JW Pharmaceutical’s ertapenem-based antibiotic secures regulatory nod in China

JW Pharmaceutical said a finished injectable formulation using its locally synthesized antibiotic ingredient, ertapenem, has received marketing approval from China’s National Medical Products Administration (NMPA).

The approved product uses ertapenem, an active pharmaceutical ingredient (API) produced at JW’s Sihwa API plant in Korea. The ingredient is exported to India-based partner Gland Pharma, which manufactures the finished injectable form. Gland Pharma and its affiliate Suzhou Erye Pharmaceutical jointly hold regulatory ownership for the product in China.

JW first signed its ertapenem API export agreement with Gland Pharma in 2017. Since then, injectable formulations based on the company’s API have received regulatory approval and have been marketed in the U.S., Canada, and other markets. The latest approval in China represents a significant step forward for the Korean firm’s expansion into broader Asian territories.

Ertapenem belongs to the carbapenem class of antibiotics -- a next-generation category that follows penicillins and cephalosporins.

It is used to treat a wide range of serious bacterial infections, including skin and soft tissue infections, pneumonia, urinary tract infections, and acute pelvic infections.

MSD developed the original brand-name product, Invanz, which is known for its broad-spectrum antimicrobial activity and efficacy against resistant strains.

“Ertapenem is recognized for its strong efficacy in treating intractable infections, and we’re proud that our domestically synthesized API has now secured a position in the highly regulated Chinese market,” a JW Pharmaceutical official said. “This achievement again proves the global competitiveness of Korean-made carbapenem antibiotics, particularly in a field where advanced synthetic expertise is required.”

JW Pharmaceutical has accumulated extensive expertise in the carbapenem segment since the early 1990s. In 2004, the company was the first in the world to develop a generic version of imipenem. It later succeeded in synthesizing other key carbapenem APIs, including meropenem, ertapenem, and doripenem. It became the only pharmaceutical company in Korea to establish a complete production portfolio across the entire carbapenem family.

Its Siwha plant is dedicated to API synthesis, while its Dangjin facility specializes in finished dosage forms. Both sites are key manufacturing hubs for JW’s growing export business.

JW Pharmaceutical plans to ramp up its global antibiotic exports—both APIs and finished products—through JW Holdings, its dedicated global business arm. The company said it will continue to strengthen collaboration with international partners to accelerate the market penetration of next-generation antibiotics, including ertapenem and doripenem, in major global markets.