Shandong Xinhua Pharmaceutical Company Limited (Xinhua Pharmaceutical) has obtained a Drug Registration Certificate for Alendronate Sodium Oral Solution from the National Medical Products Administration. The product is classified as a prescription drug for treating osteoporosis, particularly in postmenopausal women to help prevent hip and spinal fractures, and in men to increase bone mass.

Alendronate Sodium Oral Solution is specified as 75ml:70mg (calculated based on C4H13NO7P2). In 2024, alendronate sodium products registered combined sales of nearly RMB 720 million across public hospitals, primary medical institutions, and retail pharmacies in China.

According to the announcement, Xinhua Pharmaceutical entered a technology development agreement in May 2024 with Shandong Langnuo Pharmaceutical Co., Ltd. to secure all rights and benefits to the product’s registration approval documents and related intellectual property upon the full settlement of relevant fees. The subsequent change of applicant was approved, making Xinhua Pharmaceutical the formal marketing license holder of this product. The company states that securing this certificate will further enrich its product portfolio.

The announcement highlights that sales performance may be affected by factors such as policy updates, market conditions, and bidding processes. Xinhua Pharmaceutical advises investors to pay close attention to potential risks and exercise caution.