CASI Pharmaceuticals, Inc., a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, 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 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 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.”
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing, and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the greater China market leveraging the Company’s China-based regulatory and commercial competencies and its global drug development expertise. The Company’s operations in China are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., which is located in Beijing, China. The Company has built a commercial team of more than 100 hematology oncology sales and marketing specialists based in China.