China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug HS-10561, a Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of chronic spontaneous urticaria (CSU).
Licensing Agreement
HS-10561 was licensed from fellow Chinese firm Lupeng Pharmaceutical Ltd in August 2023. Under the agreement, Hansoh secured rights to develop, manufacture, and commercialize the drug for all non-oncology indications in China, including Hong Kong, Macau, and Taiwan.
Drug Profile
The small molecule BTK inhibitor is designed to target CSU, a condition characterized by recurrent hives and itching. The NMPA’s approval paves the way for clinical trials in China.-Fineline Info & Tech
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