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.

Group 1 - The core viewpoint is that by the end of 2025, the transaction volume of innovative drug BD in China is expected to exceed $100 billion, marking a significant shift towards value-driven innovation in the pharmaceutical industry [1][2] - The 2025 China Pharmaceutical Innovation Index evaluates the comprehensive innovation capabilities of local pharmaceutical companies based on new drug development, technology transfer, and commercialization [1][2] - The release of the China Innovation Drug Index serves as an international benchmark tool for Chinese innovative drug companies, helping them understand their positioning in global competition [2] Group 2 - In the first half of 2025, BD transactions involving China contributed nearly 50% of the global transaction volume, indicating a significant role in the global market [2] - The approval of 43 innovative drugs by the National Medical Products Administration in the first half of this year represents a 59% year-on-year increase, showcasing the continuous improvement in original innovation capabilities [2][3] - The shift from being global followers to value co-creators is evidenced by record-breaking collaborations, such as those between 3SBio and Pfizer, and Innovent Biologics and Takeda [2] Group 3 - Challenges remain, including the need for original innovation and improved commercialization capabilities, as many new drugs are merely process improvements rather than true novel discoveries [4] - The establishment of a multi-dimensional value pricing and payment policy for innovative drugs is suggested to facilitate quicker access to effective medications [5] - The future is expected to see more First-in-Class products emerging, with potential for new drugs to achieve annual sales exceeding $1 billion [6] Group 4 - The necessity for Chinese innovative drugs to enter international markets is emphasized, with a focus on maximizing product value and meeting international market demands [7] - The ongoing wave of BD transactions is anticipated to continue, with a shift in focus from oncology drugs to non-oncology areas by 2026 [7] - Despite significant advancements, Chinese innovative drug companies still face challenges in competing with multinational corporations on a global scale [7] Group 5 - The importance of building a deep integration global cooperation ecosystem is highlighted, with companies encouraged to leverage unique technological platforms for international collaboration [8] - The goal is to define new therapies through a combination of Chinese innovation and global resources, ultimately benefiting a wider patient population [8]

12月9日早盘，港股通创新药板块短线企稳，创新药含量100%的港股通创新药ETF（520880）水面上方 震荡，成份股走势分化，恒瑞医药、山东新华制药股份领涨超2%，MIRXES-B跌3%，信达生物跌逾 1%。 值得关注的是，港股通创新药ETF（520880）场内延续高溢价，显示低吸资金仍活跃。昨日520880回调 1%区间，单日获超5600万元资金净申购，创近1个月来单日吸金额新高。 | 分时 多日 1分 5分 15分 30分 · | | | | | | | F9 盘前盘目 盘加 九轮 面班 工具 份 (7 2) | | | | | 港股通创新药ETF O | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 0.557 | | | | 520880[高版通创新的ETF] 09:46 价 0.554 图表 0.002(0.36%) 均价 0.554 版交盘 7 _ _ _ _ | | | | | | 0.554 +0.002 +0.36% | | CONDON 7 ...

Core Viewpoint - Ascentage Pharma presented four-year follow-up data for Olverembatinib, demonstrating its long-term efficacy and safety in treating TKI-resistant/intolerant chronic-phase chronic myeloid leukemia (CML-CP) at the 67th ASH Annual Meeting [1][2][3] Group 1: Efficacy Results - Olverembatinib showed a median event-free survival (EFS) of 21.2 months compared to 2.9 months for the best available therapy (BAT) in patients with TKI-resistant/intolerant CML-CP [3][12] - For patients without the T315I mutation, Olverembatinib achieved an EFS of 11.9 months versus 3.1 months for BAT [3][12] - The complete hematologic response (CHR) rates were 85% for Olverembatinib compared to 35% for BAT, while complete cytogenetic response (CCyR) rates were 38% versus 19% [12] Group 2: Safety Profile - The safety profile of Olverembatinib was favorable, with a vascular occlusion incidence of 7% among patients [3][11] - No new safety signals were reported, and the study included patients with and without the T315I mutation [11] Group 3: Regulatory and Commercialization Status - Olverembatinib is the first third-generation BCR-ABL1 inhibitor approved in China for specific CML indications, and it is included in the China National Reimbursement Drug List (NRDL) [4][15] - Ascentage Pharma is conducting three global registrational Phase III studies for Olverembatinib in various indications, including newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and gastrointestinal stromal tumors (GIST) [4][15] Group 4: Clinical Significance - The data presented at ASH 2025 reinforces Olverembatinib's role in clinical practice for long-term treatment of CML-CP, providing confidence to physicians and patients [5][11] - The study's findings highlight the need for effective treatment options for patients resistant to or intolerant of first- and second-generation TKIs [8][12]

Core Viewpoint - Ascentage Pharma has presented promising updated data on Olverembatinib, a novel drug for second-line treatment of chronic myeloid leukemia (CML) at the 67th American Society of Hematology (ASH) Annual Meeting, indicating its potential as a safe and effective treatment option for patients resistant to prior therapies [1][3][5]. Group 1: Efficacy and Safety Data - Olverembatinib demonstrated a complete cytogenetic response (CCyR) rate of 71.8% and a major molecular response (MMR) rate of 43.6% in patients with CML resistant/intolerant to one prior line of tyrosine kinase inhibitors (TKIs) without the T315I mutation [3][12]. - In patients who failed first-line treatment with second-generation TKIs, the CCyR rate was 76.7% and the MMR rate was 43.3% [3][12]. - The safety profile of Olverembatinib was consistent with previous reports, with no new safety signals identified [3][10]. Group 2: Clinical Study Details - The study was an open-label, single-arm, multicenter clinical trial evaluating Olverembatinib at 40 mg every other day in Chinese patients with CP-CML resistant/intolerant to one prior line of TKIs [8]. - As of July 24, 2025, 47 patients were enrolled, with 39 patients receiving at least one efficacy evaluation [8][12]. - The median treatment duration was 16.0 cycles, with 89.4% of patients experiencing treatment-related adverse events [10]. Group 3: Regulatory and Commercialization Aspects - Olverembatinib is the first third-generation BCR-ABL inhibitor approved in China, currently commercialized in partnership with Innovent Biologics [4][14]. - The drug is approved for adult patients with TKI-resistant CML-CP or accelerated-phase CML harboring the T315I mutation, and is included in the China National Reimbursement Drug List [4][14]. - Ascentage Pharma is conducting three global registrational Phase III studies for Olverembatinib in multiple indications, including CML-CP and newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia [4][14].

Core Insights - Ascentage Pharma presented promising data from the Phase III POLARIS-1 study of Olverembatinib for treating newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph ALL) at the ASH Annual Meeting [1][2][3] Group 1: Study Results - The POLARIS-1 study demonstrated a minimal residual disease (MRD) negativity rate of 66.0% and an MRD-negative complete response (CR) rate of 64.2% after three induction cycles in patients treated with Olverembatinib combined with low-intensity chemotherapy [3][6][12] - High-risk IKZF1 patients showed a 90% molecular response rate, indicating the drug's effectiveness in challenging cases [6][14] - The combination therapy exhibited a favorable safety profile, with common grade ≥ 3 treatment-emergent adverse events including neutropenia (63.6%) and thrombocytopenia (56.4%) [11][12] Group 2: Drug Development and Commercialization - Olverembatinib is the first third-generation BCR-ABL inhibitor approved in China, currently commercialized in partnership with Innovent Biologics [4][15] - The drug is approved for adult patients with TKI-resistant chronic-phase chronic myeloid leukemia (CML-CP) and accelerated-phase CML (CML-AP) harboring the T315I mutation, with all indications covered by the China National Reimbursement Drug List (NRDL) [4][15] - Ascentage Pharma is conducting three global registrational Phase III studies for Olverembatinib across multiple indications, including Ph ALL and gastrointestinal stromal tumors [4][15] Group 3: Conference Highlights - The ASH Annual Meeting is a significant event for the hematology community, showcasing advancements in scientific research and investigational therapies [2] - Ascentage Pharma's innovative pipeline, including Olverembatinib, Lisaftoclax, and APG-5918, received notable attention at the conference, with multiple presentations highlighting their potential [2][5]

Core Insights - Ascentage Pharma presented promising results from a Phase Ib/II study of Lisaftoclax in combination with azacitidine for treating myeloid malignancies at the 67th ASH Annual Meeting, highlighting its potential to address unmet medical needs in this area [1][2][5] Company Overview - Ascentage Pharma Group International is a global biopharmaceutical company focused on developing novel therapies for cancer, with a strong pipeline that includes Lisaftoclax, Olverembatinib, and APG-5918 [12][14] Clinical Study Highlights - The study demonstrated a 31.8% overall response rate (ORR) in patients with venetoclax-resistant myeloid malignancies and an 80% ORR in newly diagnosed high-risk MDS/CMML [6][15] - The safety profile of Lisaftoclax was favorable, with no dose-limiting toxicities reported across all patient cohorts in the study [10][11] Drug Mechanism and Approval Status - Lisaftoclax is an orally administered Bcl-2 selective inhibitor that restores apoptosis in cancer cells and is already approved in China for CLL/SLL patients who have received prior systemic therapy [4][14] - The company is conducting four global registrational Phase III studies for Lisaftoclax in various indications, including CLL/SLL, AML, and MDS [4][16] Future Directions - Ascentage Pharma aims to accelerate clinical programs for Lisaftoclax to provide effective therapies for patients with myeloid malignancies, fulfilling its mission to address unmet clinical needs globally [5][11]

Core Viewpoint - Ascentage Pharma presented promising results from a Phase Ib/II study of Lisaftoclax in combination with azacitidine for treating myeloid malignancies at the 67th ASH Annual Meeting, highlighting its potential to address unmet medical needs in patients resistant to venetoclax [1][2][3]. Company Overview - Ascentage Pharma Group International is a global biopharmaceutical company focused on developing novel therapies for cancer, with a strong pipeline including Lisaftoclax, Olverembatinib, and APG-5918 [12][14]. Clinical Study Highlights - The study presented at ASH 2025 demonstrated a 31.8% overall response rate (ORR) in venetoclax-resistant patients and an 80% ORR in newly diagnosed high-risk MDS/CMML patients [6][15]. - The combination of Lisaftoclax and azacitidine showed a strong safety profile with no dose-limiting toxicities reported across all patient cohorts in the study involving 103 patients [10][15]. Drug Mechanism and Approval Status - Lisaftoclax is an orally administered Bcl-2 selective inhibitor that restores apoptosis in cancer cells and is currently approved in China for CLL/SLL patients who have received prior systemic therapy [4][14]. - The company is conducting four global registrational Phase III studies for Lisaftoclax across multiple indications, including CLL/SLL, AML, and MDS [4][16]. Expert Commentary - The Chief Medical Officer of Ascentage Pharma emphasized the therapeutic potential of Lisaftoclax for newly diagnosed or venetoclax-exposed patients, aiming to improve clinical management of myeloid malignancies [5].

Major Events - Chuangsheng Group-B (06628) announced updated efficacy data for osemitamab triple therapy as a first-line treatment for gastric or gastroesophageal junction adenocarcinoma at ESMO Asia [1] - Strength Development (01277) plans to acquire 100% equity of Taiyuan Shidi for approximately 384 million yuan and acquire Dongzhimen property for a total of 86.33 million yuan [1] - Innovent Biologics (01801) completed a global strategic collaboration with Takeda Pharmaceutical and issued 6.9138 million shares under general authorization [1] - Ascentage Pharma-B (06855) received FDA and EMA approval for global registration of a Phase III clinical trial for Nilotinib as a first-line treatment for Ph+ ALL [1] - Baiao Saitou-B (02315) announced that its business partner IDEAYA received IND approval from the FDA for IDE034 [1] - Jinfang Pharmaceutical-B (02595) initiated a registration clinical trial for GFH375, the world's first oral KRAS G12D inhibitor in a controlled chemotherapy Phase III study [1] - Xixiangfeng Group (02473) signed a business cooperation agreement with Hello Car Rental to develop car rental services in designated cities under a "co-branded store" model [1] - International Commercial Settlement (00147) signed a computer chip sales agreement with Hong Kong Antarctic Light to seize growth opportunities in the IC chip market [1] - CSPC Pharmaceutical Group (01093) received clinical trial approval in the U.S. for a GLP-1/GIP receptor dual agonist injection [1] - MIRXES-B (02629) plans to collaborate with Crystal Technology to build an AI-enabled integrated "diagnosis and treatment" research and industrialization platform [1] - Zhengtong Automobile (01728) intends to invest approximately 816 million yuan to acquire Xiamen Xinda 4S dealership and automotive sales and export business [1] - Guorui Life (00108) plans to acquire 78.3% of Beijing Chunyu Tianxia Software for 269 million yuan [1] - Innovent Biologics (01801) successfully included seven innovative products (including new indications) in the 2025 National Medical Insurance Drug List [1] - Peijia Medical-B (09996) had its registration application for the TaurusNXT® "non-aldehyde cross-linked" transcatheter aortic valve replacement system accepted by the National Medical Products Administration [1] - Fosun Pharma (02196) had new drugs included in the National Medical Insurance Directory and commercial insurance innovative drug directory [1] - Junshi Biosciences (01877) had Tuoyi® new indications and Junshida® included in the National Medical Insurance Directory [1] - Valiant Biotech-B (09887) presented clinical data for LBL-034 at the 67th ASH Annual Meeting [1] - Canfite BioPharma (09926) had all approved indications for five marketed drugs successfully included in the latest National Medical Insurance Drug List [1] - Fuhong Hanlin (02696) had Fuzhuoning® (Citrus Acid Vovizili Capsules) included in the National Medical Insurance Drug List [1] - Green Leaf Pharmaceutical (02186) successfully included five new products in the 2025 National Medical Insurance Drug List or commercial insurance innovative drug directory [1] - Yinnuo Pharmaceutical-B (02591) had its core products included in the National Medical Insurance Drug List [1] Operating Performance - Poly Real Estate Group (00119) reported a contract sales amount of approximately 47.7 billion yuan for the first 11 months, a year-on-year decrease of 8.45% [2] - GAC Group (02238) reported November automobile sales of approximately 179,700 units, a year-on-year decline of 9.72% [2] - Xiehe New Energy (00182) reported an equity power generation of 697.23 GWh in November, a year-on-year increase of 7.77% [2]

Major Events - Chuangsheng Group-B (06628) announced updated efficacy data for osemitamab triple therapy in first-line treatment of gastric or gastroesophageal junction adenocarcinoma at ESMO Asia [1] - Strength Development (01277) plans to acquire 100% equity of Taiyuan Shidi for approximately 384 million yuan and acquire Dongzhimen property for a total of 86.33 million yuan [1] - Innovent Biologics (01801) completed a global strategic collaboration with Takeda Pharmaceutical and issued 6.9138 million shares under general authorization [1] - Ascentage Pharma-B (06855) received FDA and EMA approval for global registration of the III phase clinical study of Nilotinib in first-line treatment of Ph+ ALL [1] - Baiao Saitou-B (02315) announced that its business partner IDEAYA received IND approval from the FDA for IDE034 [1] - Jinfang Pharma-B (02595) initiated a registration clinical trial for GFH375 in metastatic pancreatic cancer, marking the first global oral KRAS G12D inhibitor monotherapy controlled chemotherapy III phase study [1] - Xixiangfeng Group (02473) subsidiary signed a business cooperation agreement with Hello Car Rental to develop car rental business in designated cities under a "co-branded store" model [1] - International Commercial Settlement (00147) signed a computer chip sales agreement with Hong Kong Antarctic Light to seize growth opportunities in the IC chip market [1] - CSPC Pharmaceutical Group (01093) received clinical trial approval in the U.S. for GLP-1/GIP receptor dual agonist peptide injection [1] - MIRXES-B (02629) plans to collaborate with Jingtai Technology to build an AI-enabled integrated "diagnosis and treatment" research and industrialization platform [1] - Zhengtong Automotive (01728) plans to invest approximately 816 million yuan to acquire Xiamen Xinda 4S dealership and automotive sales and export business [1] - Guorui Life (00108) intends to acquire 78.3% of Beijing Chunyu Tianxia Software for 269 million yuan [1] - Innovent Biologics (01801) announced that seven innovative products, including new indications, were successfully included in the 2025 National Medical Insurance Drug List [1] - Peijia Medical-B (09996) had its registration application for the TaurusNXT® "non-aldehyde cross-linked" transcatheter aortic valve replacement system accepted by the National Medical Products Administration [1] - Fosun Pharma (02196) had new drugs included in the National Medical Insurance Directory and commercial insurance innovative drug directory [1] - Junshi Biosciences (01877) had Tuoyi® new indications and Junshida® included in the National Medical Insurance Directory [1] - Valiant Biopharma-B (09887) clinical data for LBL-034 was presented at the 67th ASH Annual Meeting [1] - Canfite BioPharma (09926) had all approved indications for five marketed drugs successfully included in the latest National Medical Insurance Drug List [1] - Fuhong Hanlin (02696) had Fuzhuoning® (Citrus Aurantium Extract Capsules) included in the National Medical Insurance Drug List [1] - Green Leaf Pharmaceutical (02186) had five new products successfully included in the 2025 National Medical Insurance Drug List or commercial insurance innovative drug directory [1] - Yinnuo Pharmaceutical-B (02591) core products were included in the National Medical Insurance Drug List [1] Operating Performance - Poly Real Estate Group (00119) reported contract sales of approximately 47.7 billion yuan in the first 11 months, a year-on-year decrease of 8.45% [2] - GAC Group (02238) reported November automobile sales of approximately 179,700 units, a year-on-year decline of 9.72% [2] - Xiehe New Energy (00182) reported November equity power generation of 697.23 GWh, a year-on-year increase of 7.77% [2]