Core Viewpoint - The company has received further validation for the efficacy and safety profile of its CLDN18.2 ADC, leading to an upward revision of long-term sales forecasts and a positive outlook on its business development opportunities abroad [1][2] Group 1: CLDN18.2 ADC Development - The company announced that its CLDN18.2 ADC ATG022 has received breakthrough therapy designation in mainland China for the treatment of 3L+ CLDN18.2 positive, HER2 negative gastric/gastroesophageal junction adenocarcinoma [1] - Latest data from the I/II phase CLINCH study shows an overall response rate (ORR) of 40% for both the high-expression groups (IHC2+ >20%) at doses of 2.4mg/kg and 1.8mg/kg, and 33% for the low/very low expression group (IHC 2+ ≤20%) at 1.8-2.4mg/kg [1] - The disease control rates (DCR) were reported at 90%, 84%, and 50% for the respective groups, indicating an improvement over previously published small sample data [1] Group 2: Competitive Advantage - The median progression-free survival (PFS) for the high-expression group was reported at 6.97 months, significantly better than competitors AZD0901 and IBI343, which had PFS of 4.8 months and 5.5 months respectively [1] - The safety profile for the 1.8mg/kg dose group is promising, with grade 3 or higher treatment-related adverse events (TRAE) occurring in less than 20%, and no occurrences of ocular toxicity or interstitial lung disease (ILD) [1] Group 3: Future Development Plans - The company's future development plans for gastric cancer include: 1) Initiating a 3L monotherapy trial for high-expression patients; 2) Exploring conditional approval for 3L low/very low expression; 3) Combining with K drug for 2L treatment in PD-L1 positive populations; 4) Combining with K drug and chemotherapy for 1L treatment in PD-L1 positive populations [2] - Management maintains a global peak sales forecast exceeding $5 billion for the product [2] Group 4: Financial Projections and Valuation - The company has adjusted its financial forecasts for 2025-2027 based on the latest performance data and product launch timelines, increasing long-term and peak sales projections by nearly 30% [2] - The DCF target price has been raised to HKD 8.8, corresponding to a target market value of approximately HKD 6 billion and a peak sales multiple of 2.1 times [2]
德琪医药(6996.HK)：CLDN18.2ADC数据再证同类最佳 TCE平台价值远被低估 上调目标价