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Crovalimab Gets First Nod In China For PNH, Fiercer Global Competition Awaits

 
• By Lisa Takagi

The anti-C5 inhibitor sets an example of swift global trial and approval in China while fiercer competition awaits in the US, Europe and Japan.

Crovalimab received global first approval in China and awaits approval decisions in the US, Europe and Japan.
Crovalimab receives global-first approval in China, awaits approval decisions in US, Europe and Japan • Source: Shutterstock

Roche Holding AG/Chugai Pharmaceutical Co., Ltd.’s subcutaneous anti-C5 antibody crovalimab has received its global-first approval, in China for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in patients 12 years of age and above not been previously treated with complement inhibitors.

Crovalimab (Chinese product name: 派圣凯) will be pitted against competitor Alexion Pharmaceuticals Inc.’s Soliris (eculizumab) which was approved for PNH in China back in 2018

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