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]

近日，先声药业发布自愿公告。披露集团与嘉兴安帝康生物科技有限公司（「安帝康」）合作的抗流感 药物玛氘诺沙韦颗粒（先林达®）新药上市申请（「NDA」）获国家药品监督管理局（NMPA）受理， 用于治疗2至11岁儿童无并发症的甲型流感和乙型流感，为中国首个成功完成III期临床并申报上市的针 对儿童患者的抗流感病毒创新药。 玛氘诺沙韦是一款cap依赖型核酸内切酶抑制剂。玛氘诺沙韦的作用机制是通过抑制流感病毒复制所必 需的cap依赖型核酸内切酶，阻断病毒自身mRNA的转录，从而精准抑制病毒复制。 临床研究显示，玛氘诺沙韦颗粒在儿童患者中安全性良好、症状缓解与病毒清除速度更快、耐药风险更 低、具有口服药效不受食物影响、剂型更适合儿科患者等潜在临床优势。 （企业公告） ...

（TL1A/IL23p19）针对IBD 大市场，具备长效化的竞争力；③SIM0815（TfR-Aβ双抗/AOC）具备透脑 特性，靶向pGlu 修饰的Aβ斑块。 "三个5"的创新产品梯队推动公司迈入加速发展的新阶段： 5 款基石产品：恩度、艾得辛、先必新注射 液、恩维达、先诺欣，为公司提供稳定的现金流。5 款快速放量新产品：科赛拉、恩立妥、恩泽舒、先 必新舌下片、科唯可，是业绩增长的重要推力，其中科赛拉、恩立妥今年纳入医保后正快速准入，恩泽 舒、先必新舌下片、科唯可已纳入2025 年商保创新药初审目录，同时恩泽舒亦通过了2025 年国家基本 医保目录初审。近期上市产品：2 款已进入NDA 审评阶段：玛氘诺沙韦（用于成人及青少年流感，其 儿童颗粒制剂的Ⅲ期研究也在进行中）、乐德奇拜单抗（有望作为国内第二款推动IL-4Rα单抗国产替 代）；3 个创新产品处于临床Ⅲ期，包括JAK1 抑制剂、三代ALK、口服SERD，覆盖自免疾病、非小细 胞肺癌和晚期乳腺癌等领域。公司已上市及后期临床阶段的产品中，有多款产品是具备差异化的潜在大 单品：①先必新舌下片：全球唯一获美国FDA"突破性疗法"认定的卒中创新药，可在舌下与唾液接 ...

Group 1 - Hong Kong Stock Exchange criticized Fuhong Hanlin for misusing IPO fundraising, highlighting governance and compliance issues [1] - Fuhong Hanlin's former CEO Liu Shigao was also reprimanded and required to undergo training [1] Group 2 - Xiansheng Pharmaceutical plans to raise approximately HKD 15.54 billion through a placement of 121 million shares at HKD 12.95 each, with about 90% allocated for R&D [2] - The funding will support clinical research for new drugs in China and the US, as well as expanding indications for approved innovative drugs [2] Group 3 - Huajian Medical announced the acquisition of a 20.31% stake in Guofu Quantum for approximately HKD 31.42 billion, making it the largest shareholder [3] - This acquisition is a strategic move to advance Huajian Medical's RWA (Real World Asset) tokenization initiative [3] Group 4 - Lighter Health Group submitted a prospectus for listing on the Hong Kong Stock Exchange, focusing on comprehensive health services and insurance solutions [4] - The company reported significant revenue growth from HKD 394 million in 2022 to HKD 945 million in 2024, but experienced a decline in gross margin from 82.6% to 38.3% [4]

Core Viewpoint - The announcement highlights the acceptance of the New Drug Application (NDA) for the influenza drug, Madaxanovir Granules (Xianlinda), by the National Medical Products Administration (NMPA) in China, marking a significant milestone for the company and the industry in pediatric antiviral treatments [1] Company Summary - The company has collaborated with Jiaxing Andikang Biotechnology Co., Ltd. for the development of Madaxanovir Granules [1] - This drug is specifically designed for treating uncomplicated Type A and B influenza in children aged 2 to 11 years [1] - Madaxanovir Granules is noted as the first innovative antiviral drug targeting pediatric patients in China to successfully complete Phase III clinical trials and submit for market approval [1] Industry Summary - The acceptance of the NDA represents a breakthrough in the antiviral drug market for children in China, addressing a significant unmet medical need [1] - The development of pediatric-specific antiviral treatments is becoming increasingly important in the healthcare landscape, particularly in response to seasonal influenza outbreaks [1]

Core Viewpoint - The announcement highlights the acceptance of the new drug application (NDA) for the influenza treatment drug, Madaxin (玛氘诺沙韦颗粒), by the National Medical Products Administration (NMPA) in China, marking a significant milestone as it is the first innovative antiviral drug targeting influenza in children to complete Phase III clinical trials and apply for market approval in China [1] Group 1: Drug Details - Madaxin is a cap-dependent endonuclease inhibitor that works by inhibiting the replication of the influenza virus, blocking the transcription of the virus's own mRNA, thereby precisely suppressing viral replication [1] - Clinical studies indicate that Madaxin shows good safety in pediatric patients, faster symptom relief and viral clearance, lower risk of resistance, oral efficacy unaffected by food, and a dosage form more suitable for pediatric patients [1]

格隆汇9月3日丨先声药业(02096.HK)公告，于2025年9月3日，集团与嘉兴安帝康生物科技有限公司("安 帝康")合作的抗流感药物玛氘诺沙韦颗粒(先林达)新药上市申请("NDA")获国家药品监督管理局(NMPA) 受理，用于治疗2至11岁儿童无并发症的甲型流感和乙型流感，为中国首个成功完成III期临床并申报上 市的针对儿童患者的抗流感病毒创新药。 玛氘诺沙韦是一款cap依赖型核酸内切酶抑制剂。玛氘诺沙韦的作用机制是通过抑制流感病毒复制所必 需的cap依赖型核酸内切酶，阻断病毒自身mRNA的转录，从而精准抑制病毒复制。 临床研究显示，玛氘诺沙韦颗粒在儿童患者中安全性良好、症状缓解与病毒清除速度更快、耐药风险更 低、具有口服药效不受食物影响、剂型更适合儿科患者等潜在临床优势。 ...

智通财经APP讯，先声药业(02096)发布公告，于2025年9月3日，本集团与嘉兴安帝康生物科技有限公司 (安帝康)合作的抗流感药物玛氘诺沙韦颗粒(先林达®)新药上市申请(NDA)获国家药品监督管理局 (NMPA)受理，用于治疗 2至11岁儿童无并发症的甲型流感和乙型流感，为中国首个成功完成III期临床 并申报上市的针对儿童患者的抗流感病毒创新药。 玛氘诺沙韦是一款cap依赖型核酸内切酶抑制剂。玛氘诺沙韦的作用机制是通过抑制流感病毒复制所必 需的cap依赖型核酸内切酶，阻断病毒自身mRNA的转录，从而精准抑制病毒复制。 临床研究显示，玛氘诺沙韦颗粒在儿童患者中安全性良好、症状缓解与病毒清除速度更快、耐药风险更 低、具有口服药效不受食物影响、剂型更适合儿科患者等潜在临床优势。 ...

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） 自願公告 瑪氘諾沙韋顆粒新藥上市申請(NDA)獲國家藥品監督管理局受理 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3日，本集團與嘉興 安帝康生物科技有限公司（「安帝康」）合作的抗流感藥物瑪氘諾沙韋顆粒（先林達®） 新藥上市申請（「NDA」）獲國家藥品監督管理局（NMPA）受理，用於治療 2至11歲兒童無併發症的甲型流感和乙型流感，為中國首個成功完成III期臨床並申 報上市的針對兒童患者的抗流感病毒創新藥。 關於瑪氘諾沙韋 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。 瑪氘諾沙韋是一款cap依賴型核酸內切酶抑制劑。瑪氘諾沙韋的作用機制是通過抑 制 ...