IMMUNOFOCO-B: Re-files HKEX Listing Application on August 18, Huatai International as Sole Sponsor, Core Product IMC002 in Phase III Registration Trial

NewTimeSpace News: On 18 August 2026, Shenzhen Immunofoco Biotechnology Co., Ltd. re-filed its listing application with the Hong Kong Stock Exchange, with Huatai International acting as sole sponsor. Founded in 2020, the company is an innovative cell therapy company focused on the discovery, development, manufacturing and commercialization of chimeric antigen receptor (CAR) T-cell therapies, employing a "dual-engine" approach encompassing both ex vivo and in vivo CAR-T cell therapies to treat solid tumors, hematological malignancies and autoimmune diseases.

The company's core product, IMC002, is a proprietary anti-Claudin18.2 (CLDN18.2) CAR-T cell therapy candidate positioned as a potential best-in-class therapy. IMC002 is currently undergoing a registration Phase III clinical trial in China for the treatment of advanced gastric/gastroesophageal junction (GC/GEJ) adenocarcinoma. In June 2026, the company submitted an Investigational New Drug (IND) application to the National Medical Products Administration (NMPA) for IMC002 as a first-line treatment for pancreatic cancer as an additional indication.

Beyond IMC002, the company's pipeline includes eight proprietary cell therapy candidates. IMC001 is a potential first-in-class anti-epithelial cell adhesion molecule (EpCAM) CAR-T cell therapy candidate currently in Phase I/IIa clinical development for EpCAM-positive solid tumors. IMV101 and IMV102 are in vivo CAR-T cell therapy candidates that have entered investigator-initiated trials (IIT), targeting hematological malignancies and autoimmune diseases, and hematological malignancies, respectively. IMV103, an in vivo CAR-T cell therapy candidate for solid tumors, has received ethics committee approval to initiate IIT, with IND filing currently expected in the first half of 2027. The pipeline also includes IMV104, a CD19/CD20 dual-specificity in vivo CAR-T cell therapy candidate for B-cell diseases; a "synthetic NKG2D receptor" CAR-T cell therapy for CLDN18.2-positive solid tumors; and two additional CAR-T cell therapy candidates in preclinical development.

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