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.

Core Insights - The incidence of hematological malignancies is rising globally, with new cases expected to reach 1.546 million by 2030, and in China, the number of new patients is projected to grow to 300,000 by the same year [2] - AstraZeneca is making significant advancements in the hematological oncology sector, particularly with its BTK inhibitor, which has recently undergone a formulation upgrade and has been included in the national medical insurance directory [2][3] - The company is focusing on patient-centric innovations, enhancing drug accessibility, and expanding its treatment options to meet the growing clinical needs in China [3][4] Industry Overview - Hematological malignancies are characterized by rapid onset, severe symptoms, and long treatment durations, leading to a substantial disease burden [2] - The aging population in China is contributing to an increase in the clinical treatment burden associated with hematological cancers [2] Company Strategy - AstraZeneca's strategy in China emphasizes addressing unmet clinical needs in hematological oncology, which is becoming a key area for market expansion [3] - The company has been actively upgrading its BTK inhibitor formulations to improve patient compliance, particularly for elderly patients who may have difficulty swallowing [3][4] - AstraZeneca's blood cancer team is expanding its workforce across various critical roles to enhance clinical collaboration and support [4] Product Development - The BTK inhibitor is projected to achieve global sales exceeding $3 billion in 2024, reflecting its strong market performance [4] - AstraZeneca is enhancing its pipeline through collaborations and acquisitions, including a $1.2 billion acquisition of Gengxi Biotech to strengthen its position in cell therapy [4][5] - The company has developed a diverse research pipeline covering major hematological malignancies, including lymphoma, myeloma, and leukemia, which is rare in the industry [5] Clinical Research and Innovation - AstraZeneca is showcasing its advancements in hematological oncology at major academic conferences, highlighting its ongoing clinical trials and research data [6] - The company aims to transform scientific innovations into accessible patient value, aligning with China's health goals for cancer prevention and treatment by 2030 [6][7] Local R&D Capabilities - AstraZeneca's local R&D system in China supports over 200 projects, with half focused on oncology, demonstrating a commitment to global synchronized research [7] - The company collaborates with local biotech firms, academic institutions, and hospitals to enhance its innovation capabilities and strengthen its market position [7]

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]