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On March 31, the official website of NMPA showed that Chengdu Shengdi, a subsidiary of Hengrui Pharmaceuticals, was officially approved for mycophenolate sodium enteric-coated tablets, which became the first domestic imitation of the product.
Mycophenolate sodium is an immunosuppressive agent and is clinically used to improve the compliance of kidney transplant patients receiving immunosuppressive therapy and reduce the loss of graft function due to drug side effects.
The drug was developed by Novartis and is the sodium salt of mycophenolic acid (MPA), and mycophenolate mofetil is its prodrug.
In 2004, mycophenolate sodium was approved by the US FDA for marketing; in 2008, the drug was approved for marketing in China, and it is currently a medical insurance category B product.
According to the Insight database, only the original research company of mycophenolate sodium has been approved for listing in China.
From the Insight database (http://db.
And its competitor, mycophenolate mofetil, currently has 32 companies with various dosage forms including capsules, dispersible tablets, tablets, injections, etc.
