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又一创新药落地 这是今年杭州第五个获批上市的1类创新药
Mei Ri Shang Bao· 2025-11-17 22:37
商报讯(通讯员高永华记者汪晓筠毛雨希)最近,派格生物医药(杭州)股份有限公司自主研发的1类新 药"维培那肽注射液"(商品名:派达康)获国家药品监督管理局批准上市。维培那肽的差异化优势,根植 于其独特的分子结构与由此带来的卓越药理特性。凭借创新的定点PEG化技术,实现有效抵御DPP-4酶 的降解,并显著降低肾脏清除率。这一结构改造,既确保了药物与GLP-1受体的高效结合,发挥药物生 物活性,使其能够快速达到较高的暴露浓度,又可明显减少副作用,实现疗效与安全的平衡。 这是今年杭州第五个获批上市的1类创新药,这一成果不仅是企业科研实力的见证,更是杭州生物医药 产业蓬勃发展的缩影。 杭州医药产业创新储备雄厚 铺就了创新"快车道" 杭州生物医药产业的快速发展,离不开市场监管部门"监管与服务并重"的精准赋能。针对生物医药研发 周期长、审批要求高的特点,杭州构建了全流程、高效率的服务体系,让企业创新之路更顺畅。 杭州将创新药企业纳入"专人服务"名单,落实"政策第一时间传达、问题第一时间响应、需求第一时间 对接"的"三个一"承诺,2024年以来已服务重点企业30余家次。建立创新品种诉求动态更新与监测机 制,依据研发阶段提供定 ...
上半年创新药上市数量同比增长59%——创新药产业跑出加速度
Jing Ji Ri Bao· 2025-11-17 22:05
2024年,我国批准48个创新药上市,仅低于美国的50个,排名全球第二。今年上半年,国家药监局批准 43个创新药上市,同比增长59%。 创新药获批数量呈现井喷式增长,是各地长期坚持政策引导、技术积累与资本培育推动创新药产业从量 变迈向质变的结果。 政策引导破局 深化罕见病药品保障先行区和临床急需进口药械审批绿色通道建设、优化创新药临床试验审评审批试 点、开展生物制品分段生产试点……近年来,北京市在医药健康领域深化全产业链开放、全环节改革, 推出一系列全国首创、全国首批、全国领先的改革举措,为产业高质量发展营造良好环境。 北京市科委、中关村管委会副主任龚维幂介绍说,北京市科委、中关村管委会积极发挥科技创新管理部 门与行业管理部门"双牵头"作用,与"三医"部门一道,从创新策源、平台构建、研审联动、全链条服务 等方面系统谋划,推动北京医药健康产业进一步提质增效。 作为优化创新药临床试验审评审批的两大试点城市之一,北京今年发布《北京市支持创新医药高质量发 展若干措施(2025年)》,推出32条新举措,包括进一步加强优化要素资源配置,培育优质创新生态, 推动创新药、创新医疗器械高质量发展等。 早在2019年10月,成都 ...
“内外”兼修 西藏药业转型谋新篇
◎记者 孙小程 西藏药业一度让不少同行艳羡——大单品新活素经久不衰,支撑其业绩常年保持稳定。 但硬币的另一面,显然是单一产品依赖度过高的风险,这是始终悬在西藏药业头顶的现实考题。 西藏药业生产线 西藏药业厂区 居安常思危,如何摆脱"单腿走路"的局面? 近日,上海证券报记者走进西藏药业,探寻其在新时期的转型密码。西藏药业董事长陈达彬将其总结 为:内源性增长与外延式扩张并重。对内拓展新活素的市场覆盖率,深挖藏药资源护城河;对外通过投 资基因编辑企业,持续探索创新药前沿领域。"内外"兼修,让谋求可持续发展的西藏药业迈向更广阔的 增长空间。 守正于"内" 夯实发展根基 从雪域高原出发,西藏药业在二十余年的时间里,逐步构建起覆盖西藏、四川、上海及海外市场的产业 版图。 目前,西藏药业产品涵盖生物制药、藏药、中药和化学药领域,主要产品涉及心脑血管、肝胆、扭挫伤 及风湿、类风湿、感冒等,代表品种有新活素、依姆多、诺迪康、十味蒂达胶囊、雪山金罗汉止痛涂膜 剂、小儿双清颗粒等。 其中,新活素是西藏药业拥有自主研发的国家生物制品一类新药,是治疗急性心衰的基因工程药物。新 活素能快速改善心衰患者的心衰症状和体征,提高患者的生存质量 ...
全球首创靶向FRαADC药物爱拉赫 获常规批准 华东医药肿瘤创新治疗领域再下一城
Zheng Quan Ri Bao Wang· 2025-11-17 13:15
Core Insights - Huadong Medicine's first-in-class drug, Somatuximab Injection (ELAHERE), has transitioned from conditional approval to regular approval by the National Medical Products Administration (NMPA) for treating FRα-positive platinum-resistant ovarian cancer (PROC) [1][2][3] - This approval marks a significant milestone in the drug's clinical research and establishes a solid foundation for its long-term commercialization in the Chinese market [1][2] Drug Details - Somatuximab Injection targets folate receptor alpha (FRα), which is highly expressed in ovarian cancer, and is composed of an FRα-binding antibody, a cleavable linker, and the cytotoxic agent DM4 [2] - The drug's regular approval is based on positive results from the pivotal Phase III clinical trial MIRASOL [2] Market Context - Ovarian cancer, often referred to as the "king of women's cancers," poses significant treatment challenges due to late diagnosis, high recurrence rates, and low survival rates [2] - In 2022, there were approximately 61,100 new cases and 32,600 deaths from ovarian cancer in China, with a five-year survival rate of only about 40% [2] Commercialization and Sales - ELAHERE has achieved sales revenue exceeding 45 million yuan from January to September 2025, with successful early sales in the domestic market [3] - The drug is expected to quickly penetrate the domestic market due to Huadong Medicine's established commercialization system and channel advantages [3] Innovation Pipeline - Huadong Medicine is focusing on innovation in oncology, endocrinology, and autoimmune diseases, with over 90 innovative drug pipeline projects currently in progress [4] - The company has received six marketing approvals for innovative drugs by October 2025, indicating strong future growth potential [4] Financial Performance - From January to September 2025, Huadong Medicine's pharmaceutical industrial segment reported a significant revenue increase of 62%, totaling 1.675 billion yuan from innovative products and agency services [5] - The company has demonstrated strong market performance with its CAR-T product and other innovative drugs, reflecting its effective commercialization strategy [5][6]
医药生物行业周报(11月第2周):地方跟进创新药支持政策-20251117
Century Securities· 2025-11-17 10:39
Investment Rating - The report does not explicitly state an investment rating for the industry [2][19]. Core Views - The pharmaceutical and biotechnology sector saw a weekly increase of 3.29%, outperforming the Wind All A index (-0.47%) and the CSI 300 index (-1.08%) during the week of November 10-14, 2025 [3][8]. - Local governments are actively implementing policies to support innovative drug development, with Chongqing aiming to approve 1-3 new drugs annually by 2027 [3][13]. - Flu activity is on the rise, with the percentage of flu-like illness cases reported in southern provinces reaching 5.5%, higher than the previous week and the same period in 2022 and 2024 [3][13]. Market Weekly Review - The pharmaceutical and biotechnology sector increased by 3.29%, with all sub-sectors recovering. The leading sub-sectors included pharmaceutical distribution (5.92%), in vitro diagnostics (5.91%), and raw materials (5.09%) [3][8]. - Notable stock performances included Jindike (61.6%), Renmin Tongtai (61.1%), and Chengda Pharmaceutical (58.3%) with significant gains, while *ST Changyao (-33.6%) and Zhend Medical (-11.3%) faced substantial declines [3][11]. Industry News and Key Company Announcements - On November 14, Chongqing's government announced comprehensive support measures for innovative drug development, including funding for research and expedited ethical review processes [3][13]. - Merck announced a $9.2 billion acquisition of Cidara Therapeutics, expected to close in Q1 2026 [3][13]. - Adicon acquired Crown Bioscience for $204 million, aiming to enhance its integrated service platform [3][13]. - Laika Pharmaceuticals entered an exclusive licensing agreement with Qilu Pharmaceutical for LAE002, with potential payments totaling RMB 25.75 billion [3][14]. - Lyell Immunopharma announced a global licensing agreement for LYL273, with significant milestone payments and royalties [3][15]. - MeiraGTx Holdings entered a strategic collaboration with Eli Lilly for gene therapy projects, with upfront and milestone payments exceeding $400 million [3][15].
医药生物行业报告(2025.11.10-2025.11.14):流感样病例占比快速爬坡,建议关注呼吸道检测、中药等相关个股
China Post Securities· 2025-11-17 09:43
Investment Rating - The industry investment rating is "Outperform the Market" and is maintained [2] Core Views - The report highlights a rapid increase in influenza-like illness (ILI) cases, suggesting that related detection and treatment products are expected to see significant growth. Recent data from the National Influenza Center indicates that the ILI percentage in southern provinces is 5.5%, up from 4.6% the previous week, and higher than the same period in 2022 and 2024 [5][14]. - The report emphasizes the long-term positive trend in the innovative drug sector, supported by China's growing capabilities in global competition and ongoing collaborations with multinational corporations [8][25][26]. - The medical device sector is showing signs of recovery, with leading companies reporting improved performance in Q3, indicating a potential influx of investment into this area [9][32]. Summary by Sections Industry Investment Rating - The industry is rated as "Outperform the Market" [2]. Recent Trends - The A-share pharmaceutical sector rose by 3.29% from November 10 to November 14, 2025, outperforming the CSI 300 index by 4.37 percentage points [7][23]. - The report notes that the medical device sector is expected to benefit from a reduction in the pressure from centralized procurement, which has been ongoing for six years [9][32]. Influenza and Related Products - The report indicates a rising trend in flu positivity rates in both southern and northern hospitals, with the southern region currently higher than the previous two years but lower than 2023 [6][16]. - Beneficiary stocks in the detection sector include companies like Innotec and Saint Shine, while traditional Chinese medicine companies such as Yiling Pharmaceutical are also highlighted [21]. Innovative Drugs - The report expresses optimism about the innovative drug sector, noting that domestic companies are expected to accelerate their growth and profitability, supported by favorable policies [25][26]. - Recommended stocks in this sector include Innovent Biologics and Kintor Pharmaceutical [27]. Medical Devices - The report suggests that the medical device sector is becoming attractive for investment, with leading companies like Mindray showing improved performance [9][32]. - Beneficiary stocks include Huadong Medicine and Aohua Endoscopy [33]. Traditional Chinese Medicine - The report indicates that traditional Chinese medicine is under pressure but may benefit from centralized procurement policies and innovation [36][38]. - Recommended stocks include Zhaoke Pharmaceutical and Kangyuan Pharmaceutical [36]. Retail Pharmacy - The report anticipates that the retail pharmacy sector will see increased concentration, with leading companies like Yifeng Pharmacy expected to benefit from market consolidation [39]. Overall Market Valuation - As of November 14, 2025, the overall valuation of the pharmaceutical sector is 30.83, with a premium of 129.30% over the CSI 300 index, indicating a positive market outlook [47].
礼邦医药冲击港股IPO,专注于肾脏病领域,存在潜在市场重叠风险
Ge Long Hui· 2025-11-17 09:33
过去两个月,港股创新药有所回调,不过近期在百济神州、三生制药、信达生物等龙头公司利好的带动下,不少公司 已经开始在120日均线附近企稳回升。 与此同时,又有不少创新药企寻求港股IPO,包括礼邦医药、时迈药业、博瑞生物医药、礼邦医药、真实生物、海纳 医药、苏州瑞博生物、科兴生物制药、江苏鼎泰药物研究等。 格隆汇获悉,礼邦医药(江苏)股份有限公司(简称:礼邦医药)于不久前递表港交所,以18A章规则寻求港股上市,由 杰富瑞、美银证券、华泰证券担任联席保荐人。 01 另一位联合创始人Jin Tian医生目前在公司担任执行董事兼首席医学官,Jin Tian获中国人民解放军海军军医大学校肾脏 病学硕士学位,后在耶鲁大学医学院内科从事博士后研究。Jin Tian医生曾于雅培及罗氏任职,专注于临床开发。 腾讯押注,估值约37.79亿元 礼邦医药的历史起步于2018年,由Gavin Xia博士与Jin Tian医生共同创办,2025年10月改制为股份公司,公司总部位于 江苏省扬州市。 过往几年,礼邦医药完成了多轮融资,总额约为20亿元。在2025年10月的融资中,公司的投后估值约为37.79亿元。 公司的投资者包括腾讯、国金集 ...
创新药概念下跌1.72%,主力资金净流出216股
截至11月17日收盘,创新药概念下跌1.72%,位居概念板块跌幅榜前列,板块内,科兴制药、舒泰神、 昂利康等跌幅居前,股价上涨的有33只,涨幅居前的有富祥药业、海南海药、百花医药等,分别上涨 12.14%、10.04%、8.63%。 | 603858 | 步长制药 | -2.89 | 0.96 | -906.39 | | --- | --- | --- | --- | --- | | 301075 | 多瑞医药 | -2.17 | 1.99 | -894.32 | | 301408 | 华人健康 | -2.92 | 22.50 | -887.82 | | 600479 | 千金药业 | -1.90 | 1.87 | -871.50 | | 000597 | 东北制药 | -1.54 | 1.20 | -835.15 | | 002099 | 海翔药业 | 1.1 1 | 1.30 | -831.28 | | 301333 | 诺思格 | -1.53 | 3.36 | -788.71 | | 300575 | 中旗股份 | 0.15 | 2.31 | -781.84 | | 300026 | 红日药业 | -1 ...
华人健康跌2.92%,成交额5.36亿元,后市是否有机会?
Xin Lang Cai Jing· 2025-11-17 07:32
1、据2023年2月17日互动易回复:公司除阿里旗下的天猫/饿了么平台外,公司在京东/拼多多/美团等国 内主要电商平台也都有布局,并且报告期内取得了长足发展。 2、2023年11月28日互动易:公司子公司江苏神华药业有限公司在经营的品种含复方灭活白葡萄球菌片 (用于慢性气管炎、支气管炎和支气管哮喘)、白葡萄球菌片(用于慢性支气管炎等呼吸道疾患引起的 咳嗽,痰多)。 来源:新浪证券-红岸工作室 11月17日,华人健康跌2.92%,成交额5.36亿元,换手率22.50%,总市值63.76亿元。 异动分析 医药电商+流感+养老概念+阿里巴巴概念+创新药 资金分析 今日主力净流入-1627.92万,占比0.03%,行业排名18/32,连续3日被主力资金减仓;所属行业主力净流 入-8.06亿,连续3日被主力资金减仓。 区间今日近3日近5日近10日近20日主力净流入-1738.40万-3844.08万-5731.82万942.80万-1164.82万 主力持仓 主力没有控盘,筹码分布非常分散,主力成交额1.44亿,占总成交额的4.55%。 3、2025年4月30日投资者关系活动记录表:公司积极布局银发大健康领域,主要通过 ...
海普瑞跌1.67%,成交额4920.36万元,近3日主力净流入-134.87万
Xin Lang Cai Jing· 2025-11-17 07:15
Core Viewpoint - The article discusses the recent performance and business operations of Haiprime, highlighting its position in the pharmaceutical industry and the impact of currency depreciation on its revenue [2][3]. Company Overview - Haiprime, established in 1998 and headquartered in Shenzhen, is a leading multinational pharmaceutical company with A+H dual financing platforms, focusing on the heparin industry chain, biopharmaceutical CDMO, and innovative drug development [2][7]. - The company's main revenue sources include formulations (63.06%), CDMO services (18.59%), and heparin sodium and low molecular weight heparin raw materials (16.05%) [7]. Financial Performance - For the period from January to September 2025, Haiprime reported a revenue of 4.194 billion yuan, representing a year-on-year growth of 3.09%, while the net profit attributable to shareholders decreased by 29.04% to 554 million yuan [7]. - As of September 30, 2025, the overseas revenue accounted for 93.04% of total revenue, benefiting from the depreciation of the Chinese yuan [3]. Market Activity - On November 17, Haiprime's stock price fell by 1.67%, with a trading volume of 49.2036 million yuan and a turnover rate of 0.32%, bringing the total market capitalization to 18.121 billion yuan [1]. - The stock has seen a net inflow of 1.2514 million yuan from major investors today, with no significant trend in buying or selling observed [4][5]. Technical Analysis - The average trading cost of Haiprime's shares is 11.59 yuan, with the stock price approaching a resistance level of 12.41 yuan, indicating potential for a price correction if it fails to break through this level [6]. Dividend Information - Since its A-share listing, Haiprime has distributed a total of 4.21 billion yuan in dividends, with 514 million yuan distributed over the past three years [8]. Shareholder Structure - As of September 30, 2025, Haiprime had 27,000 shareholders, with the Hong Kong Central Clearing Limited being the eighth largest shareholder, holding 12.0093 million shares, an increase of 691,700 shares from the previous period [9].