Core Viewpoint - Ascentage Pharma has received FDA and EMA clearance for the GLORA-4 study, a Phase III trial for lisaftoclax in combination with azacitidine for treating higher-risk myelodysplastic syndrome (HR-MDS), marking a significant step towards addressing unmet medical needs in this area [1][2][3] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on developing novel therapies for cancer, with a strong pipeline that includes innovative drug candidates targeting key proteins in the apoptotic pathway [11][12] Study Details - The GLORA-4 study is a global, multi-center, randomized, double-blind Phase III trial designed to evaluate the efficacy and safety of lisaftoclax combined with azacitidine compared to placebo plus azacitidine in newly diagnosed adult patients with HR-MDS [3][4] - This study is the second registrational Phase III trial for lisaftoclax to receive clearance from both the FDA and EMA, with simultaneous patient enrollment across multiple countries [2][3] Clinical Need - There is a significant unmet clinical need for targeted therapies in first-line treatment for higher-risk MDS, as current options like hypomethylating agents (HMA) and allogeneic hematopoietic stem cell transplantation (allo-HSCT) have limitations [3][5] - The overall response rate (ORR) for HMAs is only 30-40%, with a complete response (CR) rate of 10-17%, highlighting the urgent need for innovative therapies [5][9] Clinical Data - Earlier studies of lisaftoclax in combination with azacitidine showed an ORR of 75%, significantly higher than HMAs alone, with a favorable safety profile and low incidence of severe hematologic toxicities [8][9] - The combination therapy demonstrated a low requirement for dose adjustments and no treatment-related mortalities within 60 days, indicating its potential as a superior treatment option [8][9] Expert Commentary - Experts emphasize the challenges in treating higher-risk MDS due to the limited efficacy of current therapies and the absence of breakthrough treatments in the last two decades, underscoring the importance of the GLORA-4 study [9][10]

Core Viewpoint - Ascentage Pharma has received FDA and EMA clearance for the GLORA-4 study, a Phase III trial of lisaftoclax in combination with azacitidine for treating higher-risk myelodysplastic syndrome (HR-MDS), marking a significant step towards addressing unmet medical needs in this area [1][2][3] Company Overview - Ascentage Pharma is a global, commercial stage biopharmaceutical company focused on developing novel therapies for cancer [1][11] - The company has a robust pipeline that includes innovative drug candidates targeting key proteins in the apoptotic pathway [12][14] Study Details - The GLORA-4 study is a global, multi-center, randomized, double-blind Phase III trial designed to evaluate the efficacy and safety of lisaftoclax combined with azacitidine compared to placebo plus azacitidine in newly diagnosed adult patients with HR-MDS [3][4] - This study is notable as it is the second registrational Phase III study of lisaftoclax to receive clearance from both the FDA and EMA [2][3] Clinical Need - There is a significant unmet clinical need for targeted therapies in first-line treatment of higher-risk MDS, as current options like hypomethylating agents (HMA) and allogeneic hematopoietic stem cell transplantation (allo-HSCT) have limitations [3][5][9] - The overall response rate (ORR) for HMAs is only 30-40%, with a complete response (CR) rate of 10-17%, highlighting the need for more effective treatments [5][9] Lisaftoclax Profile - Lisaftoclax is a proprietary, orally administered Bcl-2 selective inhibitor that has shown promising clinical benefits and tolerability in earlier studies [6][8] - The drug is already approved in China for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have received prior systemic therapy [7][14] Clinical Data - Clinical data presented at major conferences indicated an ORR of 75% for the combination of lisaftoclax and azacitidine in treatment-naïve MDS, significantly higher than HMAs alone [8] - The combination therapy demonstrated a favorable safety profile with low incidence of severe hematologic toxicities [8][9] Global Collaboration - The GLORA-4 trial is being co-led by prominent researchers from leading institutions, including The University of Texas MD Anderson Cancer Center and Peking University [3][4]

Core Insights - Ascentage Pharma Group International is participating in the Evercore China Biotech Summit from August 19 to 21, 2025, in Shanghai, China [1][2] - The company is focused on addressing unmet medical needs in cancers and has developed a pipeline of innovative drug candidates [3] Company Overview - Ascentage Pharma is a global biopharmaceutical company with a rich pipeline targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [3] - The lead asset, olverembatinib, is the first third-generation BCR-ABL1 inhibitor approved in China for specific types of chronic myeloid leukemia (CML) and is included in the China National Reimbursement Drug List [4] - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor recently approved for treating relapsed and/or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) [5] Clinical Trials and Research - Ascentage Pharma is conducting several global registrational Phase III trials for olverembatinib and lisaftoclax, targeting various patient populations and conditions [4][5] - The company has established partnerships with leading biotechnology and pharmaceutical companies, enhancing its research and development capabilities [6]

Core Viewpoint - Ascentage Pharma Group International has successfully completed an offshore placement of 22 million ordinary shares, raising approximately HKD1,492 million (around US$190.1 million) to support its commercialization and global clinical development efforts in the biopharmaceutical sector [1][2]. Group 1: Offshore Placement Details - The offshore placement involved the sale of 22 million ordinary shares at a price of HKD68.60 per share, with the shares representing approximately 6.29% of the company's issued share capital prior to the placement [1]. - The net proceeds from the placement will be utilized for commercialization efforts, global clinical development of core pipeline candidates, and strengthening global operations [2]. Group 2: Regulatory and Transactional Aspects - The offshore placement was conducted outside of the United States and was not offered to the public, complying with Regulation S under the Securities Act of 1933 [3]. - The Replacement Shares will be issued in a transaction not involving a public offering, and the securities have not been registered under the Securities Act [3]. Group 3: Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancers, with a rich pipeline of innovative drug candidates targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [5]. - The lead asset, olverembatinib, is a third-generation BCR-ABL1 inhibitor approved in China for specific types of chronic myeloid leukemia (CML) and is currently undergoing global registrational Phase III trials [6]. - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor recently approved for the treatment of relapsed and/or refractory chronic lymphocytic leukemia (CLL) and is involved in multiple global registrational Phase III trials [7].

Core Viewpoint - Ascentage Pharma Group International has successfully completed an offshore placement, raising approximately HKD1,492 million (around US$190.1 million) to support its commercialization efforts and global clinical development [1][2]. Group 1: Offshore Placement Details - The company closed an offshore placement involving the sale of 22 million ordinary shares at HKD68.60 per share, with the shares representing about 6.29% of the company's issued share capital prior to the placement [1]. - The vendor, an affiliate of the CEO, will subscribe for the same number of new shares at the same price, resulting in net proceeds for the company [1]. - The issuance of the new shares is expected to occur by July 28, 2025 [1]. Group 2: Use of Proceeds - The net proceeds from the offshore placement will be utilized for commercialization efforts, enhancing patient access, advancing global clinical development of core pipeline candidates, and strengthening global operations through infrastructure and working capital [2]. Group 3: Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancer treatment, with a robust pipeline of innovative drug candidates [5]. - The lead asset, olverembatinib, is a third-generation BCR-ABL1 inhibitor approved in China for specific types of chronic myeloid leukemia (CML) [6]. - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor recently approved for treating relapsed and/or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) [7].

Core Viewpoint - Ascentage Pharma Group International Inc. has announced the pricing of an offshore placement of 22 million ordinary shares, raising approximately HKD1,509.2 million (around US$192.3 million) to support its commercialization and global clinical development efforts in cancer treatments [1][3]. Group 1: Offshore Placement Details - The placement shares are priced at HKD68.60 per share and the offering was oversubscribed by eight times, with the transaction expected to close on July 17, 2025 [1][2]. - The vendor, an affiliate of the CEO, will subscribe for 22 million new ordinary shares at the same price, subject to customary closing conditions [2]. Group 2: Use of Proceeds - The net proceeds from the offshore placement will be utilized for commercialization efforts, enhancing patient access, advancing global clinical development of core pipeline candidates, and strengthening global operations through infrastructure and working capital [3]. Group 3: Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancers, with a pipeline that includes innovative drug candidates targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [6]. - The lead asset, olverembatinib, is approved in China for treating specific types of chronic myeloid leukemia (CML) and is undergoing global registrational Phase III trials [7]. - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor recently approved for treating relapsed and/or refractory chronic lymphocytic leukemia (CLL) and is involved in multiple global registrational Phase III trials [8][9].

Core Viewpoint - Ascentage Pharma Group International Inc. is conducting an offshore placement of ordinary shares to raise funds for commercialization, clinical development, and operational strengthening [1][2]. Group 1: Offshore Placement Details - The Dajun Yang Dynasty Trust, affiliated with the CEO, will offer ordinary shares in an offshore transaction to non-U.S. persons under Regulation S of the Securities Act [1]. - The Vendor will subscribe for new ordinary shares equal to the number of Placement Shares offered, at the same price per share [1]. - The transaction is subject to customary closing conditions and will occur after the Offshore Placement [1]. Group 2: Use of Proceeds - The net proceeds from the Offshore Placement will be utilized for commercialization efforts, expanding patient access, global clinical development of core pipeline candidates, and enhancing infrastructure and working capital [2]. Group 3: Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancers, with a pipeline that includes innovative drug candidates targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [5]. - The lead asset, olverembatinib, is approved in China for treating specific types of chronic myeloid leukemia (CML) and is undergoing a global Phase III trial [6]. - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor recently approved for treating relapsed and/or refractory chronic lymphocytic leukemia (CLL) and is involved in multiple global Phase III trials [7]. Group 4: Partnerships and Collaborations - Ascentage Pharma has established a portfolio of global intellectual property rights and partnerships with leading biotechnology and pharmaceutical companies, including Takeda, AstraZeneca, Merck, and Pfizer, as well as research institutions like Dana-Farber Cancer Institute and Mayo Clinic [8].

Core Viewpoint - Ascentage Pharma's novel Bcl-2 selective inhibitor, lisaftoclax (APG-2575), has received conditional approval from China's National Medical Products Administration (NMPA) for treating adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously undergone at least one systemic therapy, marking it as the first Bcl-2 inhibitor approved for this indication in China and the second globally [1][3][7] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancer treatment, with a rich pipeline of innovative drug candidates, including inhibitors targeting key proteins in the apoptotic pathway [10][11] - The approval of lisaftoclax represents a significant milestone in the company's development efforts, following its first commercialized drug, olverembatinib [2][10] Product Details - Lisaftoclax is an orally administered small-molecule Bcl-2 selective inhibitor designed to restore normal apoptosis in cancer cells by blocking the antiapoptotic protein Bcl-2 [2][5] - The drug has demonstrated broad therapeutic potential in various hematologic malignancies and solid tumors, particularly in CLL/SLL, both as a monotherapy and in combination therapies [2][3] Clinical Study Insights - The approval was based on a pivotal Phase II study (APG2575CC201) that evaluated the efficacy and safety of lisaftoclax in patients with relapsed or refractory CLL/SLL, achieving a compelling overall response rate (ORR) that met the prespecified endpoint [3][4] - Lisaftoclax exhibited a favorable safety profile, with no occurrences of tumor-lysis syndrome (TLS) and manageable hematologic and non-hematologic toxicities [3][4] Market Context - CLL/SLL is a common hematologic malignancy, particularly affecting older populations, with over 100,000 new diagnoses globally each year [4] - In China, the incidence of CLL/SLL is rising, necessitating safer and more effective treatment options beyond the current primary therapies, such as BTK inhibitors, which have limitations including high relapse rates and associated toxicities [4][5][6] Future Development Plans - Ascentage Pharma is conducting four global registrational Phase III trials for lisaftoclax, including studies in combination with BTK inhibitors and in various hematologic malignancies [7][13] - The company aims to accelerate the global development of lisaftoclax to address unmet clinical needs and expand its therapeutic applications [7][13]

Core Viewpoint - Ascentage Pharma Group International has appointed Veet Misra, Ph.D., as Chief Financial Officer and Eric Huang as Senior Vice President of Global Corporate Development and Finance, aiming to accelerate its global growth strategy in the biopharmaceutical sector [1][2][3] Management Appointments - Dr. Veet Misra brings over 20 years of investment banking experience, particularly in the biopharmaceutical sector, and holds a Ph.D. in Molecular Biology and an MBA in Finance & Strategy [4][5] - Mr. Eric Huang has over 20 years of experience in the global pharmaceutical industry, previously serving as CFO for Greater China and Asia-Pacific at Beigene, and holds an MBA in Finance [5] Company Strategy and Growth - The company is entering a notable growth phase, with the new executives expected to enhance its global strategy and operational excellence [2][3] - Ascentage Pharma is focused on becoming a leading fully integrated global biopharmaceutical company, leveraging its dual listing on the Hong Kong Stock Exchange and Nasdaq [2][4] Product Pipeline - Ascentage Pharma has a robust pipeline of innovative drug candidates targeting cancers, including apoptosis-targeted therapies and next-generation kinase inhibitors [6][7] - The lead asset, olverembatinib, is a third-generation BCR-ABL1 inhibitor approved in China for specific types of chronic myeloid leukemia (CML) and is undergoing global Phase III trials [8] - Another key asset, lisaftoclax, is a Bcl-2 inhibitor for hematologic malignancies, with its NDA accepted for Priority Review in China and multiple global Phase III trials ongoing [9] Partnerships and Collaborations - The company has established partnerships with leading pharmaceutical firms such as Takeda, AstraZeneca, Merck, and Pfizer, enhancing its research and development capabilities [10]

Core Insights - Ascentage Pharma announced results from 13 studies of its key assets, including olverembatinib and APG-5918, at the 2025 European Hematology Association Annual Congress, highlighting their potential in treating unmet medical needs in cancers [1][2][3] Group 1: Olverembatinib - Olverembatinib, a third-generation tyrosine kinase inhibitor, showed significant clinical benefits in treating Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), with high complete remission (CR) and complete molecular response (CMR) rates [2] - In a study combining olverembatinib with blinatumomab, all patients achieved CR after one treatment cycle, with an overall survival (OS) rate of 100% and an event-free survival (EFS) rate of 91.6% at 18 months [6] - The combination of olverembatinib with the VP regimen resulted in a 100% overall response rate (ORR) and a 97.3% CR rate, indicating its effectiveness as a first-line therapy for adult patients with Ph+ ALL [11] Group 2: APG-5918 - APG-5918, an investigational EED inhibitor, demonstrated potent antitumor activity in preclinical studies for T-cell lymphoma, supporting its further clinical development [3][18] - The combination of APG-5918 with histone deacetylase inhibitor tucidinostat showed enhanced antitumor effects, indicating its potential as a therapeutic option [18] Group 3: Company Overview - Ascentage Pharma is focused on addressing unmet medical needs in cancers and has developed a pipeline of innovative drug candidates, including olverembatinib and APG-5918 [13] - The company is conducting global registrational Phase III trials for olverembatinib in various indications, including newly diagnosed Ph+ ALL and GIST patients [14]