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 collaboration between Innovent Biologics and Takeda Pharmaceutical aims to develop cancer treatment drugs, with a total deal value of $11.4 billion, marking the highest record for a biopharmaceutical licensing deal from China [2][4] - The partnership focuses on two late-stage therapies and one early-stage project, leveraging Innovent's innovative immune-oncology and antibody-drug conjugate (ADC) therapies [2][5] Group 1: Deal Structure and Strategic Importance - The deal involves a co-development model where both companies will share development costs and commercial rights, with a 40/60 cost-sharing ratio for IBI363 [9] - Takeda's leadership sees this collaboration as a way to enhance its oncology pipeline, balancing developments in hematologic and solid tumors [4][22] - Takeda has made significant investments in China over the past three years, with disclosed transaction amounts exceeding 100 billion RMB [4][23] Group 2: Product Details and Clinical Status - IBI363 is a dual-antibody product that targets PD-1/PD-L1 pathways and activates IL-2 pathways, showing promise in treating lung and colorectal cancers [5][8] - IBI343, an ADC, has demonstrated significant efficacy against advanced gastric cancer and pancreatic ductal adenocarcinoma [5][8] - Both products have entered Phase III clinical trials, indicating advanced stages of development [8] Group 3: Takeda's Global Strategy and Market Focus - Takeda's CEO, Christophe Weber, emphasizes the importance of bringing Chinese innovations to the global market, aligning with the company's "Takuvi China" strategy to make China its second-largest market by 2030 [15][22] - The company has shifted focus to oncology, neuroscience, and gastrointestinal diseases, prioritizing innovative biotherapeutics and ADCs [14][22] - Takeda's global presence spans over 80 countries, with a strong emphasis on research and development, investing over $5 billion annually [27][28] Group 4: Leadership and Future Outlook - Christophe Weber, the first non-Japanese CEO of Takeda, has been pivotal in the company's global expansion and innovation strategy [29][30] - The upcoming leadership transition to Julie Kim is expected to continue the momentum in commercializing rare disease and oncology products [32][33] - The collaboration with Innovent is viewed as a significant asset for Takeda's future growth, particularly in the context of increasing competition and innovation in the biopharmaceutical sector [11][22]

Summary of the Conference Call for Ascentage Pharma Industry and Company Overview - The conference call focuses on Ascentage Pharma, a biopharmaceutical company specializing in innovative cancer therapies, particularly in the field of apoptosis and targeted therapies [2][3]. Key Points and Arguments 1. **Orebatein Expansion**: Orebatein, a third-generation TKI, expanded its indications in October 2023 to cover more CML patients, with expectations to be included in the national health insurance by the end of 2024, significantly enhancing market potential. The domestic sales reached 217 million yuan, with a forecasted doubling for the year [2][4]. 2. **BCL-2 Inhibitor Launch**: Ascentage Pharma launched its first domestic BCL-2 inhibitor, targeting relapsed CLL/SLL, which has a superior administration method compared to venetoclax, faster cellular uptake, and higher safety. Multiple phase III registration trials are ongoing, indicating a broad market outlook [2][4]. 3. **Collaboration with Takeda**: The company entered a licensing agreement with Takeda for the drug Nilotinib, with a total transaction value of 1.3 billion USD, including an upfront payment of 100 million USD. The remaining amount consists of milestone payments and sales sharing, with three phase III registration trials currently in progress [2][5]. 4. **Sales and R&D Expenses**: In the first half of 2024, sales expenses were 138 million yuan, with an annual estimate of 250 to 300 million yuan. R&D expenses reached 529 million yuan, with expectations to exceed 1 billion yuan for the year, indicating a continued increase in R&D investment [2][5]. 5. **Clinical Trials**: Orebatein is undergoing three phase III registration trials, while the BCL-2 inhibitor is also in multiple phase III trials covering AML, CLL/SLL, MDS, and multiple myeloma [2][6]. 6. **CML Market Size**: The global TKI market for CML is approximately 6 billion USD, with the domestic market around 4 billion yuan. The rapid growth of third-generation TKIs is noted, with Nilotinib being the only domestic third-generation TKI, providing a competitive edge [2][7][8]. Additional Important Information 1. **Market Competition**: The global CML TKI market is characterized by the expiration of patents for first and second-generation TKIs, with significant market players like Novartis and Takeda. Orebatein is positioned to complete its overseas phase III trials and apply for market approval by 2026 [7][9]. 2. **Advantages of BCL-2 Inhibitor**: Compared to venetoclax, Ascentage's BCL-2 inhibitor offers advantages in administration, faster cellular uptake, and lower side effects due to a shorter half-life. Ongoing trials include combinations with other therapies for various indications [2][11]. 3. **Future Directions**: Ascentage Pharma aims to continue its focus on apoptosis pathways and advance new L-type inhibitors for solid tumors, while also pursuing international expansion and product innovation to meet market expectations [3][12].

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]

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 Viewpoint - The company’s core product, Lisaftoclax, demonstrated excellent efficacy in patients who were resistant to venetoclax, with an overall response rate (ORR) of 31.8% in 22 evaluable patients and 80% in 15 CMML patients, indicating strong potential for future clinical and international development [1][2]. Event - On June 3, 2025, the company announced the presentation of oral data on Lisaftoclax for patients who failed venetoclax treatment at the ASCO conference [1]. Efficacy Summary - In a study of 28 patients previously treated with venetoclax, 22 evaluable patients showed an ORR of 31.8%, with 22.8% achieving complete response (CR) or complete response with incomplete blood count recovery (Cri). Additionally, in 15 evaluable CMML patients, the ORR was 80%, with 40% achieving CR [1]. - Among 22 evaluable R/R MDS/CMML patients, the ORR was 50%, with 27.3% achieving CR and 18.2% achieving marrow CR [1]. Future Outlook - The company anticipates accelerated global commercialization, with core products expected to enter the U.S. market between 2026 and 2027. The commercial launch of Venetoclax is expected to further increase in 2025 as its indications expand [2]. - The POLARIS-2 clinical trial for Venetoclax is expected to be completed in 2026, with an NDA submission planned for the same year, potentially leading to U.S. market entry [2]. - The GLORA clinical trial for APG-2575 is expected to complete in 2027, with subsequent NDA submission and potential U.S. market launch [2]. Revenue Forecast and Investment Suggestion - The company has established multiple product pipelines in hematological malignancies and solid tumors, with significant revenue growth expected from international product launches and upfront payments. Revenue projections for 2025-2027 are 588 million, 883 million, and 1.324 billion respectively, with year-on-year growth rates of -40%, 50%, and 50% [2].