Investment Rating - The report maintains an "outperform" rating for Kelun-Biotech (6990 HK) with a target price of HKD 200.10 per share, up 84% from the previous target of HKD 108.61 [14][18]. Core Insights - Kelun-Biotech reported H1 2024 results with revenue of RMB 1.38 billion (+32.2%), gross profit of RMB 1.08 billion (+59.4%), R&D expenditure of RMB 650 million (+33.0%), and a profit of RMB 310 million compared to a loss of RMB 31.13 million in the same period last year [9][18]. - The core product sac-TMT has initiated 10 global registrational trials, with 2 indications having submitted NDA in China. The collaboration with Merck has been optimized, reflecting a dynamic adjustment in the scope of early-stage pipelines [10][18]. - The report highlights significant clinical data from the 2024 ASCO meeting, indicating sac-TMT's potential to provide clinical survival benefits in breast cancer and non-small cell lung cancer [10][18]. Financial Performance - For H1 2024, the company achieved a revenue of RMB 1.38 billion, a gross profit of RMB 1.08 billion, and a profit of RMB 310 million, marking a significant turnaround from a loss in the previous year [9][18]. - The company has a cash and cash equivalents balance of RMB 2.89 billion as of June 30, 2024 [9][18]. Product Pipeline and Development - The core product sac-TMT is expected to be approved in China between H2 2024 and H1 2025, with multiple indications in the pipeline [10][18]. - The report outlines four development strategies for sac-TMT, including first-to-market opportunities and biomarker enrichment strategies [10][18]. - The company has four products currently in the NDA stage, expected to be approved in 2024H2-25H1, including sac-TMT and A166 (HER2 ADC) [13][18]. Collaboration and Partnerships - Merck has exercised its option for SKB571, a bispecific antibody ADC, with a payment of USD 37.5 million, while returning the global rights to SKB315 [13][18]. - The collaboration with Merck is seen as a strategic move to cover a wide range of oncology indications through differentiated ADC pipelines [13][18]. Earnings Forecast and Valuation - Revenue forecasts for 2024-2026 have been adjusted to RMB 1.76 billion, RMB 1.53 billion, and RMB 2.36 billion, reflecting a YoY growth of +14%, -13%, and +54% respectively [14][18]. - The net profit attributable to the parent company is forecasted to be -RMB 230 million, -RMB 1.01 billion, and -RMB 782 million for the same period [14][18].
科伦博泰生物-B：Sac-TMT在中国递交肺癌NDA，与默沙东合作优化调整