Bristol Myers Squibb Submits NDA for S1P Receptor Modulator Ozanimod in China Targeting Crohn's Disease

On July 30, the marketing authorization application for Bristol-Myers Squibb's new drug ozanimod capsules in China was accepted by the NMPA.

Ozanimod is a sphingosine-1-phosphate (S1P) receptor modulator that selectively binds with high affinity to S1P receptor subtypes 1 (S1P1) and 5 (S1P5), preventing lymphocyte egress from lymph nodes, reducing peripheral blood lymphocyte counts, and thereby exerting anti-inflammatory effects.

This product was first approved by the FDA for marketing in March 2020 for the treatment of relapsing forms of multiple sclerosis (RMS) in adults, including clinically isolated syndrome, relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS). It was approved by the FDA in May this year for the treatment of moderately to severely active ulcerative colitis (UC). Based on the clinical trials conducted by Bristol-Myers Squibb in China, the indication for this submission is likely for the treatment of Crohn's disease.

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In September 2010, Novartis launched fingolimod capsules (an S1PR modulator), the world’s first oral drug for the treatment of multiple sclerosis (MS), transforming the clinical management of the disease. In 2019, Novartis introduced the second S1PR modulator, siponimod tablets, which became the first therapy approved for patients with relapsing multiple sclerosis with disease progression. Currently, both drugs are approved exclusively for MS. As the third S1PR modulator to reach the global market, Bristol-Myers Squibb’s ozanimod not only aims to capture a share of the MS market but also leads Novartis in the treatment of ulcerative colitis and Crohn’s disease. According to financial reports, the first-half sales for fingolimod (Gilenya), siponimod (Mayzent), and ozanimod (Zeposia) were $1.428 billion, $124 million, and $46 million, respectively.