对外授权收入 超预期，维持“增持”评级。公司2024H1实现 13.83亿元，同比+32.2%，主要得益于许可及合作协议的收入持续增长，其中来自默沙东合作管线相关的里程碑付款9000 万美元（约6.41亿元）；公司实现利润3.10 亿元，相较2023H1 实现扭亏为盈。考虑到公司对外授权收入与研发管线进展超预期，上调2024-2026 年收入预测为17.20/19.24/25.34 亿元（原预测11.81/15.74/23.61 亿元），维持“增持”评级。Introduction to this report:
The company's external licensing revenue exceeded expectations, and 24H1 reversed losses; the R&D pipeline progressed faster than expected, and the first indication in the lung cancer field was declared an NDA. Core varieties have entered the harvest period one after another, maintaining an “gain” rating.
Key points of investment:
Revenue from external licensing exceeded expectations and maintained an “increase in holdings” rating. The company achieved 1.383 billion yuan in 2024H1, +32.2% year-on-year, mainly due to continued revenue growth from licensing and cooperation agreements, including milestone payments of 90 million dollars (about 0.641 billion yuan) related to the MSD cooperative pipeline; the company achieved a profit of 0.31 billion yuan, which turned a loss into a profit compared to 2023H1. Considering that the company's external licensing revenue and R&D pipeline progress exceeded expectations, the 2024-2026 revenue forecast was raised to 1.72/1.924/2.534 billion yuan (the original forecast was 1.181/1.574/2.361 billion yuan), maintaining the “gain” rating.
The R&D pipeline progressed faster than expected, and the first indication in the field of lung cancer was declared NDA. The company's core product, SKB264, was approved by CDE for use in EGFR-TKI and EGFRM NSCLC after failed platinum-containing chemotherapy, and the application is to be included in the CDE priority review and approval process; in the corresponding critical clinical OptiTrop-Lung03 study, SKB264 achieved superior results in ORR and PFS statistics compared to many citracene in this patient group. Furthermore, the 3L+ TNBC indication for SKB264 is already under NDA review and is expected to be approved for marketing in 2024H2.
MSD powers new member SKB571, and global strategic cooperation continues to be adjusted and optimized. The company recently received a written notice from MSD that MSD will exercise exclusive options for the SKB571 project and pay the company a down payment of 37.5 million US dollars. As the pipeline progresses, the company is expected to receive further milestone payments and tiered royalties in the future, and the company reserves SKB571's rights in Greater China. At the same time, MSD will refund the global benefits of the SKB315 project to Colombotech.
The scope of cooperation between the two sides continues to be adjusted and optimized, and the best pipeline combination with complementary advantages is gradually formed.
Core varieties are entering the harvest period one after another, and there are plenty of potential catalysts. (1) The first indication for SKB264, 3L+ TNBC, is expected to be approved for marketing in China, and EGFR-TKI-resistant NSCLC, the first indication in the field of lung cancer, is expected to be approved for marketing in China in 2025; (2) the nasopharyngeal cancer indication of PDL1 monoclonal antibodies is expected to be approved for marketing in 2024H2; (3) HER2 ADC A166 initial indication 3L+ HER2+ BC is expected to be approved for marketing 24H2/25H1; (4) Cetuximab is expected to be approved and marketed in China; (4) Cetuximab is expected to be approved for marketing in China; (4) Cetuximab is expected to be approved for marketing in China; (4) Cetuximab is expected to be approved for marketing in China; (4) Cetuximab is expected to be approved for marketing in China; (4) Cetuximab is expected to be approved for marketing in China; (4) Cetuximab is expected to be approved for marketing in China; (4 Marketed; (5) The RET inhibitor A400 is expected to be NDA declared for 24H2.
Risk warning. Risk of clinical trials falling short of expectations; risk of failure in drug development; risk of falling short of expectations in marketing and sales.