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China drug regulator cancels registration for 80 medicines

China’s drug regulator has canceled the registration for 80 medicines, including several original brand-name drugs from foreign pharmaceutical giants, sparking concern over patient access to certain treatments, reports Caixin. An announcement by the National Medical Products Administration detailed the withdrawal of 22 products from 17 foreign companies, including Fresenius Kabi, Pfizer Inc., Xian Janssen Pharmaceutical Ltd., Merck Sharp & Dohme (MSD), BioMarin Pharmaceutical Inc., Sanofi, Novartis AG, Biogen Inc., and Bayer AG.

Among the most prominent withdrawals are two original brand-name drugs with no domestic alternatives: BioMarin’s Vimizim, for a rare disease, and Xian Janssen’s Titanoreine, for hemorrhoids. Separately, Sanofi has announced it will pull its cholesterol drug Praluent next year amid fierce competition.

The cancellations highlight the complex pressures facing multinational drugmakers in China. While many of the discontinued products are older drugs with ample generic competition, making their withdrawal a routine business decision, the exit of unique and effective treatments underscores the impact of intense price negotiations, the rapid rise of domestic competitors, and global strategic shifts by pharmaceutical firms.

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