NewG Lab Pharma Subsidiary Applies for Fast Track of Lung Cancer Treatment Drug... "Expectations for Rapid Commercialization Increase"

[Asia Economy Reporter Jang Hyowon] NewG Lab Pharma's new drug development specialist subsidiary, NewG Lab Therapeutics, announced on the 15th that it has applied for fast-track designation for the non-small cell lung cancer ROS-1 mutation treatment drug "Taletrectinib" to the Ministry of Food and Drug Safety (MFDS), and the review is currently underway.

"Taletrectinib" has received Breakthrough Therapy Designation (BTD) from the U.S. FDA and has been designated as an "orphan drug" by the MFDS in Korea. If Taletrectinib is selected as a fast-track drug by the MFDS, NewG Lab Therapeutics is expected to enjoy various benefits during the commercialization process by linking it with the already designated orphan drug system.

If selected as a fast-track target by the MFDS, the review period for new drug approval applications will be significantly shortened compared to the existing general review period (120 days). NewG Lab Therapeutics plans to promote the rapid commercialization of Taletrectinib through the conditional approval system after completing the domestic Phase 2 clinical trial.

By utilizing the conditional approval system, not only is the submission of numerous data related to safety and efficacy exempted, but post-marketing Phase 3 clinical trials can be conducted or clinical exemption applications can be made, significantly shortening the commercialization timeline of Taletrectinib.

Also, while the reexamination cycle for general drugs is 4 to 6 years, Taletrectinib, designated as an orphan drug, will have an extended reexamination cycle of 10 years, allowing NewG Lab Therapeutics to secure its domestic market position for Taletrectinib for the next 10 years.

The fast-track system, officially introduced by the MFDS in August 2020, is a system designed to prioritize the review of certain drugs to quickly guarantee treatment opportunities for patients. Fast-track targets include ▲treatments for life-threatening or serious diseases ▲preventive or therapeutic agents for infectious disease pandemics such as COVID-19 ▲innovative medical devices and rare medical devices.

A representative of NewG Lab Therapeutics said, "Taletrectinib has shown successful interim results in global Phase 1 and 2 clinical trials," adding, "Especially compared to competing drugs currently on the market, much superior data in terms of safety and efficacy have been confirmed, so we are confident it will be selected as a fast-track target this time."

He continued, "We will promptly complete patient recruitment for clinical trials and finish the ongoing domestic Phase 2 clinical trial in the shortest possible time," adding, "Afterwards, we will focus the company's capabilities on acquiring new drug approval and rapidly commercializing Taletrectinib."

Meanwhile, according to the global pharmaceutical market research firm "Fortune Business Insights," the global lung cancer treatment market is expected to grow from approximately $23.4 billion (27 trillion KRW) in 2020 to $43.7 billion (58 trillion KRW) by 2026, at an average annual growth rate of 13%. The domestic lung cancer treatment market is estimated to be about 300 billion KRW, including first-line treatments.

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