康方生物临床药物缘何流入市场？重庆药监局：系销售伪造文件套取

Core Viewpoint - The recent investigation into Kangfang Biopharma's clinical research cancer drug has revealed serious misconduct involving the forgery of seals and prescriptions by sales personnel, leading to unauthorized distribution of the drug [1][4][5]. Group 1: Investigation Findings - The Chongqing Drug Administration reported that Kangfang Biopharma's sales personnel engaged in forgery to sell clinical research drugs, prompting police intervention and educational measures for the involved parties [1][5]. - Two patients, Li and Tang, were found to have obtained the drug "Cardunilumab" through unauthorized means, despite it being designated for clinical research only [2][4]. - The drug, approved in June 2022, is priced at 13,220 yuan per unit and is intended for patients with recurrent or metastatic cervical cancer who have failed platinum-based chemotherapy [3]. Group 2: Patient Cases - Patient Li, diagnosed with cervical cancer, began using Cardunilumab in April 2024 after being recommended by her doctor, despite the drug's clinical research status [2][3]. - Patient Tang also received recommendations for Cardunilumab and began using it in January 2024, similarly acquiring it through unauthorized channels [2][3]. Group 3: Regulatory Actions - The investigation revealed that the hospitals involved had not conducted any clinical research on Cardunilumab, and the sales personnel had forged necessary documents to obtain the drug [4][5]. - The regulatory authorities have initiated further investigations into the management of clinical research projects by Kangfang Biopharma and the conduct of the involved medical personnel [5][7].