康方生物回应“临床研究用药”疑被卖,一涉事医院已启动自查

Core Viewpoint - The incident involving cervical cancer patient Li Moumei raises concerns about the use of a clinical research drug, Cardonilumab, which was allegedly sold to her despite being labeled for clinical research use only [1][4]. Group 1: Company Response - Kangfang Biotech stated that there was no situation where the patient "paid for clinical research drugs" and emphasized that no fees were charged to the patient for the clinical research drug [4][6]. - The company confirmed that the patient purchased six units of Cardonilumab at a price of 13,220 RMB each, totaling 79,320 RMB, and received an invoice from the DTP pharmacy [4][5]. - Kangfang Biotech is conducting an internal investigation and has established a special investigation team to address the incident [4][6]. Group 2: Hospital and Regulatory Response - The Chongqing University Cancer Hospital has initiated an internal review related to the incident and is cooperating with relevant authorities for investigation [2][4]. - The Chongqing Drug Administration has not provided a response regarding the investigation as of the time of reporting [2]. - Both Chongqing Medical University Second Affiliated Hospital and Chongqing Traditional Chinese Medicine Hospital have denied conducting any clinical research related to Cardonilumab [5]. Group 3: Patient's Experience - Li Moumei reported that she was recommended Cardonilumab by a doctor and purchased it from a medical representative, receiving a total of at least 70 units, some of which were labeled for clinical research use only [3][4]. - The patient indicated that the packaging of the drug she received was inconsistent, with some units being properly packaged while others were not [3][4]. Group 4: Compliance and Quality Assurance - Kangfang Biotech asserted that the drugs provided to the patient were produced in compliance with national GMP standards and adhered to strict quality management requirements [6]. - The company expressed its commitment to maintaining patient rights and cooperating with regulatory authorities during the investigation [6].