(Beijing, Shanghai, and Boston) , June XX, 2026 — Jacobio Pharma (1167.HK) today announced that its invested company HebeCell Corp. has received clearance from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for its internally developed ProtoNK™ (HC101). Phase I/Ib clinical trial of evaluating Proto NKTM in recurrent or refractory Ewing Sarcoma will be initiated soon in the United States.
HC101 is an allogenic, human embryonic stem cell (hESC)-derived natural killer (NK) cell therapy product developed based on HebeCell’s proprietary pluripotent stem cell (PSC) platform. Unlike existing personalized cell therapies, this technology is designed to enable centralized industrial scale GMP manufacturing and provide a renewable NK cell therapy option for clinical use. The IND clearance marks an important milestone as HebeCell’s core cell therapy platform advances into clinical validation.
Jacobio previously made a strategic investment in HebeCell and has collaborated with the company on the development of next-generation PSC-derived NK cell therapies. HebeCell’s advancement into clinical development underscores the value of Jacobio’s strategy of investing in innovative platforms and frontier technology. Jacobio remains committed to supporting its portfolio companies in accelerating the development and clinical translation of novel therapies that address unmet medical needs.