June 11, 2025 — JW Pharmaceutical announced today that its latest finished pharmaceutical product, formulated with the company's self-developed and synthesized antibiotic raw material, Ertapenem, has received approval from China's National Medical Products Administration (NMPA).
The product in question is a pre-filled injection produced by JW's Shihwa plant, utilizing Ertapenem raw material supplied to Indian partner Gland Pharma. Gland Pharma has manufactured the final injectable form and holds the joint regulatory approval along with its subsidiary, Suzhou Erye Pharmaceutical, for the Chinese market.
Since signing a contract to export Ertapenem raw material to Gland Pharma in 2017, JW has successfully obtained approvals and sales for Ertapenem-based finished products in major markets such as the United States and Canada. The recent approval marks a significant milestone in expanding the company's presence within Asia.
Ertapenem, a next-generation carbapenem antibiotic in the penicillin and cephalosporin class, is effective against a broad spectrum of bacterial infections, including skin and soft tissue infections, pneumonia, urinary tract infections, and acute pelvic inflammatory disease. Its potent antibacterial effect and effectiveness against resistant strains have established it as a valuable asset in treating difficult infections. The original developer of Ertapenem is Merck & Co., with their product 'Invanz'.
Since the early 1990s, JW has been committed to developing carbapenem-class antibiotics. The company was the first globally to develop a generic version of Imipenem in 2004. Subsequently, JW achieved in-house production of raw materials for Meropenem, Ertapenem, and Doripenem, establishing a comprehensive manufacturing system for the entire carbapenem class domestically. Their specialized facilities in Shihwa for raw material synthesis and in Dangjin for finished products serve as key export hubs.
A JW official stated, “This approval in China, following successful entries into the US and Canada, demonstrates the competitive strength of Korean-produced raw materials in the challenging field of carbapenem antibiotics, reaffirming JW’s technological capabilities in advanced synthesis processes.”
