Following the death of a participant in an IMC002 CAR-T cell therapy trial, the communication methods of Guangzhou-based Shenzhen Yimufeng Biotech Co., Ltd. have drawn renewed scrutiny. The passing of the trial subject comes at a critical juncture as the company, which has yet to bring a product to market, prepares for an initial public offering on the Hong Kong Stock Exchange, thrusting it into the public spotlight. In the wake of the incident, however, the firm's approach to external communication has raised further questions, as director Li Jiaxin reportedly told reporters "get lost, stop bothering me" during an interview.
According to accounts from the deceased's wife, surnamed Cheng, her husband, identified as Mr. Zhan (a 49-year-old pseudonym), was diagnosed with gastroesophageal junction adenocarcinoma in March 2025. He subsequently underwent a total gastrectomy and six rounds of chemotherapy at Shanghai Changhai Hospital, with his condition remaining stable throughout the treatment. In early 2026, following a recommendation from his attending physician, Mr. Zhan enrolled in Yimufeng's CAR-T cell clinical trial for the drug candidate IMC002.
Hours after receiving the trial drug infusion, Mr. Zhan suddenly developed bilateral subdural hematoma and cerebral herniation, requiring emergency craniotomy. He remained comatose following surgery and tragically passed away on April 26, 2026, in the intensive care unit of Shanghai Changhai Hospital. Cheng provided reporters with the signed "Main Informed Consent Form," which indicated that approximately 150 volunteers would participate in the study and stated that the research team would make every effort to ensure participant safety and rights throughout the process.
The consent form describes chimeric antigen receptor T-cell (CAR-T) therapy as a novel tumor immunotherapy strategy that selectively targets and specifically kills tumor cells through T lymphocytes in a major histocompatibility complex-independent manner. Under the section on "possible risks and discomforts," the form warns that IMC002 treatment may cause cytokine release syndrome (CRS), noting that previous clinical studies showed CRS grade levels of 1-2, which could be effectively controlled with medication and prompt intervention. The document also lists various potential adverse reactions, including gastritis, acute gastric mucosal injury, gastrointestinal bleeding, hypoalbuminemia, hypokalemia, respiratory failure, peripheral edema, coronary atherosclerosis, immune effector cell-associated hematotoxicity, immune effector cell-associated neurotoxicity syndrome, tumor lysis syndrome, immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome, CAR-T-related coagulation disorders, hypogammaglobulinemia, infections, allergic reactions, and abnormal CAR-T cell proliferation. It states that these risks would be closely monitored through laboratory examinations and physician assessments, with most capable of being effectively controlled or alleviated through timely professional treatment.
Cheng alleged that Yimufeng considers the broad term "CAR-T-related coagulation disorders" to encompass all potential consequences of coagulation abnormalities. She argued that the consent form failed to explicitly disclose the possibility of intracranial hemorrhage, cerebral herniation, or other severe outcomes. "The doctors mainly warned about cytokine storms during our discussions, saying these side effects were manageable. The form never mentioned bilateral subdural hemorrhage, subarachnoid hemorrhage, or brain herniation. Had I known such risks existed, who would have agreed to participate in such a trial?" she stated.
In response, Yimufeng issued a statement saying: "Regarding the incident, our company has cooperated with the hospital ethics committee in conducting relevant assessments in accordance with laws and regulations. We fully understand the family's desire to clarify the cause of the event and respect their right to seek factual answers. Our company will actively cooperate with medical institutions to provide necessary informational support to the family and maintain open communication channels." The company added that responsibility determination should be fairly clarified through legal procedures, and they would fully cooperate with independent investigations and evaluations without prejudgment. Reports from Xiaoxiang Morning Herald indicated that when a reporter contacted the Shanghai Changhai Hospital Ethics Committee on September 3 and identified themselves, a staff member responded dismissively, asking "you're just a reporter?" before stating "we don't know" and hanging up when asked whether they had received Cheng's complaint.
Notably, just before this incident, Yimufeng's chairman Sun Minmin had signed the "Initiative on Regulating Scientific Research Behavior and Upholding Research Ethics." On July 26 of this year, this industry self-discipline initiative, launched by the China Food and Drug Safety Promotion Association's vice president and the Tongxieyi CGT Club, received endorsements from 91 company founders and CEOs in the cell and gene therapy sector as of July 27. The first article of the initiative states that "in any human-involved clinical research or trial, the Helsinki Declaration and relevant ethical standards must be strictly followed, ensuring participants are fully informed, voluntarily participating, with their safety placed as the top priority." According to the official website, Tongxieyi is an industry platform in the innovative drug field positioned as a leading new drug industry community, focusing on industrial forums, closed-door meetings, industry initiatives, and frontier technology discussions.
Yimufeng, founded in 2020, is an innovative cell therapy company focused on discovering, developing, manufacturing, and commercializing CAR-T cell therapies using a "dual-engine" approach that combines extracorporeal and in vivo CAR-T cell therapy for solid tumors, hematological malignancies, and autoimmune diseases. The company submitted a second IPO application to the Hong Kong Stock Exchange on August 18, following an earlier filing that lapsed in February. According to the prospectus, founder Sun Minmin is 40 years old and holds a doctorate in pharmacy from Fudan University. Prior to founding Yimufeng, she served as chief executive assistant and director of drug regulatory affairs and government affairs at Fosun Kite Biotechnology under Fosun Pharma, and earlier worked as a senior manager in drug supervision at Shanghai Henlius Biotech (stock code: 2696) from July 2013 to May 2016.
Director Li Jiaxin, who made the controversial remark to reporters, is 39 years old and holds a doctorate in pharmacology from the Shanghai Institute of Materia Medica, Chinese Academy of Sciences. She has served as a director since November 2025, providing guidance on business strategy and development. Yimufeng has not yet received approval for any commercial product sales, reporting losses of 71.3 million yuan in 2024, 115 million yuan in 2025, and 109 million yuan in the first half of 2026, leading the company to seek listing under Chapter 18A rules as an unprofitable biotech enterprise.
The IMC002 involved in this incident is Yimufeng's core product. According to the prospectus, IMC002 is an autologous CAR-T cell therapy candidate targeting CLDN18.2, a stomach-specific subtype of Claudin-18 highly expressed in gastric and pancreatic cancer cells. Expanding R&D investment in IMC002 is a direct contributor to the company's widening losses, with research and development expenditures of 54.44 million yuan, 77.94 million yuan, and 82.2 million yuan in 2024, 2025, and the first half of 2026 respectively. Notably, R&D spending on IMC002 alone reached 63.11 million yuan in the first half of 2026.
The prospectus reveals that Yimufeng has completed phase I/IIa clinical trials for IMC002 as third-line treatment for advanced gastric cancer in patients who failed standard therapy and as second-line treatment for pancreatic cancer. The company is currently conducting phase III registrational clinical trials in China for IMC002 in treating advanced gastroesophageal junction adenocarcinoma. Yimufeng expects to complete the phase III trial for IMC002 in third-line treatment by 2027 and submit a new drug application to the National Medical Products Administration, and has already filed an investigational new drug application for IMC002 as first-line treatment for pancreatic cancer in June 2026.