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减肥药在中国,彻底疯狂
3 6 Ke· 2025-10-09 11:33
诺和诺德的GLP-1药物司美格鲁肽,已成为全球医药市场的现象级产品,其商业成功甚至将这家丹麦公 司的市值一度推升至超越其本国GDP。 华东医药的策略极具代表性,其采取了"自主研发+外部引进"双线布局。在引进和仿制端,它已在国内 首批获准上市了诺和诺德上一代产品利拉鲁肽的生物类似药,并获批用于体重管理。 这一步的战略价值在于,它能提前教育市场、建立与医生的合作关系、并搭建起一支经验丰富的销售团 队,为后续司美格鲁肽的竞争铺平道路,同时产生稳定的现金流。 它越成功,在中国市场就越能吸引企业入局。据估算,中国的超重及肥胖人群已达数亿,潜在的市场规 模无可限量。 故事的转折点定于2026年,届时,司美格鲁肽在中国的核心化合物专利预计将失效。这为本土制药企业 打开了法律和市场的双重窗口。 事实上,一场"抢跑"早已开始。据不完全统计,目前国内已有至少八家企业的司美格鲁肽生物类似药申 请上市,另有超过十二家同类药物处于关键的II/III期临床试验阶段。一个高度拥挤的赛道已成定局。 然而,即将到来的竞争并非千篇一律的价格战,而是不同背景的入局者,采用不同商业策略的一场多线 战争。 第一类是以华东医药、齐鲁制药为代表的传统大型 ...
江苏以全链条改革打造全球生物医药研发制造高地 减重新药16个月跑出上市加速度
Xin Hua Ri Bao· 2025-10-09 01:27
日前,信达生物制药企业生产负责人表示全球首个且唯一获批上市的双靶点减重药物玛仕度肽,从去年 2月提交减重适应症上市申请,到今年6月获批上市,凭借其独特的双靶点设计,成为搅动国际减重药物 市场的"破局者"。 传统的药品上市审评审批标准与企业实际需求之间的差距仍然存在。"我们希望实现多肽类化药与生物 制品共线生产,但常规审批难以支持这一创新需求。"殷则阳回忆说。 有别于一般医疗器械生产、检验和出厂放行过程,超大型有源医疗设备需要在医疗机构现场组装调试和 检验。此类产品尚无现场检查指导原则,企业对注册质量体系核查模式和流程不甚了解,省药监局与企 业一路"摸着石头过河"。 药品上市后表现"炸场",成为企业重要的营收增长极。而快速上市的背后,得益于江苏健全完善的体制 机制,着力实现全链条突破与赋能,促进各类先进生产要素向发展新质生产力集聚。 接到企业诉求后,省核查中心积极向国家药监局核查机构汇报,向外省检查机构同行交流请教,学习掌 握同类产品检查方式方法和关注的风险点,安排工作小组对接和跟踪服务,以"行业专家"为目标,参与 相关检查核查规范性文件的制定,积极提升专业水平,为检查争取有利条件,一路助推实现"零的突 破"。 ...
江苏以全链条改革打造全球生物医药研发制造高地减重新药16个月跑出上市加速度
Xin Hua Ri Bao· 2025-10-04 23:18
9月30日,苏州信达生物制药集团的生产车间,两层楼高的不锈钢生物反应器静静运转,pH值、溶 氧量等参数值实时显示。 隔着显示玻璃,信达生物制药企业生产负责人殷则阳告诉记者,这些模拟人体内环境的巨大罐体, 正是全球首个且唯一获批上市的双靶点减重药物玛仕度肽的诞生地。 2025年被称为"减重元年"。从去年2月提交减重适应症上市申请,到今年6月获批上市,玛仕度肽用 16个月跑出了上市"加速度",凭借其独特的双靶点设计,成为搅动国际减重药物市场的"破局者"。 药品上市后表现"炸场",成为企业重要的营收增长极。而快速上市的背后,得益于江苏健全完善的 体制机制,着力实现全链条突破与赋能,促进各类先进生产要素向发展新质生产力集聚。 玛仕度肽与质子治疗系统的待遇,都不是孤例。截至目前,江苏"创新型药械咨询服务交互平台"共 入驻企业93家,涉及208个创新药品、250多个创新医疗器械。企业可在线提交注册检验等相关问题,对 应服务专班人员在5个工作日内予以答复。完成上市申请以及上市后变更的药品项目可以从交互平台 上"毕业",同时也会不断有新的项目加入。 全球生物医药竞争日趋白热化,细胞与基因治疗、双靶点药物等新赛道不断涌现。然而 ...
创新药ETF国泰(517110)盘中上涨超2%,GLP-1减重药赛道多维升级引关注
Mei Ri Jing Ji Xin Wen· 2025-09-30 06:20
创新药ETF国泰(517110)跟踪的是SHS创新药指数(931409),该指数从A股和港股通市场中选取从 事创新药研发的上市公司证券作为指数样本,聚焦化学药与生物药领域,重点覆盖研发投入高、成长性 突出的企业,以反映创新药研发及商业化相关上市公司证券的整体表现。指数成分股主要集中于医药生 物板块,整体风格偏向成长型。 东海证券指出,GLP-1减重药赛道正从追求单一减重指标向综合考量BMI改善、副作用管理、给药便利 性和长期体重维持等多个维度演进。单纯的体重下降数字已不足以定义成功的减重药,保留甚至增加瘦 体重已成为下一代减重疗法的重要目标,联合疗法、肌肉保护、剂型创新和机制拓展将成为未来的核心 竞争领域。面对由诺和诺德和礼来主导的全球减重市场,国内药企差异化策略寻求突破的尝试初见成 效,如歌礼制药的减重不减肌候选药物ASC47通过剂型创新提升患者依从性,信达生物的玛仕度肽作为 全球首个申报上市的GCG/GLP-1双受体激动剂已在国内上市。 注:如提及个股仅供参考,不代表投资建议。指数/基金短期涨跌幅及历史表现仅供分析参考,不预示 未来表现。市场观点随市场环境变化而变动,不构成任何投资建议或承诺。文中提及指数 ...
医药生物行业周报:增肌减脂或成GLP-1赛道竞争新方向-20250929
Donghai Securities· 2025-09-29 12:19
Investment Rating - The report assigns an "Overweight" rating to the industry, indicating a positive outlook for the sector relative to the broader market over the next six months [1]. Core Insights - The pharmaceutical and biotechnology sector experienced an overall decline of 2.20% in the week from September 22 to September 26, 2025, underperforming the CSI 300 index by 3.27 percentage points. The current PE valuation for the sector stands at 30.71 times, which is at the historical median level, with a valuation premium of 131% compared to the CSI 300 index [3][11][18]. - Notable sub-sectors that declined include medical devices, biological products, and traditional Chinese medicine, with respective declines of 1.02%, 1.18%, and 1.95% [11]. - A total of 81 stocks within the sector increased in value (17.09% of the total), while 387 stocks decreased (81.65% of the total) during the same period [26]. Market Performance - The pharmaceutical and biotechnology sector ranked 25th among 31 industries in the Shenwan index for the week, with all sub-sectors showing declines [11]. - Year-to-date, the sector has increased by 21.44%, outperforming the CSI 300 index by 5.81 percentage points, with medical services and chemical pharmaceuticals leading the gains at 40.36% and 38.02%, respectively [13][19]. Industry News - On September 29, 2025, Laikai Pharmaceutical announced positive preliminary results from its Phase I multiple ascending dose study (MAD study) for LAE102, aimed at treating obesity. The study showed promising trends in muscle gain and fat loss among participants [4][28]. - The results indicate that the LAE102 6 mg/kg dosage group saw an average lean body mass increase of 1.7% and a fat mass reduction of 2.2% compared to baseline, with the placebo-adjusted average lean body mass increase reaching 4.6% and fat mass reduction at 3.6% [29]. Investment Recommendations - The report suggests focusing on investment opportunities in innovative drug chains, medical devices, and healthcare services, particularly in the context of the evolving GLP-1 weight loss drug market [4][30]. - Recommended stocks include Teabo Bio, Rongchang Bio, Betta Pharmaceuticals, Kaili Medical, and Huaxia Eye Hospital, with additional stocks to watch including Kelun Pharmaceutical, Qianhong Pharmaceutical, Yifeng Pharmacy, Baipusais, and Lingrui Pharmaceutical [30].
渤海证券研究所晨会纪要(2025.09.29)-20250929
BOHAI SECURITIES· 2025-09-29 05:15
崔健 022-28451618 SAC NO:S1150511010016 cuijian@bhzq.com 渤海证券研究所晨会纪要(2025.09.29) 宏观及策略研究 选择相信政策的力量——2025 年第四季度宏观经济季报 固定收益研究 收益率曲线再度上行——利率债周报 行业研究 第十一批集采公告发布,规则持续优化——医药生物行业周报 证 券 研 究 报 告 晨会纪要(2025/09/29) 编辑人 晨 会 纪 要 请务必阅读正文之后的声明 渤海证券股份有限公司具备证券投资咨询业务资格 1 of 6 晨会纪要(2025/09/29) 宏观及策略研究 选择相信政策的力量——2025 年第四季度宏观经济季报 周 喜(证券分析师,SAC NO:S1150511010017) 宋亦威(证券分析师,SAC NO:S1150514080001) 严佩佩(证券分析师,SAC NO:S1150520110001) 靳沛芃(研究助理,SAC NO:S1150124030005) 1、海外经济及政策环境 从 Jackson Hole 会议上鲍威尔放风,到 9 月议息会议降息落地,再到近期官员讲话暗示未来降息或仍需考量, 归 ...
丹麦巨头巨变,国产药千亿商机来了
投中网· 2025-09-28 09:16
Core Viewpoint - The global weight loss drug market is undergoing significant restructuring, with Novo Nordisk's layoffs and strategic shifts indicating the end of its dominance and the rise of competition from other pharmaceutical companies, particularly in China [4][10][14]. Group 1: Novo Nordisk's Strategic Changes - Novo Nordisk plans to cut approximately 9,000 jobs globally, with around 5,000 in Denmark, as part of a resource reallocation strategy focusing on diabetes and obesity treatments [4][7]. - The company’s revenue from semaglutide exceeded $16 billion in the first half of the year, with annual sales expected to approach $40 billion, indicating a lucrative market despite internal challenges [7][8]. - Marketing missteps have led to market chaos in China, where semaglutide was initially marketed without a comprehensive strategy, resulting in misuse and regulatory scrutiny [8][9]. Group 2: Market Dynamics and Competition - The GLP-1 drug market is projected to exceed $70 billion, with significant growth anticipated in the Chinese market, where the obesity rate is rising [7][15]. - By 2030, the Chinese weight loss drug market is expected to reach nearly $25 billion, driven by increasing obesity rates and healthcare spending [15][16]. - Domestic players are entering the market, with over 20 semaglutide generics in clinical trials, indicating a shift towards a more competitive landscape [15][16]. Group 3: Challenges and Opportunities - The competitive landscape is characterized by the need for speed, patience, and differentiation among players, as the market becomes increasingly crowded [5][20]. - Novo Nordisk's challenges highlight the importance of effective marketing and understanding consumer needs, as well as the risks associated with drug development and safety [19][20]. - The potential for GLP-1 drugs extends beyond weight loss to other therapeutic areas, with a projected global market size of over $150 billion by 2031 [21][22].
丹麦巨头大裁员,掀开国产药千亿商机
Hu Xiu· 2025-09-27 02:12
Core Viewpoint - The recent layoffs at Novo Nordisk, which will affect approximately 9,000 positions globally, signal a significant shift in the weight-loss drug market, moving from a dominant position to a more competitive landscape where multiple players are emerging [1][3][19]. Group 1: Company Actions and Strategy - Novo Nordisk's layoffs are part of a broader strategy to reallocate resources towards diabetes and obesity treatment, indicating a transformation within the company [1][7]. - The company aims to save 8 billion Danish Kroner annually by 2026 through these layoffs, but the primary goal is to refocus on competitive areas rather than just cost-cutting [7][3]. - The layoffs come as Novo Nordisk faces increased competition from other pharmaceutical companies like Pfizer and Eli Lilly, which are investing heavily in next-generation weight-loss drugs [1][6]. Group 2: Market Dynamics and Competition - The GLP-1 drug market is projected to exceed $70 billion, with expectations of reaching a $100 billion market soon, driven by rising obesity rates and demand for effective treatments [3][11]. - In China, the obesity rate among adults is reported at 34.3%, with predictions that the number of overweight and obese individuals could exceed 500 million by 2030, leading to significant healthcare expenditures [11][12]. - The competitive landscape is shifting, with multiple Chinese companies entering the market, as the patent for semaglutide will expire in 2026, allowing for generic versions to emerge [12][13]. Group 3: Challenges and Risks - Novo Nordisk has faced marketing missteps, particularly in China, where it failed to effectively manage the off-label use of its diabetes drug for weight loss, leading to market chaos [4][5]. - The company has also struggled with supply issues in the U.S., losing exclusive supply rights for semaglutide due to underestimating market demand [6][5]. - The development pipeline for Novo Nordisk has been under scrutiny, with recent failures in new drug candidates raising concerns about its future competitiveness [6][15]. Group 4: Future Outlook - The GLP-1 market is entering a new phase, with expectations of diverse product offerings and increased competition, particularly from domestic players in China [11][12]. - The industry's growth potential is significant, with forecasts suggesting that the global market could surpass $150 billion by 2031 [18]. - Companies must navigate challenges related to safety, marketing, and strategic positioning to succeed in this evolving landscape [18][17].
医药生物行业周报:第十一批集采公告发布,规则持续优化-20250926
BOHAI SECURITIES· 2025-09-26 09:51
行 行业周报 业 第十一批集采公告发布,规则持续优化 | 研 | | | | | ——医药生物行业周报 | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 究 | 分析师: | 侯雅楠 | S1150524120001 年 2025 09 | SAC NO: | | 月 | 日 | | 26 | | | 医药生物 | | 投资要点: | | | | | | | | | 证券分析师 |  | 行业要闻 | | | | | | | | | 侯雅楠 | | | | | | | | | | | houyn@bhzq.com | | (1)国家组织药品联合采购办公室关于发布《全国药品集中采购文件 | | | | | | | | | 022-23839211 | | (GY-YD2025-1)》的公告; | | | | | | | | | 研子行究业助理评级 | | 三抗启动 期临床; (2)泽璟制药 III | CD3/DLL3 | | | | | | | | 中药Ⅱ | 看好 | (3)帕博利珠单抗皮下注射剂型获批上市; ...
天风医药细分领域分析与展望:创新药、制药行业及个股2025半年度回顾与展望
Tianfeng Securities· 2025-09-26 07:13
Industry Rating - The report maintains an "Outperform" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The innovative drug sector is experiencing a positive trend with significant revenue growth and a reduction in losses, indicating a potential for sector-wide profitability [2][6] - The overall revenue for the innovative drug sector in H1 2025 reached 30.649 billion yuan, a year-on-year increase of 9.77%, while the net loss attributable to shareholders was 2.096 billion yuan, showing a substantial reduction in losses [6] - The sector's gross margin remains high at 84.43%, with a slight decrease compared to the previous year, but showing signs of recovery in Q2 2025 [3][6] Summary by Sections Innovative Drug Sector - The innovative drug sector's revenue for H1 2025 was 30.649 billion yuan, with a growth rate of 9.77% year-on-year. Q2 2025 revenue was 16.387 billion yuan, reflecting a 33.24% increase [5][6] - The sector's gross margin for H1 2025 was 84.43%, slightly down from the previous year, but Q2 2025 saw an increase to 84.73% [3][6] - The number of License-out transactions with upfront payments exceeding 10 million USD reached a new high, indicating that overseas rights have become a crucial funding source for Chinese companies [4][7] Financial Performance - The innovative drug sector's net loss for H1 2025 was 2.096 billion yuan, with a significant reduction in losses of 127.58% year-on-year. The adjusted net loss was 2.880 billion yuan, reflecting a 151.25% reduction in losses [5][6] - The sector's operating cash flow was positive at 210 million yuan, indicating improved financial health [5] Traditional Pharmaceutical Sector - The traditional pharmaceutical sector, comprising 136 listed companies, reported total revenue of 254.895 billion yuan in H1 2025, a decrease of 1.64% year-on-year. The net profit attributable to shareholders was 32.099 billion yuan, down 4.83% [26][32] - The gross margin for the traditional pharmaceutical sector was 51.05% in H1 2025, showing a slight increase compared to the previous year [27][32] - The sector is adapting to policy changes, with increased industry concentration and some leading companies achieving growth through transformation and international expansion [32]