Johnson & Johnson's (JNJ) immunology drug nipocalimab has won approval in China, the U.S. drugmaker said Thursday, expanding the market for a treatment the company sees as a multi-billion dollar growth driver.
"J&J believes 10 of its new products/pipeline candidates in the Innovative Medicine segment have the potential to deliver peak sales of $5 billion, including... Imaavy (nipocalimab)," according to a recent Zacks Investment Research report.
The approval in China follows nipocalimab's 2025 approval in the U.S. for generalized myasthenia gravis under the brand name Imaavy. The drug, an FcRn blocker, is also under review in the U.S. for warm autoimmune hemolytic anemia and is in late-stage studies for several other immune-mediated conditions, including Sjogren’s disease.
The China approval opens a significant new market for nipocalimab and reinforces J&J's strategy of advancing its pipeline to drive growth. J&J's stock has risen 50.2% over the past year, and the company expects contributions from new products to increase as 2026 progresses.
Johnson & Johnson has touted nipocalimab as having "pipeline-in-a-product" potential due to the sheer number of immune-mediated conditions it is being evaluated for. Beyond the approved and pending applications, the drug is also in mid-stage studies for idiopathic inflammatory myopathy and systemic lupus erythematosus. This broad-based approach is central to J&J's R&D strategy, which saw the company invest over $32 billion in R&D and M&A in 2025.
The company's focus on innovative medicines is already paying off. Its new cancer drugs, including Carvykti and Tecvayli, generated a combined $1.2 billion in sales in the first quarter of 2026, driven by strong market share gains. The addition of nipocalimab to the approved list in a major market like China is expected to further bolster the Innovative Medicine segment's top-line growth.
The approval comes as J&J continues to execute on its strategy of bringing new, high-value therapies to market. The company's shares have outperformed the industry over the past year, rising 50.2% compared to the industry's 21.2% appreciation.
The successful development and approval of new drugs like nipocalimab are critical for J&J to maintain its growth trajectory. The company has stated that it expects a more pronounced impact from new products in 2026 than in 2025. Investors will be closely watching the rollout of nipocalimab in China and the progress of its other late-stage pipeline candidates.
This article is for informational purposes only and does not constitute investment advice.
