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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Also, Osmotica licenses rights to ophthalmic drug in Japan, China and the EMEA nations to Santen; Lilly and Chi-Med revise their partnership around colorectal cancer drug Elunate.
Chi-Med has applied to list in Hong Kong and will undertake a new global share offering as it looks to raise new funds to support the progress and commercialization of its growing pipeline.
Despite multiple adverse factors including a leadership shakeup and the departure of its top regulator, the China FDA seemed determined to refresh itself after a name change and to speed up new drugs to market.