10月17日，据国家药品监督管理局（NMPA）官网最新公示，科伦药业旗下科伦博泰申报的1类新药注射用博度曲妥珠单抗在国内获批上市；与此同时，科 伦药业按化药注册分类4类申报的罗替高汀贴片也获批上市，且视同通过一致性评价，一举拿下国内首仿。 | 截图 | | --- | 来源：NMPA 注射用博度曲妥珠单抗是科伦博泰自主研发的HER2 ADC单抗，适用于既往接受过一种及以上抗HER2药物治疗的不可切除或转移性HER2阳性成人乳腺癌患 者。该药于2017年首次在国内申报临床，2018年启动首个临床试验。2023年5月，科伦博泰提交的首个上市申请（针对既往经二线及以上抗HER2治疗失败的 HER2阳性不可切除局部晚期、复发或转移性乳腺癌）获CDE受理，目前仍在审评中；本次获批适应症为该药第二项上市申请，于2025年1月获CDE受理。 截图来源：摩熵医药全球药物研发数据库 | 截图来源：摩熵医药中国药品审评数据库 | | --- | 目前，全球已获批的5款原研HER2 ADC均在国内获批。ADC药物是科伦药业重点布局方向，据摩熵医药数据库显示，旗下已有芦康沙妥珠单抗、博度曲妥 珠单抗2款新药获批上市。此外，科伦药业（ ...

Core Viewpoint - The IVD industry is experiencing rapid growth in domestic product registration and is increasingly focusing on international markets as a second growth curve, driven by domestic replacement and overseas expansion opportunities [13][17][27]. Market Review - The CITIC medical index fell by 2.60%, underperforming the CSI 300 index by 0.37 percentage points, ranking 14th among 30 primary industries [7]. - The top-performing stocks included Asia-Pacific Pharmaceutical, Duorui Pharmaceutical, and Guangsheng Tang, while the worst performers were Beida Pharmaceutical and Hualan Biological [7][11]. Industry and Stock Events - The IVD market is projected to grow significantly, with the global market expected to reach $128.2 billion by 2028, while China's IVD market is anticipated to grow to $8 billion [15][16]. - The registration of IVD products in China has shown robust growth, with a CAGR of 18.6% from 2021 to 2024, particularly in domestic products, which are expected to account for 80.5% of registrations by 2024 [14][17]. Overall Industry Perspective - The current valuation of the pharmaceutical sector is low, with public funds underweighting the sector. The industry is expected to benefit from macroeconomic factors and a recovery in demand for large-scale products [11]. - The domestic innovative drug sector is transitioning from quantity to quality, emphasizing differentiated products and internationalization [11]. - The medical device sector is witnessing a recovery in bidding volumes for imaging equipment and is expected to benefit from ongoing updates and overseas expansion [11]. IVD Industry Focus - The domestic IVD market is seeing accelerated replacement of imported products, with significant growth in the chemical luminescence segment, which is projected to grow at a CAGR of 15-20% from 2021 to 2025 [35]. - Companies like Mindray and New Industries are making significant strides in overseas markets, focusing on localization and expanding their product lines [32][35]. Company-Specific Developments - Mindray has strengthened its IVD capabilities through strategic acquisitions, enhancing its competitive edge in the international market [32]. - New Industries has successfully established a local operational model in India, which is now being replicated in other key markets, contributing to its overseas revenue growth [32][27]. - Ji'an Medical has rapidly expanded its brand presence in the U.S. market, leveraging its COVID-19 testing products to drive growth [33].