Henlius Wins NMPA Nod for First-in-Human Trial of Bispecific ADC HLX48

Shanghai Henlius Biotech, Inc. Class H ( (HK:2696) ) has issued an update.

Shanghai Henlius Biotech has received approval from China’s National Medical Products Administration to begin a phase 1 clinical trial of HLX48, a bispecific antibody-drug conjugate targeting EGFR and c-MET for advanced or metastatic solid tumors. The company has also secured ethics approval and acknowledgement from Australia’s Therapeutic Goods Administration for the same trial, underscoring its push to advance this novel oncology candidate through early-stage development.

HLX48 is designed to bind tumor cells expressing c-MET and EGFR, deliver a cytotoxic payload, block key growth factor pathways and trigger immune-mediated cell killing, aiming for synergistic anti-tumor effects with a favorable safety profile. With no bispecific ADC targeting EGFR and c-MET yet approved globally, Henlius’ program could position the firm at the forefront of this niche, though it cautions investors that successful development and commercialization are not guaranteed and that clinical outcomes remain uncertain.

The most recent analyst rating on (HK:2696) stock is a Buy with a HK$99.78 price target. To see the full list of analyst forecasts on Shanghai Henlius Biotech, Inc. Class H stock, see the HK:2696 Stock Forecast page.

More about Shanghai Henlius Biotech, Inc. Class H

Shanghai Henlius Biotech, Inc. is a China-based biopharmaceutical company focused on developing innovative biologics, including antibody-based therapies. Listed in Hong Kong, it targets oncology indications with a pipeline that includes antibody-drug conjugates and other targeted treatments for solid tumors.

Average Trading Volume: 929,524

Technical Sentiment Signal: Strong Buy

Current Market Cap: HK$38.67B

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