药品名称：SHR-1918 注射液 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2026-026 江苏恒瑞医药股份有限公司 关于药品上市许可申请获受理并纳入优先审评程序 的提示性公告 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。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）子公司北京盛迪医 药有限公司收到国家药品监督管理局（以下简称"国家药监局"）下发的《受理 通知书》，公司 1 类创新药 SHR-1918 注射液的药品上市许可申请获受理，且已 被纳入优先审评程序。现将相关情况公告如下： 一、药品的基本情况 剂型：注射剂 受理号：CXSS2600019 申请人：北京盛迪医药有限公司 申报阶段：上市 拟定适应症（或功能主治）：用于治疗成人和 12 岁及以上的未成年人纯合 子家族性高胆固醇血症（HoFH）患者。 二、药品的临床试验情况 此次申报上市是基于两项针对 HoFH 患者的临床试验：SHR-1918-202 研究和 SHR-1918-301 研究，均由中南大学湘雅二医院彭道泉教授牵头开展，全面评估 了药 ...

Core Viewpoint - Heng Rui Medicine's subsidiary, Beijing Shengdi Pharmaceutical Co., Ltd., has received a notice of acceptance from the National Medical Products Administration for its innovative drug SHR-1918 injection, which has been included in the priority review process [1] Group 1 - The drug SHR-1918 is intended for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH) [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Beijing Shengdi Pharmaceutical Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for its innovative drug SHR-1918 injection, which has been included in the priority review process [1] Group 1: Product Development - SHR-1918 injection is a monoclonal antibody targeting angiopoietin-like protein 3 (ANGPTL3), designed to lower serum triglycerides (TG) and LDL-C levels [1] - The total R&D investment for the SHR-1918 injection project has reached approximately 24.22 million yuan (unaudited) [1] Group 2: Market Context - The only other drug targeting the same pathway is Regeneron's EVKEEZA® (evinacumab-dgnb), which is projected to have global sales of about $216 million by 2025 according to EvaluatePharma [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Beijing Shengdi Pharmaceutical Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for its innovative drug SHR-1918 injection, which is now included in the priority review process [1] Group 1 - SHR-1918 injection is designed for the treatment of adult and adolescent patients aged 12 and above with homozygous familial hypercholesterolemia (HoFH) [1] - The drug is a monoclonal antibody targeting angiopoietin-like protein 3 (ANGPTL3), which works by inhibiting ANGPTL3 activity to lower serum triglycerides (TG) and LDL-C levels [1] - The total research and development investment for the related project has reached approximately 242 million yuan [1]

Core Viewpoint - The Hong Kong stock market's innovative drug ETF (159570) is experiencing a pullback, with several key stocks in the index declining significantly, indicating a potential shift in market sentiment towards the innovative pharmaceutical sector [1][4]. Group 1: Market Performance - As of 11:07, major stocks in the Hong Kong innovative drug ETF have mostly retreated, with notable declines: CSPC Pharmaceutical down over 5%, China Biologic Products down over 3%, and Innovent Biologics down over 4% [1]. - The ETF opened with a gain of over 2% but later experienced a decline of 0.62%, with trading volume surpassing 700 million HKD, indicating active market participation despite the pullback [4]. - The ETF has seen a net inflow of over 340 million HKD in the past five days, with its latest scale exceeding 25.2 billion HKD, leading among similar funds [4]. Group 2: Industry Developments - The innovative drug business development (BD) remains robust, with companies like Rego Biopharma and Qinhai Biotech making significant strides, and the total upfront payment for innovative drug BD transactions in China exceeding one-third of the total for 2025 by mid-February [3]. - Key innovative drug pipelines have achieved milestones overseas, such as CSPC's SYH2053 entering Phase III trials and Hanmi Pharmaceutical's approval for marketing in the EU [3]. - The FDA has reformed its drug approval policy, allowing a single pivotal trial plus confirmatory evidence as the default standard for new drug approvals, which is expected to enhance efficiency and reduce costs in drug development [6][9]. Group 3: Regulatory Changes - The National Health Commission has revised the essential drug catalog management measures for the first time in 11 years, indicating potential changes in the essential drug catalog and signaling a more rational policy environment [5]. - The overall atmosphere for drug procurement has been stable, with high rates of contract renewals and a focus on quality and pricing, reflecting a shift towards more rational procurement practices [5]. Group 4: ETF Composition - The Hong Kong innovative drug ETF (159570) is fully invested in innovative drugs, with the top ten constituent stocks accounting for over 74% of the index, highlighting its concentrated exposure to leading companies in the sector [10]. - The ETF has shown a significant increase of over 90% year-to-date, outperforming other indices in the Hong Kong pharmaceutical sector [11][12].

Summary of Key Points from the Conference Call Industry Overview - The focus is on the **Pharmaceutical (Pharma)** and **Biopharmaceutical/Biotech** sectors, highlighting companies with potential for value re-evaluation and those entering a performance ramp-up phase [1][2]. Core Insights and Arguments 1. **Value Re-evaluation of Pharma Companies**: - There is a recommendation to further support Pharma companies that have the potential for value re-evaluation, particularly emphasizing key marginal changes. The BD (Business Development) revenue for Pharma is expected to normalize, which will drive an upward shift in the valuation framework [1][2]. 2. **Performance Ramp-up in Biopharma/Biotech**: - Continuous recommendation for Biopharma/Biotech companies that are entering a performance ramp-up phase and have pipelines that are consistently delivering results. The expectation is that by 2026, leading Biopharma/Biotech companies will enter a period of accelerated performance [2]. 3. **Key Marginal Changes**: - The core marginal change driving the value re-evaluation logic for Pharma companies is the normalization of BD revenue. This is supported by two main factors: - Leading Pharma companies have a more comprehensive technology platform and pipeline layout, enhancing their ability to continuously produce BD assets [2]. - External transactions are evolving from sporadic single-asset licensing to a more platform-based and series-based licensing model, making upfront payments, milestones, and revenue sharing more replicable and predictable. Recent collaborations, such as the partnership between **Shiyao** and **AstraZeneca** for a long-acting weight loss drug (total package of $18.5 billion) and **Innovent** with **Eli Lilly** in oncology and immunology (total package of $8.9 billion), exemplify this trend [2]. Recommendations - Specific companies recommended for investment include: - **Hengrui Medicine** - **Hansoh Pharmaceutical** - **Shiyao Group** (new addition in February) - **China National Pharmaceutical Group** - **Sinopharm** (new addition in February) - **Haisco** [2]. Additional Important Insights - The oncology, metabolism, and autoimmune sectors are expected to see a concentration of critical data releases. The integration of new technology platforms such as small nucleic acids, bispecific/trispecific antibodies, next-generation ADCs, and PROTAC/molecular glue is anticipated to provide significant valuation elasticity for leading companies at key data points, potentially opening up overseas BD opportunities [3].

Summary of Key Points from the Conference Call Industry Overview - The conference call focuses on the innovative pharmaceutical sector, highlighting recent developments and regulatory approvals for various companies in the industry. Company-Specific Developments 恒瑞医药 (Hengrui Medicine) - On February 12, the CDE website indicated that the company submitted a marketing application for ANGPTL3 monoclonal antibody SHR-1918 targeting HOFH. The company has not yet disclosed the Phase III clinical results for SHR-1918 [1] 翰森制药 (Hansoh Pharmaceutical) - On February 20, the company announced that Amivantamab has been approved by the European Medicines Agency (EMA) for marketing in the EU for first-line treatment of EGFR19del or L858R NSCLC, as well as for T790M NSCLC treatment [2] 石药集团 (Shijiazhuang Yiling Pharmaceutical) - On February 16, the company announced that its receptor-biased GLP1/GIP agonist monthly formulation SYH2082 has been approved for clinical trials in the United States [3] 信立泰 (Sino Biopharmaceutical) - On February 12, the company disclosed its initial prospectus for a Hong Kong IPO, updating on R&D progress over the next 12 months, including the Phase II results for JK07 targeting HFrEF expected in 1H26, and the current pipeline status with SAL0147 AT1R/ETAR small molecule, SAL0167 PCSK9 oral cyclic peptide, and SAL012 GPC3 ADC anticipated to advance rapidly to clinical stages [4] 华东医药 (East China Pharmaceutical) - On February 12, the company announced that its self-developed FGFR2b ADC HDM2020 targeting GC/GEJ indications received orphan drug designation from the FDA in the United States [5] - On February 18, a clinical trial was registered for HDM1005 (GLP1R/GIPR weekly formulation) in a head-to-head study against Mars' dulaglutide for second-line diabetes patients in China [6] 康方生物 (CanSino Biologics) - On February 12, the company announced that its PD1*CTLA4 dual antibody cardunil combined with chemotherapy is undergoing a Phase III study for first-line gastric cancer [7] - On February 17, a clinical trial was registered for AK104 targeting MSI-H/dMMR colorectal cancer in perioperative treatment in China [8] 中国抗体 (China Antibody) - On February 20, the company disclosed preclinical data for IL17RB monoclonal antibody SM17 targeting CRSwNP and IPF in the journal ERJ OPEN RESEARCH [9] 基石药业 (CStone Pharmaceuticals) - On February 15, PR Newswire reported that the company's PD1*VEGF*CTLA4 tri-antibody CS2009 has received FDA approval to initiate a Phase II clinical trial in the United States targeting pan-solid tumors [10] 和铂医药 (HaploX) - On February 23, the company announced that it has licensed the rights for its next-generation CTLA4 monoclonal antibody HBM4003 (with significantly improved safety and expanded therapeutic window) to Solstice Oncology in Greater China. The company will receive a $50 million upfront payment, $50 million in equity, $5 million for recent milestones, and $1.1 billion in subsequent milestones and sales sharing [11]

Core Insights - The report highlights a stable continuation of the national drug procurement process, benefiting patients and encouraging active participation from companies [7][9] - The issuance of the National Essential Drug Directory Management Measures is noted, which is expected to impact the pharmaceutical industry positively [7][9] - The report emphasizes the strong performance of the innovative drug sector, particularly through collaborations like the one between Innovent Biologics and Eli Lilly, which showcases the strength of domestic innovative drug companies [8] Fixed Income Research - Inflation data indicates that the core CPI in January saw a month-on-month increase, reaching its highest level in nearly six months, driven by increased travel demand during the holiday season and rising international gold prices [3] - The primary market saw a slight decrease in the issuance scale of special bonds, with a total of 96 bonds issued amounting to 964.3 billion yuan during the reporting period [4] - The bond market exhibited a strong oscillation pattern, with the 10-year government bond yield testing downward around 1.8%, supported by manageable pre-holiday funding pressures [4][5] Industry Research - The Shanghai Composite Index rose by 1.43%, while the Shenzhen Component Index increased by 2.37% during the week, with the SW Pharmaceutical and Biological Index showing a modest increase of 0.23% [7] - The report notes that the SW Pharmaceutical and Biological Industry's price-to-earnings ratio (TTM) stands at 51.17 times, with a valuation premium of 259% relative to the CSI 300 [7] - The report suggests focusing on investment opportunities in innovative drugs, CXO, and upstream life sciences, while also monitoring performance recovery indicators as earnings reports are disclosed [8]

Investment Rating - The report maintains a positive outlook on the blood products industry, suggesting that the supply-demand relationship will gradually improve, leading to performance recovery for companies in this sector [10][34]. Core Insights - The blood products industry is characterized by a clear long-term growth trajectory, supported by a favorable regulatory environment for plasma collection and an expanding product range among companies [12][34]. - Short-term performance has been impacted by supply-demand mismatches, with a notable decline in profitability observed in 2025 due to excess supply and price reductions [19][36]. - The report highlights the importance of white albumin and immunoglobulin (IVIG) as core products, with a stable demand expected despite recent price pressures [33][34]. Summary by Sections Market Review - The report notes a decline of 0.85% in the medical index, underperforming the CSI 300 index by 1.22 percentage points, ranking 21st among 30 sectors [6]. - The top-performing stocks in the medical sector include Aidi Te, Zhendai Medical, and Olin Bio, while the worst performers include Beixin Life and Huayuan Bio [6]. Industry and Stock Events - The report emphasizes the recovery of plasma collection activities post-pandemic, which has led to increased supply and a shift in the market dynamics for blood products [19][26]. - The report identifies key companies to watch, including Tian Tan Biological and Bo Ya Biological, as they are expected to benefit from the industry's growth [12][34]. Overall Perspective and Investment Themes - The report suggests focusing on innovative drugs, medical devices, and the blood products sector, highlighting the potential for significant growth driven by domestic differentiation and international expansion [10][12]. - The report also discusses the ongoing consolidation in the industry, particularly among state-owned enterprises, which may enhance market concentration and operational efficiencies [46]. Supply and Demand Dynamics - The report indicates that the supply of blood products is expected to tighten in 2026 due to a slowdown in plasma collection growth and a decrease in imported white albumin supply [30][34]. - Demand for white albumin remains robust, with sales showing signs of stabilization despite recent challenges [33][34]. Future Outlook - The report anticipates a gradual return to a balanced supply-demand relationship in the blood products industry, which could lead to improved financial performance for key players [34][36]. - The potential for new product introductions and market expansions is highlighted as a significant driver for future growth in the sector [12][34].

Core Insights - The article highlights the recent milestones in research and development for Heng Rui Medicine, particularly the inclusion of KRAS G12D inhibitor HRS-4642 for advanced pancreatic cancer treatment by the National Medical Products Administration [1] - The company is also advancing its clinical pipelines, including IL-17 monoclonal antibody SHR-1314 and GLP-1/GIP dual-target agonist HRS-9531, showcasing its R&D strengths [1] - A supply disruption incident involving partner Lingli Pharmaceutical is ongoing, with Heng Rui Medicine stating it is legally assisting in the matter without disclosing specific adjustments to the partnership [1] Stock Performance - As of February 13, the A-share price closed at 58.23 yuan, down 0.87%, with a trading volume of 2.009 billion yuan; the Hong Kong stock price as of February 20 was 69.25 HKD, down 2.33% [1] - Technical analysis indicates short-term volatility, with a resistance level at 60.76 yuan and a support level at 55.95 yuan [1] - On February 13, there was a net outflow of 130 million yuan from major funds, but institutional target prices average at 76.40 yuan, indicating a potential upside of 31.20% from the current price [1] Institutional Insights - As of February 18, it was noted that the revenue from innovative drugs for Heng Rui Medicine has reached 60.66%, indicating a shift in valuation logic towards pipeline-driven growth [1] - The company has the second-largest pipeline globally with 163 self-developed projects, yet its market capitalization stands at 67 billion USD, highlighting a disparity compared to similar international pharmaceutical companies [1] - Business development (BD) is expected to become a new growth driver, with projected external licensing revenue of 6 billion yuan in 2026, although there are concerns regarding the global competitiveness of the Fast Follow strategy [1]