Core Viewpoint - The company, InnoCare Pharma, has announced that its drug DB-1303/BNT323 has met the primary endpoint of progression-free survival (PFS) in a Phase III clinical trial for HER2-positive unresectable or metastatic breast cancer patients previously treated with trastuzumab and taxanes [1] Group 1 - The independent data monitoring committee (IDMC) evaluated the trial and confirmed the positive results compared to the control group [1] - The company plans to communicate with the National Medical Products Administration (NMPA) in China regarding the submission of a Biologics License Application (BLA) for DB-1303/BNT323 [1]

Core Viewpoint - The company, InnoCare Pharma-B (09606), announced that its DB-1303/BNT323 has met the primary endpoint of progression-free survival (PFS) in a Phase III clinical trial for HER2-positive unresectable or metastatic breast cancer patients previously treated with trastuzumab and taxanes, as evaluated by an independent data monitoring committee (IDMC) [1] Group 1 - The Phase III clinical trial is a randomized, controlled, open-label, multi-center study conducted in China [1] - The trial aims to assess the efficacy and safety of DB-1303 compared to T-DM1 in the specified patient population [1] - Following the interim analysis results, the company plans to communicate with the National Medical Products Administration (NMPA) in China regarding the submission of a Biologics License Application (BLA) for DB-1303/BNT323 [1]

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依賴 該等內容引致的任何損失承擔任何責任。 Duality Biotherapeutics, Inc. 映恩生物 （根據開曼群島法律註冊成立的有限公司） （股份代號：9606） 內幕消息 DB-1303/BNT323用於HER2陽性不可切除或 轉移性乳腺癌患者的III期臨床試驗達到主要研究終點 緒言 本公告由映恩生物（「本公司」）根據香港聯合交易所有限公司證券上市規則（「上市 規則」）第13.09條及香港法例第571章證券及期貨條例第XIVA部內幕消息條文作 出。 根據這項中期分析結果，本公司計劃與中國國家藥品監督管理局（國家藥監局）藥 品審評中心（藥審中心）就提交DB-1303/BNT323生物製品上市許可申請(BLA)進 行溝通。 該臨床試驗之設計、目的及結論 該試驗是一項在中國進行的隨機、對照、開放標籤、多中心的III期臨床試驗，旨 在評估DB-1303相較於T-DM1在既往接受曲妥珠單抗和紫杉烷類治療的HER2陽 性不可切除或轉移性乳腺癌患者 ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年8月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 映恩生物 (「本公司」) 呈交日期: 2025年9月3日 I. 法定/註冊股本變動 1. 股份分類 普通股 股份類別 不適用 於香港聯交所上市 (註1) 是 證券代號 (如上市) 09606 說明 法定/註冊股份數目 面值 法定/註冊股本 | | 法定/註冊股份數目 | | 面值 | | | 法定/註冊股本 | | | --- | --- | --- | --- | --- | --- | --- | --- | | 上月底結存 | | 200,000,000 | USD | 0.0001 | USD | | 20,000 | | 增加 / 減少 (-) | | | | | USD | | | | 本月底結存 | | 200,000,000 USD | | 0.0001 | USD | | 20,000 | 本月底法定/註冊股本總額： USD 20,000 第 1 頁 共 10 頁 v 1.1.1 FF301 FF301 II. 已發行股份 ...

Core Viewpoint - The Hong Kong IPO market is active, with 57 new listings and a total fundraising amount of 131.9 billion HKD as of August 25. However, many companies face challenges in meeting both domestic and Hong Kong regulatory requirements for listing [1]. Group 1: Hong Kong IPO Overview - As of August 25, 2023, there have been 57 new IPOs on the Hong Kong Stock Exchange, raising a total of 131.9 billion HKD [1]. - There are currently 211 companies that have submitted applications for listing in Hong Kong [1]. Group 2: Listing Challenges - Companies looking to list in Hong Kong must comply with both domestic laws and Hong Kong's regulatory framework, making the IPO preparation process complex and demanding [1]. Group 3: Resources for Companies - A compilation of Hong Kong listing rules and disclosure documents for domestic companies planning to list in Hong Kong has been organized to assist businesses in understanding the latest regulatory dynamics [1].

Core Viewpoint - Incyte Biosciences-B (09606) reported a significant increase in revenue and profit for the first half of the year, driven by external licensing and collaboration agreements, despite not having any commercialized products yet [1] Financial Performance - The company achieved a revenue of approximately 1.229 billion RMB, representing a year-on-year growth of 22.9% [1] - Adjusted profit for the period was around 146 million RMB, reflecting a year-on-year increase of 14.2% [1] Strategic Partnerships - The revenue growth was primarily fueled by licensing and collaboration fees [1] - Incyte has established extensive partnerships with companies such as BioNTech, BeiGene, and GlaxoSmithKline, with a potential total transaction value exceeding 6 billion USD [1] - These collaborations are expected to provide ongoing financial support as clinical projects progress [1]

智通财经APP获悉，映恩生物-B(09606)早盘涨超5%，截至发稿，涨3.67%，报362港元，成交额1.04亿 港元。 消息面上，映恩生物公布中期业绩，上半年收入约12.29亿元，同比增长22.9%；经调整期内利润约1.46 亿元，同比增长14.2%。公告称，收入增加主要由于通过对外授权及合作协议进一步扩展研发活动。 招银国际发布研报称，映恩生物上半年收入12.3亿元人民币，同比增长23%，主要由授权与合作款项推 动。虽然公司目前尚未有商业化产品，但其与BioNTech、百济神州及葛兰素史克等企业建立的广泛合 作关系，潜在交易总价值超过60亿美元，加上未来可能扩展的合作项目，预计将在临床项目推进过程中 提供持续的资金支持。 ...

Group 1 - Pharmaceutical stocks continue to rise, with notable increases in companies such as BeiGene (up 7.87%), Clover Biopharma (up 6.03%), and Tigermed (up 5.03%) [1] - BlackRock increased its stake in 3SBio by acquiring approximately 47.6 million shares at a price of HKD 30.1096 per share, totaling around HKD 14.33 billion, raising its ownership to 5.1% [1] - The overall performance of Hong Kong pharmaceutical companies in the first half of the year has been robust, with companies like Hengrui Medicine and Hansoh Pharmaceutical reporting record high revenues and profits [1] Group 2 - The pharmaceutical sector has shown strong stock performance in the first half of the year, driven by continuous business development (BD) overseas, excellent clinical data, and supportive policies [2] - The innovative drug sector is experiencing rapid sales growth, with several key products being approved and included in medical insurance, leading to increased domestic sales [2] - Companies like BeiGene and Hutchison China MediTech have successfully commercialized their products overseas, contributing significantly to revenue growth [2]

Group 1 - Pharmaceutical stocks continued to rise, with notable increases in companies such as BeiGene (up 7.87% to HKD 209.8), Clover Biopharmaceuticals (up 6.03% to HKD 1.23), and Tigermed (up 5.03% to HKD 50.5) [1] - BlackRock increased its stake in 3SBio by acquiring approximately 47.6 million shares at a price of HKD 30.1096 per share, totaling around HKD 14.33 billion, raising its ownership to about 124 million shares or 5.1% [1] - The overall performance of Hong Kong pharmaceutical companies was robust in the first half of the year, with companies like Heng Rui Medicine achieving record revenue and profit, and Hansoh Pharmaceutical exceeding revenue expectations [1] Group 2 - The pharmaceutical sector performed well in the first half of the year, driven by continuous business development overseas, strong clinical data, and supportive policies, with the innovative drug sector leading the gains [2] - The innovative drug sector is experiencing rapid sales growth as several key products have been approved and included in medical insurance, leading to increased domestic sales [2] - Companies like BeiGene and Hutchison China MediTech have successfully commercialized their products overseas, contributing significantly to revenue growth [2]

Group 1 - Pharmaceutical stocks in Hong Kong have shown strong performance, with notable gains in companies such as 加科思-B (up 23.18%), 三叶草生物-B (up 22.09%), and others [1] - The overall performance of Hong Kong pharmaceutical companies in the first half of the year has been robust, with 恒瑞医药 achieving record high revenue and profit, and 翰森制药 exceeding revenue expectations [1] - Upcoming major conferences, including the World Lung Cancer Conference (WCLC) and the European Society for Medical Oncology (ESMO), will showcase research results from innovative domestic drugs [1] Group 2 - 海通国际 maintains a positive outlook on Hong Kong pharmaceutical companies due to their stable cash flow, rich R&D pipelines, and normalizing external licensing revenues [2] - The recent slight pullback in the Hong Kong pharmaceutical sector is attributed to rapid fund rotation, with expectations of short-term fluctuations [2] - The long-term value reassessment logic in the pharmaceutical industry remains unchanged, supported by the engineer dividend and a rich catalyst environment in the innovative drug industry [2]