CUTIA-B (02487.HK): BLA for CU-20101 botulinum toxin type A for injection accepted by NMPA

NewTimeSpace News: On 3 September 2026, Cutia Therapeutics (stock code: 02487) announced that the biologics licence application (BLA) for CU-20101 (botulinum toxin type A for injection) developed by the Group has been accepted by the National Medical Products Administration (NMPA), for the indication of improving moderate to severe glabellar lines.

According to the announcement, CU-20101 will not use animal-derived materials or human serum albumin in its manufacturing process, thereby eliminating the risks of transmissible spongiform encephalopathy (TSE) infection and related allergic reactions, and is expected to have a favourable safety profile. CU-20101 will further enrich the Group's dermatology product matrix and facilitate synergies with the Group's existing products; given the broad demand in the skin treatment market, a diversified product portfolio is expected to help the Group capture a larger market share.

The Company noted that it cannot ensure that CU-20101 will ultimately be successfully developed and sold.

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