Clinical trial application for HLX97 approved by the National Medical Products Administration

March 6, 2026  Source: drugdu 27

"/On March 5th, Henlius Biotech (02696.HK) issued a voluntary announcement stating that its Investigational New Drug (IND) application for HLX97 (a small molecule inhibitor of KAT6A/B), developed independently, in patients with advanced/metastatic solid tumors, has been approved by the National Medical Products Administration (NMPA). HLX97 is a small molecule inhibitor targeting the lysine acetyltransferase KAT6A/B. Non-clinical studies have shown that it has good anti-tumor efficacy and safety characteristics; currently, there are no similar KAT6A/B small molecule inhibitors approved for marketing globally. This progress marks an important milestone in the company's innovative oncology treatment pipeline, and clinical research will proceed as planned. Given the long development cycle, high investment, and high risk of new drug development, the company cautions that it cannot guarantee the ultimate successful development and commercialization of HLX97, and investors are advised to be aware of the investment risks.


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