Emerge Biotech's Autologous CAR-T Therapy IMC002 Receives FDA Regenerative Medicine Advanced Therapy Designation and Files for Hong Kong IPO
Immunofoco
Developer of Novel Therapeutics for Solid Tumors
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On December 16, 2025, Immunofoco announced that its self-developedIMC002, an autologous CAR-T cell therapy product targeting Claudin18.2 (CLDN18.2)，Granted the "Regenerative Medicine Advanced Therapy" (RMAT) designation by the U.S. Food and Drug Administration (FDA).This designation is based on the FDA's confirmation that IMC002, for the treatment of CLDN18.2-positive, unresectable locally advanced or recurrent/metastatic gastric cancer/gastroesophageal junction cancer in patients who have failed at least two prior lines of systemic therapy, meets the RMAT qualification criteria.
IMC002 is a CAR-T cell therapy product developed based on a highly specific nanobody platform. Its preclinical research data and a clinical case report showing complete pathological remission (pCR) were previously published in the international oncology journal *Molecular Cancer Therapeutics*. The patient, after a single infusion of the drug as monotherapy, has remained tumor-free for nearly three years during follow-up, sustaining a state of complete remission.The Phase I/IIa registered clinical study has been completed in China, and the product has preliminarily demonstrated good safety and efficacy potential.。
Currently,The Phase III confirmatory clinical trial of IMC002 is accelerating in China., more than 30 clinical centers across China have gradually launched, and the enrollment of patients with advanced gastric cancer is accelerating simultaneously. Meanwhile, the global development strategy of this product is also proceeding steadily, having received FDA feedback on the End of Phase I (EOP 1) meeting in March 2025.Timely initiation of key clinical studies in the United States。
RMAT designation was established by the FDA in 2017 under the 21st Century Cures Act, aiming to accelerate the development and review of regenerative medicine therapies (including cell therapies, gene therapies, etc.) for treating, modifying, reversing, or curing serious or life-threatening diseases. Obtaining this designation means that the product meets the criteria of falling within the scope of regenerative medicine, targeting serious diseases, and having preliminary clinical evidence.Can enjoy multiple policy supports, including early close interaction with the FDA, discussions on accelerated approval pathways, rolling review, and priority review qualifications, thereby systematically shortening the product development and market launch cycle.。
Dr. Sun Minmin, Founder, Chairman and CEO of Immunofoco, stated"IMC002 receiving RMAT designation marks a significant milestone in its global development process. This not only represents recognition of the existing research data but also lays the groundwork for our further collaboration with the FDA and accelerates clinical development. We will fully advance and efficiently complete the Phase III confirmatory clinical trial of IMC002 in China, striving to bring this innovative CAR-T therapy originating from China to benefit patients with gastric and pancreatic cancer worldwide as soon as possible."
Source: Immunofoco
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