BioRay Pharmaceutical’s Zuberitamab Approved by NMPA for CD20 Positive DLBCL Treatment

BioRay Pharmaceutical Co., Ltd has announced that its drug zuberitamab has been approved by the National Medical Products Administration (NMPA) to treat CD20 positive diffuse large B-cell lymphoma, non-specific (DLBCL, NOS) in adults. The approval is for the use of zuberitamab in combination with standard cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy.

Zuberitamab’s Market Position in China
CD20 monoclonal antibodies (mAbs) such as Roche’s Gazyva (obinutuzumab), Novartis’s Kesimpta (ofatumumab), and Sinocelltech’s ripertamab are commercially available in China. Both Gazyva and Kesimpta are included in the National Reimbursement Drug List (NRDL), making them accessible to a wider patient population. Ripertamab is a modified Category 2 biologic, while zuberitamab stands out as the first home-grown innovative CD20 mAb in China.

Breaking New Ground in CD20 mAb Therapy
The approval of zuberitamab marks a significant milestone for BioRay Pharmaceutical, as it is the first domestically developed innovative CD20 mAb in the country. This development not only expands treatment options for patients with CD20 positive DLBCL but also highlights the progress of China’s biopharmaceutical industry in developing innovative therapies.-Fineline Info & Tech

Fineline Info & Tech