Recently, Salubris announced that its innovative biologic, Xinfutai Plus®(Recombinant Teriparatide for Injection), received approval from the National Medical Products Administration (NMPA) for the treatment of osteoporosis in postmenopausal women at high risk of fracture[1].
Osteoporosis is a systemic bone disease with high prevalence and significant morbidity. It is particularly common in postmenopausal women, characterized by low bone mass and microarchitectural deterioration of bone tissue, leading to increased bone fragility and susceptibility to fractures. According to estimates, there are approximately 90 million osteoporosis patients in China, of whom about 70 million are women[2] .
The primary treatment goal for osteoporosis is to reduce the risk of fractures. Teriparatide helps promote bone formation, increase bone mineral density, and improve bone quality, offering a new therapeutic option for patients at very high risk of fractures, and is recommended by both domestic and international guidelines[2]. Xinfutai Plus®(Recombinant Teriparatide for Injection) is the first once-weekly teriparatide formulation approved in China. It is a powder for injection administered subcutaneously once a week. No other product with the same dosage and regimen is currently marketed in China. Previously, the company already marketed the once-daily Xinfutai Pro® (Teriparatide Injection), which has established strong brand recognition in the bone-forming agent market.
The newly approved once-weekly formulation will further improve patient compliance and offer a new option for completing a full course of bone-forming agent therapy. It will also strengthen the company's portfolio of bone-forming agents, enrich its product pipeline in the osteoporosis treatment field, and enhance its overall competitiveness in chronic disease management, serving a broader patient population.
About Osteoporotic Fracture[2]：
An osteoporotic fracture (also known as a fragility fracture) refers to a fracture that occurs after minimal trauma (equivalent to a fall from standing height or lower). It is a serious consequence of osteoporosis. Common sites of osteoporotic fractures include the vertebrae, distal forearm, hip, proximal humerus, and pelvis, with vertebral fractures being the most frequent. Osteoporotic fractures cause substantial harm and are a leading cause of disability and death in elderly patients. Studies show that within one year after a hip fracture, about 20% of patients may die from various complications, and approximately 50% of patients become disabled with a significantly reduced quality of life.
References：
[1] Shenzhen Salubris Pharmaceuticals Co., Ltd. Announcement regarding the Drug Registration Certificate for Recombinant Teriparatide for Injection (Xinfutai Plus®).
[2] Chinese Society of Osteoporosis and Bone Mineral Research. (2022). Guidelines for the diagnosis and treatment of primary osteoporosis (2022). Chinese Journal of Osteoporosis and Bone Mineral Research, 15(6), 573-611.
Disclaimer：
1. This material is intended solely to provide knowledge about the disease area and increase disease awareness. It is not for promotional purposes.
2. The information contained in this material is for reference only. Please follow the advice or guidance of a physician or other healthcare professional.
|About Salubris
Shenzhen Salubris Pharmaceuticals Co., Ltd., founded in 1998, is an innovation-driven pharmaceutical company listed on the Shenzhen Stock Exchange (stock code: 002294). Operating with an integrated R&D, manufacturing, and sales platform, Salubris is committed to its mission: “To provide outstanding pharmaceutical products for human health.” The company focuses on the CKM (cardiovascular-kidney-metabolic) chronic disease therapeutic area, with a special emphasis on cardiovascular diseases. It has launched several original drugs, including Xinlitan®, Fulitan®, Fulian® and Xinchaotuo® for hypertension; Ennaluo® for renal anemia; and Xinliting® for type 2 diabetes.
Salubris operates five global innovative drug R&D centers and three medical device R&D hubs. It has built innovation platforms covering small molecule chemical drugs, biologics, siRNA and gene-editing therapeutics, and medical devices, all dedicated to addressing unmet clinical needs and improving people’s quality of life.
