Group 1 - The company, Sihuan Pharmaceutical (02096), announced the completion of its placement and subscription matters on September 4, 2025, and September 10, 2025, respectively [1] - A total of 121 million shares were successfully placed at a price of HKD 12.95 per share to no less than six subscribers [1] - The subscription involved the same number of shares (121 million) at the same price of HKD 12.95 per share, representing approximately 4.66% of the company's enlarged issued share capital after the completion of the subscription [1]

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 (註7) 公司名稱： 先聲藥業集團有限公司 (於香港註冊成立之有限公司) 呈交日期： 2025年9月10日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | | 證券代號 (如上市) 02096 | 說明 | | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | 庫存股份變動 | | | | | 事件 | 已發行股份（不 ...

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，概不對因本公告全部或任何部分內容而產生或因依賴該等內容而引致的任 何損失承擔任何責任。 本公告並不構成在美國購買或認購任何證券之要約或招攬，亦不構成其一部分。本公告所述證券並無且將 不會根據美國《 1933 年證券法（經修訂）》（「美國證券法」）或美國任何其他州證券法登記，及不得在美國提呈 發售或出售，除非根據美國證券法作出登記或獲豁免登記或為毋須根據美國證券法作出登記之交易。本公 司無意根據美國證券法登記本公告內所述之任何證券，或在美國進行證券之公開發售。本公告中所述的證 券並無亦不會於美國或該等發售受到限制或禁止的其他司法管轄區內進行公開發售。 本公告或其任何副本概不得直接或間接在美國，或在刊發或派發本公告可能屬違法的任何其他司法管轄權 區內刊發或派發。 本公告僅供參考之用，並不構成收購、購買或認購本公司任何證券之邀請或要約。 Simcere Pharmaceutical Group Limited 先聲藥業集團有限公司 （於香港註冊成立的有限公司） （股份代號：2096） 完成配售現 ...

Core Insights - Hainan Free Trade Port's full island closure operation will positively impact companies through innovation capability building, supply chain optimization, and international development [1][2] Group 1: Innovation Capability Building - Hainan's talent introduction policies will help attract international high-end talent, boosting innovation drug research and development [1] - The "zero tariff" policy will lower the import costs of advanced equipment and raw materials, enhancing companies' hardware capabilities [1] - The pilot application of real-world data in Hainan will significantly shorten new drug approval cycles, facilitating the early market entry of internationally approved innovative drugs [1] Group 2: Production and Supply Chain Optimization - The continuation of "zero tariff" and processing value-added tax exemptions will encourage companies to increase high-end formulation production in Hainan [2] - Improved logistics and human flow, combined with the advantages of free trade port warehousing, are expected to create a more efficient, resilient, and low-cost supply chain system [2] Group 3: International Development - The company plans to use Hainan as a "bridgehead" to establish an international business expansion base, enhancing international registration and market access capabilities [2] - The company has received strong support from Hainan provincial and municipal governments, including being selected as a leading enterprise in the "Elite Action" program and receiving a reward of 10 million yuan for promoting high-quality economic development [2] Group 4: Future Expectations - The company hopes for further simplification and acceleration of new drug review and approval processes to benefit domestic patients sooner [3] - There is an expectation for improved efficiency in special drug and device approval processes, facilitating faster market entry for innovative drugs already approved abroad [3] - The company has made progress in localizing production of imported drugs, with the new insomnia drug successfully transitioning to the commercialization phase [3] - The expected localization of production by 2026 will shorten the drug listing cycle to about two weeks, improving patient access and reducing medication costs [3]

Core Viewpoint - The company, Xiansheng Pharmaceutical, has received approval from the National Medical Products Administration of China for clinical trials of its self-developed anti-tumor candidate drug SIM0609, targeting advanced solid tumors [1] Group 1: Drug Development - SIM0609 is a novel antibody-drug conjugate (ADC) targeting Cadherin 17 (CDH17), which is highly expressed in various cancers, including gastric cancer, colorectal cancer, and pancreatic cancer [1] - The drug is composed of a humanized monoclonal antibody linked to a proprietary soluble cleavable linker and a novel topoisomerase I inhibitor developed by the company [1] Group 2: Clinical Trial Focus - The clinical trials will focus on advanced solid tumors, particularly gastrointestinal tumors, highlighting the potential of CDH17 as a therapeutic target [1]

Core Viewpoint - The announcement highlights that the company has received approval from the National Medical Products Administration of China for clinical trials of its self-developed anti-tumor candidate drug SIM0609, targeting advanced solid tumors [1] Group 1: Drug Development - SIM0609 is a novel antibody-drug conjugate (ADC) targeting Cadherin 17 (CDH17), which is highly expressed in various cancers, including gastric cancer, colorectal cancer, and pancreatic cancer [1] - The drug is composed of a humanized monoclonal antibody linked to a new type of topoisomerase I (TOP-I) inhibitor developed by the company through a proprietary water-soluble cleavable linker [1] Group 2: Clinical Trial Focus - The clinical trials will focus on advanced solid tumors, particularly gastrointestinal tumors, indicating the drug's potential as a therapeutic target in late-stage cancer treatment [1]

先聲藥業集團有限公司 （於香港註冊成立的有限公司） （股份代號：2096） 自願公告 SIM0609（CDH17抗體偶聯藥物） 獲國家藥品監督管理局簽發藥物臨床試驗批准通知書 本公告由先聲藥業集團有限公司（「本公司」，連同其附屬公司統稱「本集團」）自 願作出，以告知本公司股東及潛在投資者本集團最新業務更新。 本公司董事（「董事」）會（「董事會」）欣然宣佈，於2025年9月5日，本集團自主研 發的抗腫瘤候選藥物靶向CDH17的抗體偶聯藥物（ADC）SIM0609已獲得中國國家 藥品監督管理局簽發的藥物臨床試驗批准通知書，擬開展晚期實體瘤的臨床試 驗。 關於SIM0609 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，概不對因本公告全部 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。 Simcere Pharmaceutical Group Limited SIM0609是一款靶向鈣黏蛋白17（CDH17）的新型抗體偶聯藥物，由一種人源化單 克隆抗體通過本集團專有的新型水溶性可裂解連接子，與本集團自主研發的新型 拓撲異 ...

Group 1 - The first domestically developed pediatric influenza antiviral drug, Maduonosawei granules, has had its market application accepted, targeting the treatment of influenza A and B in children aged 2 to 11 without complications. This marks a significant milestone for the Chinese pharmaceutical industry [1] - The approval of this pediatric drug is expected to provide a new growth point for Xiansheng Pharmaceutical and enhance its competitiveness in the influenza drug market, while also showcasing the innovative drug development capabilities of Antikang Bio [1] Group 2 - Huasheng Technology announced plans to re-list the transfer of a 51% stake in its subsidiary, Tibet Kangyu Pharmaceutical Co., Ltd., with a listing price of 42.5 million yuan. The company has not yet found a suitable buyer after two rounds of bidding, indicating potential market valuation discrepancies [2] - The failure to attract qualified buyers may reflect concerns regarding the future development, competitive landscape, and financial status of Kangyu Pharmaceutical, making the outcome of the re-listing uncertain [2] Group 3 - Lianhuan Pharmaceutical's subsidiary, Xinxiang Changle Pharmaceutical Co., Ltd., has received domestic approval for its Amlodipine Besylate tablets, a commonly used medication for regulating vascular pressure, with annual sales expected to reach 1.216 billion yuan in 2024 [3] - This approval enhances the product line of the company and its subsidiaries, improving market competitiveness, although the market is already crowded with numerous participants [3] Group 4 - Medisi's wholly-owned subsidiary, Medisi Puya Pharmaceutical Technology (Shanghai) Co., Ltd., has been sued for 159 million yuan due to a technical service contract dispute, with the case already filed but not yet heard [4] - The uncertainty surrounding this lawsuit may increase operational risks for the company and could lead to investor concerns regarding its future development [4] Group 5 - Shanghai Laishi announced that several executives, including the vice chairman and general manager, plan to increase their shareholdings in the company, with a total investment of no less than 6 million yuan sourced from personal funds [5] - Executive share purchases are generally viewed as a positive signal in the capital market, potentially attracting more investor interest and driving up stock prices, although the effectiveness of this plan will depend on market conditions and the company's actual performance [5]

Core Viewpoint - The announcement highlights the acceptance of the new drug application (NDA) for the influenza treatment drug, Madaxanovir granules (Xianlinda®), by the National Medical Products Administration (NMPA) in China, marking it as the first innovative antiviral drug targeting influenza in children aged 2 to 11 years to complete Phase III clinical trials and apply for market approval [1] Company Summary - The collaboration between the company and Jiaxing Antikang Biotechnology Co., Ltd. focuses on the development of Madaxanovir, an innovative antiviral drug for treating uncomplicated influenza in children [1] - Madaxanovir is a cap-dependent endonuclease inhibitor, which works by inhibiting the replication of the influenza virus through blocking the transcription of the virus's own mRNA [1] Clinical Research Summary - Clinical studies indicate that Madaxanovir granules demonstrate good safety in pediatric patients, faster symptom relief and viral clearance, lower risk of resistance, and oral efficacy that is unaffected by food, making it more suitable for pediatric patients [1]

Core Viewpoint - The company has demonstrated significant growth in its innovative drug business, which remains the core engine for revenue increase, with total revenue reaching 3.585 billion yuan in the first half of 2025, a year-on-year increase of 15.1% [1] Group 1: Financial Performance - Total revenue for the first half of 2025 was 3.585 billion yuan, up 15.1% year-on-year [1] - Revenue from innovative drugs was 2.776 billion yuan, reflecting a 26% year-on-year growth, accounting for 77.4% of total revenue [1] - Adjusted net profit reached 651 million yuan, a 21.1% increase year-on-year [1] - R&D investment rate was 28.7%, up 9 percentage points year-on-year, with cumulative R&D investment exceeding 10 billion yuan over the past decade [1] Group 2: Business Segments - Revenue from neuroscience reached 1.249 billion yuan, a 37.3% year-on-year increase, indicating a solid market position for the product Xianbixin injection [1] - Revenue from oncology was 874 million yuan, up 41.1% year-on-year, driven by rapid growth of newly launched products such as Kexaila and Enlituzumab [1] - Revenue from autoimmune diseases was 878 million yuan, reflecting a 3.3% year-on-year growth [1] Group 3: Product Pipeline and Innovation - The company has established a "three fives" product strategy, including five cornerstone products that provide stable cash flow and five rapidly growing new products that drive revenue growth [2] - Recent product developments include two products in NDA review: Maduonosawei for influenza and Ledekich for potential IL-4Rα monoclonal antibody replacement [2] - Three innovative products are in Phase III clinical trials, targeting autoimmune diseases and various cancers [2] Group 4: Future Projections - The company is expected to achieve revenues of 7.690 billion, 9.009 billion, and 10.427 billion yuan from 2025 to 2027, with year-on-year growth rates of 16%, 17%, and 16% respectively [4] - Projected net profit for the same period is 1.193 billion, 1.389 billion, and 1.609 billion yuan, with growth rates of 63%, 16%, and 16% respectively [4]