Shanghai Henlius Biotech Receives NMPA Approval for HLX701 Phase 1b/2 Clinical Trial Application

Reuters
2026.01.20 08:58
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Shanghai Henlius Biotech Inc. has received approval from the National Medical Products Administration for its IND application for a phase 1b/2 clinical trial of HLX701, a recombinant human SIRPα-IgG4 Fc fusion protein injection, aimed at treating advanced colorectal cancer. This marks a significant step as no SIRPα-Fc fusion protein targeting CD47 has been approved globally. However, the company cautions that successful development and commercialization of HLX701 is not guaranteed, advising shareholders and potential investors to exercise caution.