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].

Core Viewpoint - Ascentage Pharma has received FDA and EMA clearance for the GLORA-4 study, a Phase III trial for lisaftoclax in combination with azacitidine for treating higher-risk myelodysplastic syndrome (HR-MDS), marking a significant step towards addressing unmet medical needs in this area [1][2][3] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on developing novel therapies for cancer, with a strong pipeline that includes innovative drug candidates targeting key proteins in the apoptotic pathway [11][12] Study Details - The GLORA-4 study is a global, multi-center, randomized, double-blind Phase III trial designed to evaluate the efficacy and safety of lisaftoclax combined with azacitidine compared to placebo plus azacitidine in newly diagnosed adult patients with HR-MDS [3][4] - This study is the second registrational Phase III trial for lisaftoclax to receive clearance from both the FDA and EMA, with simultaneous patient enrollment across multiple countries [2][3] Clinical Need - There is a significant unmet clinical need for targeted therapies in first-line treatment for higher-risk MDS, as current options like hypomethylating agents (HMA) and allogeneic hematopoietic stem cell transplantation (allo-HSCT) have limitations [3][5] - The overall response rate (ORR) for HMAs is only 30-40%, with a complete response (CR) rate of 10-17%, highlighting the urgent need for innovative therapies [5][9] Clinical Data - Earlier studies of lisaftoclax in combination with azacitidine showed an ORR of 75%, significantly higher than HMAs alone, with a favorable safety profile and low incidence of severe hematologic toxicities [8][9] - The combination therapy demonstrated a low requirement for dose adjustments and no treatment-related mortalities within 60 days, indicating its potential as a superior treatment option [8][9] Expert Commentary - Experts emphasize the challenges in treating higher-risk MDS due to the limited efficacy of current therapies and the absence of breakthrough treatments in the last two decades, underscoring the importance of the GLORA-4 study [9][10]

Core Viewpoint - Ascentage Pharma has received FDA and EMA clearance for the GLORA-4 study, a Phase III trial of lisaftoclax in combination with azacitidine for treating higher-risk myelodysplastic syndrome (HR-MDS), marking a significant step towards addressing unmet medical needs in this area [1][2][3] Company Overview - Ascentage Pharma is a global, commercial stage biopharmaceutical company focused on developing novel therapies for cancer [1][11] - The company has a robust pipeline that includes innovative drug candidates targeting key proteins in the apoptotic pathway [12][14] Study Details - The GLORA-4 study is a global, multi-center, randomized, double-blind Phase III trial designed to evaluate the efficacy and safety of lisaftoclax combined with azacitidine compared to placebo plus azacitidine in newly diagnosed adult patients with HR-MDS [3][4] - This study is notable as it is the second registrational Phase III study of lisaftoclax to receive clearance from both the FDA and EMA [2][3] Clinical Need - There is a significant unmet clinical need for targeted therapies in first-line treatment of higher-risk MDS, as current options like hypomethylating agents (HMA) and allogeneic hematopoietic stem cell transplantation (allo-HSCT) have limitations [3][5][9] - The overall response rate (ORR) for HMAs is only 30-40%, with a complete response (CR) rate of 10-17%, highlighting the need for more effective treatments [5][9] Lisaftoclax Profile - Lisaftoclax is a proprietary, orally administered Bcl-2 selective inhibitor that has shown promising clinical benefits and tolerability in earlier studies [6][8] - The drug is already approved in China for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have received prior systemic therapy [7][14] Clinical Data - Clinical data presented at major conferences indicated an ORR of 75% for the combination of lisaftoclax and azacitidine in treatment-naïve MDS, significantly higher than HMAs alone [8] - The combination therapy demonstrated a favorable safety profile with low incidence of severe hematologic toxicities [8][9] Global Collaboration - The GLORA-4 trial is being co-led by prominent researchers from leading institutions, including The University of Texas MD Anderson Cancer Center and Peking University [3][4]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的全部內容概不負責，對其準 確性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因 倚賴該等內容而引致的任何損失承擔任何責任。 ASCENTAGE PHARMA GROUP INTERNATIONAL 亞盛醫藥集團 （於開曼群島註冊成立的有限公司） （股份代號：6855） 自願公告 亞盛醫藥利生妥®一線治療中高危MDS患者的全球註冊III期臨床研究 獲美國FDA和歐洲EMA批准 亞盛醫藥集團（「本公司」或「亞盛醫藥」）欣然宣佈，本公司自主研發的Bcl-2選 擇性抑制劑利沙托克拉（商品名：利生妥®；研發代碼：APG-2575）聯合阿扎胞 苷(AZA)一線治療新診斷的中高危骨髓增生異常綜合症(HR-MDS)患者的全球註 冊III期臨床研究(GLORA-4)獲美國食品藥品監督管理局(FDA)和歐洲藥品管理 局(EMA)同意開展。作為利生妥®在歐美監管機構獲批的第二個全球III期研究， GLORA-4 (NCT06641414)在多國家多中心同步入組，將加速新藥上市進程。截止 本公告日期，利生妥®也是國際上唯一正推進中高危MDS註冊I ...

Core Viewpoint - The controlling shareholder of Xuantai Pharmaceutical, Shanghai Lianhe Investment Co., Ltd., has voluntarily committed not to reduce its shareholding for 24 months starting from August 25, 2025, to enhance investor confidence and maintain market stability [1][4] Group 1: Shareholder Commitment - The commitment not to reduce shareholding is based on confidence in Xuantai Pharmaceutical's future development and long-term value recognition [1] - On August 25, 2023, a total of 311 million shares of Xuantai Pharmaceutical will be unlocked, accounting for 68.61% of the total share capital, with Lianhe Investment holding 233 million shares, representing 75% of the unlocked shares [1] Group 2: Business Development and Competitive Edge - Xuantai Pharmaceutical's controlling shareholder is optimistic due to the robust development of the company's core strategic business and the broad industry prospects [2] - The company has established three major technology platforms for high-barrier products in the generic drug sector, including "insoluble drug solubilization technology platform," "controlled-release drug formulation R&D platform," and "fixed-dose combination formulation R&D platform" [2] - By the end of 2024, Xuantai Pharmaceutical is expected to have 16 approved products, including several first-generic products domestically and internationally [2] Group 3: CRO/CMO Performance - In the CRO/CMO sector, Xuantai Pharmaceutical has successfully assisted in the approval of multiple innovative drugs and has developed over 100 innovative drug formulations [3] - The company has established partnerships with several listed companies and well-known pharmaceutical enterprises, providing CMO services for eight approved new drug products [3] Group 4: Investor Relations and Dividends - Xuantai Pharmaceutical prioritizes cash dividends to reward shareholders, having distributed a total of 74.36 million yuan in cash dividends since its listing in 2022, with plans for mid-term dividends in 2024 [3] - The commitment from the controlling shareholder serves as a strong vote of confidence in the company's existing development strategy and management team [4]

Core Insights - China's innovative drug development is transitioning from imitation to independent innovation, with significant achievements in international markets [1][4] - The number of new drugs under research in China is projected to rank second globally by 2024, indicating a growing industry scale [1][3] Group 1: R&D and Market Growth - Over 110 domestic innovative drugs have been approved since the 14th Five-Year Plan, with a market size reaching 100 billion yuan [3] - The number of domestic innovative drugs in clinical trials has surpassed 50%, showcasing the rapid development of local pharmaceutical companies [1][2] Group 2: International Expansion - In 2024, Chinese pharmaceutical companies completed over 90 overseas licensing transactions, with a total transaction value exceeding 50 billion USD [5][7] - The trend of Chinese innovative drugs entering international markets is primarily through licensing agreements, with significant deals such as a 6 billion USD agreement between 3SBio and Pfizer [6][7] Group 3: Regulatory and Financial Support - The Chinese government has implemented policies to expedite the approval process for innovative drugs, reducing review times to 30 working days [9] - A new fund has been established to support private enterprises in the pharmaceutical sector, with investments totaling 10 billion yuan [10] - The National Healthcare Security Administration has introduced measures to support innovative drug development, encouraging long-term investments from commercial insurance [11]

Core Insights - China's innovative drug development is transitioning from imitation to independent innovation, with significant achievements in international markets [1][5][7] - The number of new drugs under research in China is projected to rank second globally by 2024, indicating a growing industry scale [3][6] - The domestic innovative drug market has seen over 110 new drugs approved since the 14th Five-Year Plan, with a market size reaching 100 billion yuan [6][12] R&D Advancements - Domestic innovative drugs now account for over half of the clinical trials at Beijing University Cancer Hospital, showcasing rapid development in this sector [1][3] - Multiple innovative drugs have been approved in the first half of this year, including treatments for rare diseases and other conditions, marking breakthroughs in previously unmet clinical needs [5][6] International Expansion - Chinese pharmaceutical companies are increasingly engaging in overseas licensing agreements, with over 90 transactions completed in 2024, totaling more than 50 billion USD [7][9] - Notable licensing deals include a 60 billion USD agreement between 3SBio and Pfizer, and a 125 billion USD deal between Hengrui Medicine and GlaxoSmithKline [9][10] Policy Support - The Chinese government is implementing policies to support the entire lifecycle of innovative drugs, including expedited approval processes and financial investments [11][14] - Recent measures include a 30-day approval timeline for innovative drugs and the establishment of funds to support research and development in the pharmaceutical sector [12][15] Market Dynamics - The innovative drug market is experiencing a surge in both quantity and quality, with a notable increase in the approval of new drugs that cater to both domestic and international patients [7][8] - The market is evolving to include a diverse range of biopharmaceuticals, including monoclonal antibodies and CAR-T cell therapies, reflecting a shift towards cutting-edge technologies [10][11]

Core Viewpoint - As of August 14, 2023, AAPG's stock price increased by 3.16%, reaching $42.45 per share, with a total market capitalization of $3.946 billion. The company reported a total revenue of 981 million RMB for the year ending December 31, 2024, representing a year-on-year growth of 341.77%, while the net profit attributable to shareholders was -405 million RMB, showing a growth of 56.2% year-on-year [1][2]. Company Overview - AAPG is a biopharmaceutical company based in China, focusing on global markets, dedicated to developing innovative drugs for the treatment of 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]. - AAPG has developed a proprietary drug design platform targeting protein-protein interactions and is at the forefront of new drug development in the apoptosis pathway [2]. Product Pipeline - The company has established a pipeline of nine Class 1 small molecule new drugs that have entered clinical development, including inhibitors targeting key proteins in the apoptosis pathway such as Bcl-2, IAP, and MDM2-p53 [2]. - AAPG is the only innovative company globally with clinical development products in all key proteins of the apoptosis pathway [2]. - The core product, Orebatinib (brand name: Nairike), has been approved in China and included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2022) [2]. Clinical Trials and Regulatory Approvals - The company is conducting over 40 clinical trials across China, the United States, Australia, and Europe [2]. - Orebatinib has received priority review and breakthrough therapy designation from the China National Medical Products Administration (NMPA) and has also been granted fast track designation, orphan drug designation by the FDA, and orphan drug designation by the EU [2]. - AAPG has four investigational new drugs that have received 16 FDA orphan drug designations, two FDA fast track designations, and two FDA rare pediatric disease designations [2]. Research and Development - AAPG has undertaken multiple national science and technology major projects, including five in the "Major New Drug Creation" initiative and one in "Major Infectious Disease Prevention and Control" [2]. - The company has established global collaborations with leading biotechnology and pharmaceutical companies and academic institutions, including UNITY, MD Anderson, Mayo Clinic, Dana-Farber Cancer Institute, Merck, AstraZeneca, and Pfizer [2]. - AAPG is committed to enhancing its R&D capabilities and accelerating the clinical development of its product pipeline to meet unmet clinical needs globally [2].

Core Viewpoint - As of August 13, 2023, AAPG's stock price increased by 3.23% to $41.5 per share, with a total market capitalization of $3.858 billion. The company reported a total revenue of 981 million RMB for the year ending December 31, 2024, representing a year-on-year growth of 341.77%, while the net profit attributable to shareholders was -405 million RMB, showing a growth of 56.2% year-on-year [1][3]. Company Overview - AAPG is a biopharmaceutical company based in China with a global focus, dedicated to developing innovative drugs for the treatment of 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]. - AAPG has developed a proprietary drug design platform targeting protein-protein interactions and is at the forefront of new drug development in the apoptosis pathway [2]. Product Pipeline - The company has established a pipeline of nine Class 1 small molecule new drugs that have entered clinical development, including inhibitors targeting key proteins in the apoptosis pathway such as Bcl-2, IAP, and MDM2-p53 [2]. - AAPG is the only innovative company globally with clinical development products in all key proteins of the apoptosis pathway [2]. - The core product, Aorebatin (brand name: Nairike), has been approved in China and is included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2022) [2]. Clinical Trials and Regulatory Approvals - The company is conducting over 40 clinical trials across China, the United States, Australia, and Europe [2]. - AAPG has received multiple designations from the FDA, including orphan drug status and fast track designation for four investigational new drugs [2]. - The company has undertaken several national science and technology major projects, including five under the "Major New Drug Creation" initiative [2]. Collaborations and Talent - AAPG has established global collaborations with leading biotechnology and pharmaceutical companies and academic institutions, including UNITY, MD Anderson, Mayo Clinic, Dana-Farber Cancer Institute, Merck, AstraZeneca, and Pfizer [2]. - The company has built an international team with extensive experience in original drug research and clinical development [2].

Core Viewpoint - The stock price of HeYu-B (02256) has surged nearly 200% year-to-date, driven by favorable policies and a warming investment climate in the Hong Kong innovative drug sector, leading to increased emphasis on the commercialization capabilities of innovative drug companies [1][2]. Group 1: Stock Performance and Market Recognition - On August 11, the company's stock price surpassed the IPO price of HKD 12.46, closing up 5.93%, and reached a new high of HKD 13.67 the following day [1]. - HeYu was included in the MSCI Global Small Cap Index, which tracks over USD 17 trillion in assets, enhancing its market liquidity and international visibility [4]. Group 2: Innovation and Financial Performance - HeYu's core product, Pimicotinib, is the first Chinese-developed CSF-1R inhibitor entering global Phase III clinical trials, with significant potential in various indications [5][6]. - The company secured a high-value partnership with Merck, receiving an upfront payment of USD 70 million, which is expected to lead to its first annual profit in 2024 [5][7]. - HeYu has maintained around HKD 2 billion in cash reserves over the past three years, ensuring financial stability and supporting ongoing R&D efforts [9]. Group 3: Pipeline and Future Prospects - HeYu's pipeline includes multiple innovative drugs, with Pimicotinib and the FGFR4 inhibitor Irpagratinib being highlighted as potential blockbuster products [10]. - The company has presented promising preclinical results at major conferences, showcasing its advancements in small molecule innovation [10]. - HeYu's stock buyback program, amounting to HKD 200 million, reflects its commitment to returning value to shareholders while maintaining a low price-to-sales (PS) ratio of 13.38, indicating significant growth potential [11].