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立项只是FIC,已经不够用了?
Tai Mei Ti A P P· 2025-10-13 02:37
文 | 氨基观察 生物医药创新的 "圣杯",从来都是 "第一",但商业世界的残酷在于,"第一" 的光环未必能照亮通往最 丰厚回报的道路。 尤其是在当下,中国创新药供给端的空前繁荣与迭代速度的急剧加快,正以前所未有的力量压缩药品的 生命周期。药企被迫在有限时间内挖掘新药价值的极限,与时间的赛跑愈发白热化。 简单来说,仅将立项目标锁定为FIC可能远远不够,更重要的,还得是 BIC。 鉴于此,甚至有部分行业大拿认为,在部分现实场景中,迭代创新的BIC是更优选择。 从某种程度上说,这些声音代表着创新策略的一种进化——在深刻理解市场动态、临床需求、技术可行 性与商业回报的复杂平衡后,做出适配选择,以顺应这个加速变革、追求效率与回报的时代。 毕竟,"BIC 为王" 的逻辑,在创新药产业中曾多次上演。基于已被验证的致病机制、通路与靶点,通 过迭代优化锻造出的下一代BIC产品,确实能成为填补临床缺口的核心资产。 从降脂药王说起 BIC性价比更高? 虽然人们更迷恋FIC药物从0开始的成功,命悬一线和九死一生的剧情更符合人们的创新药研发艰难的 认知,但是,回归商业世界,不是FIC不够好,而是BIC性价比更高。 1987年,默沙东 ...
警惕!易与司美格鲁肽发生相互作用的药物
GLP1减重宝典· 2025-06-18 07:53
Core Viewpoint - The article discusses the potential drug interactions of Semaglutide, emphasizing the importance of understanding how it may interact with other commonly used medications, which could affect its efficacy or increase the risk of side effects [2][4]. Group 1: Severe Drug Interactions - Semaglutide has significant interactions with several classes of medications, particularly insulin and other diabetes drugs, which may lead to hypoglycemia if used together [5]. - Patients using anticoagulants and antiplatelet drugs, such as Warfarin and Aspirin, should be cautious as these can increase the risk of gastrointestinal bleeding and may alter the absorption and metabolism of Semaglutide [6][7]. - Opioid medications may have moderate interaction risks with Semaglutide, potentially affecting the absorption and elimination of these pain relievers due to delayed gastric emptying [8]. Group 2: Moderate Drug Interactions - Statins, such as Atorvastatin and Simvastatin, may have moderate interaction potential with Semaglutide, possibly affecting their absorption in the intestine [12]. - Hormonal contraceptives may be less effective when used with Semaglutide, increasing the risk of unintended pregnancy [15][16]. - Thyroid medications and certain antiepileptic drugs may require monitoring and potential dosage adjustments when used alongside Semaglutide due to absorption changes [17][18]. Group 3: Over-the-Counter Drug Interactions - Common over-the-counter medications, including NSAIDs and laxatives, may exacerbate gastrointestinal side effects associated with Semaglutide, such as diarrhea and nausea [20][21].
多达一的“传奇”:从全球首创到本土绽放的“一粒双控”标杆
Jiang Nan Shi Bao· 2025-05-19 06:35
Group 1 - The article highlights the global concern over hypertension, with approximately 1.3 billion people affected, and emphasizes the severe challenge in China where only 16% of the 250 million hypertensive patients achieve treatment targets [1] - The combination of hypertension and dyslipidemia significantly increases the risk of cardiovascular diseases, making effective management of both conditions a key focus in the industry [1] - The introduction of a compound drug named "Duodayi" represents a new paradigm in the combined treatment of hypertension and dyslipidemia, addressing the shortcomings of previous treatment methods [1][3] Group 2 - The compound formulation combines amlodipine and atorvastatin, which are well-known and widely used medications for hypertension and dyslipidemia, respectively [2] - Pfizer's early patent application for the combination in 1998 laid the groundwork for the development of the world's first dual-action compound drug, which received FDA approval in 2004 and has since been recognized globally [2][6] - The drug "Caduet" (Duodayi) has been approved in over 70 countries and has become a significant player in the cardiovascular medication market [2][6] Group 3 - The single-tablet formulation improves patient adherence to treatment, with a reported 26% increase in the proportion of patients maintaining treatment over 12 months compared to taking two separate medications [4] - The dual-action drug has shown a significant improvement in achieving both blood pressure and lipid level targets compared to single medications or free combinations [6] Group 4 - In July 2021, Haizheng Pharmaceutical began local production of Duodayi, maintaining original drug quality while reducing adverse reactions and treatment costs by 25% compared to single medications [7] - The drug is available in multiple dosages, allowing for tailored treatment plans based on individual patient needs, enhancing treatment efficiency [7] Group 5 - Haizheng Pharmaceutical emphasizes quality control and has implemented a comprehensive management system to ensure high standards in production, achieving FDA certification [8] - The company has adopted a digital transformation strategy, integrating modern information technology with advanced manufacturing processes to enhance the entire lifecycle of drug production [8][9] Group 6 - Duodayi is positioned as a solution for chronic disease management, simplifying medication regimens for patients and showcasing the potential of local pharmaceutical innovation [9] - The success of Duodayi reflects the growth and evolution of the Chinese pharmaceutical industry, demonstrating that local production can match or exceed the quality of original formulations [9]
2025年5月第二周创新药周报-20250511
Southwest Securities· 2025-05-11 12:43
Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical industry as of May 11, 2025 [1]. Core Insights - The A-share innovative drug sector saw a weekly increase of 2.33%, outperforming the CSI 300 index by 0.33 percentage points, while the biopharmaceutical sector rose by 0.75% [2][17]. - In the past six months, the A-share innovative drug sector has cumulatively increased by 5.43%, outperforming the CSI 300 index by 9.13 percentage points, whereas the biopharmaceutical sector has decreased by 10.55% [2][17]. - The Hong Kong innovative drug sector experienced a decline of 2.14%, underperforming the Hang Seng Index by 3.75 percentage points, with a cumulative increase of 22.08% over the past six months [2][20]. - The XBI index in the US fell by 8.59% this week, with a cumulative decline of 22.72% over the past six months [2][23]. Summary by Sections Domestic Key Innovative Drug Progress - In May, one new drug was approved for market launch in China, with no new indications approved [3][41]. Overseas Key Innovative Drug Progress - In May, there were no NDA or BLA approvals in the US, Europe, or Japan for innovative drugs [4][45]. Global Key Innovative Drug Transaction Progress - A total of 12 key transactions occurred globally this week, with one disclosed transaction amounting to 415 million USD between Alchemab Therapeutics and Eli Lilly [5]. Market Performance - The report indicates that 39 stocks in the innovative drug sector rose while 67 fell during the week, with the top gainers being HaiChuang Pharmaceutical-U (22.76%), Changchun High-tech (8.99%), and Zhongsheng Pharmaceutical (8.98%) [2][16]. - The top decliners included Fuhong Hanlin (-12.64%), Connaught-B (-12.40%), and Boan Biotechnology (-11.77%) [2][16]. Clinical Trials and Approvals - In May, there were 23 newly announced clinical trials in China, including 17 in BE/I phase, 4 in II phase, and 2 in III phase [31].
对不同医药细分业务本质的一些思考
青侨阳光投资交流· 2024-08-16 02:02
青侨阳光医药投资 - 行业思考 1 标准化程度和医生依赖度的差异, 是"药VS械VS院"业务不同特性的重要来源 "医药"里的"医"主要指医疗器械和医疗机构,"药"主要指中药、化药、生物药等药品。从这点来说,"药品、 器械、医院等医疗机构"是医药行业最核心3大业务类别。除此之外的医药细分,多数可以看成是这3类业务的 配套产业,比如原料药、CRO、CMO等可以看成是药品的配套,分销商、药店等可以看成是药品和器械的配 套,三方诊断、医疗信息化等可以看成是医疗机构的配套。 从欧美日等发达国家过去几十年的历史经验看,在医药行业相对成熟的主流经济体中,"药"的资本回报率最为 可观,"械"的资本回报率也相当优秀,但"院"的资本回报率比较糟糕。 比如有很多人统计过美股不同行业的历史ROIC,其中: 这与我们的直觉感受是一致的,虽然药品和器械占整个医药行业总盘子不到20%,但我们闭着眼睛也能数出几 十个声名显赫、历史回报强劲的来自美国、欧洲、日本的制药企业和医疗器械企业;但对于占行业总盘子超 60%的医疗服务业务,著名的海外上市医院集团我们可能一只手的指头都数不完。 为什么会这样?一个重要原因是这 三类业务在标准化程度和医生依 ...