Summary of the Conference Call for Ascentage Pharma Company Overview - **Company**: Ascentage Pharma - **Focus**: Development of innovative therapies for hematological malignancies and solid tumors Key Points from the Conference Call Clinical Data and Drug Development - **Lisatoclax**: - Achieved a 63% overall response rate (ORR) in patients with relapsed/refractory Chronic Lymphocytic Leukemia (CLL) [2][5] - Notable safety profile with low incidence of severe adverse events [5] - Approved in July 2025, demonstrating rapid development within 11 years [3] - **Orebacitinib (耐立克)**: - In first-line treatment for Ph+ Acute Lymphoblastic Leukemia (ALL), achieved a 64% MRD-negative complete response rate (CRR) at 3 months, outperforming the Falcon Trial [2][9] - In second-line treatment, both Major Molecular Response (MMR) and CRR rates improved over time, especially in patients previously treated with dasatinib or nilotinib [10] - **FGFR Rearrangement in Hematological Malignancies**: - Research led by Professor Chen Shulin showed significant responses in patients with rare FGFR rearrangements, with 5 achieving complete molecular remission [12] - **EED Inhibitors**: - Showed potential in models of anemia and multiple myeloma, with effects comparable or superior to Forcan's drugs [2][14] - Ongoing Phase I clinical trials for multiple indications [2] Regulatory and Market Position - **Global Clinical Trials**: - Significant progress in global registration trials, with multiple studies receiving FDA and EMA approvals [8] - Focus on addressing unmet clinical needs in MDS, with potential to be the first approved BCL-2 selective inhibitor for MDS [8] - **Competitive Landscape**: - Ascentage Pharma has established a strong position in the BCL-2 inhibitor market, with ongoing trials in AML and MDS [21][22] - Plans to consolidate market position through monotherapy and combination therapies [22] Future Directions - **ALL Treatment Plans**: - Advancing the combination of Orebacitinib and 2,575 for ALL, exploring chemotherapy-free options [20] - **MDS and MM Developments**: - Continued focus on MDS with plans for registration studies and addressing challenges in treatment [17][23] - BCL-2 inhibitors remain a key strategy for high-risk MDS treatment [18] - **EED Inhibitor Development**: - Despite challenges, Ascentage Pharma is leading in EED inhibitor research, with promising early results in anemia treatment [24][26] Additional Insights - **Safety and Efficacy**: - Lisatoclax demonstrated a low incidence of tumor lysis syndrome (TIS), attributed to its short half-life and effective preventive measures [16] - **Market Potential**: - The anemia market is considered larger than the lymphoma market, with ongoing research into various anemia types [26] - **Collaboration and Innovation**: - Emphasis on innovative clinical trials and collaborations to meet the needs of hematological cancer patients globally [28] This summary encapsulates the critical insights and developments discussed during the conference call, highlighting Ascentage Pharma's advancements in drug development, regulatory achievements, and strategic positioning in the market.

血液肿瘤是最常见的恶性肿瘤之一，近年来发病率持续走高。世界卫生组织(WHO)数据显示，全球血 液肿瘤新发患者数量由2015年的113.3万增长至2021年的130.5万，预计2030年增长至154.6万；中国新发 患者同步增长，预计2030年增长至30万。 在血液肿瘤治疗领域，布鲁顿氏酪氨酸激酶(BTK)抑制剂在多种亚型血液肿瘤疾病治疗中展现出显著优 势。阿斯利康旗下BTK抑制剂的市场表现，正是这一技术优势的生动印证。2024年，这一产品全球销售 额突破30亿美元，位列阿斯利康肿瘤产品第四，而今年前三季度，跃升至第三。 阿斯利康持续发力自主研发的同时，也积极牵手中国合作伙伴，通过业务拓展，赋能血液肿瘤疗法管线 布局的持续完善：与礼新医药达成GPRC5D靶向ADC全球独家合作，加速补充前沿疗法管线；斥资12亿 美元全资收购亘喜生物，一举夯实细胞治疗领域的布局实力，加速构建起多元化疗法矩阵。 在全球创新网络布局中，阿斯利康以最高10亿美元总价收购比利时EsoBiotec，获取其核心的工程化纳 米抗体慢病毒(ENaBL)平台，该平台旗下体内BCMA CAR-T药物已进入临床阶段，2025年1月在中国完 成首例复发/ ...

Core Viewpoint - The company, DIZHE Pharmaceutical (688192.SH), will present significant research findings on its core lymphoma treatment products at the upcoming 67th American Society of Hematology (ASH) conference from December 6 to 9 [1] Group 1 - The company will showcase two major products: Golixtin (generic name: Golitinib capsules) and birelentinib (DZD8586) [1] - A total of 15 abstracts from the company have been accepted for presentation at the conference, highlighting its extensive pipeline and research potential in the field of hematologic oncology [1]

Core Viewpoint - The company, DIZHE Pharmaceutical (688192), will present multiple research findings on its key lymphoma treatment products, Golitinib (generic name: Golitinib capsules) and Birelentinib (DZD8586), at the 67th American Society of Hematology Annual Meeting from December 6 to 9 [1] Group 1 - The company has 15 abstracts accepted for presentation at the conference, highlighting its extensive pipeline and research potential in the field of hematologic oncology [1]

Core Viewpoint - The company, DIZHE Pharmaceutical (688192.SH), will present multiple research findings on its key lymphoma treatment products at the upcoming 67th American Society of Hematology (ASH) conference from December 6 to 9, showcasing its robust pipeline and research potential in the field of hematologic oncology [1] Group 1 - The company will unveil research results for two core products: Golitiximab (highly regarded as 高瑞哲®) and birelentinib (DZD8586) [1] - A total of 15 abstracts from the company have been accepted for presentation at the ASH conference, highlighting its extensive pipeline in blood cancer treatment [1] - The participation in this prestigious conference reflects the company's commitment to advancing research in hematologic malignancies [1]

Core Viewpoint - The company, DIZHE Pharmaceutical (688192.SH), will present significant research findings on its core lymphoma treatment products, Golixty (generic name: Golitinib capsules) and birelentinib (DZD8586), at the 67th American Society of Hematology (ASH) conference from December 6 to 9 [1] Group 1 - The company has 15 abstracts accepted for presentation at the ASH conference, highlighting its extensive pipeline and research potential in the field of hematologic oncology [1]

Core Insights - The company, DIZHE Pharmaceutical (688192.SH), will present multiple research findings on its core lymphoma treatment products, Golitinib (高瑞哲®) and birelentinib (DZD8586), at the 67th American Society of Hematology (ASH) conference from December 6 to 9 [1] - A total of 15 abstracts from the company have been accepted for the conference, highlighting its extensive pipeline and research potential in the field of hematologic oncology [1]

Core Insights - Nuo Cheng Jian Hua has signed a global licensing agreement with Zenas BioPharma worth over $2 billion, which includes an upfront payment of up to $100 million and milestone payments [1][2] - Zenas will gain global rights to Nuo Cheng Jian Hua's core product, Obexelimab, in the field of multiple sclerosis, along with rights to new oral IL-17AA/AF inhibitors and oral TYK2 inhibitors [2] - Obexelimab is a highly selective BTK inhibitor with strong CNS penetration, already commercialized since 2021 and included in the national medical insurance directory in 2022 [3] Financial Performance - Nuo Cheng Jian Hua reported a revenue of 731 million yuan in the first half of 2025, a year-on-year increase of 74.3%, with revenue from Obexelimab reaching 637 million yuan, up 52.8% [4] - The company narrowed its net loss to 30 million yuan in the first half of 2025, compared to a loss of 262 million yuan in the same period last year [4] - As of June 30, 2025, Nuo Cheng Jian Hua had cash and cash equivalents totaling 7.7 billion yuan [4]

Core Insights - BeiGene announced positive results from the Phase 1/2 clinical trial of its next-generation BCL2 inhibitor, Sotorasib, for treating adult patients with mantle cell lymphoma (MCL) who have previously received BTK inhibitors and anti-CD20 therapy [1][2] - The trial demonstrated significant and durable responses, indicating the potential of Sotorasib to provide the first BCL2 inhibitor treatment option for MCL patients if approved [1][2] Company Developments - The clinical study (BGB-11417-201) enrolled 125 adult patients with MCL, with 22 patients in the first part receiving daily doses of 160 mg or 320 mg of Sotorasib to assess safety and tolerability [1] - In the second part, 103 patients received the recommended daily dose of 320 mg to evaluate efficacy and safety [1] - The study achieved the primary endpoint of overall response rate (ORR) and showed positive results in secondary endpoints, including complete response rate (CRR), duration of response (DOR), and progression-free survival (PFS) [2] Regulatory Progress - BeiGene is submitting data to the FDA and global regulatory agencies to seek potential approval for Sotorasib in MCL indications [2] - The new drug application for Sotorasib for treating MCL and CLL/SLL patients has been accepted by the National Medical Products Administration (NMPA) in China and is under priority review [2] - A confirmatory Phase 3 study (BGB-11417-302) is ongoing, with the first patient enrolled earlier this year [2]

Group 1 - The complexity of blood cancer classification presents numerous investment opportunities in various subtypes of treatment [1] - The promotion and application of emerging treatment methods such as targeted therapy, immunotherapy, and cell therapy have led to a trend in blood cancer treatment similar to chronic disease management for hypertension and diabetes [1] - The long survival cycle of blood cancer patients results in a large existing patient population, coupled with high drug treatment costs, leading to the emergence of blockbuster products and significant potential market opportunities [1]