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A Historic Achievement: Korea’s First Direct FDA Approval πŸš€

β€œRipictu,” a bile duct cancer treatment developed by HLB subsidiary Eleva, has received approval from the U.S. FDA, marking the first time in the history of Korea’s pharmaceutical and biotech industry that a new anticancer drug has achieved direct NDA approval.

Group Stocks Soar to Daily Limit Up πŸ“ˆ

Overcoming the setback of a request for supplemental data regarding a new liver cancer drug last July, the stock staged a dramatic comeback, causing not only HLB’s main stock but the entire group’s shares to surge to the daily price limit immediately after the market opened.

The Key Going Forward Is Actual Commercialization πŸ’°

The drug is scheduled for launch in the U.S. in the fourth quarter of this year. Since it targets patients with specific genetic mutations, the expansion of actual prescriptions in the U.S. healthcare market and the generation of revenue will determine the stock’s future trajectory.

Translated with DeepL.com (free version)

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트랜슀크립트
00:00HLB group stocks are surging to their upper limit again.
00:03What huge piece of good news triggered this kind of spike?
00:07On the 6th, HLB Pharmaceutical and HLB Bios to pit the upper limit,
00:12causing the entire group stock to explode by more than 20%
00:15following last week's FDA approval of the bile duct cancer treatment.
00:20This time, the FDA inspection of the finished product plant
00:24for the liver cancer drug RivoCirinib was successfully concluded
00:27without incident, with a voluntary corrective action, VAI.
00:32It's at a stage where corrective actions can be taken internally
00:35without regulatory measures.
00:37So the approval, obstacles disappeared one by one.
00:40Our partner, Elrava, said it would immediately ramp up efforts
00:44to resubmit the new drug approval application,
00:47a first-ever global anti-cancer drug in the history of Korean.
00:51Pharmaceuticals, will it really be able to succeed?
00:54Leave a comment.

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