China NMPA approves Chugai Pharma

China NMPA approves Chugai Pharma’s crovalimab to treat paroxysmal nocturnal haemoglobinuria

Chugai Pharmaceutical Co., Ltd. announced that crovalimab, a humanized complement inhibitor C5 monoclonal antibody discovered by Chugai, was approved by the National Medical Products Administration (NMPA) of People’s Republic of China for treatment of adults and adolescents (12 years of age and above) with PNH not been previously treated with complement inhibitors. As F. Hoffmann-La Roche Ltd. is responsible for the development of crovalimab outside Japan and Taiwan, the regulatory application was filed by a China affiliate of Roche. China is the first country in the world to approve crovalimab.

The approval is based on the results of several studies including COMMODORE 3 study, a multicenter, single-arm, phase III clinical trial conducted in China, and COMMODORE 2 study, a randomised, open-label global phase III study, for PNH without history of complement inhibitor treatment.

Crovalimab has been created using Chugai’s Recycling Antibody technology. While a typical antibody can bind to an antigen only once, crovalimab is engineered to bind to the antigen repeatedly, enabling sustained complement inhibition at a low dose and achieving subcutaneous administration every four weeks. Crovalimab is the second approved drug applying Chugai’s Recycling Antibody technology, following Enspryng for the treatment of neuromyelitis optica spectrum disorder (NMOSD).

Crovalimab (genetical recombination) is an anti-C5 recycling antibody created with Chugai’s Recycling Antibody technology. Recycling antibodies are designed to achieve pH-dependent antigen binding so that a single antibody molecule can bind with the antigen multiple times, enabling a longer efficacy compared with a conventional antibody. Crovalimab is designed to target C5, a key component of the complement system, and is expected to control complement activity. It is also expected to reduce the treatment burden for patients and their caregivers through subcutaneous administration. Since crovalimab binds to complement C5 at a different site from existing antibody drugs, it can be an effective treatment option for patients with a specific C5 gene mutation reported in Asia (appears in approximately 3.2% of Japanese patients with PNH), which causes existing antibody drugs not to bind to C5.

The drug has been filed for approval as a new drug for PNH in Japan, the US, and EU. In addition, clinical trials are ongoing for atypical haemolytic uremic syndrome (aHUS), and Roche is conducting trials for sickle cell disease (SCD) and lupus nephritis overseas.

Paroxysmal nocturnal haemoglobinuria (PNH) is an acquired hematopoietic stem cell disorder characterized by intravascular haemolysis due to complement activation. It is caused by the clonal expansion of hematopoietic stem cells, driven by acquired mutations in the PIG-A gene. While symptoms may vary in each individual, there are typically two types. One is symptoms attributed to the characteristic haemolysis in PNH, such as haemoglobinuria and thrombosis. The other is hematopoietic failures similar to those associated with aplastic anaemia. PNH may cause complications, including chronic kidney disease and pulmonary hypertension.

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