（来源：中国医药报） 转自：中国医药报 生物医药产业是福建省厦门市重点培育发展的战略性新兴产业之一。截至2025年底，厦门市集聚生物医 药企业超过1800家，产业规模近千亿元；累计上市1类新药8个，60多个新药品种进入产品注册或临床试 验阶段；获批上市境内第三类医疗器械产品72个，占福建省总量的90%……以创新为底色的生物医药产 业正持续为厦门注入发展的活力。 厦门市市场监管局副局长张志成表示："我们始终寓监管于服务之中，以高标准监管护航高水平创新， 全力支持厦门生物医药产业聚势突破、行稳致远。"据悉，近年来，厦门市市场监管局坚持以夯实监管 能力为基础、培育专业人才为支撑、优化产业服务为抓手，持续推动监管与服务深度融合，积极打造生 物医药产业高质量发展新生态。 □ 本报记者 常锐博 强化技术支撑 去年11月25日，中国食品药品检定研究院举办2025年国家药品抽检质量分析工作培训会暨现场交流评议 会。厦门市食品药品质量检验研究院（以下简称厦门市食药检院）承检的硝酸咪康唑乳膏和桑菊感冒颗 粒两个品种经网络评议初筛，成功进入会议现场评议环节。 这并非厦门市食药检院首次入围国家药品抽检质量分析现场评议。自2009年承 ...

Core Insights - The National Healthcare Security Administration and the Ministry of Human Resources and Social Security have released the new National Medical Insurance Directory and the first Commercial Health Insurance Innovative Drug Directory, set to be implemented nationwide from January 1, 2026 [1][2] Summary by Sections National Medical Insurance Directory - A total of 114 new drugs have been added to the National Medical Insurance Directory, with 111 of them being new products launched within the last five years, representing 97.3% of the new additions [2] - Among the new drugs, 50 are classified as Category 1 innovative drugs, with a success rate of 88%, an increase from 76% in 2024 [2] - The total number of drugs in the directory has increased to 3,253, including 1,857 Western medicines and 1,396 traditional Chinese medicines [2] Company Announcements - Several listed companies, including Heng Rui Medicine, Fosun Pharma, and Hai Si Ke, announced new drug inclusions or renewals in the updated National Medical Insurance Directory [3] - Heng Rui Medicine reported that 20 products/indications were included, with significant coverage across various diseases such as tumors and cardiovascular conditions [3][4] - Hai Si Ke's two Category 1 innovative drugs were included, with one being a new addition and the other a renewal [4] Commercial Health Insurance Innovative Drug Directory - The first Commercial Health Insurance Innovative Drug Directory includes 19 new drugs from 18 innovative pharmaceutical companies, with 9 being Category 1 innovative drugs [7] - Notably, five CAR-T products were included, representing over half of the CAR-T products available in China, which previously faced challenges in entering the insurance market due to high pricing [7][8] - The directory also includes treatments for rare diseases and high-profile conditions such as Alzheimer's disease, enhancing the complementarity with the basic medical insurance [7][10] Notable Drug Inclusions - The directory includes drugs for significant diseases such as triple-negative breast cancer and pancreatic cancer, as well as treatments for rare diseases like Gaucher disease [5][9] - In the diabetes sector, several domestic drugs were newly included, such as a long-acting GLP-1 receptor agonist [6] - Companies like Bei Hai Kang Cheng and Bai Ji Shen Zhou have also successfully included their innovative drugs in the Commercial Health Insurance Directory [9]

Core Points - The company has successfully included several of its products in the National Medical Insurance Catalog for 2025, which is expected to enhance sales and improve operational performance [1] - The total estimated sales for the included drugs in 2024 is approximately 8.66 billion yuan, and for the first three quarters of 2025, it is about 7.55 billion yuan [1] Drug Inclusion in National Medical Insurance Catalog - The following drugs have been newly included: - Injection of Rukang Qutuzumab - Apixaban Famitinib Capsules - Injection of Funaqi Zhumab - Sulfate of Amatuximab Tablets - Injection of Phosphorola Pitant Palonosetron - Injection of Ruikasi Zhumab - Acetate of Abiraterone Tablets (II) - Lipid Injection of Irinotecan Hydrochloride (II) - Regaglitin Metformin Tablets (I)/(II) - Perfluorohexyl Octane Eye Drops [1] - The following drugs have successfully added new indications: - Injection of Karelizumab - Fluorazepam Capsules - Injection of Fumaric Acid Tegafur [1] - The following drugs have been renewed and retained in the National Medical Insurance Catalog: - Maleate of Pyrotinib Tablets - Hecorapam Ethanolamine Tablets - Phosphate of Regaglitin Tablets - Injection of Methylsulfonylmethane Remazolam - Sulfate of Pevonedistat Injection [1] - The following drugs have new indications and have been adjusted to regular catalog management: - Mesylate of Apatinib Tablets - Lipid Injection of Bupivacaine [1] Impact on the Company - The inclusion of these drugs in the National Medical Insurance Catalog is expected to positively impact sales, although the exact effect on the company's operational performance is currently indeterminate [1] - The National Medical Insurance Catalog will officially take effect on January 1, 2026, with further details on payment standards and reimbursement rules to be announced by relevant government departments [1]

证券代码：600276 证券简称：恒瑞医药 公告编号：临2025-194 江苏恒瑞医药股份有限公司关于公司药品纳入国家医保目录的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担法律责任。 根据国家医保局、人力资源社会保障部关于印发《国家基本医疗保险、工伤保险和生育保险药品目录 （2025年）》的通知（"《国家基本医疗保险、工伤保险和生育保险药品目录》"以下简称"国家医保目 录"），江苏恒瑞医药股份有限公司（以下简称"恒瑞医药"或"公司"）部分产品纳入国家医保目录。 通过医保谈判，注射用瑞康曲妥珠单抗、苹果酸法米替尼胶囊、夫那奇珠单抗注射液、硫酸艾玛昔替尼 片、注射用磷罗拉匹坦帕洛诺司琼、注射用瑞卡西单抗、醋酸阿比特龙片（Ⅱ）、盐酸伊立替康脂质体 注射液（Ⅱ）、瑞格列汀二甲双胍片（Ⅰ）/（Ⅱ）、全氟己基辛烷滴眼液首次纳入国家医保目录；注 射用卡瑞利珠单抗、氟唑帕利胶囊、富马酸泰吉利定注射液新增适应症成功纳入国家医保目录；马来酸 吡咯替尼片、海曲泊帕乙醇胺片、磷酸瑞格列汀片、注射用甲苯磺酸瑞马唑仑、硫培非格司亭注射液续 约成功保留在国家 ...

公司上述药品2024年度合计销售额约为86.60亿元，2025年1-3季度合计销售额约为75.54亿元。公司上述 药品纳入国家医保目录，将有利于药品的销售，对公司经营业绩的影响暂无法估计。国家医保目录 (2025年)将于2026年1月1日起正式实施，医保支付标准、医保报销细则等相关信息，需以国家医疗保障 局等相关政府部门公示信息为准。敬请广大投资者谨慎投资，注意防范投资风险。 格隆汇12月7日丨恒瑞医药(600276.SH)公告，根据国家医保局、人力资源社会保障部关于印发《国家基 本医疗保险、工伤保险和生育保险药品目录(2025年)》的通知("《国家基本医疗保险、工伤保险和生育 保险药品目录》"以下简称"国家医保目录")，江苏恒瑞医药股份有限公司(以下简称"恒瑞医药"或"公 司")部分产品纳入国家医保目录。 通过医保谈判，注射用瑞康曲妥珠单抗、苹果酸法米替尼胶囊、夫那奇珠单抗注射液、硫酸艾玛昔替尼 片、注射用磷罗拉匹坦帕洛诺司琼、注射用瑞卡西单抗、醋酸阿比特龙片(Ⅱ)、盐酸伊立替康脂质体注 射液(Ⅱ)、瑞格列汀二甲双胍片(Ⅰ)/(Ⅱ)、全氟己基辛烷滴眼液首次纳入国家医保目录；注射用卡瑞利 珠单抗、氟唑帕利胶囊 ...

Core Insights - Jiangsu Hengrui Medicine Co., Ltd. reported a revenue of 15.761 billion yuan for the first half of 2025, marking a year-on-year increase of 15.88% [1] - The net profit attributable to shareholders reached 4.45 billion yuan, reflecting a growth of 29.67% year-on-year [1] - Operating cash flow net amount was 4.3 billion yuan, up by 41.80% compared to the previous year [1] Revenue Breakdown - The sales and licensing income from innovative drugs amounted to 9.561 billion yuan, accounting for 60.66% of total revenue, with innovative drug sales alone contributing 7.570 billion yuan [1] - The company received upfront payments of 200 million USD from Merck and 75 million USD from IDEAYA for licensing agreements, which further boosted revenue [1] R&D Investment - Hengrui Medicine invested 3.871 billion yuan in R&D during the reporting period, with 3.228 billion yuan classified as expense-based R&D [2] - Cumulative R&D investment exceeded 48 billion yuan, supporting a surge in innovative outcomes [1][2] Product Approvals and Pipeline - Six Class 1 innovative drugs were approved for market launch, including injection of Ricacizumab and others [2] - The company has over 100 self-developed innovative products in clinical development and more than 400 clinical trials ongoing domestically and internationally [2] Strategic Collaborations - Hengrui Medicine has strengthened international cooperation, granting exclusive global rights for the oral small molecule drug HRS-5346 to Merck outside Greater China [2] - The company also entered into a collaboration agreement with GSK to co-develop up to 12 innovative drugs across various therapeutic areas [2] Employee Incentives - To enhance team cohesion and core competitiveness, Hengrui Medicine announced a share buyback plan of 1 to 2 billion yuan for a new employee stock ownership plan, with an incentive scale not exceeding 14 million shares in 2025 [3]

Core Viewpoint - The report highlights that Heng Rui Medicine is experiencing a significant transformation driven by high-intensity R&D investments, with innovative drug sales becoming the core growth driver for the company's performance [2][3]. Financial Performance - In the first half of 2025, Heng Rui Medicine achieved operating revenue of 15.761 billion yuan, a year-on-year increase of 15.88% [2]. - The net profit attributable to shareholders reached 4.450 billion yuan, up 29.67% year-on-year [2]. - Operating cash flow net amount was 4.300 billion yuan, reflecting a 41.80% increase year-on-year [2]. - The revenue, net profit, and operating cash flow all reached record highs for the same period in previous years, indicating an explosive growth phase [2]. R&D Investment - Heng Rui Medicine's R&D investment in the first half of 2025 was 3.871 billion yuan, with 3.228 billion yuan being expensed [5]. - Cumulatively, the company has invested over 48 billion yuan in R&D [5]. - The company launched six Class 1 innovative drugs during the reporting period, contributing to its performance growth [5]. Innovative Drug Sales - Innovative drug sales and licensing revenue amounted to 9.561 billion yuan, accounting for 60.66% of the company's total operating revenue [2]. - The sales revenue from innovative drugs was 7.570 billion yuan [2]. - The strong sales of innovative drugs are a major driving force behind the company's performance growth [6]. Business Development (BD) Transactions - Heng Rui Medicine has engaged in significant BD transactions, including a $1.97 billion contract with Merck for an oral small molecule project and a partnership with GSK worth $500 million [3][4]. - The normalization of BD transactions is seen as a key feature of the development of China's innovative drug industry [3][4]. - The company received upfront payments of $200 million from Merck and $75 million from IDEAYA during the reporting period, further boosting its revenue [6]. Industry Trends - The report indicates that the Chinese innovative drug industry is experiencing a surge in BD activities, with a total of $66 billion in license-out transactions in the first half of 2025, surpassing the total for 2024 [10]. - The approval of 43 innovative drugs by the National Medical Products Administration in the first half of 2025 marks a 59% year-on-year increase, setting a historical record for the same period [9]. - The report emphasizes that the future of innovative drug companies will rely on a cycle of R&D, commercialization, and further R&D, with BD transactions becoming essential for cash flow and market feedback [10].

Investment Rating - The report assigns an "Overweight" rating to the pharmaceutical and biotechnology industry, indicating that the industry index is expected to outperform the CSI 300 index by 10% or more over the next six months [2][37]. Core Insights - The pharmaceutical and biotechnology sector saw an overall increase of 2.21% in the week from May 26 to May 30, ranking second among 31 industries in the Shenwan index and outperforming the CSI 300 index by 3.29 percentage points. Year-to-date, the sector has risen by 6.61%, ranking sixth among the 31 industries and outperforming the CSI 300 index by 9.02 percentage points [4][13][15]. - The current PE valuation for the pharmaceutical and biotechnology sector is 27.98 times, which is at the historical median level, with a valuation premium of 137% compared to the CSI 300 index. The top three sub-sectors in terms of growth are chemical pharmaceuticals, biological products, and medical services, with increases of 3.83%, 3.14%, and 2.46% respectively [4][22][15]. - A total of 373 stocks (77.9%) in the sector rose last week, while 97 stocks (20.3%) declined. The top five gainers were Shuyou Shen (60.41%), Huason Pharmaceutical (41.97%), Changshan Pharmaceutical (35.91%), Huana Pharmaceutical (32.62%), and Yifang Biological (30.51%) [4][27]. Market Performance - The pharmaceutical and biotechnology sector's performance is highlighted by the approval of 11 innovative drugs by the National Medical Products Administration (NMPA) on May 29, which enhances treatment options for patients and showcases the increasing innovation capability of China's pharmaceutical industry [5][29]. - The 2025 American Society of Clinical Oncology (ASCO) annual meeting showcased several domestic innovative drug projects, indicating that local companies are gaining international recognition for their innovative capabilities [5][32]. Investment Recommendations - The report suggests focusing on the innovative drug sector as it is the most certain and leading sub-sector within the pharmaceutical and biotechnology industry. Additionally, it recommends exploring investment opportunities in medical devices, traditional Chinese medicine, chain pharmacies, and medical services [6][35]. - Recommended stocks include Beida Pharmaceutical, Te Bao Biological, Qianhong Pharmaceutical, Ling Rui Pharmaceutical, and Lao Bai Xing. Stocks to watch include Kelong Pharmaceutical, Rongchang Biological, Kaili Medical, Huaxia Eye Hospital, and Baipu Sais [6][35].

Investment Rating - The report provides a positive outlook on the pharmaceutical and biotechnology sector, highlighting a weekly increase of 2.21%, outperforming the Wind All A index and the CSI 300 index [2][7]. Core Insights - The report emphasizes the impressive performance of domestic innovative drugs at the 2025 American Society of Clinical Oncology (ASCO) annual meeting, with over 70 oral presentations and more than 10 significant studies, indicating a growing participation of domestic innovative drugs [2][10]. - The report notes significant advancements in dual antibodies and ADC fields, with new mechanisms and targets emerging, suggesting a differentiated layout in early clinical stages [2][10]. - The report recommends focusing on early differentiated directions in anti-tumor drugs and long-term attention on biotech and traditional pharmaceutical companies deeply involved in dual antibodies and ADCs [2][10]. Summary by Sections Market Weekly Review - The pharmaceutical and biotechnology sector rose by 2.21% from May 26 to May 30, outperforming the Wind All A index (-0.02%) and the CSI 300 index (-1.08%) [7]. - The best-performing sub-sectors included other biological products (4.65%), chemical preparations (4.27%), and medical research outsourcing (4.0%), while offline pharmacies saw a decline of 2.69% [7][8]. - Notable individual stock performances included Shuyou Shen (60.4%), Huason Pharmaceutical (42%), and Changshan Pharmaceutical (35.9%) [10]. Industry News and Key Company Announcements - On May 30, Summit Therapeutics announced positive results from the global Phase III clinical trial of the dual antibody Ivorosi, achieving the primary endpoint of progression-free survival (PFS) [10][12]. - The report highlights the collaboration between Xinnuo Wei Pharmaceutical and Astellas for the development of a new generation antibody-drug conjugate, with an upfront payment of $130 million and potential milestone payments totaling up to $1.34 billion [12][13]. - The report also mentions various companies receiving approvals for innovative drugs and therapies, indicating a vibrant pipeline in the industry [14][15].

Core Insights - On May 29, 2023, Heng Rui Medicine received approval for three innovative drugs, marking a significant achievement in the pharmaceutical industry [1][3] - The approval of these drugs reflects the increasing vibrancy of the innovative drug market in China, with a notable rise in capital market enthusiasm [2][5] Company Highlights - Heng Rui Medicine has now received approval for a total of 23 innovative drugs in China, with over 90 additional products in clinical development and approximately 400 clinical trials ongoing domestically and internationally [3] - The three newly approved drugs include: 1. Injection of Phosphororapitan Palonosetron (brand name: Ruitanning) for chemotherapy-induced nausea and vomiting 2. Self-developed HER2 ADC (antibody-drug conjugate) 3. Injection of Ruikang Trastuzumab (brand name: Aivida) for cervical cancer and non-small cell lung cancer [3] Industry Trends - The approval of 11 innovative drugs by the National Medical Products Administration (NMPA) on the same day has injected strong momentum into the pharmaceutical sector, with the Hang Seng Biotechnology Index showing a year-to-date increase of over 43% [5] - The upcoming 2025 American Society of Clinical Oncology (ASCO) annual meeting is expected to showcase a record number of presentations from Chinese experts, highlighting the growing international influence of Chinese innovative drug companies [6][7] - The market is witnessing a surge in innovative drug development, with many Chinese companies demonstrating strong potential for global expansion through licensing and other strategies [5][6]