In April, a 49-year-old stomach cancer patient died in the ICU of Shanghai Changhai Hospital. More than a month prior, he had suddenly developed bilateral subdural hematoma and brain herniation on the day he received an infusion of IMC002, an experimental drug developed by Shenzhen Yimufeng Biotechnology Co., Ltd. (hereinafter referred to as "Yimufeng"), and was forced to undergo a craniotomy.
Four months later, on August 18, Yi Mu Feng re-submitted its IPO application just a few days after its prospectus became invalid, with a sense of urgency evident. The core asset supporting this IPO is IMC002, a CLDN18.2-targeting CAR-T therapy that the company claims has the "second-fastest clinical progress globally". Having been established for six years without any products on the market, and having lost nearly 300 million yuan in two and a half years, IMC002 is almost the only capital story for this 18A company.
On September 2, the patient's death accident was exposed by the media, and it quickly went viral online.
Five years ago, CAR-T entered the public eye with the phrase "one injection sells one house"; five years later, the battlefield has shifted from hematological tumors to solid tumors. Earmark Peak wants to be the next breakthrough, but a fatal accident has put its IPO road into a highly risky period.
49-Year-Old Trial Participant Dies from Brain Hernia
In March 2025, a patient identified by the surname Zhan was diagnosed with adenocarcinoma of the gastroesophageal junction and subsequently underwent total gastrectomy and six rounds of chemotherapy at Shanghai Changhai Hospital. According to family members who spoke with Blue Whale News, retroperitoneal lymph node metastasis was detected in September 2025, but subsequent treatment has remained stable overall and the patient's physical condition is good.
At the beginning of 2026, following a recommendation from his attending physician, Zhan Certain joined the IMC002 CAR-T cell clinical trial conducted by Shanghai Changhai Hospital as the research center. IMC002 is an autologous CAR-T cell therapy targeting CLDN18.2, indicated for late-stage gastric cancer and adenocarcinoma of the gastroesophageal junction.
However, just a few hours after being administered the trial drug, Zhou suffered a sudden bilateral subdural hematoma and brain herniation, prompting the hospital to perform emergency craniotomy surgery. Despite over a month of intensive treatment, Zhou ultimately died on April 26, 2026, in the ICU at Shanghai Changhai Hospital.
In terms of the timing of medication, this is a highly sensitive node. A family member, in an interview with the media, raised two core questions: first, the informed consent form for the clinical trial only mentioned "the risk of thrombosis" in general terms, without explicitly informing patients of the "risk of severe cerebral hemorrhage requiring craniotomy," which the family member believes seriously violated the patient's right to informed consent and choice; second, the family member noted that the patient's physical condition was still relatively stable during the chemotherapy phase, but a severe adverse event occurred several hours after the administration of the trial drug, leading them to suspect a link between the two, although this link has not been officially confirmed by the investigation.
After the incident, according to the family's account to the media, Yi Mu Feng and the research team insisted that the patient's cerebral hemorrhage was a side effect of chemotherapy medication and had nothing to do with the trial drug, and were only willing to provide "humanitarian compensation" rather than compensation that acknowledged the drug's responsibility.
Yi Mufeng responded to media inquiries by saying the company has "cooperated with ethical assessments and investigations in accordance with the law." Relevant facts and responsibilities should be clarified fairly through legal procedures, the company will fully cooperate with all parties to conduct investigations and assessments in accordance with the law, and respect the formal conclusions drawn from independent investigations and assessments. The amount of compensation will be based on the premise of whether wrongdoing and responsibility ratios are confirmed through legal procedures, and at that time, corresponding measures will be taken in accordance with the compensation mechanism and the law.
To date, the causal relationship between the fatal incident and the trial drug IMC002 has not been officially concluded by ethics or regulatory authorities.
It is worth noting that the death incident was exposed at a critical time when Yimifeng is rushing for a Hong Kong IPO. On February 13, 2026, the company submitted its listing application to the Hong Kong Stock Exchange for the first time, but the application lapsed on August 13. On August 18, the company resubmitted its application, planning to list under Chapter 18A of the Hong Kong Stock Exchange's rules as an unprofitable biotech company, with Huatai International serving as the sole sponsor.
29 Patient Cases Propel to 'Global Second', 150 Phase III Data is the Litmus Test
IMC002, a drug included in the Occupying Certain Group, is actually a type of medication, but its specific details are unclear.
Immunofoco's prospectus shows IMC002 is an autologous CAR-T cell therapy targeting CLDN18.2, a protein highly expressed in solid tumors including gastric and pancreatic cancer. According to Frost & Sullivan, IMC002 is the world's second-most-advanced CLDN18.2-targeted CAR-T candidate for solid tumors, trailing only the product already approved and commercialized by CARsgen Therapeutics.
On June 22, Kaisai Pharmaceuticals' CT041, with the trade name Kailimei, was approved for marketing by the National Medical Products Administration, becoming the world's first approved CAR-T therapy for solid tumors, and is seen as a historic breakthrough in the industry.
In terms of clinical progress, IMC002 has completed Phase I/IIa clinical trials and was approved by the National Medical Products Administration in August 2025 to proceed with Phase III registrational clinical trials, with a predicted New Drug Application (NDA) submission in 2027. In June 2026, the company also submitted an Investigational New Drug (IND) application to the National Medical Products Administration for IMC002 as a new indication for first-line treatment of pancreatic cancer.
Notably, the early data disclosed in the prospectus is indeed impressive. In the Phase I/IIa clinical trial, as of December 31, 2025, the recommended Phase II dose group achieved an objective response rate (ORR) of 69.2%, a disease control rate (DCR) of 84.6%, a median progression-free survival (mPFS) of 6.9 months, and a median overall survival (mOS) of 18.2 months. These results are markedly superior to apatinib, the standard third-line treatment for gastric cancer in China, which has an ORR of just 2.8%, an mPFS of 2.6 months, and an mOS of 6.5 months.
Additionally, Erimon Pharma disclosed another detail in its prospectus. In the Phase I/IIa clinical trial, one patient achieved complete remission (CR) according to RECIST1.1 standards, with all tumor tissue disappearing 36 weeks after administration of IMC002. As of the follow-up evaluation in January 2026, the patient maintained complete remission for over 70 weeks without receiving any additional anti-tumor treatment.
In second-line treatment for pancreatic cancer, IMC002 also delivered strong results in the RP2D dose cohort, with an ORR of 40%, a DCR of 100%, and a median overall survival of 9.6 months.
However, the impressive data has a limitation - the small sample size, with only 29 subjects enrolled in the I/IIa phase clinical trial of IMC002. It is understood that I/IIa phase clinical trials are essentially exploratory studies, with a highly screened and "homogenized" small group of subjects, strict inclusion criteria (such as ECOG 0-1 score, good organ function, and no active infections), and the exclusion of high-risk populations (such as active central nervous system metastases, severe cardiovascular disease, and high bleeding risk). The safety data observed under such highly controlled conditions can only reflect the performance of the drug in "ideal" patients, and cannot be extrapolated to more diverse patient populations in the real world.
The specific conclusion of the fatal accident is still pending investigation by the authorities. Nevertheless, this is an unpredictable factor that cannot be ignored in terms of whether IMC002 can be approved in the future.
Cracks Appear in 'Lone Bridge' as 80% of Every 10 Yuan in R&D Funds Go to IMC002
For Erimon Pharma, IMC002 is worth far more than just a drug under development.
Under the Hong Kong Stock Exchange's Chapter 18A listing rules, unprofitable biotech companies must have at least one core product that has passed the conceptual stage and has been under continuous research and development for at least 12 months. Yimifeng's prospectus explicitly designates IMC002 as the company's only "core product" that meets the listing rule requirements.
Of the remaining eight candidate products, IMC001 has completed two investigator-initiated trials (IITs) and received dual IND approvals from China and the US in February 2024, but it is still in the early stage of Phase I/IIa; most of the IMV series in vivo CAR-T pipeline are in the IIT or pre-IND/IND filing stage, and are still some distance from pivotal clinical trials. None of them can independently support marketing authorization.
In other words, IMC002 is the "only ticket" for Eucure Biotechnology to go public.
The concentration of research and development investment confirms this judgment. In 2024, 2025, and the first half of 2026, the company's research and development costs were 54.44 million yuan, 77.94 million yuan, and 82.20 million yuan, respectively. Among them, the proportion of IMC002's research and development costs rose from 59.0% to 76.8% - nearly 8 yuan out of every 10 yuan of research and development funds went to IMC002. The prospectus also makes it clear that the largest use of IPO funds is also the clinical advancement and commercialization of IMC002.
This single-plank bridge bears the entirety of Yimifeng's IPO qualifications and survival hopes.
The company's net losses for the first half of 2024, 2025, and 2026 were 71.312 million yuan, 115 million yuan, and 109 million yuan, respectively, with cumulative losses of nearly 300 million yuan over two and a half years. As of June 30, 2026, the company's cash and cash equivalents were approximately 402 million yuan, with 50.4% of financing funds used, and structured deposits totaling approximately 480 million yuan. The company acknowledged that, assuming a future cash consumption rate 2.5 times that of 2025, without conducting an IPO to raise funds, its existing funds would only be sufficient to sustain operations for approximately 21 months.
Yimofeng has also relied on external financing to survive until today. Since its establishment in 2020, Yimofeng has completed six rounds of equity financing, with a total financing amount of approximately 973 million yuan, and its valuation has risen from 50 million yuan to 2.075 billion yuan, an increase of more than 40 times. Investors include Guotou Venture Capital Fund, Weibo Capital, and others.
And investors are willing to continue betting on the clinical value of IMC002.
CAR-T Cell Therapy for Solid Tumors Faces Multiple Commercialization Challenges Amid Safety Concerns
This single-plank bridge has developed cracks, and whether Yimofeng can cross it safely depends on the answer to a crucial question: was this fatal incident a tragic one-off event or a warning signal of systemic safety risks?
In fact, deaths among trial participants in CAR-T clinical trials are not an isolated incident in the industry, as multiple overseas pharmaceutical companies' projects have also encountered serious adverse safety events.
In July 2016, Juno's JCAR015 experienced multiple instances of trial participant brain edema deaths during Phase II trials. The FDA briefly allowed the trial to restart, but subsequent deaths led to the project's ultimate termination in 2017. Companies such as Poseida and Cellectis have also encountered significant safety incidents, with some projects restarting after adjustments. In 2026, Novartis' CAR-T candidate rap-cel (YTB323) for autoimmune diseases was involved in three participant deaths, prompting the company to urgently suspend multiple clinical trials for investigation.
The frequent occurrence of severe adverse events also reflects the ongoing severe clinical safety challenges faced by the CAR-T and other cell gene therapy (CGT) fields. For Yimifeng, determining the causal relationship between the death and IMC002 will be a crucial factor in deciding whether the Phase III clinical trial can continue and whether the NDA timeline can be met.
Furthermore, from the auditing logic of Chapter 18A of the Hong Kong Stock Exchange, the R&D risks of core products and communication records with regulatory agencies are still the key factors in determining the success or failure of an IPO. According to the listing rules, applicants have an obligation to continuously disclose significant information that may affect investors' judgments. If a certain death is recognized as a major safety incident, the company must fully disclose the incident's process, investigation progress, and potential impact on clinical trials in the prospectus.
The deeper question is whether the company can still satisfy the listing threshold requiring that its core product remain under active development and have advanced past the concept stage, should IMC002's Phase III trial be suspended or significantly delayed over safety concerns—a scenario that would pose a severe test.
In fact, even if IMC002 is ultimately approved for marketing, Eucure Biotechnology still faces industry-wide challenges in the solid tumor CAR-T field.
The payment dilemma is the most intuitive. Currently, the prices of all domestically approved CAR-T products are close to the million-yuan level, with Fosun Kite's Axicabtagene Ciloleucel priced at 1.2 million yuan per injection, and WuXi AppTec's Tislelizumab priced at 1.29 million yuan per injection. In June this year, Kaisa Pharmaceutical's globally first solid tumor CAR-T product "Kaili Mei" was approved for marketing, with a listed price of 990,000 yuan per person. Although the new version of the commercial health insurance directory has included multiple CAR-T products, the implementation of commercial insurance is slow, and the hospital's access procedures are cumbersome, making it difficult for policy benefits to quickly translate into real sales.
The stubbornly high price tags stem from exorbitant manufacturing costs. Autologous CAR-T therapy follows a personalized production path—collecting the patient's T cells, modifying them ex vivo, expanding them, and reinfusing them—with each batch requiring a two-to-three-week production cycle. Add in hidden barriers such as cold-chain logistics and the hardware and operational qualifications required at medical institutions, and costs are inherently elevated. Even as the therapy expands into solid tumors, this cost structure remains unchanged.
For IMC002, there is another cost - licensing fees. The core VHH nano-antibody of IMC002 is not self-developed, but was exclusively licensed globally from Baoshen Bio and Sanyou Bio in 2022. If the product is successfully launched, the company will also need to pay royalties to the licensor for 10 consecutive years, at a single-digit percentage of the net sales, which will further erode its profit margin.
The capital market's cautious attitude towards solid tumor CAR-T therapy has precedent. After Kexing Biopharm's CT041 was approved, the company's stock price fell for three consecutive trading days, with a cumulative decline of over 26%. If CT041's sales are hindered by pricing and fail to meet expectations, even if IMC002 is approved smoothly, Airmass Bio may still struggle to thrive on its own.
A single-plank bridge bears the weight of a loss-making biotech company's entire listing qualification and survival hopes. Now, the cracks are not just in one place, and the other end of the bridge may not necessarily be solid ground.
Yi Mu Feng's IPO listing on the Hong Kong Stock Exchange, with the stock code IMC002, has garnered significant attention.