J P M O R G A N Asia Pacific Equity Research 21 November 2025 This material is neither intended to be distributed to Mainland China investors nor to provide securities investment consultancy services within the territory of Mainland China. This material or any portion hereof may not be reprinted, sold or redistributed without the written consent of J.P. Morgan. China Healthcare Recent China healthcare sector weakness could mean a good setup for 2026 While we are witnessing another day of weakness in the Chi ...

Largest prospective clinical trial to-date in a rare subtype of GIST ROCKVILLE, Md. and SUZHOU, China, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International Inc. (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced the publication of clinical and translational data from a Phase Ib study (NCT03594422) on the ...

Largest prospective clinical trial to-date in a rare subtype of GIST ROCKVILLE, Md. and SUZHOU, China, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International Inc. (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced the publication of clinical and translational data from a Phase Ib study (NCT03594422) on the ...

Core Insights - Ascentage Pharma Group International announced that results from two clinical studies of its drug, lisaftoclax, have been selected for presentations at the 67th American Society of Hematology (ASH) Annual Meeting, marking the fourth consecutive year for such recognition [1][2] - The company is focused on addressing unmet medical needs in cancer through the development of novel therapies, with multiple investigational drug candidates being presented at the ASH Annual Meeting [1][4] Company Overview - Ascentage Pharma is a global, commercial stage biopharmaceutical company engaged in the discovery, development, and commercialization of differentiated therapies for cancer [16] - The company has a robust pipeline that includes inhibitors targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [16][19] Drug Development and Clinical Trials - Lisaftoclax, an orally available Bcl-2 inhibitor, has shown efficacy in treating hematologic malignancies and is currently being commercialized in China for CLL/SLL patients who have received prior systemic therapy [2][18] - The company is conducting four global registrational Phase III studies for lisaftoclax, including trials in combination with BTK inhibitors and studies targeting newly diagnosed patients [18] ASH Annual Meeting Presentations - At the ASH Annual Meeting, Ascentage Pharma will present an oral report on a Phase II study of lisaftoclax monotherapy for relapsed/refractory CLL/SLL, and a poster on its combination with azacitidine in newly diagnosed or prior venetoclax-exposed myeloid malignancies [2][12] - The presentations will highlight the clinical efficacy and safety profiles of the drug candidates, reinforcing the company's commitment to innovation in cancer treatment [4][11] Efficacy and Safety Results - In a pivotal Phase II study of lisaftoclax, the objective response rate (ORR) was 62.5% among 72 evaluable patients with R/R CLL/SLL, with a median progression-free survival of 23.89 months [9][11] - The safety profile of lisaftoclax was manageable, with frequent grade ≥3 treatment-related adverse events primarily being hematologic toxicities [10][11] Future Directions - Ascentage Pharma aims to accelerate its clinical development programs to provide more treatment options for patients, with ongoing evaluations of its drug candidates in various hematologic malignancies [4][15]

Core Insights - Ascentage Pharma Group International has announced that results from two clinical studies of its drug, lisaftoclax (APG-2575), will be presented at the 67th American Society of Hematology (ASH) Annual Meeting, marking the fourth consecutive year for such presentations [1][2][4] Clinical Study Results - Lisaftoclax is an orally available Bcl-2 inhibitor showing efficacy in hematologic malignancies and solid tumors, currently approved in China for treating adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have received prior systemic therapy [2][18] - At ASH 2025, an oral report will present results from a registrational Phase II study of lisaftoclax monotherapy in patients with relapsed/refractory CLL/SLL, while a poster will feature data on its combination with azacitidine in newly diagnosed or prior venetoclax-exposed myeloid malignancies [2][11] Efficacy and Safety Data - In the Phase II study, among 72 evaluable patients with R/R CLL/SLL, the objective response rate (ORR) was 62.5%, with a median progression-free survival (mPFS) of 23.89 months [8][10] - The treatment demonstrated a manageable safety profile, with frequent grade ≥3 treatment-related adverse events primarily being hematologic toxicities, and no treatment-related deaths reported [9][10] Additional Presentations - The ASH Annual Meeting will also feature presentations on other investigational drug candidates from Ascentage Pharma, including olverembatinib and APG-5918, showcasing the company's robust capabilities in clinical development [4][5][19]

Core Insights - Ascentage Pharma's novel drug, olverembatinib, has been selected for presentations at the 67th American Society of Hematology (ASH) Annual Meeting, marking the eighth consecutive year for this recognition, highlighting its significance in the hematology community [1][4] - The company will present data from multiple clinical studies, including the global Phase III study (POLARIS-1) of olverembatinib combined with low-intensity chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) [2][6] - Ascentage Pharma is actively advancing its clinical development programs to provide more treatment options for patients [4][18] Company Overview - Ascentage Pharma Group International is a global, commercial stage biopharmaceutical company focused on discovering, developing, and commercializing novel therapies for unmet medical needs in cancer [19] - The company has a robust pipeline that includes olverembatinib, the first third-generation BCR-ABL inhibitor approved in China, and other investigational drug candidates like lisaftoclax and APG-5918 [20][22] Clinical Study Highlights - The POLARIS-1 study aims to evaluate the efficacy and safety of olverembatinib combined with low-intensity chemotherapy in patients with newly diagnosed Philadelphia chromosome-positive ALL, with a primary endpoint of minimal residual disease negativity rate [7][9] - In the study, olverembatinib demonstrated a 64.2% MRD-negative complete response rate by the end of induction therapy, indicating its potential effectiveness [9] - Safety results showed that olverembatinib combined with chemotherapy was well tolerated, with common grade ≥3 treatment-emergent adverse events including neutropenia (63.6%) and thrombocytopenia (56.4%) [8] Additional Clinical Findings - In a registrational Phase II trial, olverembatinib showed a significant therapeutic advantage over the best available therapy in patients with TKI-resistant chronic-phase chronic myeloid leukemia (CML-CP), with a median event-free survival of 21.22 months compared to 2.86 months for the control group [14] - The study also reported high complete hematologic response rates (85% for olverembatinib vs. 34.8% for BAT) and complete cytogenetic response rates (37.5% vs. 18.9%) [14] Future Directions - Ascentage Pharma is conducting global registrational Phase III trials for olverembatinib in various indications, including newly diagnosed Ph+ ALL and SDH-deficient gastrointestinal stromal tumors (GIST) [20] - The company aims to continue accelerating its clinical development programs to expand treatment options for patients [4][18]

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 Viewpoint - Morgan Stanley reports that Ascentage Pharma (06855) has seen a year-to-date stock price increase of approximately 83%, aligning with the strong performance of the Hang Seng Healthcare Index, which has risen about 78% [1] Group 1: Stock Performance and Target Price - Morgan Stanley has updated its model for Ascentage Pharma following discussions at the recent Sino-US Biotechnology Forum, considering the latest developments in the company's product pipeline [1] - The target price for Ascentage Pharma has been significantly raised by 79% from the previous HKD 52 to HKD 93, while maintaining an "Overweight" rating [1] Group 2: Key Assets and Sales Forecast - The firm remains optimistic about the company's key assets, "olverembatinib" and "lisaftoclax," which are expected to drive strong product sales this year [1] - There is an improved outlook for the overseas potential of "lisaftoclax," particularly in light of the failure of "venetoclax" to demonstrate overall survival benefits in myelodysplastic syndromes (MDS), along with the drug's market approval scope in China exceeding expectations [1]

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]