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康方生物(09926.HK):HARMONI-A最终分析达到OS临床终点 公司国际化全面加速
Ge Long Hui· 2025-08-30 23:24
Core Viewpoint - 康方生物 reported a significant increase in revenue for the first half of 2025, driven by new drug approvals and inclusion in the medical insurance directory, indicating strong growth potential in the biopharmaceutical sector [1][2][3] Financial Performance - The company achieved a revenue of 14.12 billion yuan in the first half of 2025, representing a year-on-year increase of 37.75% - Commercial sales reached 14.02 billion yuan, up 49.2% year-on-year - R&D expenses amounted to 7.31 billion yuan, reflecting a 23% increase compared to the previous year - The group reported a loss of 5.88 billion yuan for the first half of 2025 [1][2] Product Development and Clinical Trials -依沃西 (Ivosidenib) has received approval for two indications in China and is conducting 13 Phase III clinical trials, with 4 showing positive results - The first indication for 依沃西 was approved in May 2024 for EGFR-TKI resistant second-line non-squamous NSCLC and has been included in the medical insurance directory - The final analysis of the HARMONi-A trial demonstrated statistically significant overall survival (OS) benefits [1][2] International Expansion and Clinical Progress - The HARMONi-6 trial comparing 依沃西 with chemotherapy for first-line sqNSCLC achieved its primary endpoint of progression-free survival (PFS) with significant clinical benefits - The NMPA has accepted the supplemental new drug application (sNDA) for this indication - The company is actively advancing approximately 10 Phase III/registration clinical trials for 卡度尼利 (Cardonil) and has received approvals for first-line cervical and gastric cancers [2][3] Strategic Initiatives - The company is accelerating its IO 2.0 and ADC 2.0 strategies, with new generation ADCs like AK146D1 and AK138D1 entering early clinical development globally - 康方生物 has over 50 innovative projects in the pipeline and has expanded its sales team to over 1,200 personnel, positioning itself as a significant player in the pharmaceutical industry [3] Revenue Forecast - The projected revenue for 康方生物 from 2025 to 2027 is estimated at 34.83 billion yuan, 53.53 billion yuan, and 91.49 billion yuan, with growth rates of 63.98%, 53.71%, and 70.91% respectively - The expected net profit for the parent company is forecasted to be -7.73 billion yuan, 1.79 billion yuan, and 16.51 billion yuan for the same period [3]