Benzinga | Dec 10, 2021 07:03AM EST

CASI Pharma, Bioinvent Report Approval Of Co.'s Clinical Trial Application For Study Of BI-1206 In Non-Hodgkins Lymphoma In China

~ NMPA approved BI-1206 CTA a novel anti-Fc?RIIB

~~ Trials Expected to Enroll Patients starting in 1H 2022

ROCKVILLE, Md. and BEIJING, Dec. 10, 2021 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announces that the China National Medical Products Administration (NMPA) has approved the Company's Clinical Trial Application (CTA) for BI-1206, a First-in-class fully human monoclonal antibody ("mAb") that targets Fc?RIIB. 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 as part of its development program for BI-1206 in China. The studies are expected to start in 1H 2022.



Wei-Wu He, Ph.D., CASI's Chairman, and Chief Executive Officer, commented, "We are excited about the approval of BI-1206's CTA application in China. 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. We are excited to be able to accelerate the development of BI-1206 in China and contribute to its global development."

Alexander Zukiwski, M.D., CASI's Chief Medical Officer continued, "With the CTA application submitted on September 29th, 2021, the rapid NMPA review and approval, allows CASI to quickly progress both of the BI-1206 Phase 1 clinical studies in China; and in collaboration with BioInvent, we are looking forward to our participation in the future global clinical development program."

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."