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Registering a drug for market approval in China involves a comprehensive and multi-step process that requires adherence to the country's regulatory requirements.
The notice confirms that SIR-Spheres® Y-90 resin microspheres meet the relevant requirements for drug registration in China. With this confirmation, Sirtex is approved to file a New Drug Application (NDA) in the country.
Sihuan Pharmaceutical Holdings Group Ltd. (HKEX: 0460, "Sihuan Pharmaceutical" or the "Company", together with its subsidiaries, the "Group") is pleased to announce that drug registration approval has been granted by the National Medical Products Adminis