Hyundai Bio Establishes Rapid Response System for Global Demand of COVID-19 Oral Antiviral... Signs Finished Product Manufacturing Contract with Dongkook Pharmaceutical

(From left) Jin Geun-woo, Head of Research at Hyundai Bio; Kim Taek-seong, Vice President of Hyundai Bio; Park Kwang-sik, President of Hyundai Bio; Song Jun-ho, President of Dongkook Pharmaceutical; Kim Kwang-jong, Vice President of Dongkook Pharmaceutical; Kang Soo-yeon, Executive Director of Dongkook Pharmaceutical. Photo by Hyundai Bio

[Asia Economy Reporter Park Jihwan] Hyundai Bio has swiftly moved to expand its production lines to stably supply its oral COVID-19 treatment to the global market.

Hyundai Bio announced on the 9th that it signed a memorandum of understanding (MOU) with Dongkook Pharmaceutical to produce and supply CP-COV03, an oral antiviral for COVID-19, to promptly and reliably meet global demand if CP-COV03 receives emergency use authorization.

If the government grants emergency use approval for CP-COV03, Hyundai Bio's oral COVID-19 treatment, and global demand surges, Dongkook Pharmaceutical will be able to produce finished products or supply raw materials in consultation with Hyundai Bio and Yooyoung Pharmaceutical, the primary contract manufacturer of CP-COV03. Hyundai Bio signed a contract with Yooyoung Pharmaceutical last year for the contract manufacturing and supply of CP-COV03.

A Hyundai Bio official stated, "Once CP-COV03 receives emergency use approval and is officially launched, a production network capable of promptly responding to both domestic and global demand is necessary," adding, "We signed an agreement with Dongkook Pharmaceutical to expand production lines to ensure stable supply of CP-COV03."

Hyundai Bio aims to apply for emergency use authorization by next month as soon as health authorities approve the Phase 2 clinical trial plan for CP-COV03. They plan to increase the number of patients according to the relevant criteria and conduct integrated Phase 2a and 2b trials.

Building on this agreement, Hyundai Bio will also discuss outsourcing the development of clinical formulations and finished product manufacturing of several anticancer drugs it has developed, including the 'pain-free' anticancer agent Polytaxel, which is currently preparing for global clinical trials, to Dongkook Pharmaceutical.

Hyundai Bio plans to apply for and conduct clinical trials for Polytaxel in pancreatic cancer in Australia and for several other cancers such as breast cancer domestically in the first half of this year. They are developing an oral anticancer drug based on docetaxel, a representative anticancer agent currently used only as an injection, and are conducting preclinical studies. The animal anticancer drug based on Polytaxel is reportedly approaching Phase 3 clinical trials.

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