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NKF Receives US FDA Approval for High-Concentration YUSIMRY® Formulation

  • Company News
  • Oct 05, 2026
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Nanjing, China — September 29, 2026 — Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. ("NKF", SHA: 603707) today announced that the U.S. Food and Drug Administration (FDA) has approved a high-concentration formulation of YUSIMRY® (adalimumab-aqvh),marking another milestone in the company's U.S. biologics business.

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The approval, granted as a Prior Approval Supplement under BLA 761216 held by NKF's subsidiary Emerge Bioscience Pte. Ltd., covers 40 mg/0.4 mL and 80 mg/0.8 mL autoinjectors. YUSIMRY is interchangeable with HUMIRA across nine inflammatory indications, including rheumatoid arthritis, Crohn's disease, and ulcerative colitis.

This approval reflects our long-term commitment to the U.S. biologics market and our ability to deliver advanced formulations that meet the needs of American patients.YUSIMRY will be commercialized in the U.S. by Meitheal Pharmaceuticals, NKF's US team.