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 ...

Investment Rating - The report indicates a positive outlook for the pharmaceutical and biotechnology sector, with a focus on innovative drug companies [2][3]. Core Insights - The pharmaceutical and biotechnology sector saw a weekly increase of 1.82%, outperforming the CSI 300 index (0.82%) and the Wind All A index (1.71%). The market is currently focused on the expectations surrounding semi-annual reports and business development (BD) activities [8][9]. - The launch of the 2025 National Basic Medical Insurance and Commercial Health Insurance innovative drug directory is a significant development. This directory will include high-innovation drugs that provide substantial clinical value and patient benefits, which are not covered by basic medical insurance but recommended for commercial health insurance [3][13]. - The report highlights the importance of the commercial health insurance sector in the payment for innovative drugs, suggesting that the accessibility of high-priced innovative drugs is expected to improve, particularly in the areas of cell and gene therapy [3][13]. Market Weekly Review - The medical research outsourcing sector led the gains with a 9.29% increase, primarily driven by WuXi AppTec's positive semi-annual report announcement. Conversely, offline pharmacies and other biological products experienced declines of -1.29% and -1.55%, respectively [8][9]. - Notable stock performances included Frontier Biotech-U (41.4%), Mediso (38.9%), and Lianhuan Pharmaceutical (38.6%) leading the gains, while ST Unimed (-18.5%), Shenzhou Cell-U (-13.4%), and Shutai Shen (-11.6%) faced significant losses [11][12]. Industry News and Key Company Announcements - The report outlines several key industry events, including the approval of innovative drugs and strategic partnerships among major pharmaceutical companies, which are expected to enhance their market positions and product offerings [13][16][17]. - The report also mentions significant financial forecasts from various companies, indicating strong growth potential in the sector, with some companies projecting net profit increases of over 100% year-on-year [17][18].

Core Viewpoint - Hansoh Pharmaceutical's innovative drug, Amivantamab (Aumseqa®), has been approved for marketing in the UK, marking it as the first innovative drug from the company to enter the overseas market and the first Chinese-origin EGFR-TKI to be launched internationally [1][2]. Group 1: Drug Approval and Market Entry - Amivantamab is approved for use as a first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activated EGFR mutations, as well as for patients with T790M mutation-positive NSCLC [1]. - The drug has already been approved for four indications in China, making it the most approved indication for a Chinese-origin third-generation EGFR-TKI [2]. Group 2: Market Context and Competitors - As of March 2025, there are seven third-generation EGFR-TKI products available in China, including Amivantamab and others like Osimertinib and Furmonertinib [3]. - The market for NSCLC treatments is significant, with lung cancer accounting for 18.7% of global cancer deaths in 2022, and NSCLC being the most common type, representing approximately 85% of all lung cancer cases [4]. Group 3: Historical Context and Future Prospects - The first-generation EGFR-TKI, Gefitinib, was launched in the early 2000s, followed by second-generation drugs that also faced resistance issues, leading to the development of third-generation EGFR-TKIs like Osimertinib [5]. - Current research is focused on addressing resistance issues associated with third-generation EGFR-TKIs, with innovations such as EGFR/C-MET dual antibodies and ADC drugs being explored [6].