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恒瑞医药研发里程碑与股价动态引关注
Jing Ji Guan Cha Wang· 2026-02-20 05:39
A股股价截至2月13日收盘报58.23元,当日下跌0.87%,成交额20.09亿元;港股截至2月20日报69.25港 元,跌2.33%。技术面显示短期震荡,20日压力位60.76元,支撑位55.95元。资金流向方面,2月13日主 力净流出1.30亿元,但机构综合目标价76.40元,较当前价存在31.20%上行空间。 机构观点 经济观察网 恒瑞医药近期热点集中于研发里程碑及合作伙伴动态。2026年2月6日,公司公告KRAS G12D抑制剂HRS-4642被国家药监局药品审评中心纳入突破性治疗品种,适应症为晚期胰腺癌一线治 疗,该进展于2月17日通过百科更新重申。同时,IL-17单抗SHR-1314及GLP-1/GIP双靶点激动剂HRS- 9531等管线临床推进效率突出,凸显研发优势。此外,合作伙伴璎黎药业的林普利塞断供事件持续发 酵,恒瑞医药作为商业化方于2月15日回应称正依法协助处理,但未披露具体合作调整。 股票近期走势 2026年2月18日机构分析指出,恒瑞医药创新药收入占比已达60.66%,估值逻辑转向管线驱动。管线规 模全球第二(163条自研项目),但市值仅670亿美元,与同类国际药企存在差距。BD业务 ...
恒瑞医药创新药获批上市 研发管线持续丰富
Xin Lang Cai Jing· 2026-02-16 22:33
研发管线动态:公司创新药管线持续丰富,多项临床试验处于关键阶段。例如,2025年半年报显示,共 有10项临床推进至Ⅲ期、22项推进至Ⅱ期,未来需关注这些管线的申报及获批进展。 以上内容基于公开资料整理,不构成投资建议。 新药获批上市:2026年1月8日,公司公告其子公司苏州盛迪亚自主研发的1类创新药瑞拉芙普α注射液 获得国家药监局(NMPA)批准上市,适应症为联合化疗用于PD-L1阳性局部晚期或转移性胃及胃食管 结合部腺癌的一线治疗。该进展是公司创新药管线的重要里程碑。 公司项目推进 经济观察网 近期关注事件:恒瑞医药(600276)近期值得关注的事件主要集中在创新药获批及后续研 发进展。以下基于2026年2月17日前公开信息整理: 公司项目推进 ...
恒瑞医药:公司自主研发的1类创新药硫酸艾玛昔替尼片已在国内获批,用于成人重度斑秃患者
Zheng Quan Ri Bao Wang· 2026-02-13 13:13
证券日报网讯2月13日,恒瑞医药(600276)在互动平台回答投资者提问时表示,公司坚持科技创新与 国际化发展战略,促进公司业绩可持续增长,以更好的发展回馈股东。公司自主研发的1类创新药硫酸 艾玛昔替尼片已在国内获批,用于成人重度斑秃患者。 ...
恒瑞医药:不存在按规定应披露而未披露的重大信息
Zheng Quan Ri Bao Wang· 2026-02-13 12:46
证券日报网讯2月13日,恒瑞医药(600276)在互动平台回答投资者提问时表示,公司日常经营管理和 业务状况正常,不存在按规定应披露而未披露的重大信息。 ...
大健康风向标〡跨越千亿美元门槛:中国分子站在全球化起点
Jing Ji Guan Cha Wang· 2026-02-13 07:06
Core Viewpoint - The keyword for the stock market in 2025 is expected to be "innovative drugs," with significant stock price increases driven by the potential of in-development innovative drugs and BD (business development) transactions rather than traditional revenue from already marketed drugs [1] Group 1: BD Transactions - In 2025, China's innovative drug BD transaction total exceeded $100 billion, with notable orders reaching $10 billion, and upfront payments from multinational pharmaceutical companies reaching a new high of $1.25 billion [1] - Landmark transactions include a $13 billion collaboration between Qihuang Dejian and Biohaven/AimedBio in January, marking a milestone for China's ADC technology [2] - In May, 3SBio's deal with Pfizer exceeded $6 billion, setting a record for upfront payments in China at $1.25 billion, highlighting the value of both first-in-class and fast-follow drugs [2] - In July, a $12 billion strategic partnership between Hengrui Medicine and GlaxoSmithKline showcased the depth of early-stage pipelines in leading Chinese pharmaceutical companies [2] - In October, Innovent Biologics and Takeda's collaboration worth $11.4 billion included a cost-sharing model for global R&D, enhancing operational capabilities for future international ventures [2] Group 2: Milestone Payments and Emerging Fields - Several past BD transactions reached milestone payments in 2025, including a $300 million payment to China National Pharmaceutical's subsidiary from Merck and a $250 million payment to Bairui Tianheng from Bristol-Myers Squibb [3] - The focus of BD transactions is shifting from oncology to other therapeutic areas, with autoimmune diseases, metabolism, and central nervous system disorders emerging as new hot fields [3] - Notable deals include the global rights licensing of BTK inhibitor Orelabrutinib for multiple sclerosis by Nocera Biopharma, with a potential total transaction value exceeding $2 billion [3] - The metabolic field is gaining traction, driven by global weight loss trends, with several companies entering into licensing agreements for GLP-1 targeted drugs [3] Group 3: Independent Clinical Trials and Regulatory Approvals - Numerous innovative drug companies in China are advancing their own overseas clinical trials, achieving significant progress [4] - In early 2025, Dize Pharmaceutical's lung cancer targeted drug received priority review from the FDA and was approved in July, becoming the first globally innovative drug independently developed in China to gain approval in the U.S. [4] - Other advancements include breakthrough therapy designations for CS0159 by Kexi Kedi and a Phase III trial approval for a recombinant human albumin injection by Heyuan Biopharma [4] - These developments indicate that the Chinese innovative drug industry is becoming a significant force in global innovation, transitioning from fast-following to original innovation and integrating deeply into the global value chain [4]
恒瑞医药创新药HRS-5346用于治疗脂蛋白(a)水平的升高纳入突破性治疗品种名单
Xin Lang Cai Jing· 2026-02-12 12:12
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 ...
国产首个!恒瑞医药降脂新药申报上市
Xin Lang Cai Jing· 2026-02-12 07:33
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].
国联民生证券:小核酸重构减肥逻辑 INHBE与ALK7靶点初步验证
智通财经网· 2026-02-12 06:43
Core Viewpoint - The report from Guolian Minsheng Securities highlights the synergistic effects of small nucleic acid drugs and GLP-1 class drugs in the weight loss sector, suggesting they could become a "golden duo" for weight management [1][4]. Group 1: Drug Efficacy and Development - Arrowhead has reported promising initial weight loss results from two small nucleic acid drugs targeting INHBE and ALK7, with ARO-INHBE showing an average fat reduction of 9.9% and liver fat reduction of up to 38.6%, alongside a 3.6% increase in lean tissue [1]. - ARO-ALK7 demonstrated a dose-dependent average reduction of ALK7 mRNA by 88%, confirming the TRiM platform's ability to inhibit fat cell gene expression [1]. - Wave Life's WVE-007 targeting liver INHBE showed a 9.4% reduction in visceral fat and a 4.5% overall fat reduction after three months, with a 3.2% increase in lean body mass [3]. Group 2: Market Trends and Collaborations - Major pharmaceutical companies are increasingly investing in small nucleic acid drugs, with Eli Lilly committing $1.2 billion in collaboration with Saint Inbiotech for RNAi candidate drug development for metabolic diseases [3]. - Eli Lilly also invested $1 billion in HAYA's lncRNA platform for obesity and related metabolic disease treatments, while Novo Nordisk partnered with Replicate Bioscience for a $550 million project targeting obesity and type 2 diabetes [3]. - The speed of Chinese pharmaceutical companies in developing small nucleic acid drugs for weight loss is nearly on par with international counterparts, with several companies like Hengrui Medicine and Innovent Biologics actively pursuing this area [5]. Group 3: Investment Recommendations - The report suggests focusing on companies involved in small nucleic acid weight loss targets, including Hengrui Medicine, Chengdu Xian Dao, China National Pharmaceutical Group, East China Pharmaceutical, and others [6].
港股开盘:恒指跌0.2%、科指跌0.47%,AI应用及芯片股走高,锂电池概念股活跃,科网股普遍回调
Jin Rong Jie· 2026-02-12 01:33
Market Overview - The Hong Kong stock market opened slightly lower, with the Hang Seng Index down 0.2% at 27,210.56 points, the Hang Seng Tech Index down 0.47% at 5,474.25 points, and the National Enterprises Index down 0.19% at 9,250.27 points [1] - Major tech stocks mostly opened lower, with Alibaba down 1.37%, Tencent down 2.01%, and Meituan down 2.48%, while AI application stocks showed strength, with Zhihui up 8.77% and MINIMAX-WP up 5.65% [1] Company Performance - NetEase reported strong performance, with a net revenue of approximately 112.63 billion yuan, a year-on-year increase of 6.96%, and a net profit of approximately 33.76 billion yuan, up 13.68% [2] - NetEase Cloud Music saw a significant profit increase of 75.4%, with a revenue of 7.76 billion yuan and a profit of 2.75 billion yuan, confirming a turning point in performance [2] Industry Trends - The hard technology and manufacturing sectors showed signs of recovery, with Qiu Tai Technology reporting a 22.8% year-on-year increase in camera module sales and an 18.4% increase in fingerprint recognition module sales, driven by demand in IoT and smart automotive sectors [3] - The renewable energy sector also saw growth, with China Resources Power reporting a 28.4% year-on-year increase in electricity sales, and solar power sales soaring by 72.3% [3] Biopharmaceutical Sector - The biopharmaceutical sector experienced significant positive developments, with Rebio Biotech announcing a global exclusive licensing agreement worth up to 4.4 billion USD, leading to a substantial increase in stock price [4] - Heng Rui Pharmaceutical's product was included in a breakthrough therapy list, with projected global sales exceeding 6.5 billion USD in 2024 [4] Capital Market Activity - Industrial capital is actively engaging in buybacks to stabilize the market, with Geely Automobile repurchasing shares worth approximately 20.30 million HKD and other companies like Kingsoft and Bai Rong Cloud also participating in buybacks [5] - Huili Group is expected to see a profit increase of over 20 times in 2025, indicating a strong performance reversal [5] Institutional Insights - There is a divergence in institutional views regarding market fluctuations, with some suggesting that the recent pullback is a liquidity shock, while others believe that valuation recovery is nearly complete [6] - Specific sectors like AI computing and surgical robots are highlighted for potential growth, with expectations for high performance in 2025 and 2026 [6]
江苏恒瑞医药股份有限公司 关于药品纳入突破性治疗品种名单的公告
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]