HLB Group stocks are on the rise. This is interpreted as being influenced by the news that the U.S. Food and Drug Administration (FDA) has recommended the resubmission of the review application for Camrelizumab, an antibody drug from Hansoh Pharmaceutical, which is a combination drug with the liver cancer new drug 'Rivoceranib'.
As of 3:04 PM on the 3rd, HLB is trading at 76,800 KRW, up 29.95% from the previous day. Seven affiliates, including HLB Global, HLB Biosstep, and HLB Life Science, are also showing gains of over 20%.
On the 2nd (local time), HLB announced that during a meeting in the U.S. to resume the approval review of the liver cancer new drug, the FDA expressed a strong recommendation to submit a resubmission application. At this meeting, the FDA delivered an official document (PAL·Post Action) regarding the CMC (Chemistry, Manufacturing, and Controls) issues of Camrelizumab.
The meeting was attended by HLB, Elevate Therapeutics, a subsidiary of HLB, and Hansoh Pharmaceutical. According to HLB, the document included the FDA's position that Hansoh Pharmaceutical has no additional documents to submit related to the Camrelizumab CMC inspection. HLB added that Hansoh Pharmaceutical only needs to submit the Biologics License Application (BLA) to the FDA, reflecting the supplementary CMC materials already submitted twice.
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