JW Pharmaceutical's 'Ertapenem' Enters US Market... First Korean Carbapenem Antibiotic

Preparing for Expansion to Canada and Others... Expecting Over $10 Million Annual Raw Material Exports

Ertapenem (Photo by JW Jungwoo Pharmaceutical)

[Asia Economy Reporter Kim Ji-hee] JW Pharmaceutical announced on the 9th that the finished product of the antibiotic raw material Ertapenem, developed using its own technology, has been launched in the U.S. market. This is the first time that a finished product made from a domestically produced carbapenem antibiotic raw material is being sold in the world's largest market, the United States.

JW Pharmaceutical's holding company, JW Holdings, signed an export contract for Ertapenem raw materials with India's Grand Pharma in 2017. Since then, it has obtained cGMP certification for the penem-class antibiotic dedicated facility at its Siheung plant from the U.S. Food and Drug Administration (FDA) and received DMF approval for Ertapenem raw materials. Grand Pharma produced the finished product using Ertapenem raw materials manufactured at JW Pharmaceutical's Siheung plant and obtained marketing approval from the U.S. FDA in March. Dr. Reddy's Laboratories is responsible for sales within the U.S.

Ertapenem, recognized as the next-generation carbapenem antibiotic following penicillin and cephalosporins, is used to treat difficult infections such as skin tissue infections, pneumonia, urinary tract infections, and acute pelvic infections due to its excellent antibacterial activity and efficacy against resistant bacteria. The original drug of Ertapenem is INVANZ by Merck in the U.S.

JW Holdings, responsible for JW Group's global business, secured a stable export route by supplying Ertapenem raw materials to Grand Pharma. Currently, they are preparing to enter other overseas markets including Canada with Grand Pharma, and expect annual exports of Ertapenem raw materials to exceed 10 million USD in the future.

JW Holdings plans to accelerate its global market penetration of carbapenem antibiotics. While actively promoting the global launch of Doripenem, the latest carbapenem developed independently for the first time in Korea, they also plan to expand exports of Imipenem and Meropenem raw materials and finished products, which are already exported to over 40 countries including China and Japan.

Han Sung-kwon, CEO of JW Holdings, said, “Entering the U.S. market with domestically produced raw materials for carbapenem antibiotics, which require advanced synthetic technology, has proven JW's excellent technological capabilities. We will continue to strengthen cooperation with global partners to accelerate market entry of next-generation carbapenems such as Ertapenem and Doripenem.”

Meanwhile, according to global IQVIA, the worldwide carbapenem antibiotic market size exceeded 2 billion USD as of 2020. Among this, Ertapenem accounts for a market size of 410 million USD. In the U.S. market, the total carbapenem antibiotic market is approximately 344 million USD, with Ertapenem at about 213 million USD.

This content was produced with the assistance of AI translation services.