CASI Pharmaceuticals, BioInvent Gain CTA Approval for BI-1206

CASI Pharmaceuticals, Inc., a U.S. Biopharmaceutical company, received approval from the China National Medical Products Administration (NMPA) for the Company's Clinical Trial Application (CTA) for BI-1206, a first-in-class fully human monoclonal Antibody ( MAb ) that targets FcγRIIB.

CASI is planning Phase 1 trials of BI-1206 as a single agent to evaluate the PK /safety profile and in combination with rituximab in NHL (mantle Cell lymphoma, marginal zone lymphoma, and follicular lymphoma) to assess safety and tolerability, select the recommended Phase 2 dose and assess early signs of clinical Efficacy . The studies are expected to start in 1H22.
Wei-Wu He, Ph.D., CASI's Chairman, and Chief Executive Officer, said, "This approval is an important step closer to making BI-1206, a first-in-class molecule, available to patients and healthcare providers across Greater China. Our partner, BioInvent, has shown promising clinical data in Phase 1/2a clinical trial in combination with rituximab (anti-CD20 monoclonal antibody) in patients with indolent relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) and will be presenting an update at ASH 2021. CASI is responsible for conducting the studies in China, and will initiate these important Clinical Trials as soon as possible.
Martin Welschof, CEO of BioInvent commented, "We are very pleased to see the first fruit of our development collaboration with CASI on BI-1206. As BioInvent develops the molecule across Europe and the US, our Asian partnership with CASI adds significant shareholder value to the company. Our expanding pipeline of first-in-class immunotherapies creates multiple development and commercial opportunities for the company and its partners."