Teriflunomide Tablets: China's First Domestic Filing for Multiple Sclerosis Treatment Submitted by Nanjing Haina Pharma and Shengshi Tech

By Dopine

On March 5, the marketing application for the Class 4 generic drug "Teriflunomide Tablets," jointly submitted by NANJING HEALTHNICE PHARMACEUTICAL CO.,LTD and CGeneTech, was accepted by the Center for Drug Evaluation (CDE), making them the first companies in China to submit a marketing application for a generic version of teriflunomide.

Multiple Sclerosis (MS) is a severe, lifelong, progressive, and disabling demyelinating disease of the central nervous system. It predominantly affects young adults aged 20–40 years, with women accounting for approximately two-thirds of cases. MS has been included in China’s First Batch of Rare Diseases Catalogue. Statistics indicate that there are over 20 million MS patients worldwide, while more than 30,000 patients have been diagnosed in China.

In 1996, the National Multiple Sclerosis Society classified multiple sclerosis (MS) into four types based on disease course: relapsing-remitting (RR), secondary progressive (SP), primary progressive (PP), and progressive-relapsing (PR). Among these, the relapsing-remitting type is the most common, accounting for approximately 85% of cases. The remission phase represents a critical period for MS treatment, during which disease-modifying therapies (DMTs) are required to control disease progression. However, according to the “Survival Report of Chinese Patients with Multiple Sclerosis (2018 Edition),” only 10% of MS patients in China receive standard DMT treatment, a rate significantly lower than that in European and American countries (86%).

Teriflunomide, the originator drug developed by Sanofi, is a dihydroorotate dehydrogenase inhibitor with immunomodulatory effects that can suppress experimental allergic encephalomyelitis. It was approved in the United States in September 2012 for the treatment of adult patients with relapsing forms of multiple sclerosis (MS) under the brand name Aubagio. In September 2013, it was approved by the European Medicines Agency (EMA) for the treatment of adult patients with relapsing-remitting MS. In July 2018, it was approved in China for the treatment of relapsing forms of MS under the brand name Aobajie.

Clinical studies have demonstrated that teriflunomide is highly effective in the treatment of multiple sclerosis (MS), not only significantly reducing the annual relapse rate but also lowering the risk of disability progression. Furthermore, teriflunomide offers convenient administration, requiring only once-daily oral dosing. Currently, this medication has been approved in more than 70 countries and regions worldwide, with over 85,000 patients with multiple sclerosis using it.

Since its market launch, teriflunomide has seen a steady year-on-year increase in sales alongside the expansion of its approved indications, generating substantial revenue for Sanofi. According to Sanofi’s 2019 annual financial report, teriflunomide achieved sales of €1.789 billion (approximately $2 billion).

Prior to 2018, the treatment of multiple sclerosis (MS) in China relied almost exclusively on injectable therapies, which significantly limited the eligible patient population and substantially reduced long-term medication adherence. Teriflunomide, with its oral administration advantage, effectively addresses the poor adherence issues associated with previous MS treatments.

Currently, teriflunomide has been included in the “National Reimbursement Drug List for Negotiated Drugs under Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance (2019 Edition).” However, according to the Insight database, a box of Aubagio (14 mg/28 tablets) is priced at RMB 11,787.4, indicating that the treatment cost remains very high. As an oral first-line disease-modifying therapy for multiple sclerosis (MS) in China, teriflunomide enjoys substantial demand due to its favorable efficacy and convenience of administration. There is an urgent need for the emergence of affordable, high-quality domestically produced alternatives.

According to the Insight database, a total of nine companies in China have entered the teriflunomide tablet market. Among them, NANJING HEALTHNICE PHARMACEUTICAL CO.,LTD is making the fastest progress and is currently at the stage of filing for marketing approval. Once approved, it is expected to severely impact the market for the originator drug by leveraging its price advantage.

In addition, six companies have been approved for clinical trials (see the table below), and all six companies are conducting clinical trials under Class 3.1 new drug applications.

Original Title: $2 Billion Blockbuster Drug! Teriflunomide Tablets for Multiple Sclerosis See First Domestic Marketing Application