[Click eStock] "NewGeneLab Pharma, Smooth Progress in Global Clinical Trials"

[Asia Economy Reporter Hyungsoo Park] Kiwoom Securities analyzed on the 5th that NewgLab Pharma is expected to recruit patients for the Phase 1/2a trial of the metabolic anticancer agent ‘KAT-101’ and obtain initial data within this year. They also added that attention should be paid to the acquisition of global Phase 2 interim data for the targeted therapy ‘Taletrectinib’ and the announcement of domestic interim data within this year. No investment opinion or target price was provided.

Kiwoom Securities researcher Hyemin Heo introduced, "NewgLab Pharma’s KAT-101 is a 4th generation anticancer agent, a metabolic anticancer drug," and "it is targeting liver cancer as the first indication."

He continued, "It received Phase 1/2a approval from the U.S. Food and Drug Administration (FDA) in August last year and from the Ministry of Food and Drug Safety in April this year, and is currently undergoing IRB review approval," adding, "Patient recruitment is expected to be possible within August."

Researcher Heo analyzed, "KAT-101 has verified safety and efficacy," and "it has been designated as an FDA orphan drug for liver cancer and melanoma, making early commercialization possible through conditional approval after Phase 2."

He added, "By adopting an open-label clinical trial, data can be checked every 8 weeks, which has the advantage of potentially enabling early license-out (L/O) through meaningful data announcements even during the clinical trial."

He explained, "As for another pipeline, the targeted anticancer drug Taletrectinib, for which domestic rights were acquired from the U.S. company AnHeart in 2020, is currently undergoing a domestic Phase 2 clinical trial," and "in June, approval was obtained to expand the clinical trial to include ROS1-positive lung cancer patients without prior treatment experience, expanding the potential to the domestic standard treatment market worth approximately 50 billion KRW."

Researcher Heo emphasized, "AnHeart is conducting global Phase 2 trials in the U.S. and Japan, and Innovent Bio is conducting them in China," and "interim Phase 2 data from China and Japan were presented at the American Society of Clinical Oncology (ASCO), attracting attention." He explained, "For patients without prior treatment experience, an ORR (objective response rate) of 92.5% and 2 cases of CR (complete remission) were recorded, and for patients who received first-line treatment, an ORR of 50% and an ORR of 91.7% in patients with brain metastases were observed."

He stated, "Considering the indication expansion potential of KAT-101, it holds potential value as a cancer treatment regardless of cancer type," and "it is time to focus on the value of Taletrectinib, which has secured superior data compared to competing drugs."

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