Core Insights - A Chinese original drug, APG-2575 (brand name: Lisatoclax), has broken the nearly decade-long monopoly of multinational pharmaceutical companies in the global anti-cancer drug market, marking a significant shift in the competitive landscape [2][9] - The drug has received conditional approval from the National Medical Products Administration (NMPA) in China for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have undergone at least one systemic treatment including a BTK inhibitor [2][5] Drug Development Challenges - The Bcl-2 target, discovered in 1985, has only two approved drugs: AbbVie's venetoclax and APG-2575, due to the high difficulty of drug development associated with protein-protein interactions and the need for drugs to penetrate cell membranes and mitochondrial membranes [3][4] - Major pharmaceutical companies have attempted to develop Bcl-2 inhibitors over the past 20 years without success, highlighting the complexity of this target [4] Market Potential - The global targeted apoptosis therapy market is projected to grow at a compound annual growth rate (CAGR) of 24% from 2023 to 2030, reaching a market size of $22 billion by 2030 [6] - The approval of Lisatoclax is expected to change treatment paradigms and expand the market for Bcl-2 inhibitors, especially in combination therapies [6] Commercialization Strategy - The company plans to independently drive the commercialization of Lisatoclax in China, aiming to explore additional indications beyond CLL/SLL [7][8] - The CEO emphasizes the importance of generating profits from product sales to support ongoing research and development, aiming for the company to achieve overall profitability by 2027 [8] Industry Trends - Following the success of APG-2575, other Chinese companies like BeiGene and Innovent Biologics are also developing Bcl-2 inhibitors, indicating a shift towards a new ecosystem of anti-cancer drugs led by Chinese enterprises [9]

Company Update - The company announced that its self-developed Bcl-2 selective inhibitor, APG-2575 (also known as Lisangtuo), received conditional approval from the National Medical Products Administration of China for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously undergone at least one systemic therapy including a Bruton tyrosine kinase (BTK) inhibitor [1] - Lisangtuo is the first Bcl-2 inhibitor approved in China for the treatment of CLL/SLL and the second globally, following AbbVie's venetoclax [1] Clinical Value and Research - The approval of Lisangtuo is based on a pivotal Phase II clinical study (APG2575CC201) that demonstrated an overall response rate (ORR) meeting the predefined endpoint for patients who failed BTK inhibitors and/or immunochemotherapy, with a favorable safety profile [2] - The drug has been included in the "CSCO Lymphoma Diagnosis and Treatment Guidelines 2025" as of April 2025 [2] - The company is conducting four global Phase III clinical studies to further explore Lisangtuo's indications, including studies for treated CLL/SLL patients and newly diagnosed acute myeloid leukemia (AML) patients [2] Profit Forecast and Valuation - The company maintains its net profit forecast for 2025 and 2026 at a loss of 1.09 billion yuan and 320 million yuan, respectively [2] - Given the approval of Lisangtuo and the potential for global indication expansion, the company maintains an outperform rating and raises the target price by 27.5% to 88 HKD, indicating a 15.3% upside from the current stock price [2]

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company has received conditional approval from the National Medical Products Administration (NMPA) for its self-developed Bcl-2 selective inhibitor APG-2575, marking it as the first domestically produced Bcl-2 inhibitor to be launched in China [7] - APG-2575 is positioned as a new treatment option for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously undergone at least one systemic therapy, including BTK inhibitors [7] - The company expects rapid revenue growth driven by the sales of its drug Aolebatin and potential payments from Takeda, with projected revenues of 5.19 billion, 32.15 billion, and 20.95 billion yuan for 2025, 2026, and 2027 respectively [1][7] Financial Projections - Total revenue is projected to reach 980.65 million yuan in 2024, followed by 519 million yuan in 2025, and then a significant increase to 3,215 million yuan in 2026, before declining to 2,095 million yuan in 2027 [1][8] - The net profit attributable to the parent company is expected to be (405.43) million yuan in 2024, (726.53) million yuan in 2025, 1,097.79 million yuan in 2026, and (841.66) million yuan in 2027 [1][8] - The earnings per share (EPS) are forecasted to be (1.16) yuan in 2024, (2.08) yuan in 2025, 3.15 yuan in 2026, and (2.42) yuan in 2027 [1][8]

Core Viewpoint - The approval of the new Bcl-2 selective inhibitor, Lisengmato, by the National Medical Products Administration (NMPA) in China marks a significant milestone for Ascentage Pharma, making it the first domestically developed Bcl-2 inhibitor to be conditionally approved for marketing and the second globally [2][3]. Group 1: Product Development and Market Position - Lisengmato is an oral Bcl-2 selective inhibitor developed by Ascentage Pharma, designed to restore the normal apoptosis process in tumor cells, thereby treating tumors [2]. - The approval of Lisengmato highlights Ascentage Pharma's strong innovation capabilities and establishes its leading position in the hematological oncology field [4]. - The company has been engaged in Bcl-2 target drug development for over 30 years, indicating deep expertise in this area [2]. Group 2: Clinical Relevance and Market Need - Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) is a prevalent blood cancer in aging populations, with an increasing incidence in China despite lower rates compared to Europe and the U.S. [3]. - The introduction of Bcl-2 inhibitors like Lisengmato addresses unmet clinical needs in the treatment of CLL/SLL, providing new therapeutic options for patients facing challenges such as drug resistance and complex long-term management [3]. - Ascentage Pharma is conducting four global Phase III clinical trials for Lisengmato, indicating ongoing commitment to expanding its clinical applications [4].

Core Viewpoint - The approval of the novel Bcl-2 inhibitor, Lisatoclax (APG-2575), by the National Medical Products Administration (NMPA) in China marks a significant milestone for Ascentage Pharma, as it becomes the first domestically developed Bcl-2 inhibitor approved for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in China and the second globally [1][2]. Group 1: Product Approval and Significance - Lisatoclax is the first Bcl-2 inhibitor approved in China for CLL/SLL, highlighting its potential in the treatment landscape [2][3]. - The drug is expected to restore normal apoptosis in tumor cells by selectively inhibiting the Bcl-2 protein, offering new treatment options for patients [2][3]. - The approval signifies Ascentage Pharma's commitment to global clinical innovation and represents a key milestone in its journey to enter the global market [2]. Group 2: Clinical Research and Development - Ascentage Pharma is conducting four global Phase III clinical trials for Lisatoclax, targeting various patient groups, including those with previously treated CLL/SLL and newly diagnosed acute myeloid leukemia (AML) [2]. - The ongoing studies include the GLORA study for treated CLL/SLL patients and GLORA-2 for treatment-naive CLL/SLL patients, among others [2]. Group 3: Challenges in Bcl-2 Inhibition - The development of Bcl-2 inhibitors has been challenging due to the complex nature of protein-protein interactions and the need for drugs to penetrate cellular membranes and mitochondrial membranes [3]. - Prior to Lisatoclax, no Bcl-2 inhibitors had been approved for CLL/SLL treatment in China, indicating a significant advancement in addressing this treatment gap [3].

Company Updates - The company presented data on Bcl-2 inhibitor APG-2575 (lisaftoclax) in combination with azacitidine for myeloid malignancies at the 2025 ASCO annual meeting, along with updates on MDM2-p53 inhibitor APG-115 (alrizomadlin) for advanced adenoid cystic carcinoma (ACC) and other solid tumors [1][2] Clinical Data Highlights - APG-2575 demonstrated promising results in a global multicenter Ib/II study for relapsed/refractory acute myeloid leukemia (R/R AML) with an overall response rate (ORR) of 43.2% among 44 evaluable patients, including a complete response (CR) or complete response with incomplete blood count recovery (CRi) rate of 31.8% [1] - In a subgroup of 22 patients previously treated with venetoclax, the ORR was 31.8%, with 22.8% achieving CR/CRi [1] - For newly diagnosed myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML), APG-2575 showed an ORR of 80% in 15 evaluable patients, with 40% achieving CR [2] - Among 22 evaluable R/R MDS/CMML patients, the ORR was 50%, with 27.3% achieving CR [2] - APG-115 showed anti-tumor activity with an ORR of 16.7% in advanced ACC patients and 100% disease control rate (DCR) in a cohort of cholangiocarcinoma patients [2] Financial Forecast and Valuation - The company maintains its net loss forecast for 2025 and 2026 at 1.095 billion and 319 million respectively [3] - Due to the promising data from APG-2575, the company sees potential for unlocking more commercial value in AML/MDS indications and has raised its target price by 25.5% to HKD 69, indicating a 16.2% upside from the current stock price [3]

Core Viewpoint - Ascentage Pharma's stock surged over 7%, reaching a historic high of 59.55 HKD, following the presentation of promising clinical trial data for its Bcl-2 inhibitor, APG-2575 (lisaftoclax), at the 61st American Society of Clinical Oncology (ASCO) annual meeting [1] Group 1: Clinical Research and Development - The latest data from the Ib/II clinical study of APG-2575 combined with azacitidine for treating newly diagnosed or previously treated myeloid malignancies demonstrated both excellent efficacy and safety [1] - The study reported for the first time that lisaftoclax showed good therapeutic responses in patients who previously failed treatment with venetoclax, highlighting its differentiated efficacy and potential advantages over similar products [1] Group 2: Regulatory Progress - Lisaftoclax, a novel Bcl-2 selective inhibitor developed by Ascentage Pharma, has had its New Drug Application (NDA) accepted for priority review by the National Medical Products Administration (NMPA) in November 2024 for treating relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [2] - It is the second Bcl-2 inhibitor globally to submit an NDA and the first domestically developed Bcl-2 inhibitor in China to enter priority review [2] - Currently, there are four global registration III clinical trials underway for Lisaftoclax, covering indications such as CLL/SLL, acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS), with one trial being FDA-approved for global registration [2]

Core Viewpoint - The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting is a significant event in the oncology field, attracting global attention from both academia and investors, particularly regarding investment opportunities in innovative drugs like Lisaftoclax from Ascentage Pharma [1][3]. Group 1: Company Developments - Ascentage Pharma's stock price surged by 9.13% on May 23, reaching a peak of 53.20 HKD, marking the highest level since August 2021, following the announcement of data at the ASCO meeting [1]. - Lisaftoclax (APG-2575), a Bcl-2 inhibitor, is the second globally to submit a New Drug Application (NDA) and the first domestic Bcl-2 inhibitor in China to enter priority review, showcasing its potential in treating various hematological malignancies [3][12]. - The drug has been included in the 2025 CSCO Lymphoma Diagnosis and Treatment Guidelines, marking its first inclusion and recognition by a top academic institution in China [4]. Group 2: Clinical Research and Data - The latest clinical data presented at ASCO demonstrated that Lisaftoclax, in combination with Azacitidine, showed good tolerability and preliminary efficacy in treating newly diagnosed or previously treated acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) patients [5][7]. - In a study involving 103 patients, the overall response rate (ORR) for newly diagnosed AML patients was 83.3%, while the ORR for relapsed/refractory AML patients was 43.2% [6]. - Among 28 patients with relapsed/refractory AML who were previously treated with Venetoclax, the ORR was 31.8%, indicating Lisaftoclax's potential to overcome Venetoclax resistance [8][11]. Group 3: Market Potential - The global market for hematological malignancy treatments is projected to reach $40 billion by 2024, with a compound annual growth rate (CAGR) of 6% from 2024 to 2029, highlighting the significant unmet clinical needs in this area [10]. - Lisaftoclax is expected to achieve over $2 billion in sales potential, driven by its unique positioning and clinical data that suggest it could surpass the market performance of existing Bcl-2 inhibitors like Venetoclax [9][11].