HLB Pharmaceutical and HLB group stocks are all showing strong gains. The news that HLB's liver cancer drug 'LivoCamrel combination therapy' has been listed as a first-line treatment in the 'Hepatocellular Carcinoma Diagnosis/Treatment Guidelines (HCC)' published by the European Society for Medical Oncology (ESMO), the world's most prestigious cancer society, appears to be influencing the stock prices.
The guidelines published by the ESMO liver cancer subcommittee provide extensive information on cancer diagnosis, treatment, and subsequent follow-up management. Along with the National Comprehensive Cancer Network (NCCN) guidelines, they are representative manuals applied by many specialists worldwide in patient treatment. It is quite unusual for a drug that has not yet received new drug approval to be recommended for prescription to physicians in the field.
As of 9:56 AM on the 27th, HLB Pharmaceutical is trading at 31,600 KRW, up 17.47% from the previous day. HLB is also up more than 10%.
The U.S. Food and Drug Administration (FDA) decision date for new drug approval of the LivoCamrel combination therapy is less than a month away. HCC guidelines strongly recommend LivoCamrel as a prescription drug.
The journal, revised for the first time in three years since 2022, introduced the 'Livoseranib + Camrelizumab combination therapy' as the first combination of a newly developed angiogenesis inhibitor (VEGFR) TKI treatment and an immune checkpoint inhibitor (anti PD-1) that demonstrated remarkable therapeutic effects. It included key clinical data, such as the median overall survival (mOS) of 23.8 months, the longest ever recorded.
The guidelines evaluated the clinical research evidence supporting the therapeutic effect of the LivoCamrel combination therapy as very strong (Level of Evidence I) and 'strongly recommend' it as a first-line treatment for liver cancer patients with relatively good liver function.
Along with the LivoCamrel combination therapy, the currently most widely used first-line treatments, 'Bevacizumab + Atezolizumab' and 'Durvalumab + Tremelimumab,' were also recommended as first-line treatments. However, it was specified that the Bevacizumab combination therapy requires a screening procedure for patients at risk of or with a history of gastrointestinal bleeding. This means that due to the high risk of gastrointestinal bleeding side effects with this treatment, internal bleeding must be checked through endoscopy or other methods before prescribing to patients.
While the LivoCamrel combination therapy is a combination of angiogenesis inhibitors and immune checkpoint inhibitors similar to the Bevacizumab combination therapy, it does not have gastrointestinal bleeding issues. The company expects that if approved as a first-line treatment, it will quickly capture market share.
Han Yonghae, CTO (Chief Technology Officer) of HLB Group, said, "With new drug approval imminent, the strong recommendation of the LivoCamrel combination therapy as a first-line treatment for liver cancer by the globally prestigious ESMO means that HLB's liver cancer drug has risen to the ranks of internationally recognized standard treatments." He added, "This will be a positive signal not only for approval by the European Medicines Agency (EMA) but also for FDA approval in the U.S. and NCCN listing."
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