Xinhua Pharmaceutical (00719.HK / 000756.SZ) Announces Epinephrine Hydrochloride Injection Passes Generic Consistency Evaluation

Bulletin Express11-27

Shandong Xinhua Pharmaceutical Company Limited recently announced that its Epinephrine Hydrochloride Injection has officially passed the Consistency of Quality and Efficacy Evaluation for Generic Drugs, as approved by the National Medical Products Administration in November 2025. According to the announcement, the company submitted the application materials in February 2024, resulting in final approval in late 2025.

The injection is primarily used to address severe dyspnea caused by bronchospasm, anaphylactic shock, and for prolonging infiltration anesthesia. It also serves as a key rescue medication in cardiopulmonary resuscitation for various causes of cardiac arrest. The product is included as a Category A drug in the 2024 National Drug Catalogue for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance. Company data indicate that the Epinephrine Hydrochloride Injection market in China’s public medical institutions reached approximately RMB 270 million in sales in 2024. Passing the consistency evaluation is viewed in the announcement as beneficial to enhancing the product’s competitiveness, while noting that market conditions may be influenced by policy and procurement changes.

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