引言：从差点倒闭的"小公司"到全球资本追捧的"小分子玩家" 如果把时间拨到今天，亚盛医药已经是一家"站在聚光灯下"的公司： 一边是在香港联交所主板挂牌，早在2019年就成为首批登陆港股的小分子创新药企之一； 一边是在2025年1月敲开纳斯达克的大门，拿下约1.26亿美元募资，成为 首家"先港后美"双重上市的中国生物医药企业 。 资本市场之外，2024年又与武田制药签下总金额高达13亿美元的全球合作，将核心产品耐立克的海外权益打包交给这家跨国巨头， 刷新国产小分子肿瘤 药的对外 BD 纪录 。 产品线的"现实画面"同样不逊色。 第三代BCR-ABL抑制剂耐立克已在中国获批两项适应症，2023年进入国家医保目录后加速放量，2025年上半年贡献了2.17亿元销售收入，同比大增 93%，一款单品就撑起了公司九成以上营收。 另一边，Bcl-2抑制剂利生妥也在2025年7月迎来首个上市许可，成为 中国首个国产原研Bcl-2抑制剂、全球第二个同类产品 ，被普遍视作具备Best-in- class潜力的新一代重磅品种。 但如果把时间轴向回拨20多年，故事的开头却完全不是这样。亚盛医药的前身，是2003年三位海归科学家在美国创 ...

Core Insights - Ascentage Pharma (亚盛医药-B) announced that three of its products (Neratinib, Lisatinib, APG-5918) have multiple clinical and preclinical advancements selected for presentation at the 67th American Society of Hematology (ASH) Annual Meeting, with one receiving an oral presentation [1][2] Group 1: Product Developments - Neratinib (耐立克) is the first third-generation BCR-ABL inhibitor approved in China, with commercialization jointly managed by Ascentage Pharma and Innovent Biologics. The company will present the latest data from the global Phase III POLARIS-1 study on Neratinib combined with low-intensity chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) patients at the ASH meeting [2] - The company will also update data from a randomized controlled Phase II study on Neratinib for patients with tyrosine kinase inhibitor-resistant chronic myeloid leukemia in chronic phase (CML-CP) during the conference [2] - Lisatinib (利生妥), a novel oral Bcl-2 selective inhibitor developed by Ascentage Pharma, has broad therapeutic potential in various hematological malignancies and solid tumors. It has been approved in China for adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have undergone at least one systemic treatment including a Bruton tyrosine kinase (BTK) inhibitor. The latest progress of its Phase II clinical study for monotherapy in relapsed/refractory CLL/SLL patients will be reported orally at the ASH meeting [2] Group 2: ASH Annual Meeting - The ASH Annual Meeting is one of the largest international academic events in the field of hematology, covering research on the etiology and treatment of blood diseases. The 67th ASH Annual Meeting will be held from December 6 to December 9, 2025, in Orlando, Florida, in a hybrid format [3]

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 亞盛醫藥耐立克®、利生妥®、APG-5918的多項臨床進展將 在2025年美國血液學會年會(ASH)展示，其中一項獲口頭報告 亞盛醫藥集團（「本公司」或「亞盛醫藥」）欣然宣佈，本公司3個品種（耐立克®、利 生妥®、APG-5918）有多項臨床和臨床前進展入選第67屆美國血液學會(American Society of Hematology, ASH)年會展示及報告，其中一項獲口頭報告。其中，本 公司原創1類新藥奧雷巴替尼（商品名：耐立克®）有多項臨床進展獲選第67屆ASH 年會，這是該品種的臨床進展連續第8年入選ASH年會。此外，本公司原創1類新 藥利沙托克拉（商品名：利生妥®；研發代碼：APG-2575）共有2項臨床進展獲選 第67屆ASH年會， ...

Core Insights - The article highlights the journey of Ascentage Pharma, emphasizing its commitment to addressing unmet clinical needs through innovation and perseverance in the pharmaceutical industry [2][6]. Group 1: Company Overview - Ascentage Pharma, founded in 2009, has evolved from a small startup to a publicly listed company on both the Hong Kong Stock Exchange and NASDAQ, marking significant milestones in its growth [2][5]. - The company has successfully developed and commercialized two products: Nilotinib, which treats drug-resistant chronic myeloid leukemia, and a new Bcl-2 selective inhibitor, Lisenglitazone, which is the first domestically developed Bcl-2 inhibitor approved in China and the second globally [2][6]. Group 2: Financial and Investment Highlights - Ascentage Pharma has secured substantial funding over the years, including a $300 million investment from 3SBio in 2010, which was crucial for its survival during challenging times [4]. - The company raised nearly $100 million in Series A financing in 2015, which facilitated its establishment in Suzhou, benefiting from the region's vibrant biopharmaceutical ecosystem [4]. Group 3: Research and Development Focus - The company is dedicated to developing drugs that meet real clinical needs, with a pipeline that includes six products in clinical stages targeting various cancers, including non-small cell lung cancer and ovarian cancer [6][7]. - Ascentage Pharma aims to accelerate the internationalization of Nilotinib and further commercialize Lisenglitazone while expanding its pipeline to benefit more patients globally [6][8]. Group 4: Strategic Partnerships and Market Position - The company has engaged in significant business development (BD) transactions, including a notable $1 billion deal with Takeda Pharmaceutical for the global development and commercialization of Nilotinib, setting a record for domestic small molecule oncology drugs [7]. - Ascentage Pharma is transforming into a full-cycle enterprise encompassing drug research, production, and commercialization, enhancing its role in the biopharmaceutical industry ecosystem [7].

Group 1 - The company reported a revenue of 234 million yuan for the first half of 2025, with its core product, Nairike, generating sales of 217 million yuan, representing a 93% year-on-year increase, primarily due to all approved indications being included in medical insurance [1] - The company has over 3 billion yuan in cash, indicating improved cash flow and strong liquidity [1] - The company’s other core product, Lisengmo, was approved for market launch by the National Medical Products Administration (NMPA) in July 2025, marking the beginning of a dual-engine growth phase for the company [1] Group 2 - Lisengmo, in combination with Azacitidine (AZA), received approval to conduct a global Phase III clinical trial (GLORA-4) from both the FDA and EMA, which is currently underway with patient enrollment [2] - The GLORA-4 study has already completed the first patient enrollment in China and Europe, facilitating the clinical development and registration process for Lisengmo in myelodysplastic syndromes (MDS) [2] Group 3 - The company has signed cooperation agreements with major pharmaceutical distribution companies to advance the commercialization of Lisengmo, achieving rapid product rollout in over 30 cities and 40 hospitals within 15 days of approval [1] - The company is accelerating the global clinical development of its pipeline products, with nine Phase III clinical studies progressing steadily, three of which have received FDA approval [1]

Core Viewpoint - Ascentage Pharma-B (06855) saw a significant increase in stock price, opening over 4% higher and reaching a historical high of 90 HKD, with a trading volume of 16.89 million HKD, following the announcement of a global Phase III clinical trial approval for its drug, APG-2575 [1] Group 1: Clinical Development - The company announced that its self-developed Bcl-2 selective inhibitor, APG-2575 (trade name: Lisatuzumab), has received approval from both the FDA and EMA to initiate a global Phase III clinical study (GLORA-4) for treating newly diagnosed high-risk myelodysplastic syndromes (HR-MDS) patients in combination with Azacitidine [1] - GLORA-4 is the second global Phase III study for Lisatuzumab approved by regulatory agencies in Europe and the U.S., which will expedite the drug's market entry [1] - Lisatuzumab is a novel oral Bcl-2 selective inhibitor that selectively inhibits the Bcl-2 protein, restoring the normal apoptosis process in cancer cells to achieve tumor treatment [1] Group 2: Market Position - The product has already been approved for marketing in China for adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have previously undergone at least one systemic treatment, including a Bruton tyrosine kinase (BTK) inhibitor [1] - Lisatuzumab 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 [1]

Group 1: Hong Kong Stocks - Ascentage Pharma-B (06855) opened over 5% higher after receiving FDA and EMA approval for its drug, Lisenglitazone, for high-risk MDS in Phase III clinical trials [1] - Haijia Medical (06078) fell over 5% following a profit warning, expecting a mid-term net profit decline of approximately 34% to 39% due to factors like centralized procurement and increased depreciation from new hospitals [1] - Hua Hong Semiconductor (01347) dropped over 6% as it announced plans to acquire a controlling stake in Shanghai Huali Microelectronics to address industry competition [1] - Zhonghui Biotech-B (02627) rose over 8% after receiving IND approval for its recombinant respiratory syncytial virus vaccine in both the US and China [1] - NetDragon (00777) surged over 10% after forming a strategic alliance with Zhongke Wenge to promote AI technologies abroad [1] - Great Wall Motors (02333) increased over 12% following the completion of its factory in Brazil, with an initial production capacity of 30,000 vehicles per year [1] - Yuewen Group (00772) rose over 20% as its first-half performance exceeded expectations, benefiting from growth in licensing business and steady performance of short dramas [1] Group 2: Other Notable Stocks - Huirui Group (00806) increased over 8% after reporting first-half results that met market expectations and is applying for MRF mutual recognition for other products [2] - Soundon Technology (02495) surged nearly 30% after announcing a projected net profit exceeding 50 million yuan for the first half, marking a turnaround from losses [2] - Robotics concept stocks saw significant gains, with Jinshang Machine Tool (01651) up over 11% and Lijin Technology (00558) up over 3% [2] Group 3: US Stocks - Intel (INTC.US) rose 2.93% amid reports of negotiations with the Trump administration for government investment to support domestic manufacturing [3] - Hesai Technology (HSAI.US) increased 9.73% after reporting over 50% year-on-year revenue growth for Q2 2025 [3] - UnitedHealth (UNH.US) surged 11.98% following Berkshire Hathaway's new investments in the company [3] - NIO (NIO.N) rose 8.09% as it announced the upcoming launch of its new ES8 model [4] - Xunlei (XNET.US) continued to rise by 26.53% after reporting a 30.6% year-on-year revenue increase for Q2 2025 [5]

Group 1 - The Hong Kong stock market is experiencing a strong performance, particularly in the technology and innovative pharmaceutical sectors, with significant gains in related ETFs [1][2][3] - As of August 18, the Hong Kong Internet ETF (513770) has risen by over 1.54%, while the Hong Kong Innovation Drug ETF (520880) has increased by more than 2% [1][2] - The Hong Kong stock market is expected to benefit from the acceleration of AI commercialization and continued inflow of southbound funds, indicating a clear recovery in valuations [3][4] Group 2 - As of July 31, the Hong Kong Internet Index has shown a cumulative increase of over 35% since the beginning of the year, outperforming the Hang Seng Tech Index, which rose by 22.05% [4][5] - The top four holdings in the Hong Kong Internet ETF (513770) include Xiaomi Group-W, Tencent Holdings, Alibaba-W, and Meituan-W, collectively accounting for 54.74% of the fund [6][5] - The Hong Kong Innovation Drug Index has surged by 101.58% year-to-date, significantly outperforming the Hang Seng Index and Hang Seng Tech Index by 78.08% and 79.53% respectively [8][9] Group 3 - The Hong Kong Innovation Drug ETF (520880) is the first ETF tracking the Hang Seng Hong Kong Innovation Drug Select Index, focusing on innovative drug development companies [6][8] - The fund size of the Hong Kong Internet ETF (513770) has exceeded 7.4 billion yuan, with an average daily trading volume of 593 million yuan [6][5] - The performance of the Hong Kong stock market is expected to continue upward in the second half of the year, driven by favorable conditions such as potential interest rate cuts by the Federal Reserve [3][4]

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].