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].

Core Viewpoint - The investigation into the use of clinical research anti-cancer drugs by two patients in Chongqing highlights issues related to medical recommendations, drug procurement, and regulatory compliance in the healthcare sector [1][2][3]. Group 1: Patient Cases - Patient Li was diagnosed with cervical cancer in June 2013 and underwent surgery, later receiving treatment at Chongqing University Cancer Hospital, where she was recommended to use the drug Cadonilimab starting April 17, 2024 [2]. - Patient Tang was diagnosed with cervical cancer in June 2017 and was also recommended to use Cadonilimab after a recurrence in January 2024, starting her treatment on January 30, 2024 [2][4]. Group 2: Medical Professional Conduct - The investigation revealed that the doctor, referred to as Li, recommended Cadonilimab to both patients, despite the initial recommendation for a different drug, Pembrolizumab, citing cost and effectiveness [4][5]. - Doctor Li admitted to discussing potential risks associated with Cadonilimab, which has a reported incidence of immune-related pneumonia at 1.7% [3][4]. Group 3: Drug Procurement and Usage - Cadonilimab was approved for sale on June 28, 2022, with a market price of 13,220 yuan per unit, and patients could obtain it through various means, including self-purchase and charity programs [6][7]. - Both patients acquired a total of 70 and 90 units of Cadonilimab, respectively, through a combination of self-purchase, charity donations, and clinical research supplies [6][7]. Group 4: Regulatory and Compliance Issues - The investigation found that the clinical research drugs obtained by the patients were improperly sourced, with evidence of forged documents used to acquire these drugs from pharmacies [8][9]. - The pharmacies involved were penalized for non-compliance with drug management regulations, highlighting systemic issues in the oversight of drug distribution [9]. Group 5: Quality and Safety of the Drug - The investigation confirmed that the Cadonilimab used by the patients was produced according to national standards and did not exhibit quality issues, despite being labeled for clinical research use [10][11]. Group 6: Institutional Response - Following the investigation, health authorities initiated a comprehensive review of medical practices and regulatory compliance to prevent similar incidents in the future, emphasizing the need for improved oversight in clinical research and drug management [12].

Core Viewpoint - The investigation into the use of clinical research anti-cancer drugs by two patients in Chongqing has revealed significant issues regarding the recommendation and procurement of these medications, highlighting potential violations of medical ethics and regulations [1][5]. Group 1: Patient Cases - Patient Li was diagnosed with cervical cancer in June 2013 and underwent surgery, later receiving treatment at Chongqing University Cancer Hospital, where she was recommended to use the drug Cadonilimab after a positive PD-L1 test in August 2023 [2]. - Patient Tang was diagnosed with cervical cancer in June 2017 and, after a recurrence, was recommended to use Cadonilimab instead of the initially suggested Pembrolizumab due to cost considerations [2][4]. Group 2: Medical Professional Conduct - The investigation found that the doctor involved, referred to as Li, recommended Cadonilimab to both patients, which is within the scope of normal medical practice according to clinical guidelines [5]. - However, the doctor violated local regulations by recommending a sales representative to the patients, leading to disciplinary actions including warnings and suspension of prescription rights [5]. Group 3: Drug Procurement and Usage - Cadonilimab was approved for market sale on June 28, 2022, with a price of 13,220 yuan per unit, and patients could obtain it through various means, including self-purchase and charity programs [6][7]. - Both patients acquired a total of 70 and 90 units of the drug respectively, with a significant portion obtained through clinical research channels, raising concerns about the legitimacy of these sources [7]. Group 4: Clinical Research Drug Sources - The investigation revealed that the clinical research drugs obtained by the patients were marked as "for clinical research use" and were not part of any approved clinical trials at the hospitals involved [8][10]. - Sales personnel from the drug company were found to have forged documents to obtain these drugs, leading to regulatory scrutiny and potential legal consequences [8][9]. Group 5: Quality and Compliance of Drugs - The drugs used by the patients were confirmed to meet national quality standards, despite being labeled for clinical research, indicating compliance with production regulations [10][11]. - The investigation prompted a review of the management of clinical research drugs and the implementation of stricter regulations to prevent future violations [12].

Core Viewpoint - The article discusses the investigation into the use of clinical research anti-cancer drugs by two patients in Chongqing, highlighting the actions taken by health authorities and the implications for medical practices and drug distribution in the region [1]. Group 1: Basic Situation - Patient Li was diagnosed with cervical cancer in June 2013 and underwent surgery, later receiving treatment at Chongqing University Cancer Hospital. In August 2023, her condition relapsed, leading to the recommendation of the drug Cadonilimab by her doctor [2]. - Patient Tang was diagnosed with cervical cancer in June 2017 and also underwent surgery. In January 2024, she was recommended to use Cadonilimab after her condition relapsed [2]. Group 2: Investigation and Handling - The investigation revealed that the doctor recommended Cadonilimab to both patients, which was a legitimate treatment option according to clinical guidelines. However, the doctor also violated ethical guidelines by recommending a sales representative to the patients [3][5]. - The investigation found that the doctor had informed the patients about potential risks associated with the drug, which has a 1.7% incidence of immune-related pneumonia [4][5]. Group 3: Drug Acquisition - Cadonilimab was approved for sale in June 2022 at a price of 13,220 yuan per unit. Patients could obtain it through self-purchase, charity programs, or clinical trials. Both patients acquired the drug through a combination of self-purchase and free clinical research supplies [6][7]. - The drug was included in the national medical insurance directory as of January 2025, reducing the out-of-pocket cost for patients to between 300 and 1,000 yuan per unit [7]. Group 4: Clinical Research Drug Sources - The investigation revealed that the clinical research drugs obtained by the patients were improperly sourced, with evidence of forgery by sales personnel from the drug company to acquire these drugs [8]. - The pharmacies involved were found to be in violation of drug management regulations by storing and distributing clinical research drugs without proper authorization [9]. Group 5: Drug Quality Verification - The drugs used by the patients were confirmed to be produced according to national standards, and no quality issues were found with the Cadonilimab they received [10]. Group 6: Investigation of Clinics - The clinic where the patients received treatment was found to have engaged in improper practices, including the use of forged prescriptions. The clinic faced penalties and was ordered to rectify its practices [11]. - Following the incident, health authorities initiated a comprehensive review of medical quality and ethical standards to prevent similar occurrences in the future [11].