Chong Kun Dang Bio files in China for CU-20101 botulinum toxin

Chong Kun Dang Bio has applied for approval in China for CU-20101, its in-house botulinum toxin formulation, as it pushes into the world's second-largest market for the treatment type. The company said on the 18th that it recently filed a Biologics License Application with the National Medical Products Administration (NMPA, China's drug regulator) and is aiming to launch the product in the second half of next year. In a Phase 3 trial in China involving 554 patients with glabellar lines, CU-20101 showed non-inferior efficacy to Botox, while safety findings were similar and no serious treatment-related adverse events were reported. Repeated dosing also maintained efficacy and safety comparable to a single dose, supporting longer-term use. Chong Kun Dang Bio plans to commercialize the product through Cutia Therapeutics under a 2022 exclusive license agreement covering China and Greater China, using the Hong Kong-listed biotech company's local aesthetic sales and marketing network to expand sales.

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