高盛：科伦博泰_2025 年中国医疗企业日 —— 关键要点

Investment Rating - The report assigns a Buy rating to Kelun Biotech with a 12-month price target of HK$284.14, indicating a downside potential of 12.6% from the current price of HK$325.00 [7]. Core Insights - The management of Kelun Biotech is shifting the focus of sac-TMT from China to global trials, highlighting the significant commitment from Merck (MRK) with 14 ongoing global phase 3 trials across various tumor types [5][6]. - The early-stage pipeline is progressing steadily, with notable developments in SKB315 and SKB410, and a focus on radio-drug conjugates (RDC) as a promising area of research [6]. - Key catalysts expected in the second half of 2025 include NMPA approvals and data readouts for sac-TMT and other assets, with projected sales ramp-up for sac-TMT aiming for RMB 800 million to 1 billion for FY25 [6]. Summary by Sections Sac-TMT Global Trials - Sac-TMT (TROP2 ADC) is entering a mature R&D stage in China with two approved indications and two under NDA, while five phase 3 trials are ongoing [5]. - The strategy involves leveraging global trials for smaller indications in China, which are deemed less appealing from a return on investment perspective [5]. Early-Stage Pipeline - The early-stage pipeline includes SKB315 (CLDN18.2) for gastric cancer and SKB410 (Nectin4), which is licensed to Merck, showing complementary effects compared to existing therapies [6]. - Several phase 1 assets are under dose-escalation without a data sharing plan for 2025 [6]. Radio-Drug Conjugates (RDC) - RDCs are highlighted for their potential in tumors with strong encapsulation, offering a more straightforward payload release mechanism compared to traditional methods [6]. - The management emphasizes the need for target-specific delivery mechanisms in RDC development [6]. Key Catalysts - Anticipated catalysts in 2H25 include NMPA approval for sac-TMT in 2L EGFRmut NSCLC, A166 (HER2 ADC) approval, and phase 1 data readout for SKB315 [6].