"借船出海"成效显著，BD 打开第二增长曲线。公司 25H1 收到 MSD 公司 2 亿美元及 IDEAYA 公司 7500 万美元的对外许可首付 款，显著增厚业绩；2025 年至今公司陆续达成多项重磅合作，包 括口服 GnRH 受体拮抗剂与德国默克达成合作（首付款 1500 万欧 元）、Lp(a)抑制剂与 MSD 达成合作（首付款 2 亿美元+最高 17.7 亿美元里程碑付款+销售提成）、PDE3/4 等 12 款新药与 GSK 达成 合作（首付款 5 亿美元+潜在约 120 亿美元选择权行使费和里程碑 付款+销售提成）。创新药对外许可已成为公司常态化业务。 创新研发步入收获期。公司 25H1 累计研发投入 38.71 亿元，其中 费用化研发投入 32.28 亿元（占营业收入 20.48%）。目前公司围绕 100 余款在研创新产品开展超过 400 项海内外临床试验，ADC（抗 体偶联药物）、AI 药物研发等技术平台日益成熟。25H1 公司 6 款 1 类新药获批上市，包括全球首款超长效 PCSK9 单抗瑞卡西单抗、 首款国产 JAK1 抑制剂艾玛昔替尼片、HER2 ADC 瑞康曲妥珠单 抗等、多靶点 RTK ...

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 industry investment rating is "stronger than the market" (预计6个月内，行业指数表现强于市场表现5%以上) [35] Core Viewpoints - The report emphasizes the importance of multi-party collaboration in supporting the development of innovative drugs and medical devices, highlighting the integration of data, policy, and funding as essential elements for growth [4] - The report notes that recent measures from the Financial Supervisory Administration and the Medical Insurance Bureau aim to promote the development of commercial health insurance, which will provide additional support for the innovation and development of drugs and medical devices [4] Summary by Sections Industry Insights - The Medical Insurance Bureau's recent meetings have established a comprehensive support system for innovative drugs and medical devices, involving various stakeholders such as research institutions, enterprises, medical institutions, financial companies, and government departments [4] - The Financial Supervisory Administration has released measures to enhance the quality of commercial health insurance, which will further support the biopharmaceutical industry's innovation [4] Investment Strategy - The report suggests focusing on innovative pharmaceutical companies with rich pipelines, such as 恒瑞医药 (Hengrui Medicine), 百济神州 (BeiGene), and 中国生物制药 (China Biologic Products) [6] - It also highlights companies with significant single-product potential and those leading in advanced technology platforms, recommending关注 (focus on) companies like 凯莱英 (Kailaiying) and 药明康德 (WuXi AppTec) [6] Market Performance - The pharmaceutical sector experienced a decline of 0.84% last week, ranking last among 28 industries, while the Shanghai and Shenzhen 300 Index rose by 1.23% [9][21] - The report indicates that the pharmaceutical sector's valuation is currently at 30.91 times (TTM), with a premium of 37.32% compared to the overall A-shares excluding financials [27]

Core Insights - The National Medical Products Administration (NMPA) approved 43 new class 1 innovative drugs in the first half of 2025, a 59% increase year-on-year, nearing the total of 48 approvals for the entire year of 2024 [1] - The approval of innovative drugs is accelerating, with expectations for a record high in 2025 [1] Drug Type Distribution - Chemical drugs lead with 24 varieties, accounting for 56% of approvals; biological products follow with 14 varieties (32%); and traditional Chinese medicine and natural products account for 5 varieties (12%) [2] - The industry is transitioning from a "single-pole dominance" to a "multi-polar balance" [2] Therapeutic Area Insights - Oncology drugs dominate with 20 varieties, making up 47% of approvals; anti-infective drugs, traditional Chinese medicine, and endocrine/metabolic drugs each have 5 varieties (12%) [2] - The approval landscape shows a diverse range of therapeutic areas, with notable mentions for rare diseases and pediatric drugs [3] Review and Approval Process - 17 new drugs, approximately 40% of the total, received breakthrough therapy designation, including 8 biological products and 8 chemical drugs [2] - The NMPA is prioritizing the development of drugs for rare diseases and pediatric use, with specific plans in place for expedited review [3] Policy Support for Innovation - China's pharmaceutical innovation is rapidly advancing, with the country holding about 25% of the global innovative drug pipeline [4] - Recent policy measures, such as the implementation of the "Full Chain Support for Innovative Drug Development" plan, have significantly improved the speed of new drug inclusion in medical insurance [4] Future Initiatives - The NMPA plans to implement further measures to support innovative drug development, focusing on clinically valuable products and global synchronization of research [5] - Efforts will include optimizing review processes, enhancing intellectual property protections, and aligning with international standards to facilitate global competitiveness [5]

Core Viewpoint - Heng Rui Medicine's stock experienced a significant surge, with a maximum increase of over 18% in Hong Kong and over 8% in A-shares, following a buy rating from Citigroup, which highlighted the market's underestimation of the company's business development (BD) expectations and the rapid launch of several innovative drugs [2][5]. Group 1: Stock Performance and Analyst Ratings - On July 9, Heng Rui Medicine's Hong Kong stock price reached 68 HKD, with a rise of 12.96%, while the A-share price was 57.1 CNY, up 6.93%, resulting in a market capitalization of 380.2 billion CNY [2]. - Citigroup assigned a buy rating for Heng Rui Medicine's H-shares with a target price of 134 HKD and an A-share target price of 123 CNY, citing significant catalysts from upcoming performance and BD developments [2][5]. Group 2: Clinical Trials and Drug Approvals - Heng Rui Medicine announced the approval of clinical trials for two new drugs: SHR-2173 injection, aimed at treating primary membranous nephropathy, and HRS-9821 inhalation powder, intended for chronic obstructive pulmonary disease (COPD) maintenance therapy [4][6]. - SHR-2173 is a biologic targeting abnormally activated immune cells, while HRS-9821 is a small molecule PDE3/PDE4 inhibitor, with the latter expected to compete with Ensifentrine, which is projected to generate approximately 42 million USD in sales in 2024 [4][6]. Group 3: Research and Development Progress - Heng Rui Medicine has 23 first-class innovative drugs and 4 second-class new drugs approved in China, with 8 first-class innovative drugs launched in 2024 alone [8]. - The company has invested 46 billion CNY in R&D, with R&D expenditure accounting for 29.4% of sales revenue in 2024, positioning it among the top in the pharmaceutical industry [8]. - The company is expected to have over 40 innovative products approved for market launch in the next three years, covering various therapeutic areas including oncology, metabolism, cardiovascular, immune, and respiratory diseases [9].

Core Viewpoint - Heng Rui Medicine's stock experienced a significant surge, with a maximum increase of over 18% in Hong Kong and over 8% in A-shares, driven by positive market sentiment and new clinical trial approvals [2][3]. Group 1: Stock Performance - On July 9, Heng Rui Medicine's Hong Kong stock rose by a maximum of over 18%, while A-shares peaked at over 8% [3]. - Citigroup initiated a buy rating for Heng Rui Medicine's H-shares with a target price of 134 HKD and A-shares at 123 CNY, citing underappreciated business development (BD) expectations and rapid growth of several innovative drugs [3]. - As of the report, Heng Rui Medicine's market capitalization reached 380.2 billion CNY, with Hong Kong shares priced at 68 HKD and A-shares at 57.1 CNY [3]. Group 2: Clinical Trials and Drug Approvals - Heng Rui Medicine announced the approval of two new drugs for clinical trials: SHR-2173 injection and HRS-9821 inhalation powder [6]. - SHR-2173 is a biologic targeting abnormally activated immune cells, potentially offering new treatment options for primary membranous nephropathy, with no similar drugs currently available [7]. - HRS-9821 is a small molecule PDE3/PDE4 inhibitor aimed at treating chronic obstructive pulmonary disease (COPD), with a global competitor, Ensifentrine, expected to generate approximately 42 million USD in sales in 2024 [8]. Group 3: Innovation and R&D - Heng Rui Medicine has 23 first-class innovative drugs and 4 second-class new drugs approved in China, with 8 first-class innovative drugs approved in 2024 alone [10]. - The company has invested 46 billion CNY in R&D, with R&D expenditure accounting for 29.4% of sales revenue in 2024, ranking among the top in the pharmaceutical industry [10]. - The company is expected to have over 40 innovative products approved for market launch in the next three years, covering various therapeutic areas including oncology, metabolism, cardiovascular, immune, and respiratory diseases [11].

Core Insights - Lung cancer remains the leading cause of cancer-related deaths globally, with ongoing research and development of innovative drugs targeting this disease [1][2] - A total of 2813 drugs are currently in development for lung cancer indications, with a significant focus on non-small cell lung cancer (NSCLC) [2] - In the first half of this year, 9 innovative drugs for lung cancer have been approved, providing new treatment options for patients [3] Group 1: Drug Development Trends - The number of drugs in development for lung cancer has increased from 1655 in November 2022 to 2813 by July 2023, with the majority targeting NSCLC [2] - Among the 2813 drugs, small molecule drugs are the most prevalent, totaling 1028, followed by monoclonal antibodies (264), antibody-drug conjugates (ADC) (226), and bispecific antibodies (110) [2] - The most common drug targets include EGFR (66 drugs), PD-1 (42 drugs), and PD-L1 (27 drugs) [2] Group 2: Recent Drug Approvals - The 9 newly approved lung cancer drugs include products from major companies such as Johnson & Johnson, Bristol-Myers Squibb, and domestic firms like Hengrui Medicine and Hansoh Pharma [3][5] - Johnson & Johnson's Evotazumab is the first bispecific antibody approved for lung cancer, initially for second-line treatment of EGFR exon 20 insertion mutations [4] - The domestic drug Luconisumab, developed by Kelun-Biotech, is the second globally and the first in China ADC targeting TROP2, approved for treating advanced NSCLC [5] Group 3: Emerging Treatment Strategies - The approval of new drugs is addressing rare mutations such as EGFR exon 20 insertion, which accounts for 4%-10% of EGFR mutations and has poor prognosis with existing treatments [3] - The PD-1/VEGF bispecific antibody Ivosidenib has been approved for first-line treatment of PD-L1 positive NSCLC, marking a significant advancement in immunotherapy [7] - The introduction of drugs targeting KRAS mutations, previously considered "undruggable," indicates a shift in treatment possibilities for advanced NSCLC [6]

Core Viewpoint - In the first five months of this year, China's innovative drug licensing agreements have exceeded $45.5 billion, nearly matching the total for the entire previous year, but the recent licensing deal by Rongchang Biopharma has surprised investors negatively [1][2]. Group 1: Licensing Deal Details - Rongchang Biopharma announced a licensing agreement with Vor Bio, granting exclusive rights for the development and commercialization of its product, Taitasip, outside Greater China [1]. - As part of the deal, Rongchang will receive $125 million in cash and warrants, including a $45 million upfront payment and $80 million in warrants, which represents approximately 23% of the company [2]. - Vor Bio is also obligated to pay up to $4.105 billion in milestone payments based on clinical development and commercialization, along with sales royalties [2]. Group 2: Market Reaction - Following the announcement, Rongchang's stock plummeted, with A-shares hitting a 20% limit down and H-shares dropping over 25% [2]. - The A-share price fell from a high of 72 yuan per share to 61.61 yuan, while H-shares closed at 55.55 HKD, reflecting a 6.17% decline [2]. - Prior to the announcement, Rongchang's market capitalization had surged significantly, with A-shares increasing by 18 billion yuan and H-shares quadrupling in value [2][3]. Group 3: Concerns and Criticism - The upfront payment of $45 million was significantly lower than market expectations, contributing to the stock's decline [4]. - Vor Bio, the partner company, has a market capitalization of only $69.28 million and has faced financial difficulties, raising concerns about its ability to fulfill payment obligations [4]. - The "shell company" nature of the deal has led to skepticism, as it appears Rongchang is trading a product for a company with limited resources [4][5]. Group 4: Future Outlook - Despite the negative market reaction, some investors see potential in the new leadership at Vor Bio, with Jean-Paul Kress, an experienced executive in immunology, appointed as CEO [6]. - However, Rongchang's other product, Vidisitamab, faces competition from new entrants like Hengrui Medicine, which could threaten its market share [6].

Investment Rating - The report maintains a positive outlook on the pharmaceutical industry, focusing on innovation, overseas expansion, thematic investments, and dividend strategies as the main investment themes [2][17]. Core Insights - The pharmaceutical sector experienced a short-term pullback but remains optimistic about the innovation-driven growth trajectory. Key areas of focus include innovative drugs, international market expansion, and supportive policies for innovation [2][17]. - The report highlights the importance of innovative drugs as a new productive force, with significant policy support expected to accelerate their development [17]. - The report emphasizes the potential of companies with strong clinical pipelines and innovative capabilities, particularly in the context of recent supportive policies for innovative drugs [16][17]. Summary by Sections Current Industry Investment Strategy - The pharmaceutical index fell by 2.72% in the week, underperforming the CSI 300 index by 1.97 percentage points. Year-to-date, the sector has risen by 1.11%, outperforming the CSI 300 by 1.75 percentage points [15]. - The current valuation level (PE-TTM) for the pharmaceutical industry is 26.53 times, with a premium of 75.91% relative to the entire A-share market [15]. Key Companies and Their Performance - **Hengrui Medicine**: Recent updates on lung cancer data show promising results, with an overall response rate (ORR) of 73% and median progression-free survival (mPFS) of 11.5 months, indicating strong commercial potential [16]. - **Innovative Drug Policies**: New policies are expected to encourage commercial insurance companies to invest in innovative drug companies and improve pricing standards [16][17]. Thematic Investment Lines - **Innovation and Overseas Expansion**: The report identifies innovative drugs as a key area, with a high success rate in recent insurance negotiations for innovative drugs [17]. - **Dividend Strategy**: With the 10-year government bond yield falling below 2%, dividend-paying assets with stable growth and cash flow are highlighted as defensive and offensive investment options [9][18]. Recommended Investment Combinations - The report lists several recommended stocks, including Hengrui Medicine, Enhua Pharmaceutical, and Yifan Pharmaceutical, among others, indicating a strong buy rating for these companies based on their growth potential and market performance [19][22].