East China Medicine Submits New Drug Application for Rilonacept Injection; 12 Generic Drug Specifications Pass Consistency Evaluation

On November 9, the National Medical Products Administration (NMPA) released the latest drug approval documents.

This batch includes the approval of supplementary applications for 6 varieties and 12 specifications of drugs., passing the consistency evaluation. Among them,Compound Sodium Acetate Ringer's Injection/Sodium Potassium Magnesium Calcium Glucose Injection from two companies, Chia Tai Tianqing Pharmaceutical and Hengrui Pharmaceutical, passed the evaluation on the same day. Currently, three companies have passed the evaluation.。

The approved varieties are as follows:

November 13,The marketing authorization application for Rilonacept for Injection (ARCALYST), developed by Hangzhou Zhongmei Huadong Pharmaceutical, a wholly-owned subsidiary of Huadong Medicine, has been accepted by the NMPA for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in adults and children aged 12 years and older, including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).。

Source: Huadong Medicine

Currently, the injectable Rilonacept is being co-developed by Sinopharm Huadong and Kiniksa. Sinopharm Huadong holds the exclusive license for this product in 24 Asia-Pacific countries and regions, including China, South Korea, Australia, New Zealand, and India (excluding Japan), encompassing development, registration, and commercialization rights.

To date, Zhongmei Huadong has invested approximately 87 million yuan in the R&D of the injectable Rilonacept project (including 3 indications).

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