Group 1 - The core point of the article is that CSPC Pharmaceutical Group (01093.HK) has received approval from the National Medical Products Administration of China to conduct clinical trials for its self-developed drug SYH2085 [1] - SYH2085 is a novel oral small molecule candidate drug designed to inhibit the RNA polymerase acidic protein (PA) endonuclease activity of the influenza virus, targeting both influenza A and B viruses [1] - The clinical indication approved is for the treatment of uncomplicated influenza in adults and adolescents aged 12 and above, with preclinical studies showing significant antiviral effects and favorable pharmacokinetic properties [1] Group 2 - The approval of SYH2085 is expected to enhance the company's product pipeline in the field of anti-infective treatments, indicating high clinical development value [1] - Additionally, CSPC Pharmaceutical Group announced the appointment of Cai Lei as Vice Chairman and Executive Director [2]

Core Viewpoint - The approval of SYH2085 by the National Medical Products Administration of China marks a significant advancement for the company in the development of innovative antiviral treatments for influenza [1] Group 1: Product Development - SYH2085 is a novel oral small molecule candidate drug developed by the company, designed to inhibit the RNA polymerase acidic protein (PA) endonuclease activity of influenza viruses [1] - The clinical indication approved is for the treatment of uncomplicated influenza A and B in adults and adolescents aged 12 and older [1] Group 2: Clinical Research and Efficacy - Preclinical studies have demonstrated that SYH2085 exhibits clear, broad-spectrum, and excellent inhibitory effects against both influenza A and B viruses [1] - The drug has shown effectiveness in reducing viral load and flu-like symptoms in animal models, along with favorable pharmacokinetic properties and safety [1] Group 3: Market Potential - The approval of SYH2085 is expected to enhance the company's product pipeline in the field of anti-infective treatments, indicating high clinical development value [1]

Core Viewpoint - The approval of SYH2085 by the National Medical Products Administration of China marks a significant advancement for the company in the development of innovative antiviral treatments for influenza [1] Group 1: Product Development - SYH2085 is a novel oral small molecule candidate drug developed by the company, designed to inhibit the RNA polymerase acidic protein (PA) endonuclease activity of influenza viruses [1] - The clinical indication approved is for the treatment of uncomplicated influenza A and B in adults and adolescents aged 12 and older [1] - Preclinical studies have demonstrated that SYH2085 exhibits clear, broad-spectrum, and excellent inhibitory effects against both influenza A and B viruses, effectively reducing viral load and flu-like symptoms in animal models [1] Group 2: Clinical and Market Potential - The drug shows promising pharmacokinetic properties and safety, indicating a high clinical development value [1] - The introduction of SYH2085 is expected to enhance the company's product pipeline in the field of anti-infective treatments [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之內容概不負責，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之任何損失承擔任何責任。 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司 （股份代號：1093） （於香港註冊成立之有限公司） 自願公告 SYH2085片在中國獲臨床試驗批准 石 藥 集 團 有 限 公 司（「 本 公 司 」， 連 同 其 附 屬 公 司 統 稱「 本 集 團 」）董 事 會（「 董 事 會 」）欣 然 宣 布 ， 本 集 團 開 發 的 SYH2085 片（「 該 產 品 」）已 獲 得 中 華 人 民 共 和 國 國 家 藥 品 監 督 管 理 局 批 准，可在中國開展臨床試驗。 該 產 品 為 本 集 團 自主 研 發 的 化 學 1 類創 新 藥 ， 是 一 款 可 抑 制 流 感 病 毒的 RNA 聚 合 酶 酸 性 蛋 白(PA)核酸內切酶活性的新型口服小分子候選藥物。本次獲批的臨床適應症為用於治療成 人及12歲以上青少年單純性甲型和乙型流感。臨床 ...

Core Insights - The National Medical Products Administration has approved the listing of a new innovative drug, Suojirolin Tablets (brand name "Xintuoan"), developed by Shanghai Shiyin Pharmaceutical Co., Ltd., for the treatment of primary hypertension, marking the ninth domestically developed innovative drug approved in Shanghai this year [1][3] Group 1: Product Details - Suojirolin is a new generation oral non-peptide small molecule renin inhibitor aimed at addressing unmet clinical needs in hypertension treatment, providing a new therapeutic option for over 300 million patients with primary hypertension in China [1][4] - Compared to traditional antihypertensive drugs, Suojirolin directly inhibits renin activity, targeting the core issues in hypertension treatment and enhancing safety through optimized molecular structure [4] Group 2: Clinical Efficacy - Clinical trial results indicate that a daily dose of 100mg Suojirolin taken for 12 weeks can safely and effectively lower blood pressure in patients with primary hypertension, providing solid evidence for a significant reduction in average sitting diastolic blood pressure [4] Group 3: Production and Commercialization - Shanghai Shiyin Pharmaceutical has designed a new production line for Suojirolin and is currently testing core equipment for tablet compression, with plans to commence commercial production by the first quarter of 2026 [2][4]

Investment Rating - The investment rating for the company is "Buy" [4] Core Insights - The company's core products have successfully been included in the 2025 National Medical Insurance Drug List, which is expected to drive sales growth [1][3] - The clinical data for the PD-1/VEGF bispecific antibody RC148 shows promising efficacy and safety in treating non-small cell lung cancer, indicating a significant clinical advantage [2][4] - The management team is experienced, and the company has a strong R&D capability, with a stable pipeline of clinical indications [8] Summary by Sections Event 1 - Two innovative drugs from the company have been successfully included in the 2025 National Medical Insurance Drug List, with one new indication for 泰爱® (Tai'ai) and three renewed indications for both 泰爱® and 爱地希® (Aidiqi) [1] Event 2 - The clinical research data for RC148 in treating non-small cell lung cancer has been disclosed, showing outstanding clinical efficacy and manageable safety [2] Clinical Data - The clinical trial results for RC148 indicate an objective response rate (ORR) of 61.9% for monotherapy and 66.7% for combination therapy, with a disease control rate (DCR) of 100% and 95.2% respectively [4] Financial Projections - Revenue projections for 2025-2027 are adjusted to 27.52 billion, 33.85 billion, and 44.13 billion yuan, reflecting year-on-year growth rates of 60.95%, 22.97%, and 30.40% respectively [8] - The net profit for the same period is projected to improve significantly, with estimates of -7.63 billion, -3.16 billion, and 3.84 billion yuan [8]

Group 1: Policy and Regulatory Developments - The National Healthcare Security Administration and the Ministry of Human Resources and Social Security announced the "National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog (2025)" and the "Commercial Health Insurance Innovative Drug Catalog (2025)", effective from January 1, 2026, nationwide [1] - The medical insurance catalog adds 114 new drugs, including 50 innovative first-class drugs, with an overall success rate of 88%, a 12 percentage point increase from 2024 [1] - The first version of the commercial health insurance innovative drug catalog includes 19 drugs, marking a significant breakthrough in the "medical insurance + commercial insurance" multi-layered medical security system [1] Group 2: Market Trends and Investment Opportunities - The Chinese innovative drug sector is experiencing active out-licensing (BD) transactions, with a total transaction amount exceeding $92 billion and 103 deals completed in the first three quarters of 2025, indicating strong international recognition of Chinese R&D achievements [2] - The innovative drug R&D is entering a harvest period, with pipeline values gradually being realized, supported by overseas payment capabilities and a shift towards hard-core technology-driven growth [2] - Emerging technologies such as small nucleic acids, in vivo CAR-T, and AI drug development platforms are expected to see a clinical value explosion, while the CXO industry remains robust, benefiting from new tracks like ADC, peptides, and CGT [2] Group 3: ETF Performance and Market Sentiment - As of December 18, 2025, the Hong Kong innovative drug ETF (513120) has seen a strong increase of 10.56% over the past six months, with significant contributions from major stocks like WuXi Biologics and 3SBio [3] - The latest scale of the Hong Kong innovative drug ETF reached 24.322 billion yuan, making it the largest in the Hong Kong market for pharmaceutical ETFs, with a net inflow of 327 million yuan over the past five trading days [3] - The innovative drug ETF (515120) also experienced a rise, with major stocks like Zai Lab and WuXi AppTec contributing to the gains, indicating a positive market sentiment towards innovative drug investments [4]

Core Viewpoint - The Xi'an Municipal Government has released an implementation plan to enhance the biopharmaceutical industry from 2025 to 2027, focusing on breakthroughs in key drug development technologies and supporting the research and commercialization of innovative drugs [1][2]. Group 1: Industry Goals - The plan sets three main objectives: achieving a biopharmaceutical industry scale of 40 billion yuan by 2027, with specific targets for traditional Chinese medicine (9 billion yuan), chemical drugs (12 billion yuan), biological drugs (6 billion yuan), and medical devices (13 billion yuan) [2]. - It aims to achieve clinical approval for one innovative drug and production approval for another by 2027, along with 40 Class III medical devices and 400 Class II medical devices [2]. Group 2: Innovation and Collaboration - The plan emphasizes the development of innovative drugs, particularly in areas such as targeted liver delivery drugs, peptide products, and addiction treatment drugs, while encouraging collaboration between pharmaceutical companies and academic institutions [3][4]. - It outlines a comprehensive innovation ecosystem for cell therapy, focusing on stem cell therapy, immune cell therapy, and cell-derived therapies, with a full chain from basic research to clinical application [4][5]. Group 3: Policy Support and Trends - Multiple cities, including Beijing, Shanghai, Chongqing, and Sichuan, have introduced policies to support the innovative drug industry, indicating a new cycle of policy support for the biopharmaceutical sector [7][8]. - The policies include expedited clinical trial approvals and financial support for innovative drug development, reflecting a trend towards enhancing the overall innovation ecosystem in the pharmaceutical industry [7][8].

Group 1: Eli Lilly - Eli Lilly has submitted a new oral weight loss drug, orforglipron, for FDA approval, indicating a competitive edge in the weight loss medication market [1] - Participants switching from Novo Nordisk's Wegovy to orforglipron maintained most of their weight loss, with an average rebound of only 0.9 kg [1] Group 2: Fosun Pharma - Fosun Pharma's subsidiary has signed a collaboration agreement with Clavis Bio, which could yield up to $363 million in payments [2] - Clavis Bio will have exclusive global rights (excluding mainland China, Hong Kong, and Macau) for development, production, and commercialization of the selected targets [2] - Fosun Pharma will also gain a minority stake in a new project company established by Clavis Bio for this collaboration [2] Group 3: Baidu - Baidu has announced plans to issue H-shares and list on the Hong Kong Stock Exchange to enhance its global strategy and competitiveness [3] - The issuance and listing are subject to shareholder approval and regulatory approvals, with specific details yet to be finalized [3] Group 4: BeiGene - BeiGene has appointed Dr. Wang Lai as the new President and Global Head of R&D, reflecting the company's commitment to innovation in drug development [4] - Dr. Wang has been with BeiGene since 2011 and has progressively taken on more responsibilities in R&D leadership [4] Group 5: Junshi Biosciences - Junshi Biosciences announced that major shareholder Shanghai Tanying plans to reduce its stake by up to 2%, equating to approximately 2,053,380 shares [5] - The reduction is scheduled between January 13, 2026, and April 10, 2026, despite the shareholder's long-term confidence in the company's prospects [5]

香港聯合交易所有限公司及證券及期貨事務監察委員會對本申請版本的內容概不負責，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申請版本全部或任何部分內容而產生或依賴該等內容而引致 的任何損失承擔任何責任。 Suzhou Zelgen Biopharmaceuticals Co., Ltd. 蘇州澤璟生物製藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （「本公司」） 的申請版本 警告 本申請版本乃根據香港聯合交易所有限公司（「聯交所」）及證券及期貨事務監察委員會（「證監會」）的要求 而刊發，僅用作提供資訊予香港公眾人士。 本申請版本為草擬本。本聆訊後資料集內所載資訊並不完整，亦可能會作出重大變動。 閣下閱覽本文 件，即代表 閣下知悉、接納並向本公司、獨家保薦人、整體協調人、顧問或包銷團成員表示同意： 倘在適當時候向香港公眾人士提出要約或邀請，有意投資者務請僅依據於香港公司註冊處處長註冊的本公 司招股章程作出投資決定。該文件的文本將於發售期內供公眾人士查閱。 (a) 本文件僅向香港公眾人士提供有關本公司的資料，概無任何其他目的。投資者不應根據本文件中的 資料作出任何投資決定； (b) 在聯交 ...