Taizhou, Zhejiang, China, December. 2nd, 2021--BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as “BioRay”) announced that the first patient with Primary immunologic thrombocytopenic purpura (ITP) had been dosed in the Phase II Clinical trial of self-developed Zuberitamab (development code: HS006). The study aims to evaluate the safety and efficacy of Zuberitamab (HS006) in subjects with primary persistent or chronic ITP who failed from  prior therapy(ies). The leading entity of the clinical trial is Tongji Medical College, Union Hospital, Huazhong University of Science and Technology and the principal investigator is Prof.Yu Hu.

Zuberitamab (HS006) is a human-mouse chimeric monoclonal antibody that specifically binds to B-lymphocyte antigen CD20 and can kill B cells via ADCC and CDC action. Zuberitamab (HS006) has demonstrated a favorable safety and efficacy profile in B-cell lymphoma in clinical trials. As B cells play an important role in the pathogenesis of autoimmune diseases such as primary immunologic thrombocytopenic purpura (ITP), rheumatoid arthritis (RA), and multiple sclerosis (MS), Zuberitamab (HS006) has the potential to be used in the treatment of autoimmune diseases.

Primary immunologic thrombocytopenic purpura (ITP) is an acquired autoimmune disease characterized by thrombocytopenia. The pathogenesis of ITP is mainly due to the loss of immune tolerance to the patient's platelet membrane antigens. The patient's B cells produce antibodies against different platelet antigens, leading to the formation of antigen-antibody complexes, and resulting in excessive destruction of platelets in the spleen or liver. Meanwhile, thrombopoiesis is impaired. Zuberitamab (HS006) specifically clears B-lymphocytes, thereby reducing autoantibody production and platelet destruction. Zuberitamab (HS006) is expected to bring an alternative treatment optionfor ITP patients and improve their quality of life.

“Zuberitamab (HS006) is a self-developed monoclonal antibody that targets the CD20 protein on the surface of B cells. It can rapidly, thoroughly and durably remove CD20+ B cells, and this effect is reversible after drug withdrawal, ” said by Dr. Haibin Wang, the Chief Medical Officer (CEO) of BioRay, “The Phase III Clinical trial of Zuberitamab (HS006) for primary treatment of diffuse large B-cell lymphoma has completed the observation of the primary endpoint, and the study results confirmed its good safety, tolerability and efficacy, which provides strong support for the subsequent clinical development of ITP. Based on the existing achievements, BioRay will make every effort to promote its clinical research in ITP and other diseases and promote the early launch of this product in China to benefit more patients.”