Hutchison China Meditech Ltd. (Chi-Med) has scored the first approval in China of a fully domestically developed anticancer drug, with a nod for Elunate (fruquintinib) from the country's newly renamed National Medical Products Administration of China (NMPA, formerly CFDA).
New Drug Bonanza as Chi-Med, Eisai, Alexion Harvest Big Wins In China
In a busy week for new drug approvals in China, the NMPA hands out nods for anticancers Elunate and Lenvima, rare disease treatment Soliris, and an additional indication for Humira, with Elunate being hailed by developer Chi-Med as the first fully "Made in China" novel oncology drug to receive unconditional approval.
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A new annual report from China's CDE shows a rise in overall product approvals but a fall in the transition rate for conditional to full approvals, possibly signalling more stringent requirements.
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Japan adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.
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