HRS-5346是恒瑞医药自主研发的口服小分子Lp(a)抑制剂，通过与阻断载脂蛋白(a)[apo(a)]和载脂蛋白B100（ApoB100）之间最初的非共价结合，从而抑制 二硫键和Lp(a)的形成，降低Lp(a)水平。研究结果显示，HRS-5346可有效降低Lp(a)，且安全性良好[3]。 近日，恒瑞医药子公司山东盛迪医药有限公司的HRS-5346用于治疗脂蛋白（a）水平的升高被国家药品监督管理局药品审评中心纳入突破性治疗品种名 单。 脂蛋白(a)[Lp(a)]水平升高是全球最普遍的单基因脂质疾病，是脂蛋白紊乱的典型表现之一。中国成年人的Lp(a)水平＞30mg/dL和50mg/dL的患病率分别为 18.67%和8.41%[1]。Lp(a)升高已被证实为动脉粥样硬化性心血管疾病（ASCVD）包括冠心病、缺血性脑卒中、外围血管疾病及钙化性主动脉瓣狭窄等疾 病的独立危险因素[2]。靶向Lp(a)的降脂疗法是心血管疾病防治的潜在新方向之一，但目前尚无针对降低Lp(a)适应症的治疗药物，该疗法仍处于临床研究 阶段。 近日，恒瑞医药子公司山东盛迪医药有限公司的HRS-5346用于治疗脂蛋白（a）水平的升高被国家药品监督 ...

Core Insights - 2025 marks a milestone year for China's innovative pharmaceuticals, with a significant increase in the number of approved drugs and vaccines, driven by supportive policies, international expansion, and expedited review processes [1][2] Group 1: Drug Approvals and Market Trends - In 2025, China approved 76 innovative drugs, surpassing the 48 approved in 2024, setting a historical record [1] - The number of approved innovative drugs in China exceeded that of the US FDA, which approved 46 new drugs in the same year [1] - China saw the approval of 11 First-in-class drugs, with 4 being independently developed domestically [1] - The total value of licensing transactions for innovative drugs exceeded $130 billion, with over 150 deals made, marking another historical high [1] Group 2: Breakthrough Therapies and Innovations - Among the 76 approved drugs, 17 were recognized as breakthrough therapies, with 13 focused on oncology [2] - Notable drug launches included the first stem cell therapy in China, marking a historic breakthrough in stem cell treatment [2] - The launch of targeted HER2 drugs for non-small cell lung cancer and cholangiocarcinoma signifies a new phase in precision treatment for solid tumors in China [2] Group 3: Disease-Specific Developments - In oncology, 34 new drugs were approved, with breast cancer treatments leading at 9 new drugs, followed by 6 for lung cancer and 8 for hematological malignancies [3] - Two CAR-T cell therapies targeting CD19 were approved, bringing the total number of domestic CAR-T therapies to 7 [3] Group 4: Innovations in Other Therapeutic Areas - In the influenza treatment sector, four new drugs were launched, addressing public health needs during peak flu seasons [4] - The innovative vaccine sector saw significant advancements, including the launch of China's first nine-valent HPV vaccine and a 13-valent pneumococcal conjugate vaccine [5] - The emergence of a serum-free rabies vaccine is expected to fill a market gap, showcasing China's growing capabilities in biopharmaceutical innovation [5]

Core Viewpoint - The news highlights the submission of SHR-1918, a new lipid-lowering drug developed by Shengdi Pharmaceutical, a subsidiary of Heng Rui Medicine, for the treatment of homozygous familial hypercholesterolemia (HoFH) in adults and adolescents aged 12 and above [1][2]. Group 1: Drug Development and Approval - SHR-1918 is an ANGPTL3 monoclonal antibody that lowers triglyceride (TG) levels and low-density lipoprotein cholesterol (LDL-C) levels by inhibiting the activity of ANGPTL3, which plays a crucial role in lipid metabolism [2][7]. - The drug received breakthrough therapy designation for HoFH from the CDE in September 2024 and was included in priority review last month [2][7]. - A Phase III registration study for SHR-1918 began in December 2024 and was marked as "completed" in November 2025, with results yet to be disclosed [5][10]. Group 2: Clinical Trial Results - A single-arm, non-randomized Phase II clinical study showed that after 12 weeks of treatment with SHR-1918 (600mg, subcutaneously every 4 weeks), LDL-C levels decreased by 59.09% [3][8]. - In a randomized controlled Phase II clinical study, after 16 weeks of treatment, LDL-C levels were reduced by 21.7%, 27.3%, 29.9%, and 22.5% for the 150mg, 300mg, 600mg (every 4 weeks), and 600mg (every 8 weeks) dosage groups, respectively [3][8]. Group 3: Market Context and Competition - HoFH is a rare and severe genetic disorder characterized by a defect or absence of low-density lipoprotein cholesterol receptors (LDLR), leading to increased LDL-C levels in the blood and heightened risk of heart disease and stroke [6][12]. - Current treatment options for HoFH include statins, ezetimibe, lomitapide, mipomersen, PCSK9 monoclonal antibodies, and evinacumab, with evinacumab being the only marketed ANGPTL3 monoclonal antibody, projected to generate $162 million in U.S. sales by 2025 [6][12].

Group 1 - The core viewpoint of the article highlights the performance of the HuShen 300 Growth ETF managed by Huaxia Fund Management, which has seen a return of 31.56% since its inception on September 5, 2023 [1] - As of the midday close on February 12, the HuShen 300 Growth ETF (159523) increased by 0.76%, reaching a price of 1.324 yuan with a trading volume of 4.6693 million yuan [1] - The top holdings of the ETF include companies such as CATL, which rose by 2.57%, and Gree Moutai, which fell by 1.42%, indicating mixed performance among its key stocks [1] Group 2 - The ETF's performance benchmark is the CSI Select 300 Growth Innovation Strategy Index, which reflects its investment strategy [1] - The fund manager is Zhao Zongting, indicating a specific leadership in the management of the ETF [1] - The ETF has shown a monthly return of 1.97%, suggesting a stable short-term performance [1]

Group 1 - The core viewpoint of the article highlights the performance of the 180 Governance ETF (510010), which saw a slight increase of 0.27% to 1.845 yuan as of midday closing on February 12 [1] - The ETF's major holdings include Guizhou Moutai, which fell by 1.42%, China Ping An down by 1.04%, and China Merchants Bank down by 1.60%, while Zijin Mining rose by 1.70% [1] - The ETF is managed by China International Fund Management Co., with a performance benchmark of the Shanghai Stock Exchange 180 Corporate Governance Index, achieving a return of 105.50% since its inception on September 25, 2009, and a return of 0.54% over the past month [1]

Investment Rating - The report maintains a "Recommended" rating for companies involved in the small nucleic acid drug sector targeting obesity [4]. Core Insights - The obesity treatment market is gaining significant attention, with GLP-1 drugs demonstrating efficacy in weight loss, but they also have high rebound rates post-treatment and associated muscle loss. Small nucleic acid drugs offer a different approach by targeting fat metabolism at the genetic level [12][21]. - Arrowhead and Wave Life have shown promising initial results for their small nucleic acid drugs ARO-INHBE and WVE-007, respectively, indicating effective fat reduction without muscle loss [22][38]. - The collaboration between major pharmaceutical companies and small nucleic acid drug developers is intensifying, with significant investments aimed at advancing RNAi therapies for metabolic diseases [49]. Summary by Sections 1. Unmet Needs in Obesity Treatment - The report highlights the unmet demand in obesity treatment, emphasizing that small nucleic acid drugs could provide solutions by directly intervening in fat metabolism [12][16]. 2. Initial Efficacy of Small Nucleic Acid Drugs - Arrowhead's ARO-INHBE demonstrated an average fat reduction of 9.9% and a liver fat reduction of 38.6%, while also increasing lean tissue by 3.6% [22][27]. - Wave Life's WVE-007 showed a 9.4% reduction in visceral fat and a 4.5% reduction in total fat after three months, with a 3.2% increase in lean body mass [38][49]. 3. Investment Recommendations - The report suggests focusing on companies developing small nucleic acid drugs for obesity, including HengRui Medicine, Chengdu XianDao, China Biopharmaceutical, and others [50].

Policy Developments - The National Health Commission and 10 other departments jointly issued the "National Basic Drug Directory Management Measures," which revises six key areas, including legal policy basis, directory structure optimization, management mechanism improvement, emphasis on clinical value, dynamic adjustment mechanism, and monitoring and evaluation enhancement [1][2]. Drug and Device Approvals - Hengrui Medicine announced that its injection of Rukang Qutuzumab has been included in the list of breakthrough therapy varieties, marking the 10th indication for this drug, aimed at treating locally advanced or metastatic non-small cell lung cancer patients with HER2 mutations [3]. - Shanghai Pharmaceuticals received approval for the listing application of the raw material drug Tamsulosin Hydrochloride, which is used for treating benign prostatic hyperplasia, with an investment of approximately RMB 1.5 million in its development [4]. Financial Reports - WuXi Biologics expects a 46.3% year-on-year increase in net profit for the full year 2025, projecting revenues of approximately RMB 21.79 billion and an adjusted net profit of about RMB 6.59 billion [5]. - Eucare Pharmaceuticals reported a 48.21% decline in net profit for 2025, with revenues of RMB 334 million, reflecting a 7.73% increase [6]. Capital Markets - Watson Bio plans to invest RMB 450 million to establish a biological industry investment fund with a target size of RMB 1 billion, focusing on synthetic biology and related sectors [7]. - Hite Bio intends to acquire a 23.08% stake in Beijing Shadong for RMB 62.02 million, increasing its ownership to 98.84% [8]. - Duorui Pharmaceuticals announced a partial tender offer to acquire 24.30% of its shares at a price of RMB 32.07 per share [9]. Industry Events - China's first C909 "airplane hospital" successfully completed its first in-flight surgery in Laos, providing medical services to over 600 patients since its launch [10]. - Researchers revealed the key mechanism of the "weight loss miracle drug" Semaglutide, showing its significant cartilage protection effects independent of weight loss, providing new drug development targets for metabolic osteoarthritis [11]. Public Sentiment Alerts - Shuyou Shen announced that its major shareholder, Xiangtang Group, has cumulatively reduced its holdings by 4.78 million shares, accounting for 1% of the total share capital [12].

丨2026年2月12日星期四丨 NO.1 国家卫健委等11部门联合印发《国家基本药物目录管理办法》 2月11日，国家卫生健康委等11部门联合印发《国家基本药物目录管理办法》。与原有的文件相比， 《国家基本药物目录管理办法》主要修订六个方面：一是增加法律政策依据；二是合理优化目录结构， 将国家基本药物分为化学药品和生物制品、中药等，化学药品和生物制品主要依据临床药理学分类，中 成药主要依据功能分类；三是完善目录管理机制；四是突出药品临床价值，明确根据疾病谱变化、药品 临床应用实践、药品标准变化、药品新上市情况等，坚持中西医并重、临床首选的原则，综合考虑我国 基本医疗卫生服务需求、基本医疗保障水平、药品供应保障等因素，对基本药物的品种和数量进行调 整；五是规范动态调整机制，强化基本药物功能定位，坚持定期评估、动态管理，调整周期原则上不超 过3年，必要时可适时组织调整；六是强化监测评价。 点评：新版《国家基本药物目录管理办法》的公布，有利于巩固完善国家基本药物制度，健全国家基本 药物目录遴选管理机制。 NO.2 瑞博生物与Madrigal达成44亿美元全球独家许可协议，携手开发MASH创新siRNA疗法 2月11日 ...

Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. announced that its subsidiary, Suzhou Merdia Biopharmaceutical Co., Ltd., has received inclusion of its injectable SHR-A1811 (Rocatinib) in the list of breakthrough therapies by the National Medical Products Administration (NMPA), marking the 10th indication for which it has received breakthrough therapy certification [1] Group 1: Drug Information - Drug Name: Injectable Rocatinib (SHR-A1811) [1] - Acceptance Number: CXSL2000087 [1] - Drug Type: Therapeutic biological product [1] - Registration Category: Class 1 [1] - Application Date: December 2, 2025 [1] - Proposed Indication: First-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) activating mutations [1] Group 2: Approved Indications - The injectable Rocatinib was approved for domestic market launch in May 2025, indicated for adult patients with unresectable locally advanced or metastatic NSCLC who have previously received at least one systemic therapy and have HER2 (ERBB2) activating mutations [2] Group 3: Market Context - Primary lung cancer is the most common malignant tumor globally, with GLOBOCAN 2022 data indicating approximately 2.48 million new cases and 1.82 million deaths annually, making it the leading cause of cancer mortality [3] - In 2022, China reported 1.06 million new lung cancer cases, accounting for 22.0% of all malignant tumors, and 733,300 deaths, representing 28.5% of all cancer deaths [3] - NSCLC accounts for about 85% of lung cancer cases, with approximately 2%-4% of NSCLC patients experiencing HER2 mutations, which are associated with high tumor invasiveness and poor prognosis [3] - Recent advancements in antibody-drug conjugates and highly selective HER2-TKIs have provided new treatment options for patients with advanced NSCLC harboring HER2 mutations [3] Group 4: Drug Mechanism and Competition - Injectable Rocatinib binds to HER2-expressing tumor cells, inducing cell cycle arrest and apoptosis through the release of toxins in the tumor cell lysosome [4] - Competing intravenous products in the domestic market include Roche's Ado-trastuzumab emtansine, AstraZeneca and Daiichi Sankyo's Fam-trastuzumab deruxtecan, Rongchang Biopharmaceutical's Vidisichu monoclonal antibody, and Kelun-Biotech's Bodo-trastuzumab [4] - According to EvaluatePharma, the global sales of similar products are projected to reach approximately $6.557 billion by 2024 [4] - Cumulative R&D investment for injectable Rocatinib is approximately 1.7725 billion yuan (unaudited) [4]

Core Viewpoint - Heng Rui Medicine (600276.SH) emphasizes a differentiated research and development strategy focused on clinical needs, leveraging advanced technology platforms to create a matrix of differentiated innovative products [1] Group 1: Product Development - The company has developed the first-in-class innovative drug, Ruilafup α injection, which was approved for domestic market launch in January 2026, marking it as the world's first approved PD-L1/TGF-βRII bispecific antibody fusion protein [1] - There are over 100 self-innovated products currently in clinical development, including those with potential for first-in-class or best-in-class status [1] Group 2: Future Strategy - The company plans to continue exploring cutting-edge international drug targets that have potential for first-in-class or best-in-class innovations, aiming to continuously produce differentiated and competitively innovative products [1]