Investment Rating - Maintain BUY rating for Kelun-Biotech based on promising data for SKB264 in 1L NSCLC and late-line TNBC, with a target price raised from HK$200.77 to HK$246.13, indicating a 35.8% upside potential from the current price of HK$181.30 [1][3][19] Core Insights - SKB264 combined with A167 shows significant efficacy in 1L NSCLC, achieving a median progression-free survival (mPFS) of 15.4 months, outperforming current standard of care (SoC) treatments [1][12] - The drug demonstrates a favorable safety profile, with less than 1% of patients discontinuing treatment due to adverse events, compared to higher rates in competing therapies [1][12][13] - Strong Phase 3 results in 3L+ TNBC support the drug's approval in China, with an overall response rate (ORR) of 43.8% and mPFS of 5.7 months, which is superior to competitors [1][16] Summary by Sections Efficacy in NSCLC - SKB264+A167 shows promising efficacy in 1L NSCLC, with mPFS of 15.4 months, significantly better than Keytruda+chemo (9.0 months) and tislelizumab+chemo (9.7 months) [1][12] - In Phase 2 trials, cohort 1A (Q3W) had an ORR of 48.6% and cohort 1B (Q2W) had an ORR of 77.6%, indicating strong potential across different PD-L1 expression levels [8][12] Safety Profile - SKB264 exhibits a more tolerable safety profile than competitors, with <1% discontinuation due to treatment-related adverse events (TRAEs), compared to 29% for Dato-DXd and 17% for Trodelvy [1][12][13] - The most common grade ≥3 TRAEs were manageable, with neutropenia rates of 30.0% in cohort 1A and 30.2% in cohort 1B, lower than those seen in competing therapies [11][13] Commercial Potential - The wide indication coverage for SKB264 in NSCLC is expected, with ongoing Phase 3 trials planned in both China and globally, which could significantly enhance its commercial value [1][12][19] - The drug's promising data in late-line TNBC, with a BLA filed in China, positions it favorably against competitors like Trodelvy and Dato-DXd [1][16][19]
科伦博泰生物-B：Data release at ASCO further confirmed SKB264’s potential