Shandong Xinhua Pharmaceutical Co., Ltd. (00719): Azithromycin tablets passed generic drug consistency evaluation

Zhitong Finance App News, Shandong Xinhua Pharmaceutical Co., Ltd. (00719) issued an announcement. Recently, Shandong Zibo Xinda Pharmaceutical Co., Ltd. (hereinafter referred to as “Xinda Pharmaceutical”), a wholly-owned subsidiary of Shandong Xinhua Pharmaceutical Co., Ltd., received azithromycin tablets (hereinafter referred to as “this product”) “Drug Supplement Application Approval Notice” approved and issued by the State Drug Administration. The product passed the consistent evaluation of the quality and efficacy of generic drugs.

In September 2025, Xinda Pharmaceuticals submitted the consistency evaluation application data for azithromycin tablets to the Drug Evaluation Center (CDE) of the China Drug Administration and was accepted. The “Drug Supplement Application Approval Notice” was obtained in August 2026. The review concluded that after review, this product passed the consistent evaluation of the quality and efficacy of generic drugs.

Azithromycin is a macrolide antimicrobial drug suitable for treating mild to moderate infections caused by designated microbial sensitive strains in the following specific conditions: (1) acute attacks of chronic bronchitis bacterial infections caused by Haemophilus influenzae, Catarrhal, or Streptococcus pneumoniae. (2) Community-acquired pneumonia caused by Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae. (3) Acute otitis media caused by Haemophilus influenzae, Mora catarrhalis, or Streptococcus pneumoniae. (4) Acute bacterial sinusitis caused by Haemophilus influenzae, Catarrh or Streptococcus pneumoniae. (5) Pharyngitis/tonsillitis caused by Streptococcus pyogenes. (6) Simple skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus acutis. (7) Urethritis and cervicitis caused by Chlamydia trachomatis or Neisseria gonorrhoeae. (8) Male genital ulcer disease (chancroid) caused by Haemophilus ducreus.

This product belongs to category A of the “National Catalogue of Drugs for Basic Medical Insurance, Work Injury Insurance and Maternity Insurance (2025)”. According to relevant statistics, sales of azithromycin tablets in public medical institutions in China in 2025 will be approximately RMB 670 million.

Xinda Pharmaceuticals' azithromycin tablets passed the consistent evaluation of generic drug quality and efficacy in August 2026, which is conducive to further improving market competitiveness.