SHANDONG XINHUA (00719.HK): Azithromycin Tablets Pass Generic Drug Consistency Evaluation

NewTimeSpace News: On 31 August 2026, Shandong Xinhua Pharmaceutical Company Limited (stock code: 00719) disclosed that its wholly-owned subsidiary Shandong Zibo Xinda Pharmaceutical Co., Ltd. has received the Drug Supplementary Application Approval Notice for azithromycin tablets issued by the National Medical Products Administration, with the product passing the consistency evaluation of generic drug quality and therapeutic equivalence. The product has a specification of 0.25g, acceptance number CYHB2550334 ; the application was submitted in September 2025 and approved in August 2026.

According to the announcement, azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by susceptible strains, including acute exacerbation of chronic bronchitis, community-acquired pneumonia, acute otitis media and pharyngitis. The product is a Class A item in the National Reimbursement Drug List (2025), with sales of approximately RMB 670 million in Chinese public medical institutions in 2025.

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