Nanjing King-friend Biochemical Pharmaceutical Co Ltd

Jianyou Co., Ltd. announced that its subsidiary Emerge recently received approval from the US FDA for an additional manufacturing site for its adalimumab injection, permitting production at the Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. facility. The injection is indicated for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, chronic plaque psoriasis, hidradenitis suppurativa, and non-infectious uveitis.

Tonghua Dongbao announced that its Insulin Aspart Injection, co-developed with Nanjing King-Friend Biochemical Pharmaceutical, has officially received marketing approval from the US Food and Drug Administration for improving glycemic control in adult and pediatric patients with diabetes.

Jianyou announced that its wholly-owned subsidiary Emerge received formal approval from the U.S. FDA on July 24, 2026, for the Biologics License Application of Insulin Aspart Injection, indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. To date, cumulative R&D investment in this project is approximately 199.59 million yuan.

Meitheal Pharmaceuticals, Inc., a subsidiary of NKF Pharma, has recently received a manufacturing site transfer approval letter from the U.S. FDA for desmopressin acetate injection, authorizing production at the facility of NKF Pharma. The product comes in strengths of 4 micrograms per milliliter and 40 micrograms per 10 milliliters, with ANDA number 074888. Indications include central diabetes insipidus and hemostatic management in patients with hemophilia A and type I von Willebrand disease. Approximately 4.78 million yuan has been invested in research and development for this project. This approval demonstrates that the company's sterile injectable production lines and quality system comply with U.S. cGMP standards, and is expected to enrich the injectable product portfolio for North American healthcare institutions while improving the overseas self-owned supply chain system.