Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced its Adalimumab Injection and Denosumab Injection have been approved for Phase III clinical studies in Russia, which will be operated and invested by the Russian partner Binnopharm Group. According to Russian regulations, Russian clinical data are required for local marketing in Russia.

The clinical study application approved this time was submitted by Binnopharm Group. The primary objective of the Phase III clinical study approved for adalimumab is to evaluate the efficacy, safety, and immunogenicity of Adalimumab Injection in patients with moderate to severe chronic plaque psoriasis. This study will help accumulate the Phase III head-to-head comparative clinical data in Caucasian patients with psoriasis.

The primary objective of the Phase III clinical study approved for denosumab is to evaluate the efficacy, safety, and immunogenicity of Denosumab Injection in postmenopausal women with osteoporosis. This study will help accumulate the Phase III head-to-head comparative clinical data in Caucasian patients.