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CONTACTWe will continue to strengthen innovation-driven development, will vigorously encourage the integration of production and research, strengthen and improve the five domains: new drugs, biological drugs, traditional Chinese medicine, generic drugs and APIs
Shijiazhuang Sihua Pharmaceutical Group’s Two New Products—Potassium Dihydrogen Phosphate Injection and Vortioxetine Hydrobromide Tablets—Have Been Approved
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发布时间：2025-01-20
【概要描述】
As the Spring Festival approaches, encouraging news has emerged: on January 20, two new products developed by Shijiazhuang Sihua Pharmaceutical Group—the Class 3 chemical drug potassium hydrogen phosphate injection (5 mL) and the Class 4 chemical drug vortioxetine hydrobromide tablets (5 mg)—were simultaneously approved, receiving drug production registration approvals from the National Medical Products Administration and being deemed to have passed the consistency evaluation. Notably, the potassium hydrogen phosphate injection was the first of its kind in China to receive approval.
With the Spring Festival just around the corner, good news has arrived: on January 20, two new products developed by Shijiazhuang Sihua Pharmaceutical Group—the Class 3 chemical drug potassium hydrogen phosphate injection (5 mL) and the Class 4 chemical drug vortioxetine hydrobromide tablets (5 mg)—were simultaneously approved, receiving drug production registration approvals from the National Medical Products Administration and being deemed to have passed the consistency evaluation. Notably, the potassium hydrogen phosphate injection was the first of its kind in China to receive approval.
To date, the Group has received approval for five new finished dosage forms since the beginning of this year, bringing the total number of products that have passed evaluation to 153 specifications across 115 varieties.
According to available information, Potassium Dihydrogen Phosphate Injection is an inorganic phosphate supplement. This product is primarily used as a phosphate replacement in total parenteral nutrition, such as in patients undergoing moderate-to-severe surgery or other traumatic injuries who require fasting for more than five days. It may also be employed to treat hypophosphatemia resulting from certain medical conditions. The first approval of this product further enriches the Group’s product pipeline and portfolio, while providing additional therapeutic options for adults and children with hypophosphatemia and for patients receiving parenteral nutrition.
The newly approved vortioxetine hydrobromide tablets (5 mg) are primarily indicated for the treatment of adult depression. Previously, the Group had already secured approval for an integrated API–formulation product: vortioxetine hydrobromide API was approved in December 2023, followed by vortioxetine hydrobromide tablets (10 mg) in January 2024. According to data from MeneNet, sales of this product across China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled RMB 147 million in 2022, RMB 156 million in 2023, and RMB 81.98 million in the first half of 2024. The approval of yet another dosage strength of vortioxetine hydrobromide tablets further expands the Group’s portfolio in the psychiatric therapeutic area, underscoring the competitive advantage of its integrated API–formulation development model.
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