Recently, Salubris announced the completion of enrollment in the phase 3 trial of the biological drug "recombinant human parathyroid hormone for injection (1-34)[56.5μg]" (project code: SAL056) developed by its subsidiaries, Salubris (Chengdu) Biotech co., Ltd and Salubris (Suzhou) Pharmaceuticals co., Ltd,
SAL056 is intended to treat osteoporosis in postmenopausal women at high risk of fracture. In December 2021, the first patient in the phase 3 trial was enrolled, all patients have been enrolled successfully now.
SAL056 is a lyophilized preparation of teriparatide injected once a week. At present, there is no product with the same specification, usage and dosage on the market in China. After the product listed, it will greatly improve patient compliance and be complementary to Xinfutai Pro® (teriparatide injection, a liquid preparation injected once a day) as well as Xinfutai ® (recombinant teriparatide for injection, a powder injection once a day), therefore further enrich the pipeline in the field of osteoporosis, and better benefit the patients.
Clinical trial related
This is a multicenter, randomized, open, active-drug parallel-controlled phase 3 clinical trial designed to evaluate the efficacy and safety of SAL056 in the treatment of osteoporosis in postmenopausal women at high risk of fracture. The PI (principal investigator) is Professor Zhenlin Zhang from Shanghai Sixth People's Hospital,
Teriparatide is the only bone-promoting anti-bone loosening drug approved in China, which can effectively improve bone microstructure, increase bone strength, promote bone healing, reduce the risk of vertebral and non-vertebral fractures. Teriparatide is one of the ideal drugs for the treatment of osteoporosis. It has been recommended by domestic and foreign guidelines.
Teriparatide, originally developed by Eli Lilly, was approved in the United States in 2002 and in China in 2011. With the increasing aging population, the gradual improvement of the medical insurance system and the residents' affordability, there is a great market potential for osteoporosis drugs in China.