LISCure Bioscience Co., Ltd.

SEOUL, South Korea, Nov. 10, 2025 /PRNewswire/ -- LISCure Biosciences ("LISCure"), a clinical-stage biopharmaceutical company, announced the initiation of patient dosing in a global Phase 2 clinical trial of LB-P8, a novel therapeutic candidate for Primary Sclerosing Cholangitis (PSC), a rare and progressive liver disease with no approved treatments on November 5 (local time in the U.S.). LB-P8: A First in Class Candidate Targeting the Gut-Liver axis PSC is a cholestatic liver disease of unknown etiology, characterized by inflammation and fibrosis of the bile ducts, and currently has no approved treatment options worldwide. LB-P8, LISCure's investigational drug, acts by modulating the gut–liver axis to suppress inflammation and fibrosis. Preclinical and Phase 1 studies have demonstrated its safety and initial efficacy. Moreover, LB-P8 has shown therapeutic effects in inflammatory bowel disease (IBD), which coexists in approximately 80% of PSC patients, giving it a differentiated competitive edge over other drug candidates currently in development. LB-P8 received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) in 2022 for the treatment of PSC and was granted Fast Track Designation in 2024. Recently, the Committee for Orphan Medicinal Products (COMP) under the European Medicines Agency (EMA) issued a positive opinion for LB-P8's ODD, paving the way for its formal designation in Europe. The ongoing Phase 2 trial (ClinicalTrials.gov Identifier: NCT06699121) will be conducted across 28 clinical sites in the United States and Europe.. The study aims to evaluate the safety, tolerability, and efficacy of LB-P8 in patients with PSC. Hwasup Chin, CEO of LISCure, stated, "PSC represents an area of extremely high unmet medical need, as there are currently no approved therapeutic options. This milestone marks a meaningful step forward for both patients and healthcare professionals." He added, "Together with our other core pipeline asset, the BBB shuttle platform ExoPN-101, we aim to continue advancing as a trusted global biotech company founded on solid scientific evidence and clinical data." SOURCE LISCure BioSciences 21% more press release views with Request a Demo

SEOUL, South Korea, Oct. 22, 2025 /PRNewswire/ -- LISCure BioSciences ("LISCure") announced that its proprietary joint health probiotic, JointWorks®, has been officially approved by the Korean Ministry of Food and Drug Safety (MFDS) as Recognized Health Functional Ingredient. This approval marks a historic milestone — JointWorks® is the world's first probiotic clinically proven to support joint health and remains the only probiotic ingredient approved by the MFDS for joint functionality. Breakthrough in Joint Health Innovation Developed exclusively by LISCure, JointWorks® represents a paradigm shift in the joint health market, which has long been dominated by natural extracts. By introducing a new functional probiotic ingredient, LISCure is expected to play a pivotal role in driving innovation and growth in the category. In a 12-week clinical study, JointWorks® demonstrated statistically significant improvements (p<0.05, 95% confidence level) across multiple indicators of joint health, including: Total WOMAC score (pain, stiffness, and physical function) Visual Analogue Scale (VAS) score Quality of life assessment (EQ-5D-5L) Reduction of inflammatory cytokines related to joint function and pain Further preclinical and clinical studies confirmed JointWorks® mechanisms of action — including joint and cartilage protection, inflammation suppression, pain reduction, and cartilage cell preservation — validating its scientific foundation. Participants also reported notable improvement in daily joint function and quality of life. With these differentiated benefits, JointWorks® is being recognized as a next-generation "Healthcare Probiotic." Key preclinical and clinical data have been published in peer-reviewed journals, including J. Microbiol. Biotechnol. (MK Song et al) and Scientific Reports(BK Shine. MD. et al), providing strong scientific validation. Expanding Market and Growing Demand Korea's joint health functional food market is valued at approximately KRW 480 billion (USD 350 million), making it the third-largest segment in the domestic health supplement industry, following probiotics and multivitamins. The rise of "active seniors" and an aging population committed to wellness and preventive care is fueling demand for new, science-backed joint health solutions. Executive Commentary "The MFDS approval of JointWorks® goes beyond functional validation — it signifies the expansion of probiotics into a new category: joint health," said Jae-Seok Shim, Vice President of LISCure. "This achievement strengthens our position not only in Korea but also in the global nutraceutical market." he added. "Following the MFDS approval of our hair-health probiotic ingredient Mobiome® earlier this year, JointWorks® marks our secondary regulatory milestone, reaffirming LISCure's pioneering position in next-generation probiotics." LISCure is developing next-generation probiotics that go beyond gut health – supporting systemic benefits in areas such as joint, kidney, cognitive and metabolic health. He added, "With a commitment to evidence-based R&D, LISCure will continue developing next-generation probiotics targeting systemic health and accelerating collaborations with global partners across North America, Europe, and Southeast Asia." Upcoming Global Showcase at SupplySide Global 2025 LISCure will present JointWorks® and Mobiome® — both approved by the MFDS — at SupplySide Global 2025 in Las Vegas next week, the world's largest food ingredient exhibition. The company will also highlight its expanding portfolio focused on kidney health, weight management, and blood sugar regulation and ongoing U.S. FDA NDI notification and global partnerships. Advancing Drug Development Pipeline In parallel with its nutraceutical business, LISCure continues to advance its core biopharmaceutical programs, including: Technology transfer of BBB-shuttle platform ExoPN-101 U.S. Phase II clinical trial of liver disease treatment LB-P8, designated as Orphan Drug (ODD) and Fast Track by the U.S. FDA U.S. clinical entry of anti-cancer candidate LB-P2D, which demonstrated strong efficacy in preclinical studies LISCure aims to secure sustainable growth by balancing innovation-driven drug development with stable revenue generation from its functional health ingredient business. SOURCE LISCure Biosciences Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SEOUL, South Korea, Sept. 9, 2025 /PRNewswire/ -- LISCure BioSciences ("LISCure") today announced that Mobiome®, its proprietary hair health probiotic, has received New Dietary Ingredient (NDI) Notification from the U.S. Food and Drug Administration (FDA) —the first such recognition worldwide for targeting hair health. Mobiome® had previously been approved by the Korean Ministry of Food and Drug Safety (MFDS) as a new functional ingredient, based on extensive scientific validation in both preclinical and clinical studies. Results demonstrated multiple mechanisms of action, including enhanced antioxidant activity, reduced inflammation, stimulation of hair follicle cell proliferation, and regulation of the hair follicle cell cycle. In clinical trials, Mobiome® archieved statistically significant improvements (p<0.05, 95% CI) in hair gloss and elasticity, as along with higher consumer satisfaction scores in parameters such as hair texture, split ends, dryness, and damage. A New Standard for Probiotic Innovation The FDA's NDI Notification process is one of the most rigorous in the world, requiring comprehensive evidence of safety and scientific efficacy. Evaluations cover the ingredient's characteristics, toxicological safety, gastrointestinal survivability, and functional validation data — Achieving NDI status therefore represents a critical credential for companies seeking to expand in the global dietary supplement market. Accelerating Global Expansion "With FDA acceptance of the NDI notification for Mobiome®, we have strengthened our competitive position not only in Korea but across the global nutraceutical market," said Hwa-sup Chin, CEO of LISCure BioSciences. "We are now accelerating expansion plans with partners in North America, Europe, and key Asian markets." Beyond hair health, LISCure is developing a pipeline of individually recognized functional ingredients for body fat reduction, joint health, kidney health, and cognitive improvement, with additional FDA NDI submissions underway. Parallel Advancement in PharmaceuticalsIn its core pharmaceutical business, LISCure is advancing multiple programs: Brain Shuttle Platform 'ExoPN-101' – global partnership and potential licensing LB-P8, a therapeutic candidate for PSC, granted FDA Orphan Drug Designation (ODD) and Fast Track Designation, now in U.S. Phase 2 LB-P2D, immuno-oncology therapeutic candidate supported by robust preclinical efficacy data, is advancing toward clinical trials in the U.S. By combining innovation in both pharmaceuticals and functional health products, LISCure is positioned to drive sustainable growth and deliver impactful health solutions worldwide. About LISCure BioSciences LISCure BioSciences is a biotechnology company specializing in the development of novel therapeutics and scientifically validated functional ingredients. With a dual focus on pharmaceutical innovation and health supplement commercialization, the company is committed to improving quality of life and contributing to the advancement of global healthcare. SOURCE LISCure Biosciences Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED