The National Medical Products Administration (NMPA) has approved Eli Lilly and Company’s (NYSE: LLY) Omvoh (mirikizumab), an interleukin-23 p19 antagonist, for the treatment of moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC) in adult patients. The IgG4 monoclonal antibody, first approved in the US in 2023, becomes the first IL-23 p19 inhibitor cleared for both inflammatory bowel disease indications in China, challenging Johnson & Johnson’s Stelara and AbbVie’s Skyrizi in the rapidly expanding biologics market.
Regulatory Milestone
Item
Detail
Company
Eli Lilly and Company (NYSE: LLY)
Agency
NMPA (China)
Asset
Omvoh (mirikizumab) – IL-23 p19 antagonist
Drug Class
IgG4 monoclonal antibody
Approved Indications
Moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC)
Competitive safety vs. anti-TNF and JAK inhibitors
Market Context & Competitive Positioning
Factor
Strategic Analysis
China IBD Market
>1.5 million IBD patients; biologic penetration <15% vs. >50% in US/EU; massive growth runway
IL-23 Class Competition
Stelara (J&J) – IL-12/23 approved for CD/UC; Skyrizi (AbbVie) – IL-23 p19 approved for CD (UC pending)
Differentiation vs. Anti-TNF
IL-23 selectivity avoids TNF-related immunogenicity and secondary loss of response; convenient dosing (every 4-8 weeks)
Eli Lilly China Strategy
Omvoh joins Mounjaro/Zepbound (tirzepatide) and Verzenio (abemaciclib) in high-growth therapeutic franchises; leverages established immunology sales force
Commercial & Reimbursement Outlook
Priority
Execution Plan
Timeline
Launch
Hospital formulary access in tier-1/2 cities; gastroenterology specialist education
Q1-Q2 2026
NRDL Negotiation
National Reimbursement Drug List inclusion for CD/UC
2026-2027
Market Share Capture
Position as first-line biologic in anti-TNF failures and biologic-naïve patients
2026-2028
Combination Strategy
Explore Omvoh + JAK inhibitors or biosimilars in refractory IBD
Investigational
Forward‑Looking Statements This brief contains forward‑looking statements regarding Omvoh commercial launch timelines in China, NRDL pricing and reimbursement outcomes, and competitive dynamics with J&J Stelara and AbbVie Skyrizi. Actual results may differ due to NMPA post-marketing requirements, hospital procurement delays, and physician adoption curves for novel biologics in IBD.-Fineline Info & Tech
By Fineline Cube 