Generics
Shanghai Henlius Biotech's HANSIZHUANG receives Chinese regulatory approval
28 March 2022 -

China-based Shanghai Henlius Biotech, Inc. (2696.HK) announced on Friday that the company's first self-developed innovative PD-1 inhibitor HANSIZHUANG (generic name: serplulimab injection) has received approval from Chinese regulator the National Medical Products Administration (NMPA) to treat adult patients with advanced unresectable or metastatic MSI-H (Microsatellite Instability-High) solid tumours that have failed to respond to earlier standard treatments, offering an alternative treatment option for patients.

The product received approval mainly based on a single-arm, multi-centre, pivotal phase II clinical study. The study was conducted on 108 patients, in which 68 patients with MSI-H, confirmed by central laboratory or study sites, were included in the main efficacy analysis population (MEAP).

Zhang Wenjie, Henlius chairman, executive director, and CEO, said, 'I'm very glad to see the first indication of HANSIZHUANG was approved in China. As one of the pioneering PD-1 inhibitors for the 'pan-cancer' treatment of MSI-H solid tumours in China, HANSIZHUANG would give full play to its advantages in clinical practice to enable patients to live longer with more comfortable lives and accelerate the development of tumour immunotherapy. In addition, HANSIZHUANG is the fifth product launched by Henlius as well as a significant milestone in the company's evolution toward Biopharma, which will actively drive Henlius to move forward, and inspire more innovative achievements centred on patient needs.'

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