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Medicine

JW Pharm exports new antibiotic substance to US

Antibiotics made of JW's generic substance shipped to the US for first time

By Jun 10, 2021 (Gmt+09:00)

JW Pharm exports new antibiotic substance to US

JW Pharmaceutical Co. has become the first South Korean drug maker to develop the generic version of a next-generation antibiotic substance, the medications made of which have recently begun shipment to the US.

The new antibiotic medication is based on JW's generic ertapenem, better known as Merck Sharp & Dohme Corp.'s (MSD) Invanz, one of four notable carbapenem antibiotics. 

Invanz belongs to a class of drugs called carbapenems, used to treat bacterial infections of the skin, lungs, stomach, pelvis and urinary tract. Among the four carbapenem antibiotics, ertapenem is emerging as a next-generation medication.

The antibiotics made of JW's generic ertapenem won FDA approval in March of this year. It became the first carbapenem medication made of the substance developed by a South Korean company. 

India's Gland Pharma Ltd. took charge of product manufacturing and packaging, with India-based Dr. Reddy's Laboratories Ltd. responsible for the US distribution. In the long term, JW expects the new substance to rake in over $10 million from exports, compared with the company's 2020 revenue of $490.5 million, according to its statement on June 9. 

The US accounts for more than half of the ertapenem antibiotic market valued at $401 million as of 2020, representing a big chunk of the $2 billion overall carbapenem antibiotics market, according to Global IQVIA, a pharmaceutical research firm.

Carbapenems are regarded as third-generation antibiotic agents, after penicillin and cephalosporins.

JW Pharmaceutical's laboratory
JW Pharmaceutical's laboratory

JW's generic version of ertapenem received the US FDA-enforced cGMP certificate that stands for current Good Manufacturing Practice. The company has also submitted drug master files (DMF) on the antibiotic ingredient to the FDA.

A JW official said that there are only five to six pharmaceutical companies in the world that have GMP-certified facilities.

The patent on MSD's Invanz expired several years ago. But its generic version had not been introduced in South Korea until JW unveiled one. JW is also one of only a few drugmakers to have developed all of the four notable carbapenem antibiotics -- imipenem, meropenem, ertapenem and doripenem -- in the world.

JW entered the carbapenem antibiotic substance market in the early 1990s and in 2004 was the first in the world to roll out generic imipenem. It has recently become the first South Korean company to develop generic doripenem with its own technology. 

Now, it will put its efforts into expanding the market base for the generic ertapenem to Canada, while boosting the shipments of the substance and medications of imipenem and meropenem beyond the current 40 export markets.

Despite the pharmaceutical industry's transition into biomedicines from chemical drugs, JW expects steady demand growth for antibiotics as a common medication to fight bacteria.

Write to Sang-hun Oh at ohyeah@hankyung.com

Yeonhee Kim edited this article.

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