Irinotecan, a nano-modified new drug… Tax benefits and 7-year exclusivity granted
[프레스나인] SN Bioscience received orphan drug designation in the United States as a new drug candidate for nanoparticle small cell lung cancer.
According to the industry on the 19th, the US Food and Drug Administration (FDA) designated ‘SNB-101’ developed by SN Bioscience as an orphan drug for small cell lung cancer indications on the 18th. The designated substances are ‘7-ethyl-10-hydroxycamptothecin and irinotecan hydrochloride trihydrate’.
SNB-101 is a nano-sized new drug of Pfizer’s anti-cancer drug ‘irinotecan’ (product name: Camptosar). Its main ingredient is ‘SN-38 (7-ethyl-10-hydroxycamptothecin)’, an anticancer active metabolite.
When irinotecan is administered to the human body, it is decomposed by ‘Carboxyesterase 2’ and converted into an active form, SN-38. SN-38 has 100 to 1000 times higher efficacy than irinotecan, but the conversion rate is about 2 to 8% of the total dose, so it has limitations in exhibiting anticancer effects. For this reason, the indication is limited to colorectal cancer with high carboxyesterase 2 activity.
SN Bioscience developed a technology that can directly administer active SN-38 using dual nanomicelle technology. The treatment effect was higher than that of irinotecan and side effects were reduced. SN Bioscience is developing SNB-101 for indications such as pancreatic cancer, lung cancer, ovarian cancer, and prostate cancer, which are carboxysterase 2-deficient tumors.
As a result of preclinical trials, SNB-101 showed up to 9 times more tolerability and up to 8 times more drug accumulation in tumors than existing irinotecan drugs. When administered alone in various solid cancer mouse models such as pancreatic cancer, stomach cancer, colorectal cancer, breast cancer, and lung cancer, it proved its effectiveness by showing up to 1.8 times the tumor growth inhibitory effect compared to existing irinotecan injections.
FDA’s orphan drug designation is a system that supports the smooth development and approval of treatments for rare intractable or life-threatening diseases. Candidates designated as orphan drugs receive benefits such as tax cuts, exemption from license application fees, and granting of exclusivity for 7 years upon approval of marketing approval.
Photo/SN Bioscience
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2023-07-19 06:02:43
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