On October 19, HEC Group announced on its official WeChat public account that on October 18, the U.S. court officially judged the 405 patent invalid, and the first generic fingolimod Gilenya of Guangdong HEC Pharmaceutical Co., Ltd. was officially approved to be marketed in the United States. Consequently, HEC and its fingolimod generic drug became the first domestically produced drug to challenge the patent of the original drug in the United States and succeed.

It is reported that Guangdong HEC Pharmaceutical Co., Ltd. and Hong Kong-listed are related parties, both belonging to HEC Group. Fingolimod, originally the world's first oral drug for the treatment of adult relapsing multiple sclerosis originally developed by Novartis named as Gilenya, was approved by the FDA on September 21,2010, reaching its peak sales at $3.341 billion in 2018. On July 12, 2019, Novartis' fingolimod was approved by the State Drug Administration for marketing in China.

From Weizhishu

October 21st, 2022