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SHANGHAI, April 22, 2021 /PRNewswire/ Shanghai Henlius Biotech, Inc. (2696.HK) announced that the New Drug Application (NDA) of serplulimab injection (HLX10), a novel anti-PD-1 monoclonal antibody (mAb), for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) solid tumors that fail to respond to the standard therapy, has been accepted by the National Medical Products Administration (NMPA) and proposed to be granted priority review. Serplulimab is potentially to be the first anti-PD-1 mAb in MSI-H solid tumors in China. For this indication, patients are screened for specific MSI-H tumor markers, rather than classifying the tumor types, covering a wide range of cancer types. Henlius adopts the Combo+Global development strategy for serplulimab, focusing on indication differentiation and combination therapy, with a total of 10 clinical trials conducted worldwide.
The NDA of the Novel Anti-PD-1 mAb Serplulimab of Henlius Accepted by NMPA and Proposed to be Granted Priority Review
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Medigrow scores big - Sunday Express
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BUSINESS NEWS - A Lesotho-based medicinal cannabis cultivator and manufacturer recently became the first African country able to legally export medical cannabis to the European Union (EU).
MG Health got the nod that their manufacturing processes are now officially aligned with the EU’s Good Manufacturing Practice (GMP) standards.
Fewer than 20 companies worldwide have been able to achieve this, which is a “massive achievement” for Lesotho’s economy, MG Health business development manager Luke van der Next said.
“Having a GMP means we can access global markets. It means MG Health can access and tap into the global supply chain, a significant first for Africa.”