Core Insights - Company subsidiary Guangdong Hengrui Medicine Co., Ltd. and Shanghai Hengrui Medicine Co., Ltd. received approval from the National Medical Products Administration for the clinical trial of SHR-3045 injection [1] - SHR-3045 injection is a self-developed biological product aimed at treating rheumatoid arthritis, expected to suppress immune cell function, reduce inflammation, and improve clinical symptoms [1] Company Developments - The clinical trial for SHR-3045 injection will commence shortly following the approval [1] - This development highlights the company's ongoing commitment to advancing its pipeline of innovative treatments in the biopharmaceutical sector [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Shanghai Heng Rui Medicine Co., Ltd., has announced that its injectable SHR-1501 has been included in the list of proposed breakthrough therapeutic varieties by the National Medical Products Administration, with a public announcement period of 7 days [1] Group 1: Product Development - SHR-1501 is a self-developed interleukin-15 (IL-15) fusion protein that stimulates the proliferation of T cells, B cells, and NK cells, enhancing the immune system's ability to eliminate foreign substances such as tumors [1] - The proposed indication for SHR-1501 is in combination with Bacillus Calmette-Guérin (BCG) for patients with non-muscle invasive carcinoma in situ (CIS) who do not respond to BCG [1] - The combination of SHR-1501 with BCG is expected to significantly enhance the immune response within the bladder, achieving a synergistic anti-tumor effect [1] Group 2: Market Context - Currently, there are no approved products in China targeting the same mechanism as SHR-1501, while a similar product, Nogapendekin Alfa Inbakicept (marketed as Anktiva), has been approved for sale in the United States [1] - The cumulative research and development investment for SHR-1501 has reached approximately 10.218 million yuan [1]

南财智讯9月18日电，恒瑞医药公告，广东恒瑞医药有限公司收到国家药品监督管理局关于SHR-1139注 射液的《药物临床试验批准通知书》，同意开展溃疡性结肠炎的临床试验。该药物是公司自主研发的治 疗用生物制品，预期可通过抑制炎症反应和维持上皮屏障等机制协同增效。目前国内外尚无同类药物获 批上市。截至目前，该项目累计研发投入约7,128万元。公司提醒投资者注意药品研发过程中的不确定 性风险，并将按国家有关规定积极推进研发项目，及时披露项目后续进展。 ...

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of SHR-1139 injection, a self-developed biological product aimed at treating ulcerative colitis through mechanisms that inhibit inflammation and maintain epithelial barrier [1] Group 1 - The company’s subsidiary, Guangdong Hengrui Medicine Co., Ltd., is responsible for the clinical trial of SHR-1139 injection [1] - SHR-1139 injection is expected to enhance treatment efficacy for ulcerative colitis by targeting inflammation and epithelial barrier maintenance [1]

SHR-1501为公司自主研发并具有知识产权的白细胞介素-15（IL-15）融合蛋白，可以刺激体内T细胞、 B细胞和NK细胞增殖，发挥调动机体免疫系统清除体内异物（如肿瘤）的作用，其与BCG联用可明显 增强膀胱内的免疫反应，达到协同抗肿瘤的效果。 格隆汇9月18日丨恒瑞医药(600276.SH)公布，公司子公司上海恒瑞医药有限公司的注射用SHR-1501被国 家药品监督管理局药品审评中心（称"药审中心"）纳入拟突破性治疗品种公示名单，公示期7日。 ...

Core Viewpoint - The announcement indicates that Shanghai Henlius Biopharma Co., Ltd.'s injectable SHR-1501 has been included in the list of potential breakthrough therapies by the National Medical Products Administration, with a public notice period of 7 days [1] Group 1: Product Information - SHR-1501 is a recombinant interleukin-15 fusion protein developed by the company, which, when used in conjunction with Bacillus Calmette-Guérin (BCG), can enhance immune response and synergistically combat tumors [1] - The primary indication for SHR-1501 is for patients with non-muscle invasive bladder cancer who do not respond to BCG treatment [1] Group 2: Financial Investment - The cumulative research and development investment for the SHR-1501 project has reached approximately 102 million yuan [1]

港股三大指数今日集体下跌，药企龙头恒瑞医药(1276.HK)逆势上扬，一度涨7.18%至91港元，股价创上市新高，市值超6000亿港元。该股于今年5月23日登 陆港交所，迄今不到4个月，现价较IPO价格(44.05港元)已累涨106.58%。 消息面上，恒瑞医药昨日晚间公告称，公司子公司苏州盛迪亚生物医药有限公司收到国家药监局下发的《受理通知书》，公司注射用瑞康曲妥珠单抗(SHR- A1811)用于治疗既往接受过一种或一种以上抗HER2药物治疗的局部晚期或转移性HER2阳性成人乳腺癌患者的新适应症上市许可申请获国家药监局受理， 且已被纳入优先审评程序。该药品已在国内获批上市，适用于治疗存在HER2(ERBB2)激活突变且既往接受过至少一种系统治疗的不可切除的局部晚期或转 移性非小细胞肺癌(NSCLC)成人患者。(格隆汇) ...

2024年中国药企完成超90笔海外授权交易，总交易金额超519亿美元，参与了全球约三分之一的大型授权交易。今年上半年，中国创新药 授权出海交易已超过50起，总金额超过660亿美元。近年来，中国生物医药产业快速崛起并在这两年进入收获期，中国药企和科研机构正展现 出国际前沿的原始创新能力。 和黄医药临床开发高级副总裁范颂华称："从中国产业融合来讲，确实这十年的发展或者二十年的发展也让中国诞生了越来越多具有国际 视野的中国研究者，并且中国产生的数据也越来越得到美国FDA（食品药物管理局）的认证。" 央视网消息：今年以来，中国创新药"出海"步伐持续加快。数据显示，2025年上半年创新药对外授权总金额已超过660亿美元，超过2024 年全年519亿美元的交易总额，其中多笔交易金额超过10亿美元，展现出中国创新药实力的显著提升和全球化进程的提速。 近日，在上海张江生物医药创新基地，恒瑞医药与英国葛兰素史克公司完成包含5亿美元首付款、潜在120亿美元里程碑付款及销售分成的 合作交易，这是今年以来中国第100笔对外授权交易。 江苏恒瑞医药股份有限公司总裁冯佶称："中国的研发已经得到了全球的认可，很多大公司都在中国看什么样的产 ...

9月18日午后，大盘跳水走低，沪指跌超1%。热门ETF中，创新药ETF天弘（517380）回落小幅下跌 0.46%，溢折率0.32%，盘中溢价交易明显。成分股中，汇宇制药-W涨超4%，信立泰、科伦药业、恒 瑞医药等涨幅居前， 生物医药ETF(159859）紧密跟踪生物医药指数。国证生物医药指数以A股市场属于生物医药产业相关上 市公司为样本空间，根据市值规模和流动性的综合排名，选出前30只股票作为指数样本股（数量不足时 则按实际数量选入），反映了生物医药行业的整体运行情况，向市场提供了细分行业的指数化投资标 的。该ETF还配备了联接基金（A：011040，C：011041）。 消息面上，创新药企再传来利好消息。9月17日晚间，恒瑞医药公告，公司子公司苏州盛迪亚生物医药 有限公司收到国家药监局下发的《受理通知书》，公司注射用瑞康曲妥珠单抗（SHR-A1811）用于治疗 既往接受过一种或一种以上抗HER2药物治疗的局部晚期或转移性HER2阳性成人乳腺癌患者的新适应 症上市许可申请获国家药监局受理，且已被纳入优先审评程序。该药品已在国内获批上市，适用于治疗 存在HER2（ERBB2）激活突变且既往接受过至少一种系统治 ...

Investment Rating - The report maintains an investment rating of "Outperform" for the pharmaceutical and biotechnology industry, indicating a positive outlook compared to the broader market [4]. Core Insights - The pharmaceutical and biotechnology industry is experiencing a recovery in Q2 2025, with innovative drugs poised for significant development opportunities [1][10]. - The overall revenue for 461 A-share pharmaceutical companies in H1 2025 was CNY 11,939.5 billion, a year-on-year decrease of 3.21%, while net profit attributable to shareholders was CNY 1,016.2 billion, down 8.55% [8][24]. - The medical services sector showed positive growth, with revenue increasing by 3.92% year-on-year, while other segments like raw materials, chemical preparations, traditional Chinese medicine, and medical devices faced declines [8][24]. Summary by Sections 1. Market Review - The pharmaceutical and biotechnology index rose by 7.36% in H1 2025, outperforming the CSI 300 index by 7.33 percentage points, with the chemical preparation sector leading with a 20.09% increase [15][21]. 2. Industry Performance - In H1 2025, the chemical preparation sector reported a revenue of CNY 2,044.3 billion, down 5.77%, and a net profit of CNY 223.1 billion, down 22.92% [43]. - The medical services sector achieved a revenue of CNY 890.2 billion, with a significant net profit increase of 40.22% [8][24]. - The report highlights a trend of improving performance in Q2 compared to Q1, with several sectors showing signs of recovery [30]. 3. Subsector Analysis Raw Materials - The raw materials sector generated CNY 459.1 billion in revenue, a decrease of 6.74%, with a net profit of CNY 45.4 billion, down 2.71% [32][38]. - The report suggests a long-term growth outlook for the raw materials sector, driven by increasing demand and regulatory changes [38]. Chemical Preparations - The chemical preparations sector is expected to benefit from new policies supporting innovative drugs, with a focus on balancing price and clinical needs [48][49]. - The sector's revenue and profit are under pressure but are anticipated to recover as innovation and reform take hold [43][48]. Traditional Chinese Medicine - The traditional Chinese medicine sector reported a revenue of CNY 1,731.95 billion, with a slight profit increase of 0.24% [52]. - The sector is seen as having structural opportunities despite overall revenue declines [52]. Medical Services - The medical services sector is highlighted for its robust growth, with a focus on integrated service platforms [30][31]. Medical Devices - The medical devices sector is expected to recover as demand for equipment updates increases, with a revenue of CNY 1,155.6 billion, down 4.47% [8][30]. 4. Recommendations - The report recommends focusing on leading companies in various sectors, such as Tianyu Co. in raw materials, BeiGene in innovative drugs, and Yifeng Pharmacy in medical commerce [8][42][50].