Group 1 - U.S. stocks experienced a decline, with the Dow Jones index dropping over 100 points on Tuesday [1] - Cementos Pacasmayo SAA – ADR shares surged 47.4% to $10.30 following Holcim's agreement to acquire 50.01% of its owner, Inversiones Aspi. S.A. [1] Group 2 - Rezolve AI PLC reported preliminary December revenue results, leading to a 23.7% increase in its stock price to $2.87 [2] - Emerald Holding Inc announced a review of potential strategic options, resulting in a 17% rise in its stock price to $4.14 [2] - NovaBay Pharmaceuticals Inc's stock increased by 16.2% to $3.15 [2] - Tilray Brands Inc saw a 15% surge in its stock price to $12.57 [2] - Clearpoint Neuro Inc's stock jumped 14.2% to $14.14 [2] - Fermi Inc gained 11.4%, reaching $9.57 [2] - Sezzle Inc authorized a $100 million stock buyback, leading to a 9.6% increase in its stock price to $72.49 [2] - WW International Inc launched a new platform for the GLP-1 era, resulting in a 7.8% gain to $26.19 [2] - Circle Internet Group Inc rose 7.7% to $81.24 [2] - Lemonade Inc's stock surged 7.4% to $80.59 [2] - Netskope Inc gained 6.9%, reaching $20.37 [2] - Ascentage Pharma Group International's stock rose 6% to $29.26 [2] - RH's stock increased by 5.5% to $172.60, with Barclays analyst maintaining an Overweight rating and lowering the price target from $385 to $283 [2] - Affirm Holdings Inc gained 4.4%, reaching $68.56 [2]

据交易所数据显示，12月16日，亚盛医药(AAPG)开盘上涨5.43%，截至22:34，报29.1美元/股，成交 1.79万美元，总市值27.16亿美元。 财务数据显示，截至2025年06月30日，亚盛医药收入总额2.34亿人民币，同比减少71.63%；归母净利 润-5.91亿人民币，同比减少462.43%。 资料显示，亚盛医药集团是一家立足中国、面向全球的生物医药企业,致力于在肿瘤、乙肝及与衰老相 关的疾病等治疗领域开发创新药物。2019年10月28日,亚盛医药在香港联交所主板挂牌上市,股票代 码:6855.HK。亚盛医药拥有自主构建的蛋白-蛋白相互作用靶向药物设计平台,处于细胞凋亡通路新药研 发的全球前沿。公司已建立拥有9个已进入临床开发阶段的1类小分子新药产品管线,包括抑制Bcl-2、 IAP或MDM2-p53等细胞凋亡通路关键蛋白的抑制剂;新一代针对癌症治疗中出现的激酶突变体的抑制剂 等,为全球唯一在细胞凋亡通路关键蛋白领域均有临床开发品种的创新公司。目前公司正在中国、美 国、澳大利亚及欧洲开展40多项临床试验。用于治疗慢性髓细胞白血病的核心品种奥雷巴替尼(商品名: 耐立克)曾获中国国家药品监督管理局 ...

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 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].

Core Viewpoint - Ascentage Pharma presented promising results from a Phase II study of Lisaftoclax, a Bcl-2 selective inhibitor, for treating relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) at the ASH Annual Meeting, supporting its recent NDA approval in China [1][6][7] Company Overview - Ascentage Pharma Group International is a global biopharmaceutical company focused on developing novel therapies for unmet medical needs in cancer [16] - The company has a pipeline that includes inhibitors targeting key apoptotic pathway proteins and next-generation kinase inhibitors [16] Study Results - Lisaftoclax monotherapy showed a 62.5% objective response rate (ORR) in heavily pretreated BTK-refractory R/R CLL/SLL patients, with a median progression-free survival of 23.89 months [6][11] - Among 77 enrolled patients, 42.9% had chromosomal complex karyotype, 39% had del(17p)/TP53 mutation, and 53.2% had unmutated IGHV, indicating a high-risk patient population [3][13] - The study reported no tumor lysis syndrome (TLS) and a manageable safety profile, with frequent grade ≥3 treatment-related adverse events being hematologic toxicities [14][6] Clinical Significance - The results highlight Lisaftoclax's potential as a new treatment option for patients with high-risk CLL/SLL, addressing an urgent clinical need for effective therapies [5][7] - The study's findings suggest that even in ultra-high-risk patients, Lisaftoclax can achieve deep and durable responses, with 21.8% of patients achieving minimal residual disease (MRD) negativity in peripheral blood [11][15] Future Directions - Ascentage Pharma is conducting four global registrational Phase III studies for Lisaftoclax in various indications, including CLL/SLL, acute myeloid leukemia (AML), and myelodysplastic syndrome (MDS) [4][18] - The company aims to accelerate clinical programs to provide safe and effective therapies to patients globally [7]

Core Viewpoint - Ascentage Pharma has received regulatory clearance from the US FDA and EMA to conduct a global Phase III study of olverembatinib for treating newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), marking a significant advancement in its clinical development efforts [1][3]. Company Overview - Ascentage Pharma Group International is a global biopharmaceutical company focused on developing novel therapies for unmet medical needs in cancer, with a strong pipeline that includes third-generation kinase inhibitors and Bcl-2 inhibitors [6][7]. Clinical Development - The POLARIS-1 trial is a global, multicenter, randomized controlled Phase III study aimed at evaluating the efficacy and safety of olverembatinib in combination with chemotherapy for newly diagnosed Ph+ ALL patients [2][3]. - The trial is designed to accelerate the registration process for olverembatinib, particularly in the US and European markets, with simultaneous patient enrollment across multiple countries [1][2]. Efficacy and Safety Data - Preliminary data from the POLARIS-1 study indicates that approximately 65% of treatment-naïve Ph+ ALL patients achieved minimal residual disease (MRD) negativity and molecular MRD-negative complete response (CR) after three treatment cycles, significantly outperforming other drugs in the same class [3]. - The combination therapy demonstrated a favorable safety profile, with a low incidence of manageable adverse events [3]. Market Context - Ph+ ALL accounts for 20%-30% of all adult acute lymphoblastic leukemia cases and is associated with high relapse rates and poor prognosis, particularly in elderly patients [3]. - Prior to the introduction of tyrosine kinase inhibitors (TKIs), the five-year overall survival rate for Ph+ ALL was less than 20%, highlighting the need for improved treatment options [3]. Strategic Partnerships - Ascentage Pharma has signed an exclusive option agreement with Takeda for olverembatinib, which could lead to Takeda licensing global rights for the drug outside of certain regions, enhancing its commercial potential [4].