Baiyunshan Pharmaceutical Division Secures NMPA Approval for Calcitriol Soft Capsules

Stock News
04/01

Baiyunshan (00874) announced that its subsidiary, Baiyunshan Pharmaceutical General Factory, recently received a Drug Supplement Application Approval Notice for Calcitriol Soft Capsules from the National Medical Products Administration (NMPA). Calcitriol Soft Capsules are indicated for: 1) postmenopausal osteoporosis; 2) chronic renal failure, particularly renal osteodystrophy in patients undergoing hemodialysis; 3) postoperative hypoparathyroidism; 4) idiopathic hypoparathyroidism; 5) pseudohypoparathyroidism; 6) vitamin D-dependent rickets; and 7) hypophosphatemic vitamin D-resistant rickets. The original developer of Calcitriol Soft Capsules is Roche Pharmaceuticals, which first obtained approval for marketing in China in October 1992. On February 5, 2026, Baiyunshan Pharmaceutical General Factory submitted an application to the NMPA for a change in the drug marketing authorization holder, which was accepted on March 4, 2026. Major domestic manufacturers and distributors of Calcitriol Soft Capsules currently include Qingdao Guoxin Pharmaceutical Co., Ltd., Henan Taifeng Biotechnology Co., Ltd., and Sichuan Guowei Pharmaceutical Co., Ltd. According to data from Menet, the sales of Calcitriol Soft Capsules in Chinese urban and county-level public hospitals, as well as urban and online pharmacies, reached RMB 483.59 million in 2025. As of the announcement date, Baiyunshan Pharmaceutical General Factory has invested approximately RMB 18.8286 million (unaudited) in the research and development of Calcitriol Soft Capsules. The approval of the Drug Supplement Application Approval Notice for Calcitriol Soft Capsules expands the product portfolio of Baiyunshan Pharmaceutical General Factory and enhances the company's competitive advantage in the endocrine treatment drug market. Baiyunshan Pharmaceutical General Factory will proceed with production in accordance with relevant requirements and market demand.

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