Core Viewpoint - Ascentage Pharma Group International is actively participating in investor conferences in December 2025, highlighting its ongoing commitment to engage with the investment community and showcase its advancements in biopharmaceuticals [1][7]. Company Overview - Ascentage Pharma is a global, commercial stage biopharmaceutical company focused on discovering, developing, and commercializing novel therapies for unmet medical needs in cancer [2]. - The company has developed a robust pipeline of innovative drug products, including inhibitors targeting key apoptotic pathway proteins and next-generation kinase inhibitors [2]. Product Portfolio - The first approved product, Olverembatinib, is a third-generation BCR-ABL1 inhibitor for treating chronic myeloid leukemia (CML) with specific mutations, and is included in the China National Reimbursement Drug List [3]. - The second approved product, Lisaftoclax, is a Bcl-2 inhibitor for various hematologic malignancies, currently being commercialized in China after receiving NMPA approval for chronic lymphocytic leukemia/small lymphocytic lymphoma [4]. - Ascentage Pharma is conducting multiple global registrational Phase III trials for both Olverembatinib and Lisaftoclax, indicating a strong focus on expanding its clinical footprint [3][4]. Research and Development - The company has established a portfolio of global intellectual property rights and formed partnerships with leading biotechnology and pharmaceutical companies, enhancing its research capabilities [5]. - Collaborations include relationships with prominent research institutions, which support the company's innovative drug development efforts [5].

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 Group International is actively participating in investor conferences in November 2025, highlighting its ongoing commitment to engage with the investment community and showcase its innovative biopharmaceutical pipeline [1][7]. Company Overview - Ascentage Pharma is a global, commercial stage, integrated biopharmaceutical company focused on discovering, developing, and commercializing novel therapies for unmet medical needs in cancer [2][5]. - The company has developed a rich pipeline of innovative drug products, including inhibitors targeting key apoptotic pathway proteins and next-generation kinase inhibitors [2]. Product Pipeline - The first approved product, Olverembatinib, is a third-generation BCR-ABL1 inhibitor for chronic myelogenous leukemia (CML) patients with specific mutations and is included in the China National Reimbursement Drug List [3]. - Olverembatinib is currently undergoing registrational Phase III trials, including POLARIS-2 for CML and POLARIS-1 and POLARIS-3 for other leukemia types [3]. - The second approved product, Lisaftoclax, is a Bcl-2 inhibitor for hematologic malignancies, with multiple global registrational Phase III trials ongoing [4]. Collaborations and Partnerships - Ascentage Pharma has established a portfolio of global intellectual property rights and formed partnerships with leading biotechnology and pharmaceutical companies, including Takeda, AstraZeneca, Merck, and Pfizer [5]. - The company collaborates with prominent research institutions such as Dana-Farber Cancer Institute and Mayo Clinic to enhance its research and development capabilities [5].

Core Viewpoint - Ascentage Pharma Group International is actively participating in investor conferences in November 2025, highlighting its ongoing commitment to engage with the investment community and showcase its innovative biopharmaceutical pipeline [1][7]. Company Overview - Ascentage Pharma is a global, commercial stage, integrated biopharmaceutical company focused on discovering, developing, and commercializing novel therapies for unmet medical needs in cancer [2][5]. - The company has developed a rich pipeline of innovative drug products, including inhibitors targeting key apoptotic pathway proteins and next-generation kinase inhibitors [2]. Product Pipeline - The first approved product, Olverembatinib, is a third-generation BCR-ABL1 inhibitor for chronic myelogenous leukemia (CML) patients with specific mutations and is included in the China National Reimbursement Drug List [3]. - Olverembatinib is currently undergoing registrational Phase III trials for CML and other leukemia types [3]. - The second approved product, Lisaftoclax, is a Bcl-2 inhibitor for hematologic malignancies, with multiple global registrational Phase III trials ongoing [4]. Research and Development - Ascentage Pharma has established a robust R&D capability and holds a portfolio of global intellectual property rights [5]. - The company has formed partnerships with leading biotechnology and pharmaceutical companies, enhancing its research and development efforts [5].

Summary of the Conference Call for Ascentage Pharma Industry and Company Overview - The conference call focuses on Ascentage Pharma, a biopharmaceutical company specializing in innovative cancer therapies, particularly in the field of apoptosis and targeted therapies [2][3]. Key Points and Arguments 1. **Orebatein Expansion**: Orebatein, a third-generation TKI, expanded its indications in October 2023 to cover more CML patients, with expectations to be included in the national health insurance by the end of 2024, significantly enhancing market potential. The domestic sales reached 217 million yuan, with a forecasted doubling for the year [2][4]. 2. **BCL-2 Inhibitor Launch**: Ascentage Pharma launched its first domestic BCL-2 inhibitor, targeting relapsed CLL/SLL, which has a superior administration method compared to venetoclax, faster cellular uptake, and higher safety. Multiple phase III registration trials are ongoing, indicating a broad market outlook [2][4]. 3. **Collaboration with Takeda**: The company entered a licensing agreement with Takeda for the drug Nilotinib, with a total transaction value of 1.3 billion USD, including an upfront payment of 100 million USD. The remaining amount consists of milestone payments and sales sharing, with three phase III registration trials currently in progress [2][5]. 4. **Sales and R&D Expenses**: In the first half of 2024, sales expenses were 138 million yuan, with an annual estimate of 250 to 300 million yuan. R&D expenses reached 529 million yuan, with expectations to exceed 1 billion yuan for the year, indicating a continued increase in R&D investment [2][5]. 5. **Clinical Trials**: Orebatein is undergoing three phase III registration trials, while the BCL-2 inhibitor is also in multiple phase III trials covering AML, CLL/SLL, MDS, and multiple myeloma [2][6]. 6. **CML Market Size**: The global TKI market for CML is approximately 6 billion USD, with the domestic market around 4 billion yuan. The rapid growth of third-generation TKIs is noted, with Nilotinib being the only domestic third-generation TKI, providing a competitive edge [2][7][8]. Additional Important Information 1. **Market Competition**: The global CML TKI market is characterized by the expiration of patents for first and second-generation TKIs, with significant market players like Novartis and Takeda. Orebatein is positioned to complete its overseas phase III trials and apply for market approval by 2026 [7][9]. 2. **Advantages of BCL-2 Inhibitor**: Compared to venetoclax, Ascentage's BCL-2 inhibitor offers advantages in administration, faster cellular uptake, and lower side effects due to a shorter half-life. Ongoing trials include combinations with other therapies for various indications [2][11]. 3. **Future Directions**: Ascentage Pharma aims to continue its focus on apoptosis pathways and advance new L-type inhibitors for solid tumors, while also pursuing international expansion and product innovation to meet market expectations [3][12].

Core Viewpoint - Ascentage Pharma Group International is actively participating in several investor conferences in October 2025, highlighting its ongoing commitment to engage with investors and stakeholders in the biopharmaceutical sector [1][7]. Company Overview - Ascentage Pharma is a global, commercial stage, integrated biopharmaceutical company focused on discovering, developing, and commercializing novel therapies for unmet medical needs in cancer [2][5]. - The company has developed a robust pipeline of innovative drug products, including inhibitors targeting key apoptotic pathway proteins and next-generation kinase inhibitors [2]. Product Portfolio - The first approved product, Olverembatinib, is a third-generation BCR-ABL1 inhibitor for chronic myelogenous leukemia (CML) patients with specific mutations and is included in the China National Reimbursement Drug List [3]. - The second approved product, Lisaftoclax, is a Bcl-2 inhibitor for various hematologic malignancies, with multiple global registrational Phase III trials currently underway [4]. Research and Development - Ascentage Pharma has established a strong R&D capability and has built a portfolio of global intellectual property rights [5]. - The company has formed partnerships with leading biotechnology and pharmaceutical companies, including Takeda, AstraZeneca, Merck, and Pfizer, as well as collaborations with prominent research institutions [5].

Summary of Ascentage Pharma Conference Call Company Overview - **Company**: Ascentage Pharma - **Core Products**: Olverembatinib (APG-115), Fayankirin, APG-2,575 - **Industry**: Pharmaceutical/Biotechnology Key Points and Arguments Product Performance 1. **Olverembatinib (APG-115)**: - Sales doubled in the first half of 2024 after being included in the medical insurance coverage, with expectations to maintain the same growth rate in the second half [2][4][7] - Targeting chronic myeloid leukemia (CML) with significant market potential for future growth [2][4] 2. **Fayankirin**: - Currently undergoing POS D1 trials in China and Phase III registration trials in the U.S. [2][4] - Key data on 3-6 month MMR and 3 month CMR rates expected soon [2][4] 3. **APG-2,575**: - Launched in July 2024, it is the second BCL-2 inhibitor globally and the first for CLL in China [2][5] - Expected peak sales could exceed $4 billion, providing substantial growth potential [3][16] Financial Position 4. **Funding and Cash Reserves**: - Completed two rounds of financing through NASDAQ IPO and Hong Kong placement, currently holding approximately 3 billion RMB, sufficient to meet funding needs until 2027 [2][5] 5. **Collaboration with Takeda**: - A $100 million option payment and $75 million equity investment from Takeda, with potential future payments and royalties of 12%-19% [6] Market Dynamics 6. **Sales Performance in Hematology**: - Sales in the hematology sector have exceeded expectations due to the chronic disease management characteristics of the drugs, leading to sustained use by existing patients and an increase in new patients [9] - The company leverages the DOT (Duration of Therapy) effect to enhance sales [9] Clinical Development and Future Catalysts 7. **Clinical Trials and Pipeline**: - APG-2,575's daily dose escalation improves patient compliance and safety, with a faster onset of action compared to competitors [3][12] - The company is also advancing FAK inhibitor 2,449 into Phase III trials, with potential for commercial value through combination therapies [3][17] 8. **Comparative Advantage**: - APG-2,575 shows better safety and efficacy profiles compared to existing treatments like Venetoclax, with a lower rate of dose reduction and treatment interruption [13][16] Future Plans 9. **Upcoming Milestones**: - Plans to initiate the next U.S. registration clinical study and complete multiple Phase III clinical enrollments for APG-115 and APG-2,575 by 2026 [19] 10. **Expansion into New Areas**: - The company is exploring additional therapeutic areas, including apoptosis pathway inhibitors and anemia treatments, indicating a broadening of its research pipeline [17][18] Additional Important Insights - **Market Trends**: - BCL-2 inhibitors are gaining traction in hematological malignancies, with a focus on selective targeting to improve safety and efficacy [14][15] - **Strategic Positioning**: - The company’s strong cash position and ongoing clinical trials position it well for future growth and market expansion [5][19]

Company Overview - Ascentage is undergoing significant developments and has recently provided updates on its progress and milestones [1][2] Recent Updates - The company had its first half update a couple of weeks ago, highlighting key progress and future milestones [1][2]