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On January 23, Humanwell Healthcare Group Co., Ltd. announced that its subsidiaryYichang Humanwell Pharmaceutical Co., Ltd.'s Mycophenolate Sodium Enteric-Coated Tablets Approved for Marketing, which is deemed to have passed the consistency evaluation. Yichang Humanwell Pharmaceutical Co., Ltd. is the marketing authorization holder of this product.
Sodium Mycophenolate is an inosine monophosphate dehydrogenase (IMPDH) inhibitor, used in combination with cyclosporine and corticosteroids for the prophylaxis of acute rejection in adult patients receiving allogeneic renal transplants. Sodium Mycophenolate Enteric-Coated Tablets were developed by Novartis and were first approved for marketing in Switzerland in October 2002. They have now been marketed in multiple countries and regions, including the United States, China, and the European Union.The development of mycophenolate sodium enteric-coated preparations presents certain challenges in terms of formulation process, BE, stability studies, and dissolution.Only Chengdu Shengdi Pharmaceutical and Yichang Humanwell Pharmaceutical Co., Ltd. have been approved among Chinese pharmaceutical companies.Welcome to the group chatFor Communication Only
In March 2021, Chengdu Shengdi Pharmaceutical, a subsidiary of Hengrui Medicine, received approval for the marketing of its Mycophenolate Sodium Enteric-Coated Tablets, which were deemed to have passed the consistency evaluation, making it the first domestically produced generic version of this drug in China. According to Hengrui Medicine's announcement,The total R&D investment in the Mycophenolate Sodium Enteric-coated Tablets project is approximately 27.96 million yuan.Yichang Humanwell Pharmaceutical Co., Ltd. submitted a marketing authorization application for Mycophenolate Sodium Enteric-Coated Tablets to the National Medical Products Administration in June 2022 and received approval in January this year.As of now, the total R&D investment has amounted to approximately 17 million Chinese yuan.Humanwell Healthcare Group Co. Ltd. Announcement Disclosure,In 2022, the sales of mycophenolate sodium enteric-coated tablets in China's urban, county, and township public hospitals amounted to approximately 1.15 billion RMB.According toPharmCube DatabaseDisplay,Currently, there are 10 approved documents for the use of sodium mycophenolate enteric-coated tablets in China., involving 4 companies:Original Research Company Novartis, Indian pharmaceutical company Biocon Pharma Limited、Chengdu Shengdi Pharmaceutical Co., Ltd.AndYichang Humanwell Pharmaceutical Co.,Ltd.。
In addition,Shandong New Era Pharmaceutical Co., Ltd.、Chongqing Shenghuaxi Pharmaceutical Co., Ltd.、Sichuan Kelun PharmaceuticalThe enteric-coated mycophenolate sodium tablets from several pharmaceutical companies, including Humanwell Healthcare, have also been submitted for marketing approval and are currently under review.
