Chugai Pharma's Crovalimab Approved for PNH by China NMPA

Chugai Pharmaceutical Co., Ltd. said. 'Crobalimab,' an anti-C5 monoclonal antibody discovered by Chugai, has been approved by China's National Medical Products Administration (NMPA) as a treatment for adults and adolescents (adolescents or 12 years). Above) If you have PNH that has not been previously treated with supportive measures. Because F. Hoffmann-La Roche Ltd. was responsible for developing crovalimab outside of Japan and Taiwan, the Chinese group Roche filed a legal application. China is the first country in the world to approve crovalimab.

This agreement is based on the results of several studies, including the COMMODORE 3 study, a multicenter, single-arm, phase 3 clinical trial conducted in China, and the COMMODORE 2 study, which is a randomized, open-label, international phase 3 study in the PNH There was no history of adjuvant therapy.

Crovalimab was developed using Chugai's recycled antibody technology. While typical antibodies can only bind to a single antigen, crovalimab is designed to attach to the antigen at any time and can prevent binding even at low doses that can be given under the skin every four weeks. Crobalimab is the second drug approved using Chugai's recycled antibody technology for treating neuromyelitis optica spectrum disorder (NMOSD) after Enspryng.

Crobalimab (gene fusion) is a recycled anti-C5 antibody developed with Chugai's immune technology. Recyclable antibodies are designed to achieve pH-dependent antigen binding, allowing a single antibody molecule to bind to an antigen multiple times, resulting in higher potency than conventional antibodies. Crobalimab is designed to target C5, a key component of the complement system, and is expected to regulate complement activity.