Chongqing reports investigation and verification of two patients using clinical research anticancer drugs

Today (July 13), the Chongqing Health and Drug Administration Joint Investigation Team issued a notice on the investigation and verification of patients’ use of clinical research anticancer drugs. The full text is as follows:

Recently, the use of clinical research anticancer drugs by two patients in Chongqing has aroused social concern. Chongqing Municipal Health Commission, Chongqing Municipal Drug Administration, Shapingba District People’s Government and other units quickly formed a joint investigation team to conduct investigations and verifications through visits and on-site inspections. The relevant situation is now reported as follows.

I. Basic situation

After investigation, the patient Li Moumei was diagnosed with cervical cancer in June 2013 and underwent surgery. Since August 2016, Li Moumei has been receiving follow-up treatment at the Affiliated Tumor Hospital of Chongqing University (hereinafter referred to as the Tumor Hospital), and the attending physician is Li. Since then, the patient Li Moumei has consulted the doctor Li Mou many times about the condition and examination and treatment through telephone, text messages, etc., and Li Mou has given corresponding guidance. In August 2023, the patient Li Moumei’s disease relapsed and metastasized. After a joint consultation by multidisciplinary experts from the Cancer Hospital, it was recommended to perform PD-L1 (programmed cell death-ligand 1) testing, and the result was positive. Doctor Li recommended the use of cardunilimab injection to the patient Li Moumei (the drug was launched in June 2022, hereinafter referred to as cardunilimab). The patient Li Moumei obtained the contact information of Ran Mouyuan, a salesperson of Kangfang Pharmaceutical Co., Ltd. (hereinafter referred to as Kangfang Pharmaceutical), through other personnel, and began to purchase and use the drug outside the hospital on April 17, 2024.

Patient Tang Moulian was diagnosed with cervical cancer in June 2017 and underwent surgery. In January 2024, Tang Moulian was treated in the Cancer Hospital due to dull pain in the right lower abdomen and was diagnosed with postoperative recurrence and metastasis of cervical cancer. After a joint consultation by multidisciplinary experts, it was recommended to perform radiotherapy + chemotherapy + immunotherapy, among which pembrolizumab was recommended for immunotherapy. Patient Tang Moulian chose the relatively cheap cardunilimab recommended by doctor Li, and began to purchase and use the drug outside the hospital on January 30, 2024.

II. Verification and disposal

(I) Verification and disposal of doctor Li’s medical behavior

The joint investigation team questioned patient Li Moumei on site on June 9, 2025, and she said, “After Director Li (doctor Li) recommended cardunilimab, I contacted Ran Mouyuan through a friend and knew that he was making this drug.” On June 20, 2025, Ran Mouyuan was questioned on site, and he said, “Li Moumei added my WeChat through her friend, and we agreed to meet outside the surgical outpatient building of the Cancer Hospital. She consulted me about the effect, price, assistance policy, medication process, and drug side effects of cardunilimab.” After checking the WeChat chat records between Ran Mouyuan and Li Moumei, it was confirmed that Li Moumei contacted Ran Mouyuan through a friend on February 27, 2024, and then contacted Ran Mouyuan on his own to purchase and use the drug outside the hospital.

The joint investigation team questioned patient Tang Moulian on site on June 9, 2025. She said, “When I was hospitalized in Chongqing Cancer Hospital in January 2024, the doctor requested an expert consultation opinion of pembrolizumab, but Director Li (doctor Li) said that cardunili is a dual-target drug, which is more effective than pembrolizumab and cheaper, so he recommended me to use cardunili. On January 29, Director Li recommended me to the pharmaceutical sales Ran Mouyuan. I agreed to meet with Ran Mouyuan. Director Li said that Ran Mouyuan would take the initiative to come to my bed in a while.” On June 10, 2025, after being questioned on site, doctor Li admitted the above situation.

According to the investigation by the joint investigation team, doctor Li reported that when recommending the treatment plan, he verbally informed patient Li Moumei of the possible risks caused by the use of the drug. The instructions for the drug of cardunilimab clearly state that there is “the possibility of causing immune-related pneumonia” and that the proportion of patients with immune-related pneumonia treated with monotherapy is 1.7%. On September 18, 2024, salesperson Ran Mouyuan sent the electronic version of the instructions for use of cadunilizumab to patient Li Moumei via WeChat. From June 1, 2024 to January 21, 2025, patient Li Moumei underwent chest CT or chest X-ray examinations once at the Cancer Hospital and twice at Wushan County People’s Hospital, and no obvious abnormalities were found in the lungs. Until February 2025, patient Li Moumei underwent chest X-ray and chest CT examinations at Wushan County People’s Hospital, indicating the possibility of lung infection and interstitial pneumonia.

According to the “Physician Law of the People’s Republic of China”, physicians can choose reasonable medical, preventive and health care plans in accordance with relevant regulations within the scope of their registered practice. According to the “Guidelines for the Diagnosis and Treatment of Cervical Cancer of the Chinese Society of Clinical Oncology (2023 Edition)”, pembrolizumab and cadunilizumab are both recommended drugs for the treatment of recurrent or metastatic cervical cancer. Doctor Li recommended the treatment plan and the approved cardunilimab to the patient based on the patient’s condition and in combination with the diagnosis and treatment guidelines, which is within the scope of normal diagnosis and treatment activities.

Doctor Li’s recommendation of salesperson Ran to patient Tang Moulian violated the “Implementation Rules for the Nine Guidelines for Honest Practice of Medical Institution Staff in Chongqing (Trial)”. Further investigation found that doctor Li had violated the rules by re-prescribing at the request of patients. In accordance with the “Physician Law”, “Chongqing Medical Institution Staff Code of Conduct” and “Chongqing Medical Staff Bad Practice Score Management Measures (Trial)”, doctor Li was given a warning, interview, and suspension of prescription rights. The Municipal Health Commission interviewed the cancer hospital for problems such as inadequate conduct education and loopholes in prescription management, and ordered it to rectify within a time limit.

Regarding whether doctor Li and salesperson Ran had engaged in interest transfer, commercial bribery, etc., the joint investigation team conducted a preliminary investigation on Li and Ran, and no interest exchanges were found between the two parties. At present, the disciplinary inspection and supervision organs are conducting further investigations and will handle the case in accordance with the law and regulations based on the investigation results.

(II) Investigation on patients’ access to drugs

Cardonilimab was approved for marketing as a Class I innovative drug on June 28, 2022, with a market price of 13,220 yuan per vial. Patients can obtain the drug in compliance with three ways: by purchasing it at a pharmacy at their own expense, applying for charity donations from Kangfang Pharmaceutical’s “Medical Funding Cardonilimab Patient Relief Project” (buy 1 get 1 free, 2 vials or more, 1 year of medication for cumulative purchases of 12 vials), and joining clinical research projects. After investigation, it was found that in order to improve sales performance, Ran Mouyuan promised Li Moumei in February 2024 that if she bought 6 drugs, she could get 1 year of drugs for free. From April 2024 to February 2025, Li Moumei obtained a total of 70 drugs, including 6 commercially available drugs purchased at a price of 13,220 yuan per drug at a pharmacy (a total of 79,320 yuan), 5 charity drugs, and 59 clinical research drugs for free (marked with the words “for clinical research use only”). Tang Moulian obtained drugs in a similar way to Li Moumei. From January 2024 to January 2025, she obtained a total of 90 drugs, including 6 commercially available drugs purchased at a price of 13,220 yuan per drug at a pharmacy (a total of 79,320 yuan), 6 charity drugs, and 78 clinical research drugs for free (marked with the words “for clinical research use only”).

Through national medical insurance negotiations, the drug was included in the national medical insurance drug catalog on January 1, 2025. Depending on the different regional medical insurance reimbursement ratios, the actual cost paid by patients is 300-1000 yuan per bottle. After checking the purchase records, the two patients’ self-paid purchases occurred before the drug was included in the medical insurance drug catalog.

(III) Investigation and disposal of the source channels of clinical research drugs

The clinical research drugs received by the two patients were marked with “Applicant: The Second Affiliated Hospital of Chongqing Medical University” and “Applicant: Chongqing Traditional Chinese Medicine Hospital”. After retrieving the ethics review records of the Second Affiliated Hospital of Chongqing Medical University and Chongqing Traditional Chinese Medicine Hospital, and querying the “National Medical Research Registration and Filing Information System”, the two hospitals did not conduct relevant clinical research on cardunilimab. After investigation, it was found that on May 8 and June 19, 2024, Kangfang Pharmaceutical’s Chongqing sales staff forged the research project documents and hospital ethics approval documents of the above two hospitals, obtained clinical research drugs from the company, and distributed them to three pharmacies including Shapingba Pharmacy of Chongqing Heping New Health Xinte Health Management Chain Co., Ltd., Chongqing Care Direct Urban Garden Pharmacy Co., Ltd., and Xinqiao Store of Sinopharm Holdings Care Direct Chongqing Health Management Co., Ltd. through cold chain, and then received them for free by Li Moumei and Tang Moulian. According to the investigation by the public security organs, Kangfang Pharmaceutical’s sales staff forged seals and forged doctors’ prescriptions. Considering their illegal facts, direct harm and profits, their actions do not constitute a criminal offense. The public security organs have conducted legal education and criticism on the relevant personnel. The clues of Kangfang Pharmaceutical’s clinical research project management problems have been transferred to the drug regulatory authorities in the company’s location for investigation and disposal.

In order to maintain a cooperative relationship with Kangfang Pharmaceutical, the above three pharmacies stored and distributed clinical research drugs for it free of charge, and did not charge patients. However, this behavior does not comply with Article 160 of the “Pharmaceutical Business Quality Management Standards” that “items unrelated to sales activities shall not be placed”. The local Shapingba District Market Supervision Department issued warnings and penalties to the three pharmacies in accordance with Article 126 of the “Pharmaceutical Administration Law of the People’s Republic of China”.

(IV) Verification of the quality of the drugs involved

“Clinical trial drugs” are usually drugs that have not yet been registered and marketed during the research and development process, and the safety and effectiveness of the drugs need to be verified through trials; “clinical research drugs” are usually drugs that have been approved for marketing, and are mainly used to explore and expand the scope of drug indications.

According to the investigation by relevant provinces and cities, cardunilimab was approved for marketing by the National Medical Products Administration on June 28, 2022, and the drug approval number is “National Medicine Standard S20220018”. The drugs used by patients Li Moumei and Tang Moulian, which are marked with the words “for clinical research use only”, are “clinical research drugs” and not “clinical trial drugs” that have not yet been approved for marketing. They are produced in accordance with the drug standards and prescription processes approved by the state, and the production quality management system of the enterprise meets the relevant regulatory requirements. No substandard quality of the above-mentioned drugs has been found.

(V) Investigation and disposal of the clinic involved

After investigation, the two patients received the drugs and went to Liu Moufen Clinic in Shapingba District for infusion. The individual clinic has legal qualifications and can provide infusion services. The prescription based on which the clinic infused the patients was forged by the salesperson Ran Mouyuan. The clinic had medical staff who failed to carefully check the infused drugs and did not write medical documents in a standardized manner. The local Shapingba District Health and Health Administrative Department has filed a case for investigation and ordered immediate rectification. According to Article 47, paragraph (1), item 4 of the “Regulations on the Prevention and Handling of Medical Disputes”, if a medical institution and its medical staff fail to fill in and keep medical records in accordance with the regulations, the health authorities of the people’s governments at or above the county level shall order them to correct the violations, give them a warning, and impose a fine of not less than RMB 10,000 and not more than RMB 50,000. The clinic involved was given a warning and fined RMB 41,000. The doctor involved was given a warning and fined RMB 15,000, and was included in the credit supervision of medical institutions and medical staff.