Immunotech-B Targets 39-Month Timeline for EAL Resubmission in Liver Cancer, Advances ATL Cell Therapy Commercialization
核心洞察
Immunotech-B (搜索) expects to re-submit its new drug application for EAL for prevention of post-operative liver cancer (搜索) recurrence approximately 39 months after initiating the confirmatory clinical trial.
The company is currently in discussions with China's Center for Drug Evaluation (CDE) (搜索) to finalize the confirmatory trial protocol before commencement.
Immunotech-B (搜索)'s second-generation Activated T Lymphocytes (ATL) (搜索) therapy has entered early commercialization, with two patients having completed three ATL infusions to date.
Immunotech-B (搜索) (06978.HK) has provided a regulatory roadmap for its lead cell therapy candidate EAL, announcing that it expects to re-submit a new drug application (NDA) for the prevention of post-operative recurrence of liver cancer (搜索) within approximately 39 months after initiating a confirmatory clinical trial. The company is currently engaged in discussions with China's Center for Drug Evaluation (CDE) (搜索) to finalize the trial protocol, with trial commencement contingent upon reaching agreement with the regulatory body.
The timeline projection is based on the company's past experience navigating the regulatory pathway for EAL, an autologous cell-based immunotherapy. The confirmatory clinical trial represents a critical step toward securing full marketing authorization for the product in liver cancer (搜索), a disease with significant unmet need for effective adjuvant therapies following surgical resection.
ATL Therapy Gains Regulatory Momentum
In parallel with the EAL program, Immunotech-B (搜索) has advanced its next-generation Activated T Lymphocytes (ATL) (搜索) therapy toward commercialization. ATL is manufactured by extracting peripheral blood mononuclear cells from patients and is designed to combine the potent anti-tumor properties of T lymphocytes with the tumor-killing characteristics of Natural Killer (NK) cells that operate independently of Major Histocompatibility Complex (MHC) restriction.
In September 2025, the company obtained conditional approval from the Hainan Lecheng Medical Products Administration to conduct clinical translational application of ATL for the prevention of post-operative recurrence of liver cancer (搜索) at the Boao Lecheng International Medical Tourism Pilot Zone in Hainan. The commercialization process was subsequently initiated in April 2026.
Further expanding its geographic footprint, Immunotech-B (搜索) also received approval in April 2026 for the clinical use of ATL in the Beidaihe Life and Health Industry Innovation Demonstration Zone, with commercialization in that region expected to commence in June 2026.
Early Clinical Experience
The company reported that two patients have received ATL therapy to date, with both completing three ATL infusions. This early clinical experience marks the initial real-world application of the ATL platform, though detailed safety and efficacy data from these cases have not yet been disclosed.
The dual-track development strategy — pursuing formal regulatory approval for EAL through a confirmatory trial while simultaneously commercializing ATL through China's special medical pilot zones — positions Immunotech-B (搜索) to address the liver cancer (搜索) recurrence prevention market through multiple avenues. The Boao Lecheng and Beidaihe zones offer expedited pathways for innovative therapies, allowing patient access while pivotal trial data are being generated.