The National Medical Products Administration (NMPA) website has indicated that Israel-based Teva Pharmaceutical Industries’ (NYSE: TEVA) innovative chemical drug Copaxone (glatiramer acetate) has been approved for use as a treatment for multiple sclerosis (MS) in China. This marks the second MS therapy available in China following Bristol-Myers Squibb (BMS, NYSE: BMY)’s Zeposia (ozanimod), which was launched to market in April this year.
Understanding Multiple Sclerosis and Copaxone’s Role
Multiple sclerosis is a chronic inflammatory, demyelinating central nervous system disease characterized by symptoms such as visual impairment, muscle weakness, depression, speech difficulties, severe fatigue, cognitive impairment, and more. Severe cases can lead to activity disorder and disability. Copaxone, a synthetic peptide compound consisting of glutamic acid, lysine, alanine, and tyrosine, has shown in clinical trials to effectively arrest disease progression and lower the average annual recurrence rate.
Copaxone’s Global Presence and Market Entry in China
Copaxone was first approved in the US in 1996, and multiple generics from companies like Mylan, Sandoz, Takeda, and others are already available in the US, EU, Japan, and other markets. Teva filed the drug for marketing approval in China in July 2021. The molecule was included in the first batch of generic drugs encouraged for local development in China in 2019. Despite this encouragement, currently only one domestic company, Tianjin Happy Life Technology Co., Ltd, is believed to have begun generic development of the drug.-Fineline Info & Tech
