On September 1, Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. (Jianyou, 603707.SH) announced that its subsidiary, Emerge Bioscience Pte. Ltd., recently received a letter from the U.S. Food and Drug Administration (FDA) approving an additional manufacturing site for adalimumab injection (40 mg/0.8 mL, single-dose) under BLA No. 761216. The approval authorizes production at the Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. facility.
Adalimumab injection, a biosimilar, was first approved by the U.S. FDA on December 17, 2021. Its indications cover multiple autoimmune diseases including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis, and plaque psoriasis. The approval of the additional Nanjing manufacturing site further strengthens the product's supply chain capabilities, providing more stable supply assurance for the U.S. market.
Jianyou is an integrated pharmaceutical group focusing on R&D, production, and sales, with core business centered on heparin API and formulation supply. It has over 80 formulation products worldwide, covering more than 60 countries and regions, and has grown into one of the major high-end injectable suppliers in the U.S. market. The company has been recognized as a national-level green factory and selected among China's top 100 pharmaceutical industry companies by main business revenue and top 100 chemical drug R&D strength.
In recent years, Jianyou has accelerated its internationalization pace. In addition to adalimumab, the company's subsidiary product insulin aspart injection has also received U.S. FDA approval covering three specifications, further enriching its international product portfolio. This approval of an additional manufacturing site for adalimumab demonstrates that the company's R&D and production capabilities in biosimilars have gained recognition from international regulatory authorities, providing another successful case for domestic biopharmaceutical companies expanding overseas.

Source: Sina Finance / Jianyou Announcement | https://finance.sina.com.cn/jjxw/2026-09-01/doc-iniqihzw1628912.shtml