FOSUN PHARMA (02196.HK): HLX109 cleared for Phase I trial in Australia
- HLX109 is an IL1RAP-targeting monoclonal antibody for generalized pustular psoriasis.
- The Phase I protocol was approved by the ethics committee and filed with Australia's TGA, the drug's first clinical clearance worldwide.
NewTimeSpace News: On 4 November 2026, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (stock code: 02196) published an overseas regulatory announcement under Rule 13.10B, saying its controlling subsidiary Shanghai Henlius Biotech, Inc. and its units won ethics approval and TGA filing for a Phase I trial of HLX109 injection, an IL1RAP-targeting monoclonal antibody for generalized pustular psoriasis, the drug's first clinical trial clearance worldwide.
HLX109 is intended for generalized pustular psoriasis. Cumulative R&D spending reached about RMB 34 million as at September 2026, unaudited. No IL1RAP-targeting monoclonal antibody has been approved for marketing worldwide. HLX109 still needs clinical trials in Australia and local regulatory approval before launch.
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