康宁杰瑞制药-B(09966)发布公告，中国国家药品监督管理局已正式受理KN035(恩沃利单抗注射液)(商 标名：恩维达)联合吉西他滨和奥沙利铂方案，用于一线治疗不可切除或转移性胆道癌的新药上市申 请。 此次受理基于III期临床试验(KN035-CN-005)的临床研究结果，这是一项针对中国晚期一线BTC患者设 计的随机、平行对照、多中心III期临床试验。试验旨在评估KN035联合GEMOX方案对比单纯GEMOX 方案的疗效与安全性。 ...

思路迪医药股份(01244)发布公告，国家药品监督管理局(NMPA)已正式受理公司商业化产品恩维达(通用 名：恩沃利单抗注射液，原研代号：KN035)联合吉西他滨和奥沙利铂(GEMOX)方案，用于一线治疗不 可切除或转移性胆道癌(BTC)的新药上市申请(NDA)。此次受理基于III期临床试验(KN035-CN-005)的临 床研究结果，这是一项针对中国晚期一线胆道癌患者设计的随机、平行对照、多中心III期临床试验，旨 在评估恩维达(KN035)联合GEMOX方案对比单纯GEMOX方案的疗效与安全性。 ...

Core Viewpoint - The new drug application for Savolitinib, intended for adult patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with MET gene amplification, has been accepted by the National Medical Products Administration of China and prioritized for review [1] Group 1: Company Information - The new drug application is based on a Phase II registration study conducted in China, which demonstrated an objective response rate (ORR) as the primary endpoint according to RECIST1.1 criteria [1] - Savolitinib was included in the breakthrough therapy designation by the National Medical Products Administration in 2023, recognizing its significant advantages over existing treatment options for severe diseases [1] Group 2: Industry Context - Gastric cancer is one of the most common cancers in China and is a leading cause of cancer-related deaths [1] - Approximately 4-6% of gastric cancer patients have MET amplification, with an estimated 18,000 new cases of MET-amplified gastric cancer diagnosed annually in China [1]

于2025年6月，兆科的伙伴兼BRIMOCHOL PF的开发商Tenpoint Therapeutics,Ltd.宣布，美国FDA已受理 该药品的新药上市申请。FDA已就BRIMOCHOL PF制定处方药使用者付费法案(Prescription Drug User Fee Act)(PDUFA)，审核截止日期为2026年1月28日。 兆科眼科-B(06622)公布，公司与以台湾为基地的东生华制药股份有限公司订立策略性伙伴关系，于台 湾地区共同推进BRIMOCHOL PF的临床导论及未来商业化。东生华制药精于慢性病及精准医疗，提供 安全而易于获取的照护解决方案。根据协议条款，兆科授予东生华制药以独家分销商身份于台湾地区注 册、进口、推广、分销、营销及销售BRIMOCHOL PF的权利。 ...

Core Viewpoint - The company Shouyao Holdings (688197) has received a notice of acceptance from the National Medical Products Administration for its new drug application (NDA) for SY-5007, a treatment for RET fusion-positive non-small cell lung cancer (NSCLC) in adults [1] Company Summary - SY-5007 is a fully self-developed drug by the company, specifically designed for the treatment of locally advanced or metastatic RET fusion-positive NSCLC [1] - The drug has demonstrated significant and durable efficacy in both treatment-naive and previously treated patients with RET fusion-positive NSCLC [1] - SY-5007 shows good safety and tolerability, confirming its clinical potential as a highly selective RET inhibitor [1] - The approval of SY-5007 is expected to provide a new treatment option for patients in China with RET fusion-driven non-small cell lung cancer [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所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1276） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定，江蘇恒瑞醫藥股份有限公司（「本公司」）在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下，僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2025年8月20日 於本公告日期，董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生；(ii)非執行董事郭叢照女士；及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 江苏恒瑞医药股份有限公司 2025 年半年度报告 公司代码：600276 ...

Investment Rating - The report maintains an investment rating of "Outperform" with a target price set for leading stocks [3][4]. Core Insights - The innovative drug sector is experiencing fluctuations, but several catalysts are anticipated, including academic conferences, business development achievements, and negotiations for medical insurance [2]. - The National Medical Insurance Administration has updated the data on innovative drugs included in the medical insurance directory, showing rapid hospital admissions for several newly included domestic innovative drugs [2][22]. Summary by Sections Weekly New Drug Market Review - From August 4 to August 10, 2025, the top five companies in the new drug sector by stock price increase were: Beihai Kangcheng (+73.1%), Jiahe Biotech (+39.0%), Gilead Sciences (+30.3%), Heyu Biotech (+21.1%), and Hengrui Medicine (+15.3%). The top five companies with the largest declines were: Hutchison China MediTech (-13.8%), Frontier Biotech (-13.4%), Yifang Biotech (-11.7%), Haichuang Pharma (-9.9%), and Maiwei Biotech (-9.2%) [1][16]. Recommended Stocks to Watch - The report suggests focusing on potential overseas licensing opportunities for significant products, including differentiated GLP-1 assets from companies like Zhongsheng Pharma, Kangyuan Pharma, and Gilead Sciences. Additionally, upgraded PD-1 products from Kangfang Biotech and others are highlighted [2][22]. Key Analysis of the New Drug Industry - The report notes that several innovative drugs newly included in the medical insurance directory are rapidly entering hospitals, with notable growth in hospital admissions for drugs such as Zaiqiang Pharma's recombinant thrombin and Hengrui Medicine's Tazemetostat [2][22][23]. New Drug Approval and Acceptance Status - This week, three new drug applications were approved, including Adalimumab injection from Wuhan Biological Products Research Institute, Dulaglutide injection from Shandong Boan Biotech, and Evinacumab injection from Xi'an Janssen [28][29]. Additionally, four new drug applications were accepted, including Trastuzumab injection from Amgen and others [28][30]. Clinical Application Approval and Acceptance Status - A total of 55 new drug clinical applications were approved this week, while 31 new drug clinical applications were accepted [10][31].

Investment Rating - The report maintains an investment rating of "Outperform-A" for the biopharmaceutical sector [6]. Core Insights - The biopharmaceutical sector is experiencing rapid growth, particularly with the inclusion of several innovative drugs into the national medical insurance directory, leading to increased hospital admissions [2][19]. - Notable increases in hospital admissions for specific drugs have been observed, such as the rapid uptake of drugs like Budesonide enteric-coated capsules and monoclonal antibodies from Kangfang Biotech [2][19]. - The report highlights significant clinical approvals and applications for new drugs, indicating a robust pipeline and ongoing innovation within the industry [3][4][23]. Summary by Sections 1. Weekly New Drug Market Review - From June 9 to June 13, 2025, the top five companies in the new drug sector by stock price increase were Beihai Kangcheng-B (up 118.12%), Oconview Biotech-B (up 28.59%), Junshengtai Pharmaceutical-B (up 23.75%), WuXi AppTec-B (up 23.63%), and Gilead Sciences-B (up 23.40%) [1][13]. - The top five companies with stock price declines included Sangamo Therapeutics (-7.41%), Nossland (-7.14%), Yiming Oncology-B (-6.10%), Hualing Pharmaceutical-B (-4.38%), and Yongtai Biotech-B (-3.48%) [1][13]. 2. Key Industry Analysis - The National Healthcare Security Administration updated the hospital admission data for innovative drugs included in the medical insurance directory as of April 2025, showing rapid hospital admissions for several newly included domestic innovative drugs [2][19]. - The drugs with the fastest growth in hospital admissions compared to March 2025 include Budesonide enteric-coated capsules, Kangfang Biotech's monoclonal antibodies, and others [2][19]. 3. New Drug Application Approvals & Acceptances - Two new drug or new indication applications were approved this week, including the inhalation solution of Revinase and the injection of Pembrolizumab [23][24]. - Nine new drug applications were accepted, including Bevacizumab intravitreal injection and various insulin formulations [23][24]. 4. New Drug Clinical Application Approvals & Acceptances - A total of 45 new drug clinical applications were approved this week, with six new drug clinical applications accepted [4]. 5. Domestic Market Key Events TOP3 - Lepu Biotech's new drug MRG007 was approved for clinical trials, targeting locally advanced or metastatic solid tumors [5]. - Nocera Biotech presented multiple drug research data at the European Hematology Association annual meeting, showing significant efficacy in treating various blood diseases [5][9]. 6. Overseas Market Key Events TOP3 - Bristol-Myers Squibb announced positive results for Deucravacitinib in a Phase III trial for psoriatic arthritis, significantly improving patient symptoms [10]. - Nuvation Bio's Ibtrozi received FDA approval for treating ROS1-positive non-small cell lung cancer, demonstrating high response rates and good tolerability [10]. - Merck's enlictide decanoate showed positive results in two Phase III trials, potentially becoming the first oral PCSK9 inhibitor approved in the U.S. [10].

Core Viewpoint - The announcement indicates that the National Medical Products Administration of China has accepted the new drug application for cyclosporine eye gel, which is developed by the company for the treatment of moderate to severe dry eye disease [1] Group 1: Product Development - Cyclosporine eye gel is an innovative formulation developed by the company in China, specifically designed for treating moderate to severe dry eye disease [1] - The product is a patented hydrogel that has received international patent approval [1] Group 2: Clinical Trial Results - Phase II and Phase III clinical trial results demonstrate that cyclosporine eye gel shows good efficacy and safety [1] - The treatment can take effect quickly, with results potentially observable within two weeks [1] Group 3: Patient Compliance - The once-daily dosing regimen is expected to significantly improve patient adherence to the treatment and enhance their quality of life [1]