Kelun Pharma receives approval for biapenem injection

Sichuan Kelun Pharmaceutical (SZSE:002422) announced that its subsidiary, Hunan Kelun Pharmaceutical, has received drug registration approval from the National Medical Products Administration for its chemical drug, Biapenem/Sodium Chloride Injection. Classified as a Category 3 chemical drug, the injection is presented in a powder-liquid dual-chamber bag, an advanced IV product designed to minimize contamination risks and streamline preparation. The powder chamber contains 0.3g of Biapenem (based on C15H18N4O4S), while the liquid chamber contains 100ml of 0.9g sodium chloride. The biapenem powder injection market in China reached CNY220 million in 2024. This approval marks the first dual-chamber bag formulation of biapenem injection in the domestic market. The company has also developed advanced manufacturing systems with 40 core patents in the field.