Workflow
药品临床试验
icon
Search documents
监管部门回应康方生物“临床试验抗癌药流入市场”:正展开调查
Bei Ke Cai Jing· 2025-06-06 04:24
Core Viewpoint - The incident involving a cervical cancer patient purchasing a clinical trial drug from a representative of Kangfang Biopharma raises serious concerns about the distribution and management of clinical trial medications in China [1][2][4]. Company Summary - Kangfang Biopharma's drug, Cardunilumab, was conditionally approved by the National Medical Products Administration in June 2022 for treating recurrent or metastatic cervical cancer after platinum-based chemotherapy failure [3]. - The company stated that the sales personnel had forged research documents to obtain the drug under the guise of clinical research, and the patient was given the drug without charge [4]. - Kangfang Biopharma has committed to cooperating with regulatory authorities in the investigation and ensuring the protection of patient rights [5][8]. Industry Summary - The incident highlights the regulatory challenges in the management of clinical trial drugs, emphasizing the responsibility of drug manufacturers for the safety and efficacy of their products throughout the entire lifecycle [9]. - The ongoing investigation by the Chongqing Drug Administration indicates a proactive approach to addressing potential violations in drug distribution practices [7][8].