AKESO(HK:09926) Xin Lang Zheng Quan·2025-06-11 01:14Core Viewpoint - The recent controversies surrounding Kangfang Biopharma highlight significant compliance and clinical data challenges, raising concerns about the company's internal controls and the clinical value of its drug, Cadonilimab [2][3][4]. Group 1: Compliance Issues - A patient purchased 70 doses of Cadonilimab for 79,320 yuan, with most labeled for "clinical research use only," indicating a serious compliance breach [2]. - Kangfang Biopharma acknowledged that the issue stemmed from a sales representative forging research documents to obtain the drug, emphasizing that no fees were charged to patients [2]. - The incident reveals a critical lack of internal controls within the company's distribution process [2][4]. Group 2: Clinical Data Controversy - The Phase III HARMONi study showed a significant progression-free survival (PFS) benefit (risk ratio of 0.52) for EGFR-mutant lung cancer patients, but the overall survival (OS) benefit (risk ratio of 0.79) did not reach statistical significance [3]. - Summit Therapeutics and Kangfang attempted to downplay the OS results, highlighting that no EGFR second-line treatment has shown significant OS benefit in registration studies [3]. - The FDA considers "significant OS benefit" a necessary condition for drug approval, adding uncertainty to future submissions [4]. Group 3: Strategic Challenges - Kangfang Biopharma faces dual pressures from compliance issues and clinical data scrutiny, necessitating a strengthening of its sales compliance system [4]. - The company reported a 12.51% increase in sales and marketing expenses to 1.002 billion yuan, while R&D spending decreased by 5.29% to 1.188 billion yuan, raising questions about maintaining innovation [4]. - The founder expressed intentions to continue clinical research for products like Ivosidenib and accelerate global development, but the company must navigate compliance and data challenges to transform pressure into opportunity [5].