North China Pharmaceutical subsidiary gets key drug approval for antibiotic

North China Pharmaceutical Co., Ltd. announced today that its wholly-owned subsidiary, Shenzhen Huayao South Pharmaceutical Co., Ltd., has received a drug registration certificate from the National Medical Products Administration for "Imipenem and Cilastatin Sodium for Injection" (1.0g). This certificate, issued in September 2025, allows the subsidiary to produce and market the drug, which has passed quality and efficacy consistency evaluation.

The approved drug, a combination of Imipenem and Cilastatin Sodium, is classified as a Class 4 chemical drug with an 18-month validity. It is indicated for various infections caused by sensitive bacteria, including intra-abdominal, lower respiratory tract, gynecological, septicemia, urinary tract, bone and joint, skin and soft tissue, and endocarditis infections. The total R&D investment for this drug amounted to CNY 5.2243 million.

This approval strengthens North China Pharmaceutical's product portfolio in the anti-infective segment and grants basic eligibility for centralized procurement tenders. The domestic market for Imipenem and Cilastatin Sodium for Injection saw strong growth in recent years, with sales reaching CNY 2.3 billion and approximately 20 million units sold in 2024. However, the company cautioned investors about potential risks due to policy changes and market uncertainties in the pharmaceutical industry.