Core Viewpoint - The company's 1H25 performance aligns with expectations, showing significant revenue decline due to prior year licensing income, but new product approvals are expected to drive future growth [1][2]. Financial Performance - 1H25 revenue was 234 million yuan, a year-on-year decrease of 71.6%, primarily due to last year's licensing income [1]. - The net profit attributable to the parent company was a loss of 591 million yuan in 1H25 [1]. Development Trends - The entry of the new indication for Nairike into medical insurance has led to rapid growth in commercial revenue, with Nairike (Orebatin) generating 217 million yuan in 1H25, a year-on-year increase of 93% [1]. - The approval of Lisengsu (Lishazhuokela) for market launch is expected to contribute to new growth, being the first Bcl-2 inhibitor approved for CLL/SLL in China [1]. R&D Progress - The global Phase III clinical trial GLORA-4 for Lisengsu in combination with Azacitidine has received approval from both the FDA and EMA, marking it as the only Bcl-2 inhibitor advancing in this area [2]. - Data from the 2025 ASCO indicated an overall response rate (ORR) of 75% for Lisengsu combined with Azacitidine in treating newly diagnosed MDS, highlighting a significant unmet need in this patient population [2]. Profit Forecast and Valuation - The company maintains its profit loss forecast for 2025 and 2026 at 1.09 billion HKD and 304 million HKD, respectively [2]. - The target price has been raised by 19.3% to 105 HKD, indicating a potential upside of 15.8% from the current stock price [2].

Core Viewpoint - The recent approval of the second global Phase III clinical trial for the drug Lisatoclax (brand name: Lishengtuo®) has led to a significant increase in the stock price of Ascentage Pharma-B (06855), reaching a new high of 95.35 HKD, with a year-to-date increase of 100.88% [1][2]. Group 1: Clinical Development - The GLORA-4 study, which is a global Phase III clinical trial for Lisatoclax in combination with Azacitidine (AZA) for newly diagnosed high-risk myelodysplastic syndromes (HR-MDS) patients, has received approval from the FDA and EMA [1][2]. - This study is notable as it is the only ongoing Phase III clinical trial for a Bcl-2 inhibitor in the high-risk MDS category, aiming to address a significant clinical gap in this area [2]. - The trial is designed as an international, multi-center, randomized, double-blind study to evaluate the efficacy and safety of Lisatoclax combined with AZA compared to placebo plus AZA in adult HR-MDS patients [2]. Group 2: Disease Context - Myelodysplastic syndromes (MDS) are characterized by a significant age-related incidence, with a rate of 22 per 100,000 in individuals over 65 years old, and a median diagnosis age of 70 years [3]. - The transformation rate to acute myeloid leukemia (AML) in high-risk MDS patients is alarmingly high, with a 5-year transformation rate of 40-60%, leading to poor prognosis [3]. - Current first-line treatments for high-risk MDS, such as demethylating agents, show limited efficacy, with overall response rates of only 30-40% and complete response rates of 10-17% [3]. Group 3: Drug Profile - Lisatoclax is a novel oral Bcl-2 selective inhibitor developed by Ascentage Pharma, designed to restore normal apoptosis in cancer cells [4]. - The drug has already been approved in China for use in adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have undergone prior systemic therapy [4]. - Preliminary data from the 2024 American Society of Hematology (ASH) and 2025 American Society of Clinical Oncology (ASCO) meetings indicate that Lisatoclax combined with AZA achieves an overall response rate of 75% in treatment-naive MDS, significantly outperforming existing therapies [4]. Group 4: Market Potential - The approval of the GLORA-4 study is expected to accelerate the clinical development and registration process for Lisatoclax in MDS indications, addressing a substantial unmet clinical need in the market [5][6]. - The company aims to position Lisatoclax as the first targeted therapy approved for first-line treatment of high-risk MDS patients, potentially reshaping the treatment landscape in this area [5][6].

Group 1 - The stock of Ascentage Pharma-B (06855) opened over 4% higher, reaching a historical high of 90 HKD, with a trading volume of 16.89 million HKD [1] - The company announced that its self-developed Bcl-2 selective inhibitor, Lisatoclax (brand name: Lifespan; R&D code: APG-2575), has received approval from the FDA and EMA to conduct a global Phase III clinical trial (GLORA-4) for the treatment of newly diagnosed high-risk myelodysplastic syndromes (HR-MDS) patients [1] - GLORA-4 is the second global Phase III study for Lisatoclax approved by regulatory agencies in Europe and the US, which will accelerate the new drug's market entry process [1] Group 2 - Lisatoclax is a novel oral Bcl-2 selective inhibitor developed by Ascentage Pharma, which selectively inhibits the Bcl-2 protein to restore the normal apoptosis process of cancer cells, thereby treating tumors [2] - The product has already been approved for marketing in China for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have received at least one systemic treatment including a Bruton tyrosine kinase (BTK) inhibitor [2] - Lisatoclax is the first domestically developed original Bcl-2 inhibitor approved for marketing in China and is currently the only Bcl-2 inhibitor advancing to a Phase III clinical trial for high-risk MDS internationally [2]

Core Viewpoint - The announcement highlights the approval of the global Phase III clinical trial (GLORA-4) for the Bcl-2 selective inhibitor, Lisatoclax (APG-2575), in combination with Azacitidine (AZA) for treating newly diagnosed high-risk myelodysplastic syndromes (HR-MDS) patients, marking a significant milestone in the drug's global clinical development [1][2]. Group 1: Clinical Trial Details - GLORA-4 is an international, multicenter, randomized, double-blind Phase III clinical trial aimed at evaluating the efficacy and safety of Lisatoclax combined with AZA compared to placebo plus AZA in adult HR-MDS patients [2]. - The trial has received clinical trial approval from the CDE in 2024 and is currently enrolling patients globally, with the first patients enrolled in China and Europe [2]. - Leading principal investigators include Professor Garcia Manero from MD Anderson Cancer Center and Professor Huang Xiaojun from Peking University [2]. Group 2: Disease Background and Treatment Challenges - Myelodysplastic syndromes (MDS) are hematopoietic clonal proliferative diseases with significant age-related characteristics, showing an exponential increase in incidence with age, particularly affecting those over 65 years [2]. - The core risk of MDS is the transformation to acute myeloid leukemia (AML), with a 5-year transformation rate of 40-60% in high-risk patients, leading to poor prognosis [2]. Group 3: Current Treatment Landscape - Current first-line treatment options for high-risk MDS, such as hypomethylating agents (HMAs), have an overall response rate (ORR) of only 30-40% and a complete response (CR) rate of 10-17%, with a median duration of response of 9-12 months [3]. - Allogeneic hematopoietic stem cell transplantation (allo-HSCT) offers potential cure but is limited by patient age, complex conditions, and a transplant-related mortality (TRM) rate of 25-35%, making only 5-10% of patients suitable for transplantation [3]. Group 4: Drug Profile and Efficacy - Lisatoclax is a novel oral Bcl-2 selective inhibitor developed by the company, designed to restore normal apoptosis in cancer cells by selectively inhibiting the Bcl-2 protein [3]. - The drug has already been approved in China for use in adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have undergone at least one prior systemic therapy [3]. - Preliminary data from the 2024 American Society of Hematology (ASH) and 2025 American Society of Clinical Oncology (ASCO) meetings indicate that Lisatoclax combined with AZA achieved an ORR of 75% in treatment-naive MDS, significantly outperforming HMAs, with a favorable safety profile [4].

Core Viewpoint - The announcement highlights the approval of the global Phase III clinical trial (GLORA-4) for the Bcl-2 selective inhibitor, lisatoclax (brand name: Lishengtuo), in combination with azacitidine (AZA) for treating newly diagnosed high-risk myelodysplastic syndromes (HR-MDS) patients, marking a significant milestone in the drug's global clinical development [1][2]. Company Summary - As of the announcement date, lisatoclax is the only Bcl-2 inhibitor advancing to a Phase III clinical trial for high-risk MDS globally, indicating its unique position in the market [1]. - The drug has already been approved in China for use in adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have undergone at least one prior systemic therapy, making it the first domestically developed Bcl-2 inhibitor approved in China [3]. Industry Summary - The GLORA-4 study is an international, multicenter, randomized, double-blind Phase III trial aimed at evaluating the efficacy and safety of lisatoclax combined with AZA compared to placebo plus AZA in newly diagnosed adult HR-MDS patients [2]. - MDS is characterized by significant age-related features, with an incidence rate that increases exponentially with age, particularly affecting individuals over 65 years, where the annual incidence rate reaches 22 per 100,000 [2]. - The core risk of MDS lies in the clonal evolution leading to acute myeloid leukemia (AML) transformation, with a 5-year transformation rate of 40-60% for high-risk patients, resulting in a median survival of less than 6 months post-transformation [2]. - Current first-line treatments for high-risk MDS, such as hypomethylating agents (HMAs), show a total response rate of only 30-40% and a complete response rate of 10-17%, highlighting the urgent need for breakthrough therapies [3]. - Recent data from the 2024 American Society of Hematology (ASH) annual meeting and the 2025 American Society of Clinical Oncology (ASCO) annual meeting indicate that lisatoclax combined with AZA achieved an overall response rate of 75% in treatment-naive MDS, significantly outperforming HMAs [4].

Group 1 - As of recent announcements, the company has completed a fundraising of approximately HKD 14.93 billion (around CNY 1.368 billion), bringing total fundraising to over CNY 2.2 billion within six months [1][3] - The core purpose of the fundraising is to commercialize the newly approved core product, APG-2575, a selective Bcl-2 inhibitor, which is the first domestically developed Bcl-2 inhibitor approved for market [1][4] - The company plans to establish its own commercialization team for APG-2575, with expectations to achieve breakeven by 2027 [1][6] Group 2 - The recent fundraising was completed through the sale of 22 million shares at HKD 68.60 each, with all preconditions for the placement being met [2][3] - The net proceeds from the recent fundraising are expected to be allocated as follows: 40% for expanding coverage and improving patient access (approximately CNY 5.47 billion), 35% for global clinical development of core pipeline products (approximately CNY 4.76 billion), and 25% for infrastructure and operational funding (approximately CNY 3.42 billion) [3] - The company has signed cooperation agreements with major pharmaceutical distributors to advance the commercialization of APG-2575 [6] Group 3 - The company reported a revenue of CNY 981 million in 2024, with a loss of CNY 405 million, marking the lowest loss level in recent years [6] - The company is currently conducting four global Phase III clinical trials for APG-2575, targeting multiple indications including acute myeloid leukemia and multiple myeloma [7] - The global sales of the first Bcl-2 inhibitor, Venclexta, are projected to exceed USD 3 billion in 2024, indicating a strong market potential for Bcl-2 inhibitors [7]

Core Insights - The article highlights the launch of a new oral Bcl-2 selective inhibitor, Lisangtuo® (generic name: Lishatoklaku), developed by Ascentage Pharma, which is now exclusively available on JD Health [1][3] - Lisangtuo® is the first domestically approved original Bcl-2 inhibitor in China and the second globally, aimed at treating adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have undergone at least one prior systemic therapy including BTK inhibitors [1][3] - The drug works by selectively inhibiting the Bcl-2 protein, restoring normal apoptosis in tumor cells, and is expected to have fewer interactions with common drugs and more controllable effects on platelets compared to traditional CLL/SLL medications [1][3] Industry Context - The development of Bcl-2 inhibitors is challenging due to complex protein-protein interactions and the need for the drug to penetrate both the cell membrane and mitochondrial membranes [3] - Prior to Lisangtuo®, no Bcl-2 inhibitors had been approved for CLL/SLL treatment in China, indicating a significant advancement in the field [3] - The successful launch of Lisangtuo® represents a major step for China in the treatment of hematological malignancies and showcases Ascentage Pharma's leading capabilities in global innovative research and development [3] Distribution Strategy - JD Health is leveraging its capabilities in pharmaceutical supply chain and healthcare services to provide comprehensive support, including drug consultation, doctor consultations, and efficient delivery for users in need [4]

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].