JW Pharma gains China nod for antibiotic, boosting Asian ambitions

South Korean drugmaker JW Pharmaceutical has received regulatory approval in China for an injectable antibiotic made with its own synthesized active ingredient, marking a strategic expansion into the Asian market.

The company announced that China’s National Medical Products Administration has cleared the ertapenem injection, which is manufactured by India-based partner Gland Pharma using the API produced at JW’s Sihwa facility. Regulatory ownership of the finished product is shared between Gland and its affiliate, Suzhou Erye Pharmaceutical.

The approval builds on JW’s earlier successes in the USA and Canada and reinforces the competitiveness of Korean-made carbapenem antibiotics—a class often reserved for hard-to-treat infections.