On October 29, 2026, Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. (603707.SH) received an ANDA approval letter (ANDA No.: 216996) from the U.S. Food and Drug Administration (FDA) for its salmon calcitonin injection, officially approving the product for marketing in the U.S. market. This marks another significant step in Jianyou's international expansion of sterile injectable drugs and signifies the continued expansion of the company's product portfolio targeting the high-end markets of Europe and the United States.
What is salmon calcitonin injection ?
Salmon calcitonin is a peptide hormone with an activity approximately 40–50 times stronger than human calcitonin. It inhibits osteoclast activity, reduces bone resorption, and regulates renal excretion of calcium and phosphorus. Its injection is mainly used clinically for:
Symptomatic osteitis deformans (Paget's disease): relieves bone pain and improves bone metabolism disorders;
Hypercalcemia: Used for early intervention in critical hypercalcemia;
Postmenopausal osteoporosis: For postmenopausal women who are not suitable for other treatment options.
As a classic bone metabolism regulating drug, salmon calcitonin injection has long enjoyed stable clinical demand in the US market, and it is also a key area of expertise for Jianyou Pharmaceutical in the sterile injectable market.
From project initiation to approval: The long-term perspective behind a single injection
Since the project's inception, Jianyou Pharmaceutical has invested approximately RMB 49.1951 million in R&D for salmon calcitonin injection, covering the entire process from formulation and process development, quality research, bioequivalence/equivalence studies, and FDA application and review. The successful approval of the ANDA is not only proof that the company's R&D and quality systems are aligned with international standards, but also demonstrates Jianyou's end-to-end delivery capabilities in the field of sterile injectables, from the laboratory to the global market.
Strategic significance: A further step in internationalization
The product is not yet on the market in the United States and will not have a significant impact on the company's operating performance in the short term. However, from the perspective of the product matrix, each ANDA approval reinforces the same thing: continuously enhance the international influence of Jianyou products and enrich the company's international market product line; enhance Jianyou's international market competitiveness and lay the foundation for Jianyou's subsequent commercialization in the US market; and further solidify Jianyou's integrated overseas capabilities of " R&D - application - manufacturing - global sales ".
From a single approval document to the globalization of a single product, Jianyou Pharmaceutical is continuously bringing "Chinese injectable drugs" to the world stage with its solid R&D and quality system. The FDA approval of salmon calcitonin injection is a milestone, but also a new starting point.

Source: https://mp.weixin.qq.com/s?__biz=MzA3MTc0NzUyOQ==&mid=2649549275&idx=1&sn=bd957b86ccde2f1a5767d384f3b325eb&chksm=86018789cbcf9877967ca6260071b532fb49aefd3dbfbd212695b36bfe77580a27bafc061b0c&scene=126&sessionid=0#rd