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康方生物临床试验药“失控”背后:授权收入“断奶”,创新“缩水”、销售“内卷”,合规防线如何失守

Core Viewpoint - Kangfang Biopharma is facing significant scrutiny and potential reputational damage due to the improper distribution of a clinical trial cancer drug, which raises serious questions about its compliance management and internal controls [2][3][4]. Compliance Management Issues - The incident involving a cervical cancer patient in Chongqing highlights the failure of Kangfang Biopharma's compliance management, as the patient received a drug intended only for clinical research [3][4]. - Kangfang Biopharma attributed the issue to a sales representative who allegedly forged research documents to obtain the drug, but this explanation has not alleviated public concerns regarding the company's internal management systems [4]. Financial Performance and Revenue Decline - Kangfang Biopharma, once a leading player in the innovative drug sector, reported a dramatic decline in revenue, with overseas licensing income plummeting over 95% from 2023 to 2024, dropping from 29.23 billion RMB to 1.22 billion RMB [5][6]. - Despite a 24.88% increase in commercial product sales to 20.02 billion RMB in 2024, the overall revenue fell from 45.26 billion RMB in 2023 to 21.24 billion RMB in 2024, indicating a heavy reliance on single licensing transactions [6][7]. Sales and Marketing Strategy - The company has increased its sales team from 788 to 816 members in 2024, but the cost of sales has surged by 116.92% to 289 million RMB, while gross profit only increased by 16.53% to 1.713 billion RMB [10][11]. - The sales expense ratio reached 47.17%, raising concerns about the sustainability of its commercial expansion strategy as R&D spending decreased by 5.29% to 1.188 billion RMB [11][12]. Future Outlook - Despite the current challenges, Kangfang Biopharma's leadership remains optimistic about 2025, anticipating increased sales following the implementation of new insurance pricing for its dual-antibody products [9]. - The company aims to expand its hospital coverage significantly, targeting over 2,000 hospitals by the end of 2025 [9].