Company Overview - CICC maintains a "outperform" rating and a target price of HKD 89 for Ascentage Pharma-B (06855), highlighting positive recent R&D progress [1] - The global Phase III study (POLARIS-1) of Olverembatinib (耐立克) for first-line treatment of Ph+ ALL has received approval from both the FDA and EMA [2] - The company is set to present multiple data points at the 2025 American Society of Hematology (ASH) annual meeting, including domestic Phase II clinical data for APG-2575 and initial results from POLARIS-1 [2] R&D Progress - POLARIS-1 data shows that as of July 18, 2025, 94.3% of 53 first-line Ph+ ALL patients achieved CR/CRi within three months, with best MRD negative rates at 66.0% and MRD negative CR rates at 64.2% [2] - The company views Olverembatinib as its first commercial product, with steady expansion of indications and promising data readouts [2] APG-2575 Efficacy - APG-2575 demonstrated a 62.5% overall response rate (ORR) in 72 R/R CLL/SLL patients, with a median progression-free survival (mPFS) of 23.89 months and 21.8% achieving MRD negativity [3] - Notably, nearly half of the patient population had complex chromosomal abnormalities, indicating a higher risk profile and underscoring the drug's efficacy potential [3] Combination Therapy Data - The combination of APG-2575 and Azacitidine showed an ORR of 40.4% in 47 R/R AML/MPAL patients, with a complete response (CR) rate of 29.8% and mPFS of 7.6 months [4] - In 15 newly diagnosed high-risk MDS/CMML patients, the ORR was 80.0%, with CR and bone marrow CR rates at 40%, although mPFS was not reached [4]

Company Overview - CICC maintains a "outperform" rating and a target price of HKD 89 for Ascentage Pharma-B (06855), citing positive recent R&D progress [1] - The global Phase III study (POLARIS-1) for Nilotinib (Orelabrutinib) as a first-line treatment for Ph+ ALL has received approval from both the FDA and EMA [1][2] - The company plans to present multiple data points for three products at the 2025 American Society of Hematology (ASH) annual meeting, including oral reports on APG-2575's domestic Phase II registration clinical data and the first readout of POLARIS-1 data [1] POLARIS-1 Study Results - The POLARIS-1 study shows promising initial data, with 94.3% of 53 first-line Ph+ ALL patients achieving complete response (CR) or complete response with incomplete blood count recovery (CRi) within three months [2] - The best minimal residual disease (MRD) negative rate and MRD negative CR rate were reported at 66.0% and 64.2%, respectively [2] APG-2575 Efficacy in High-Risk Populations - APG-2575 demonstrated a 62.5% overall response rate (ORR) in 72 patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL), with a median progression-free survival (mPFS) of 23.89 months [3] - Notably, nearly half of the patient population had complex chromosomal abnormalities, indicating a higher risk profile, which underscores the drug's potential efficacy [3] Combination Therapy Data - The combination of APG-2575 and Azacitidine showed an ORR of 40.4% in 47 patients with R/R acute myeloid leukemia/mixed phenotype acute leukemia (AML/MPAL), with a complete response (CR) rate of 29.8% and mPFS of 7.6 months [4] - In 15 patients with newly diagnosed high-risk myelodysplastic syndromes/chronic myelomonocytic leukemia (MDS/CMML), the ORR was 80.0%, with CR and bone marrow CR rates of 40% [4]

Core Viewpoint - Aosheng Pharmaceutical (AAPG) has experienced a significant decline in revenue and net profit, while its stock price has seen a recent increase, indicating potential market volatility and investor interest [1][2]. Group 1: Financial Performance - As of June 30, 2025, Aosheng Pharmaceutical reported total revenue of 234 million RMB, a year-on-year decrease of 71.63% [1]. - The company's net profit attributable to shareholders was -591 million RMB, reflecting a staggering year-on-year decline of 462.43% [1]. Group 2: Company Overview - Aosheng Pharmaceutical is a biopharmaceutical company based in China, focusing on developing innovative drugs for cancer, hepatitis B, and age-related diseases [2]. - The company was listed on the Hong Kong Stock Exchange on October 28, 2019, under the stock code 6855.HK [2]. - Aosheng has established a drug design platform targeting protein-protein interactions and is at the forefront of new drug development in the apoptosis pathway [2]. Group 3: Product Pipeline and Clinical Trials - The company has a pipeline of nine Class 1 small molecule new drugs in clinical development, including inhibitors targeting key proteins in the apoptosis pathway [2]. - Aosheng is conducting over 40 clinical trials across China, the United States, Australia, and Europe [2]. - The core product, Orebatinib (brand name: Nairike), has received priority review and breakthrough therapy designation from China's National Medical Products Administration and is included in the National Basic Medical Insurance Drug List [2]. Group 4: Collaborations and Research Initiatives - Aosheng has formed global partnerships with leading biotech and pharmaceutical companies and academic institutions, including UNITY, MD Anderson, and Merck [2]. - The company has undertaken multiple national science and technology major projects, including five related to "major new drug creation" [2]. - Aosheng is committed to enhancing its R&D capabilities and accelerating the clinical development of its product pipeline to meet unmet clinical needs globally [2].

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.

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]

Core Viewpoint - Ascentage Pharma-B (06855) saw a stock increase of over 6%, currently trading at 64.2 HKD with a transaction volume of 19.93 million HKD, following the announcement of the global registration Phase III clinical trial POLARIS-1 for its novel drug Olverembatinib (brand name: Nilotinib) in combination with chemotherapy for newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) patients, which has received approval from both the FDA and EMA [1][2] Group 1 - The POLARIS-1 study is the second global registration Phase III trial for Nilotinib approved by regulatory agencies in Europe and the U.S. [1] - The trial will enroll patients across multiple countries and centers, accelerating the market entry of Nilotinib, particularly in Europe and the U.S. [1] - The latest data from the POLARIS-1 study will be presented at the upcoming 2025 American Society of Hematology (ASH) annual meeting, marking the first public disclosure of this data [2] Group 2 - Preliminary results indicate that the molecular minimal residual disease (MRD) negative rate and complete response (CR) rate for patients treated with Nilotinib and low-intensity chemotherapy are around 65%, significantly higher than similar products under the same conditions [2] - The treatment has shown effective results even in high-risk subtypes, such as those with IKZF1plus gene mutations [2] - The safety profile of the combination therapy is favorable, with a low and manageable incidence of side effects [2]

Core Viewpoint - Ascentage Pharma-B (06855) saw a stock increase of over 6%, currently trading at 64.2 HKD with a transaction volume of 19.93 million HKD, following the announcement of the global registration Phase III clinical trial POLARIS-1 for its novel drug Olverembatin (brand name: Nairik) in treating newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) patients, which received approval from both the FDA and EMA [1][2]. Group 1 - The POLARIS-1 study is the second global registration Phase III trial for Nairik approved by regulatory agencies in Europe and the US, which will expedite its market entry, particularly in Europe and the US [1]. - The POLARIS-1 study's latest progress will be presented at the upcoming 2025 American Society of Hematology (ASH) annual meeting, marking the first public disclosure of the study data [2]. - Preliminary data from the study indicates that the molecular MRD (minimal residual disease) negative rate and molecular MRD negative complete response (CR) rate for patients treated with Nairik combined with low-intensity chemotherapy reached approximately 65%, significantly outperforming similar products under comparable conditions [2]. Group 2 - The treatment regimen demonstrated excellent safety profiles, with a low and manageable incidence of side effects, even for high-risk subtypes such as those carrying the IKZF1plus gene mutation [2].

Core Viewpoint - Ascentage Pharma-B (06855) has seen a stock price increase of over 6%, currently trading at 64.2 HKD, following the announcement of the global Phase III clinical trial POLARIS-1 for its novel drug Olverembatinib (brand name: Nilotinib) in treating newly diagnosed Ph+ acute lymphoblastic leukemia (ALL) patients, which has received approval from both the FDA and EMA [1][2] Group 1 - The POLARIS-1 study is the second global Phase III trial for Nilotinib approved by major regulatory agencies in Europe and the U.S., which will expedite its market entry, particularly in Europe and the U.S. [1] - The study will present its latest findings at the upcoming 2025 American Society of Hematology (ASH) annual meeting, marking the first public disclosure of the data [2] - Preliminary data indicates that the molecular MRD (minimal residual disease) negative rate and molecular MRD negative complete response rate for patients treated with Nilotinib combined with low-intensity chemotherapy are around 65%, significantly outperforming similar products under comparable conditions [2] Group 2 - The treatment has shown promising efficacy even in high-risk subtypes, such as those with IKZF1plus gene mutations, demonstrating good therapeutic outcomes [2] - The safety profile of the combination therapy is favorable, with a low and manageable incidence of adverse effects [2]

Core Viewpoint - The announcement highlights the approval of the global Phase III clinical trial (POLARIS-1) for the novel drug Orebatinib (brand name: Nairike®) in treating newly diagnosed Ph+ acute lymphoblastic leukemia (ALL) patients, which is expected to accelerate its market entry in Europe and the US [1][2]. Group 1: Clinical Trial Details - The POLARIS-1 study is an international, multicenter, randomized, open-label Phase III clinical trial aimed at evaluating the efficacy and safety of Nairike® in combination with chemotherapy for newly diagnosed Ph+ ALL patients [1]. - The trial has received clinical trial approval from China's CDE in 2023 and has been rapidly initiated [1]. Group 2: Study Results and Efficacy - Preliminary data from the POLARIS-1 study indicates that the molecular MRD (minimal residual disease) negative rate and molecular MRD negative complete response (CR) rate in patients treated with Nairike® and low-intensity chemotherapy are approximately 65%, significantly higher than similar products under the same conditions [2]. - The treatment shows promising efficacy even in high-risk subtypes, such as those with IKZF1plus gene mutations, and demonstrates excellent safety with low and manageable adverse effects [2]. Group 3: Market Position and Collaborations - Nairike® is a first-in-class oral third-generation TKI and the first third-generation BCR-ABL inhibitor approved in China, with commercialization in China managed by the company and Innovent Biologics [3]. - The drug has received multiple indications for treatment in CML resistance areas and is included in the national medical insurance drug list [3]. - The company has signed an exclusive option agreement with Takeda for the global development and commercialization rights of Nairike®, excluding certain regions in Greater China [3].

Core Viewpoint - The announcement highlights the approval of the global Phase III clinical trial (POLARIS-1) for the novel drug Orebatin (brand name: Nairike) in treating newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) patients, which is expected to accelerate its market entry in Europe and the US [1][2]. Group 1: Clinical Trial Details - POLARIS-1 is an international, multicenter, randomized, open-label Phase III clinical trial aimed at evaluating the efficacy and safety of Nairike in combination with chemotherapy for newly diagnosed Ph+ ALL patients [1]. - The trial has received clinical trial approval from China's CDE in 2023 and has been rapidly initiated [1]. Group 2: Efficacy and Safety Data - Preliminary data from the POLARIS-1 study indicates that the molecular minimal residual disease (MRD) negative rate and complete response (CR) rate for patients treated with Nairike and low-intensity chemotherapy are approximately 65%, significantly higher than similar products under comparable conditions [2]. - The safety profile of the combination treatment is favorable, with a low and manageable incidence of adverse effects [2]. Group 3: Market Context and Product Background - Ph+ ALL accounts for about 20%-30% of adult ALL cases, characterized by high relapse rates and poor prognosis, particularly in older patients [2]. - Nairike is a third-generation TKI and the first of its kind approved in China, with commercial promotion in China being jointly managed by the company and Innovent Biologics [3]. - The drug has received multiple indications for treatment in the CML resistant field and is included in the national medical insurance drug list [3].