Core Viewpoint - During the "14th Five-Year Plan" period, China has approved 210 innovative drugs, with a focus on ensuring drug safety and effectiveness through strict regulations and quality management in drug development, production, and post-marketing supervision [1][2]. Group 1: Innovative Drug Approval and Market Impact - In the first eight months of this year, China approved 56 innovative drugs, surpassing the total of 48 from the previous year, indicating a rapid growth trend in innovative drug approvals [1][2]. - The approval of innovative drugs has provided new treatment options for patients, with significant improvements in managing previously difficult-to-treat conditions, such as neurofibromatosis type I [2][3]. Group 2: Drug Development and Quality Management - The National Medical Products Administration (NMPA) has established four expedited pathways for innovative drugs, including breakthrough therapy designation and conditional approval, to accelerate the drug approval process [2][7]. - Companies are investing heavily in research and development, with examples like Hengrui Medicine investing over 48 billion yuan since its establishment, maintaining a research investment ratio of over 20% of revenue [5][6]. Group 3: Regulatory Framework and Post-Market Surveillance - The NMPA is enhancing the drug approval process by implementing a drug marketing authorization holder system and emphasizing lifecycle risk management responsibilities for companies [7][8]. - Continuous post-marketing surveillance is crucial for ensuring drug quality and safety, with the NMPA establishing a comprehensive risk monitoring system to detect and manage potential safety risks associated with newly launched drugs [8][9].

登录新浪财经APP 搜索【信披】查看更多考评等级 申请的适应症：代谢相关脂肪性肝炎。 受理号：CXHL2501038、CXHL2501039、CXHL2501040、CXHL2501041、CXHL2501042 通知书编号：2025LP03262、2025LP03263、2025LP03264、2025LP03265、2025LP03266 证券代码：002317公告编号：2025-112 广东众生药业股份有限公司关于控股子公司 收到一类创新药RAY1225注射液新增适应症的药物临床试验批准通知书的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误导性陈述或重大遗 漏。 近日，广东众生药业股份有限公司（以下简称"公司"）控股子公司广东众生睿创生物科技有限公司（以 下简称"众生睿创"）自主研发的一类创新多肽药物RAY1225注射液新增适应症治疗"代谢相关脂肪性肝 炎"的药物临床试验获得国家药品监督管理局批准，并收到《药物临床试验批准通知书》，同意 RAY1225注射液新增适应症进行临床试验。具体情况如下： 一、《药物临床试验批准通知书》基本情况 根据《中华人民共和国药品管理法》及 ...

Investment Rating - The report gives a "Buy" rating for the company, 康哲药业 (0867.HK), for the first time [7]. Core Views - The company has successfully transitioned into a new product era, with its innovative transformation showing significant results. The impact of national procurement on its products has reached a turning point, and the sales of exclusive/brand and innovative products continue to grow, indicating a recovery in performance [7]. - The company is focusing on dual engines of "cooperative research and independent research" to drive innovation, with a rich product pipeline covering multiple therapeutic areas. The company aims to enhance its market position through strategic international expansion and innovative product launches [6][10]. Summary by Sections 1. Successful Innovation Transformation - The company has adopted a dual approach of "cooperative research + independent research" to efficiently promote clinical development and commercialization. It has transitioned from a single drug agency model to an innovation-driven pharmaceutical enterprise since 2018 [10]. - As of the first half of 2025, the company has a pipeline of 40 products, with five innovative products approved for sale in China [10]. 2. Impact of National Procurement - The company faced a decline in revenue and net profit in 2023 due to three products being included in national procurement, leading to a significant drop in sales and market share [12]. - In 2025, the company’s performance rebounded, achieving revenue of 40.02 billion yuan (up 10.8% year-on-year) and a net profit of 9.41 billion yuan (up 3.3% year-on-year) [12]. 3. Innovative Drug Strategy - The company has successfully launched four innovative drugs, with a focus on chronic kidney disease, psoriasis, and epilepsy. Two additional products are pending approval, and three are in clinical phase III trials [34][36]. - The company’s innovative pipeline includes products targeting skin health, with plans for a spin-off of 德镁医药 to unlock its value in the skin health sector [21][34]. 4. Financial Forecast and Valuation - The company is expected to achieve net profits of 16.70 billion yuan, 20.05 billion yuan, and 23.72 billion yuan for the years 2025, 2026, and 2027, respectively, with corresponding P/E ratios of 18, 15, and 12 times [7]. - The company’s P/E valuation for 2025 is estimated at 18 times, which is lower than the average P/E of comparable companies at 28 times [7].

Core Insights - The Hong Kong and A-share innovative drug sectors have shown significant weekly performance, with notable increases in specific stocks such as Haiwang Bio and Kangfang Biotech, indicating a positive trend in the market [2][4][5]. Market Performance - The pharmaceutical and biotechnology index rose by 1.50%, outperforming the Shanghai Composite Index by 0.10 percentage points, marking two consecutive weeks of gains [4]. - The innovative drug sector (BK1106) saw a weekly increase of 4.26%, while the Hang Seng Healthcare Index (HSCICH) rose by 3.64% and the Hong Kong innovative drug ETF (513120) increased by 4.00% [4]. Stock Highlights - Haiwang Bio experienced a remarkable weekly increase of 38.21%, while Kangfang Biotech led with a 14.86% rise [2]. - The focus on children's antiviral drugs is highlighted by the initiation of Phase III trials for the drug Anladiwei by Zhongsheng Pharmaceutical, targeting a critical market need [12][13]. IPO Developments - Lingke Pharmaceutical has filed for an IPO in Hong Kong, focusing on innovative drugs for autoimmune and inflammatory diseases, with its lead candidate LNK01001 facing intense competition from existing JAK inhibitors [6][7]. - The company reported R&D expenditures of approximately 186 million yuan, 223 million yuan, and 121 million yuan for the years 2023, 2024, and the first nine months of 2025, respectively [7]. Clinical Trials - A total of 110 clinical trial registrations were disclosed by the National Medical Products Administration, with 39 trials in Phase II or higher, indicating robust activity in drug development [8]. - The ongoing clinical trials for various drugs, including SKB500 for small cell lung cancer and Anladiwei for pediatric influenza, reflect the industry's focus on addressing unmet medical needs [14][12]. Regulatory Approvals - Four innovative drugs received approval during the week, including Yimazhi for pediatric Tourette syndrome and a radiopharmaceutical for prostate cancer detection [11]. - The approval of Anladiwei for adult treatment earlier this year and its subsequent pediatric trial initiation underscores the strategic expansion of product lines to meet market demands [13].

Core Viewpoint - Multinational pharmaceutical companies (MNCs) are adjusting their strategies in the Chinese county market, with Novartis deciding to dissolve its county team while emphasizing its commitment to county patients [1][2]. Group 1: Novartis' County Market Strategy - Novartis is terminating its county business operations, which began in 2021, affecting nearly 1,000 county markets [1][2]. - The company has achieved significant results in the county market, establishing nearly 1,000 pharmacies across over 800 counties, focusing on various disease areas [2][3]. - Novartis' psoriasis drug, Cosentyx, has seen high penetration in county hospitals, with a sales revenue of 2.07 billion yuan in 2024, capturing 88% of the market share for psoriasis treatment [3][4]. Group 2: Industry Trends and Adjustments - Other MNCs, like AstraZeneca and Eli Lilly, are also restructuring their operations in response to the unbalanced return on investment in lower-tier markets [2][5]. - The trend of MNCs outsourcing mature products or consolidating divisions is becoming common as they focus on innovation [11][12]. - The county market remains a significant opportunity, with over 900 million people, but the return on investment is currently not favorable for MNCs [13][17]. Group 3: Challenges in the County Market - The growth of innovative drug sales in county hospitals is lagging behind urban hospitals, with only 11.2% of the market share and a growth rate of 9.5% [15][17]. - Barriers to the adoption of innovative drugs in county markets include conservative clinical practices among county doctors and limited patient payment capabilities [15][16]. - Local pharmaceutical companies have a competitive advantage in the county market, making it difficult for foreign companies to compete effectively [17][18].

Core Viewpoint - A number of A-share pharmaceutical companies are planning to raise funds through refinancing, with a focus on innovative drug projects, reflecting the industry's shift towards innovation due to high R&D costs and long profit cycles [1][3][6]. Group 1: Fundraising Plans - International Medicine announced plans to raise up to 1.008 billion yuan through a private placement, targeting smart healthcare projects and a proton therapy center [3][4]. - Zoli Pharmaceutical plans to issue convertible bonds to raise up to 1.556 billion yuan for an intelligent traditional Chinese medicine factory and product development [3][4]. - A total of 10 pharmaceutical companies have disclosed refinancing plans since the second half of the year, including Shutaishen and Hanyu Pharmaceutical [1][3]. Group 2: Focus on Innovative Drugs - Many of the fundraising projects from these companies are directed towards innovative drug development, with Shutaishen planning to allocate 883 million yuan for R&D of new drugs [5][6]. - Other companies like Anglikang and Apac Pharmaceutical are also focusing their fundraising efforts exclusively on innovative drug projects [5][6]. Group 3: Financial Pressure and Fund Utilization - Some companies are experiencing a decline in cash reserves, with examples like Weiguang Biological, whose cash balance dropped from 256 million yuan to 80 million yuan [7][9]. - The fundraising efforts are aimed at alleviating financial pressure and improving liquidity, with companies like Hanyu Pharmaceutical planning to use part of the funds to reduce their debt ratio [9][10]. - The overall trend indicates that refinancing is a necessary strategy for pharmaceutical companies to ensure project advancement and optimize capital structure [9][10].

代谢相关脂肪性肝炎(MASH)是由过量脂肪细胞引起的肝脏炎症，可导致进行性肝纤维化和肝硬化。 MASH的患者基数相当庞大，目前国内尚无专门获批用于治疗MASH的药物，存在巨大的未被满足的临 床治疗需求，因此开发有效的MASH治疗药物对改善患者的健康状况至关重要。 众生药业（002317）(002317.SZ)发布公告，近日，公司控股子公司广东众生睿创生物科技有限公司(以 下简称"众生睿创")自主研发的一类创新多肽药物RAY1225注射液新增适应症治疗"代谢相关脂肪性肝 炎"的药物临床试验获得国家药品监督管理局批准，并收到《药物临床试验批准通知书》，同意 RAY1225注射液新增适应症进行临床试验。 RAY1225注射液是众生睿创研发的、具有全球自主知识产权的创新结构多肽药物，具有GLP-1受体和 GIP受体双重激动活性，得益于优异的药代动力学特性，具备每两周注射一次的长效药物潜力。目前， RAY1225注射液用于治疗中国肥胖/超重患者的安全性和有效性的III期临床试验(REBUILDING-2研究)已 顺利启动并完成全部参与者入组工作;RAY1225注射液单药治疗2型糖尿病患者的安全性和有效性、安慰 剂对照的 ...

RAY1225注射液是众生睿创研发的、具有全球自主知识产权的创新结构多肽药物，具有GLP-1受体和 GIP受体双重激动活性，得益于优异的药代动力学特性，具备每两周注射一次的长效药物潜力。目前， RAY1225注射液用于治疗中国肥胖/超重患者的安全性和有效性的III期临床试验（REBUILDING-2研 究）已顺利启动并完成全部参与者入组工作；RAY1225注射液单药治疗2型糖尿病患者的安全性和有效 性、安慰剂对照的III期临床试验（SHINING-2）和RAY1225注射液与口服降糖药物联合治疗2型糖尿病 患者的安全性和有效性、司美格鲁肽注射液对照的III期临床试验（SHINING-3）两项降糖III期临床试验 目前参与者入组情况顺利。 格隆汇12月4日丨众生药业(002317.SZ)公布，公司控股子公司广东众生睿创生物科技有限公司（称"众 生睿创"）自主研发的一类创新多肽药物 RAY1225 注射液新增适应症治疗"代谢相关脂肪性肝炎"的药物 临床试验获得国家药品监督管理局批准，并收到《药物临床试验批准通知书》，同意RAY1225注射液 新增适应症进行临床试验。 ...

RAY1225 能选择性结合并激活GLP-1受体和GIP受体，以葡萄糖依赖的方式促进胰岛素分泌和抑制胰高 血糖素从而控制血糖，同时抑制胃排空，抑制食欲，降低体重，降低外周胰岛素抵抗，改善肝脏脂肪变 性和气球样变等。RAY1225 的临床前研究结果表明，在MASH动物模型中RAY1225可改善的NAS评分 (评估肝脏炎症、坏死、纤维化等)、降低体重、改善脏体系数、糖脂代谢和肝脏脂肪水平，并呈现剂量 相关性，临床上有望用于MASH的治疗。 RAY1225注射液是众生睿创研发的、具有全球自主知识产权的创新结构多肽药物，具有GLP-1受体和 GIP受体双重激动活性，得益于优异的药代动力学特性，具备每两周注射一次的长效药物潜力。目前， RAY1225注射液用于治疗中国肥胖 /超重患者的安全性和有效性的III期临床试验(REBUILDING-2研究) 已顺利启动并完成全部参与者入组工作;RAY1225注射液单药治疗2型糖尿病患者的安全性和有效性、安 慰剂对照的III期临床试验(SHINING-2)和RAY1225注射液与口服降糖药物联合治疗2型糖尿病患者的安 全性和有效性、司美格鲁肽注射液对照的III期临床试验(SHIN ...

财通证券表示，中国药企的BD交易在全球交易总额占比约30%，创新药研发呈现"多快好省"的特 点，成为海外药企产品引进的重要来源。国内药企从创新药项目需求方转变为提供方，BD收入已成为 拓展收入的重要来源。 （责任编辑：董萍萍 ） 【免责声明】本文仅代表作者本人观点，与和讯网无关。和讯网站对文中陈述、观点判断保持中立，不对所包含内容 的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部责任。邮箱： news_center@staff.hexun.com 注：如提及个股仅供参考，不代表投资建议。指数/基金短期涨跌幅及历史表现仅供分析参考，不 预示未来表现。市场观点随市场环境变化而变动，不构成任何投资建议或承诺。文中提及指数仅供参 考，不构成任何投资建议，也不构成对基金业绩的预测和保证。如需购买相关基金产品，请选择与风险 等级相匹配的产品。相关标的在市场波动、基本面变化等因素下，向下弹性或释放。基金有风险，投资 需谨慎。 每日经济新闻 科创创新药ETF国泰（589720）聚焦科创板创新药企业，跟踪汇聚30家代表性优质公司的上证科创 板创新药指数，以高成长biotech为主，产品20%涨 ...