On April 20th, 2022, Salubris announced that Salubris (Suzhou) Pharmaceuticals Co., Ltd. (“Salubris Suzhou”), one of its subsidiaries, has received market approval of Teriparatide Injection (Xinfutai Pro®) from the National Medical Products Administration (NMPA) for osteoporosis treatment.
Teriparatide Injection (Xinfutai Pro®) is derived from the previously approved Recombinant Teriparatide for Injection (Xinfutai®, 2019), with improved user-friendly liquid formulation and auto injector. For women with postmenopausal osteoporosis and subject to high risk of bone fracture, daily administration using an auto injector is more convenient.
Teriparatide is the only medicine approved in China that promotes the formation of new bone tissue. It can effectively improve the bone microstructure, strengthen the bones, and promote the bone healing process to reduce the risk of vertebral and non-vertebral fractures. As an ideal therapeutic agent for the treatment of osteoporosis, it is recommended in guidelines both domestic and overseas.
Commercialization of Teriparatide Injection (Xinfutai Pro®) further enhances Salubris’ pipeline of orthopedic products, lays a foundation for orthopedic therapeutics and provides patients with more treatment options. It is noted that Salubris will continue its effort in biologics development, with nine projects (including five innovative products) currently ongoing, and strategically set mid to long-range development goals by bringing more to develop from its early-phase discovery program. Salubris commits to high-quality products that will meet unmet clinical needs and improve the quality of life for patients.
Osteoporosis is a systematic skeleton disease that results in low bone mass and microstructure degeneration of bone tissue. The bones become brittle and fracture easily. In early stages, osteoporosis often does not cause any noticeable symptoms or problems, and the patients usually do not know they are suffering from the disease until the onset of pains, spinal deformity or bone fracture, when their life quality is compromised.
According to an epidemiological survey of osteoporosis, the first of its kind released by the National Health Commission (NHC), osteoporosis affects 19.2% of the population above 50 years of age in China, and the figure raises to 32.0% for those aged above age 65, where the male and female figures are 10.7% and 51.6% respectively. China has an enormous population with low bone mass who are more likely to develop osteoporosis. Among those above age 50, 46.4% have low bone mass (46.9% for male and 45.9% for female).
In 2021, the National Bureau of Statistics (NBS) published the Communiqué of the Seventh National Population Census, where the Chinese population aged above 60 has surpassed 260 million, and the figure for 65 and older is above 190 million.
About Salubris (Suzhou) Pharmaceuticals Co., Ltd.
Salubris (Suzhou) Pharmaceuticals Co., Ltd. is a wholly-owned subsidiary as well as an important business unit for biologics development of Shenzhen Salubris Pharmaceuticals Co., Ltd. The company consists of business operation units that focus on process development and optimization, prokaryotic production by E. coli fermentation and eukaryotic production by mammal cell cultivation, and final drug product production of multiple presentations (cartridges, prefilled syringes, penicillin vials). The eukaryotic production lines have the state of art production technology, 2000L Flexfactory production platform, which can be used for clinical production and commercial production of extracellular expression products such as CHO cells.