Kangchen Pharmaceutical's clinical application for the import of teriparatide similar drugs has been accepted

On December 2, the website of the Center for Drug Evaluation (CDE) of the State Drug Administration of China announced that the clinical trial of overseas production of teriparatide injection submitted by Kangchen Pharmaceuticals was accepted by CDE

On April 21, 2020, Kangchen Pharmaceuticals and Telink Pharmaceuticals reached a cooperation agreement to obtain commercial interests in two orthopaedic drug assets held by the latter, including Migaxi injection and nasal spray (salmon calcitonin), Bonsity injection (teriparatide biosimilar)

Bonsity is a drug developed by Pfenex, which acquired Bonsity’s rights in mainland China, Hong Kong, Singapore, Malaysia and Thailand from Pfenex in 2018

Osteoporosis is a systemic skeletal disease characterized by varying degrees of decreased bone mineral density, altered bone tissue microarchitecture, and decreased bone quality throughout the body, resulting in decreased bone strength and increased risk of fractures under non-gravity trauma

Teriparatide is a 34 amino acid recombinant human parathyroid hormone analog that promotes bone formation and is suitable for the treatment of osteoporosis in postmenopausal women with a high risk of fractures, as well as glucocorticoid-induced continuous treatment.

From the perspective of the market structure, the market share of drugs that promote bone formation and treat osteoporosis represented by teriparatide is gradually increasing, and it has better safety and efficacy than calcium supplements and drugs that inhibit bone resorption.

From the perspective of the domestic market, there are currently only three manufacturers selling teriparatide, namely Eli Lilly, Shanghai Lianhe, and Xinlitai.

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