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康方生物(09926):25H1:HARMONi-A 获统计学显著获益结果,建议关注 2025 WCLC 数据催化
Investment Rating - The report maintains an "Outperform" rating for the company [2][10]. Core Insights - The HARMONi-A study achieved statistically significant benefits, and attention is recommended for the data catalyst at the 2025 WCLC [1][7]. - The company reported a revenue of RMB 1.41 billion in 25H1, reflecting a growth of 37.8%, with commercialization revenue at RMB 1.40 billion, up 49.2% [3][15]. - The gross profit reached RMB 1.12 billion, with a gross margin of 79.4%, down 12.6 percentage points [3][15]. - The company is expanding its product pipeline, with significant advancements in both oncology and immunology sectors [5][19]. Financial Performance - Revenue projections for 2025-2027 are RMB 3.10 billion, RMB 5.08 billion, and RMB 7.16 billion, representing year-on-year growth of 46%, 64%, and 41% respectively [10][22]. - The net loss for the period was RMB 0.59 billion, a decrease of 136% compared to the previous period [3][15]. - R&D expenses were RMB 0.73 billion, with an R&D ratio of 51.8% [3][15]. Product Development and Pipeline - The company has successfully launched new products, including ebronucimab (PCSK9) and ebdarokimab (IL-12/IL-23), contributing to revenue growth [4][16]. - The ADC pipeline includes bispecific ADCs, with ongoing phase I trials for AK145D1 and AK138D1 [5][17]. - The company is also advancing multiple bispecific T-cell engagers and trispecific IO antibodies, with several IND filings expected [20]. Upcoming Catalysts - Key upcoming catalysts include updates on HARMONi data and potential BLA submissions for ivonescimab and cadonilimab [21][22]. - The company anticipates potential approvals for AK111 (IL-17A) in psoriasis and AK120 (IL-4Rα) in atopic dermatitis [21][22].