepping into territories that are yet to be explored, and taking on challenges that others may not fully comprehend."

The license will also help strengthen the Bank’s focus on customer-centricity, especially its ability to provide innovative solutions that enhance its clients’ overall financial well-being. In addition, the Bank’s expanded offerings through the license can provide clients with more comprehensive financial experiences, covering a broader range of financial services powered by blockchain, such as lending, cross-border payments, and other smart contract-based financial products.

"This is a call for laser focus on the target only we see, and through the twists and turns and ups and downs of these avenues, we shall persist and persevere with our one North Star, which is to elevate lives and fulfill dreams," said UnionBank Vice Chairman Dr. Justo A. Ortiz.

The VASP license positions the Bank as a responsible player in the digital finance ecosystem, particularly in terms of surveillance and compliance. UnionBank’s focus on surveillance is not merely a regulatory requirement but a commitment to maintaining the trust of clients and of the industry as robust surveillance mechanisms help ensure the legitimacy of virtual assets and prevent illicit activities. The Bank’s dedication to complying with regulatory standards and working proactively with the BSP to shape the future of digital finance in the Philippines can serve as an example for others to emulate.

"This achievement underscores the importance of doing something that’s never been done before, not being reckless, and most of all, daring to be bold, not being afraid to go there," said UnionBank Executive Vice President and Chief Technology and Operations Officer Dennis Omila highlighting that the Bank’s obtaining a license is relevant for the entire banking industry.

Through the milestone, UnionBank sets new standards and redefines what it means to be a bank in the digital age through collaborations and partnerships that define progress for a brighter future. The initiative aligns with the Bank’s "Tech-Up Pilipinas" advocacy, aimed at advancing digital literacy among Filipinos and enhancing financial inclusion and technological empowerment in the country.

Source : UnionBank Makes History as BSP-Authorized Provider of Virtual Asset Services in the Philippines

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HONG KONG, Nov. 3, 2023 /PRNewswire/ — FWD Group Holdings Limited (“FWD Group” or “FWD”) today announced new business highlights[1] for the nine months ended 30 September 2023.

New business sales grew 22 percent[2] to US$1,253 million. Value of new business increased to US$724 million, up 21 percent compared to the same period in 2022.

Huynh Thanh Phong, Group Chief Executive Officer and Executive Director of FWD Group, said, “In our 10th anniversary year, we’re very pleased to post another quarter of robust double digit new business growth. It’s a clear sign that our digitally enabled model and commitment to put customers at the heart of everything we do is working.”

The new business results reflect the continued recovery in Hong Kong SAR & Macau SAR, with the return of Mainland Chinese visitors. Thailand & Cambodia posted strong growth in value of new business, particularly through the agency channel. The Emerging Markets segment also posted very strong value of new business growth excluding Vietnam, where the market remains disrupted. In Japan, consistent with FWD’s strategy to focus on the individual protection business, its corporate owned life insurance business continued to reduce and has now largely run off.

 “FWD is well-positioned for the expanding insurance sector in Asia, against the backdrop of growing middle classes and digital adoption. Looking ahead, we’ll continue to play our part in bridging the large protection gap in the region,” added Huynh Thanh Phong.

Over the three-year period ended 2022[3], FWD Group expanded its value of new business at a compound annual growth rate of 33 percent.

– End-

About FWD Group

FWD Group is a pan-Asian life insurance business with more than 11 million customers across 10 markets, including some of the fastest-growing insurance markets in the world. FWD reached its 10-year anniversary in 2023. The company is focused on making the insurance journey simpler, faster and smoother, with innovative propositions and easy-to-understand products, supported by digital technology. Through this customer-led approach, FWD is committed to changing the way people feel about insurance.

For more information, please visit www.fwd.com

[1] New business sales are measured in annual premium equivalent (APE) terms, representing the sum of 10% of single premiums and 100% of annualised first year premiums for all new policies, before reinsurance ceded. Value of new business (VNB) is present value, measured at point of sale, of future net-of-tax profits on a local statutory basis less the corresponding cost of capital. VNB is calculated quarterly, based on assumptions applicable at the start of each quarter.
[2] All growth rates are represented on a constant exchange rate basis.
[3] Value of new business growth for FWD in 2019-22 excludes contribution from corporate owned life insurance and retrocession reinsurance in Japan.

Source : FWD Group announces robust growth momentum in new business highlights

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SINGAPORE, Nov. 3, 2023 /PRNewswire/ — Treehouse, a Web3 company transforming digital assets data into actionable insights for professional investors and institutions, announced the intellectual property (IP) acquisition of Origins Analytics to bolster its non-fungible token (NFT) product offering.

Treehouse acquires Origins Analytics to foray into NFT analytics

Origins, an enterprise-grade NFT analytics platform, raised US$4M in 2022 and had a robust community of 10,000+ users. The company’s software utilizes both on- and off-chain data to enable experienced NFT traders, protocols, and game studios to make informed decisions.

With this acquisition, Origins’ founding team will join Treehouse to integrate Origins’ technology into its product suite, offering Treehouse clients access to popular tools such as:

AlphaStream: A live algorithmically tagged NFT wallet notification system NFT Analytics Bots: Command-based generated NFT market analytics NFT Wallet Profiling Application Programming Interface (API).

These tools will help Hyperion users understand and analyze NFT trading volumes, social sentiment, holder behavior, and more to make better NFT trading and collector decisions.

The acquisition comes amidst a bear market and increasing consolidation in the space—a testament to Treehouse’s commitment to Web3 analytics. The firm last raised US$18M in its seed round in 2021 from leading venture capital (VC) and strategic investors, including Lightspeed, MassMutual, Binance, Mirana, LeadBlock, Jump, GSR, Wintermute, and more. With a strong balance sheet, the company is currently assessing mergers and acquisitions (M&A) opportunities in its mission to become "The Most Comprehensive Digital Asset Analytics Platform."

"Treehouse is excited to make this move into NFT analytics. This strategic acquisition underscores our commitment to our clients, many of whom have NFT exposures. Our team is gearing up to integrate Origins’ system into our flagship product, Hyperion, confident that its technology aligns with our users’ needs and paves the way for us to serve the wider NFT community. Despite the bear market, Treehouse is expanding and is actively looking to acquire synergetic businesses,” said Brandon Goh, CEO of Treehouse.

David Toh, Partner at Mirana Ventures, said, "We are proud to support Treehouse in their mission to lay the foundation for deep analytics for the future of a connected, interoperable, and increasingly complex Web3 ecosystem. The combination of Treehouse’s flagship platform, Hyperion, and Origins’ will be game-changing for the industry."

About Treehouse

Treehouse is a digital assets data firm focused on institutional-grade portfolio, protocol, and market analytics. The company is headquartered in Singapore and backed by traditional VC and Web3 firms such as Mirana Ventures, Lightspeed, MassMutual Ventures, Binance, LeadBlock Partners, Global Founders Capital, Jump Capital, Wintermute, GSR, Coinhako, Bitpanda, Pintu, AlphaLab Capital, Pulsar Trading, Portofino, senior executives from the SoftBank Vision Fund, and more.

Hyperion, the company’s flagship product is the most comprehensive portfolio management and markets intelligence platform that provides institutional investors and professional traders with full control of their digital assets. Featuring a selection of 30+ portfolio and market widgets for personalized dashboard visualizations, the platform redefines how finance professionals monitor movements in the cryptocurrency space and analyze their portfolio risk and performance.

Visit www.treehouse.finance to learn more about Treehouse.

Brand Kit

Refer to the Treehouse Brand Kit for the company’s cover images and logo variants.

Social Media Channels

Twitter: @TreehouseFi
Discord: https://discord.gg/ufxhSgxBNF
Telegram Community: @treehousefi
Telegram Insights: @treehouseinsights
LinkedIn: Treehouse

Source : Treehouse Acquires Origins to Expand Into NFT Analytics

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JIASHAN, China, Oct. 31, 2023 /PRNewswire/ — Makato Inoue, President & CEO of NExT-e Solutions Inc., accompanied by senior representatives from Tokyo Electric Power, recently toured BatteroTech Co., Ltd, a world-leading lithium-ion battery manufacturer. The visit was warmly welcomed by Dr. Zhong Kaifu, CEO of BatteroTech, Dr. Huang Haining, Director of Battery R&D, and their executive team.

Makato Inoue, president of NExT-e Solutions Inc., accompanied by representatives from Tokyo Electric Power, visited BatteroTech’s state-of-the-art automated production facility and digital showroom. BatteroTech’s team provided an in-depth presentation on the company’s history, product offerings, and strategic growth initiatives.

Dr. Zhong Kaifu began the day’s discussion by warmly welcoming Makato Inoue, president of NExT-e Solutions Inc. and the Tokyo Electric Power delegation. He emphasized BatteroTech’s focus on strategic expansion into overseas markets as a key initiative for the company’s growth. Dr. Zhong expressed optimism about the opportunities for cooperation between the two companies in advancing renewable energy solutions.

During the discussion, Dr. Huang, the Battery R&D director, detailed the company’s flagship products: the 314Ah battery and the 280Ah long-life battery. He presented the innovative methodologies and data behind them. The 314Ah battery, notable for its high energy, longevity, and safety features, represents the next trend in high-capacity energy storage. It boasts a revolutionary chemical design, ensuring a lifespan of over 20 years at 80% End of Life (EOL). Furthermore, it retains over 95% efficiency in its first year, even with daily cycling, offering a marked improvement in user experience. Emphasizing its commitment to safety, BatteroTech consistently blends this with their pursuit of cutting-edge innovation.

President Inoue and the leadership team from Tokyo Electric Power placed significant emphasis on longevity and safety concerns. Notably, BatteroTech’s 314Ah battery has passed the industry’s most stringent safety evaluations.

During the meeting, Makato Inoue, president of NExT-e Solutions Inc. lauded BatteroTech for its state-of-the-art smart factory. He also commended the BatteroTech team for its swift growth and exceptional technical expertise within the industry. Upon gaining a comprehensive insight into BatteroTech’s technological prowess, product superiority, and the industrial synergies presented by Tsingshan Holdings, President Inoue articulated a heightened enthusiasm for an intensified collaboration between the two entities in the future.

For more information, please visit BatteroTech’s official website: https://en.batterotech.com/.

Founded in July 2020, BatteroTech Co., Ltd. (hereinafter referred to as "BatteroTech") is a world leading lithium-ion battery manufacturer dedicated in the new energy industry which invested by Tsingshan Holding Group Co., Ltd. (a Fortune 500 corporation).

BatteroTech has products from Li-ion battery cell, battery modules, battery systems, etc. with strong expertise of R&D, production know-how in house. BatteroTech offers the cutting-edge solutions and first-class services for the new energy automobile manufacturers and smart energy investors globally, which support them to achieve the goal of "Carbon Peaking Emission and Carbon Neutrality". Currently BatteroTech has both R&D and manufacturing Center in Shanghai and Jiashan, Zhejiang Province.

Source : NExT-e Solutions President and Tokyo Electric Power Leadership Tour BatteroTech's Advanced Facilities, Eyeing Future Collaboration

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SHANGHAI, Nov. 3, 2023 /PRNewswire/ — A total of 154 countries, regions and international organizations have confirmed their participation in the sixth edition of China International Import Expo (CIIE), which will take place from Nov 5 to 10 in Shanghai.

The National Exhibition and Convention Center (Shanghai), the main venue for the China International Import Expo (CIIE), in East China’s Shanghai.

As the world’s first national-level import-themed trade fair, the CIIE will once again comprise a business exhibition, a country exhibition, the Hongqiao International Economic Forum, a number of supporting activities as well as people-to-people cultural exchange events.

This year’s Business Exhibition will feature 289 of the world’s top 500 enterprises and industry giants, including the world’s top 15 automotive brands, top 10 industrial electrical companies, top 10 medical device companies, three major mining giants, four major grain traders and five major shipping companies. Some 1,500 small and medium-sized enterprises (SMEs) will also be showcasing their products at the event.

Over 400 new products, technologies and services will be presented at the six exhibition areas — Food and Agricultural Products, Intelligent Industry and Information Technology, Medical Equipment and Healthcare Products, Consumer Goods, Trade in Services, and Automobiles, said Sheng.

The sixth CIIE will again feature the physical Country Exhibition. Eleven countries, including Bahrain, Central African Republic, the Commonwealth of Dominica, Gambia, Guinea-Bissau, Honduras, Mali, Oman, Sierra Leone, Togo and Zimbabwe will attend the Country Exhibition for the first time. Honduras, Kazakhstan, Serbia, South Africa and Vietnam are this year’s guest countries of honor.

In line with the tenth anniversary of the Belt and Road Initiative (BRI), many countries involved in the initiative are set to be a part of the expo. Sixty-four BRI countries will join the Country Exhibition and over 1,500 companies from BRI countries will be present at the Business Exhibition, which occupies an exhibition area of nearly 80,000 square meters, an increase of about 30 percent compared with the previous edition.

The CIIE has also encouraged the least developed countries (LDCs) involved in the BRI to introduce their premium products to the Chinese market by offering free booths, construction subsidies and tax incentives.

As an integral part of the CIIE, this year’s Hongqiao International Economic Forum will focus on global openness, green development, digital economy and smart technologies.

Some parallel sessions will be co-hosted by international organizations, including the United Nations Conference on Trade and Development (UNCTAD), the United Nations Development Programme (UNDP), the United Nations Industrial Development Organization (UNIDO), International Trade Center (ITC), the United Nations Global Compact and more.

Nobel laureates, Turing Award winners, and a host of high-profile entrepreneurs will take part in several sub-forums and share their insights into global issues. Authoritative reports, including the World Openness Report 2023, will also be released during the forum.

Exhibitor application for the 7th CIIE is now open. Join us and reap your benefits at CIIE 2023 & CIIE 2024 where opportunities await! https://www.ciie.org/exhibition/f/book/register?local=en&from=press

Contact：Ms. Cui Yan
Tel.：0086-21-968888

Email: [email protected]
Website：http://www.ciie.org/zbh/en/
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Source : The Sixth CIIE is ready to welcome the world

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