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康方生物(09926.HK):商业化持续推进 HARMONI-A达到OS终点
Ge Long Hui· 2025-09-03 07:26
Core Insights - 康方生物 reported a 37.8% year-on-year revenue growth in the first half of 2025, reaching 1.41 billion yuan, with a net loss attributable to shareholders of 570 million yuan, aligning with expectations [1] - The company's product net revenue increased by 49.2% to 1.40 billion yuan, primarily driven by the sales growth of 卡度尼利 and 依沃西纳 after their inclusion in medical insurance [1] - R&D expenses rose by 23.0% to 731 million yuan, while sales expenses increased by 29.8% to 670 million yuan [1] - As of June 30, 2025, the company's cash reserves were approximately 7.14 billion yuan [1] Product Development - The clinical trial for AK112 achieved the overall survival (OS) endpoint, showing statistically and clinically significant OS benefits for patients with EGFR mutation non-squamous NSCLC after progression on EGFR-TKI treatment [2] - AK112 has been approved for one indication and is under review for another, with detailed data expected to be presented at international academic conferences in the second half of 2025 [2] - AK112 is involved in around 30 clinical trials across various indications, including 13 Phase III trials and 6 head-to-head studies, with 4 Phase III trials already yielding positive results [2] - 卡度尼利 (AK104) is undergoing clinical development with three approved indications, including 2L+ CC, 1L CC, and 1L GC, with 2L+ CC included in medical insurance [2] Non-Oncology Pipeline Expansion - The company has received approval for two non-oncology products, including 伊努西单抗 (PCSK9) and 依若奇单抗 (IL-12/IL-23), with additional products under review [3] - The company is accelerating the development of ADC pipelines, with AK138D1 (HER3 ADC) and AK146D1 (Trop2/Nectin4 ADC) currently in global Phase I clinical trials [3] - The earnings per share forecast for 2025 has been adjusted from 0.02 yuan to -0.97 yuan, with subsequent years also revised downwards, while the target price has been raised from 87 HKD to 189 HKD, indicating a 21% upside potential [3]