Cenobamate

SK Biopharmaceuticals forms a joint venture, Mentis Care, to develop an integrated epilepsy care ecosystem through AI-driven platform commercialization. SEOUL, South Korea, Oct. 20, 2025 /PRNewswire/ -- SK Biopharmaceuticals, Co., Ltd., a biotech company focusing on research, development, and commercialization of treatments for disorders of the central nervous system (CNS) and oncology worldwide, today announced the establishment of Mentis Care, Inc., a joint venture with a leading Brazil-based pharmaceutical company, Eurofarma, with presence in 24 countries, including North America, Latin America and Africa, to commercialize an AI-based epilepsy management platform. The company hosted a launching ceremony on October 20 (EDT) in Toronto, Canada, to celebrate its full-scale expansion into digital healthcare beyond its innovative drug development portfolio. Continue Reading Executives celebrate the launch of Mentis Care, a joint venture established by SK Biopharmaceuticals and Eurofarma. From left: Rodrigo Pereira (Global Executive Director of Entrepreneurship and Digital, Eurofarma), Shelley Carroll (Toronto City Councillor & Budget Chief), Donghoon Lee (CEO, SK Biopharmaceuticals), Honorable Victor Fedeli (Ontario Province Minister of Economic Development, Job Creation and Trade), Hassan Kotob (CEO, Mentis Care), Stephen Lund (CEO, Toronto Global), Khawar Nasim Since 2018, SK Biopharmaceuticals has built its proprietary expertise in AI-driven electroencephalography (EEG) and wearable device technologies with seizure detection and real-time monitoring. Mentis Care will leverage these technologies to develop a comprehensive digital platform that combines real-time seizure detection and prediction algorithms with clinical decision support tools, creating an integrated system for personalized patient care. Mentis Care is located in the MaRS Discovery District in Toronto, Canada — one of North America's largest innovation hubs bringing research institutions, startups, and investors in life sciences and healthcare together. The company plans to expand its local team, strengthen academic and industry collaborations, and pursue clinical validation of its AI algorithms. As a pharmaceutical company representing Latin America, Eurofarma leads business strategy planning and AI data learning of the venture. SK Biopharmaceuticals has collaborated with Eurofarma since 2022 to develop and commercialize its anti-seizure medication, cenobamate (U.S. brand name: XCOPRI®) in Latin America. The partnership extends into digital healthcare through the joint venture establishment. Mentis Care has appointed Hassan Kotob, former Chief Executive Officer of Brain Scientific, as Chief Executive Officer (CEO). Kotob, a veteran healthcare and technology executive with a proven track record across high-growth and emerging technology companies, will lead Mentis Care's development of a first-of-its-kind, AI- and data-driven platform for predictive brain health — transforming how seizures and other neurological events are forecast and managed. "Mentis Care is an AI-driven digital health company with the mission to help patients with epilepsy live safer and more independently through AI-powered seizure prediction and monitoring," said Hassan Kotob, CEO of Mentis Care. "By combining the innovation capabilities of our partners, SK Biopharmaceuticals and Eurofarma, we aim to establish a new standard in digital epilepsy management for patients worldwide." "For Eurofarma, the JV represents the future we envision for healthcare, combining digital technologies and medicines for a transformative and positive leap in patients' lives. We are a reference in central nervous system treatments in Latin America, with a broad portfolio of medicines and close relationships with psychiatrists and neurologists. For some years now, we have added digital innovation investments to our R&D activities, and since 2022, we have maintained a small operation in North America. With this new partnership, we will strengthen these fronts in a single move," says Rodrigo Pereira, Global Executive Director of Entrepreneurship and Digital at Eurofarma. "SK Biopharmaceuticals is expanding beyond pharmaceuticals into digital healthcare to open new possibilities in patient care," said Donghoon Lee, CEO of SK Biopharmaceuticals. "Through Mentis Care, we will advance toward patient-centered innovation by integrating AI and clinical data to improve epilepsy treatment." About SK Life Science, Inc. and SK Biopharmaceuticals Co., Ltd. SK Life Science, Inc., with headquarters in Paramus, New Jersey, is a U.S. subsidiary of SK Biopharmaceuticals Co., Ltd., a pioneering South Korean company in drug development and commercialization. Together, they are advancing innovative treatments for central nervous system (CNS) disorders and oncology, with eight compounds currently in development. Utilizing target-based drug discovery, high-throughput organic screening/high content screening, computer-aided drug design, and combinatorial chemistry, the companies drive R&D efforts in biology/discovery, medicinal chemistry, pharmacology, and clinical development. For more information, visit . SK Biopharmaceuticals Co., Ltd. is part of SK Group, South Korea's second-largest conglomerate. SK Group is a collection of global industry-leading companies driving innovations in energy, advanced materials, biopharmaceuticals and digital business. Based in Seoul, SK invests in building sustainable businesses around the world with a shared commitment to reducing global greenhouse gas emissions. SK companies combined have $151 billion in global annual revenue and employ more than 100,000 people worldwide. SK Group is one of TIME's 100 Most Influential Companies of 2023. SK Inc., the parent company of SK Biopharmaceuticals, continues to enhance its portfolio value by executing long-term investments with a number of competitive subsidiaries in various business areas, including pharmaceuticals and life science, energy and chemicals, information and telecommunication, and semiconductors. In addition, SK Inc. is focused on reinforcing its growth foundations through profitable and practical management based on financial stability, while raising its enterprise value by investing in new future growth businesses. For more information about SK Inc., visit . For more information about SK Biopharmaceuticals, visit . About Eurofarma Founded in 1972, Eurofarma operates in the healthcare sector through the production and commercialization of products and services aimed at improving people's quality of life. With a focus on generating shared value, the company covers key pharmaceutical segments such as prescription drugs, generics, hospital, oncology, OTC, personal care, and animal health, in addition to providing contract manufacturing services. With broad coverage across therapeutic classes, its portfolio includes over 4,000 SKUs, serving nearly all medical specialties. Eurofarma is the leader in medical prescriptions in Brazil, where it also holds second place in the generics market. The company is present in 24 countries, with full coverage across Latin America and retail leadership in the region. It also maintains operations in the United States and Africa, with more than 13,500 employees and 11 manufacturing facilities. In 2024, Eurofarma produced 600 million units. That same year, the company invested over R$ 800 million in innovation projects and achieved net revenue exceeding R$ 11 billion. About Mentis Care, Inc. Mentis Care is an AI-driven health company transforming neurological care through the first predictive AI platform for brain health. The platform is designed to detect and forecast seizures and other neurological events in real time. By combining advanced machine learning with clinical expertise, Mentis Care aims to give patients and families greater safety, confidence, and peace of mind — while setting a new global standard in brain health and digital neuromonitoring. About XCOPRI® (cenobamate tablets) CV Cenobamate is an antiseizure medication (ASM) discovered and developed by SK Biopharmaceuticals and SK Life Science. Cenobamate reduces neuronal excitability through a unique dual mechanism of action, preferentially inhibiting the persistent sodium currentand enhancing GABAergic inhibition at the type A γ-aminobutyric acid (GABAA) ion channel. The precise mechanism by which cenobamate exerts its therapeutic effect is unknown. Cenobamate is marketed under the brand name XCOPRI® in the U.S. by SK Life Science, Inc. Additionally, XCOPRI is commercialized in Canada and Israel by SK Biopharmaceuticals' partners, Paladin Labs Inc. and Dexcel Ltd. Cenobamate is marketed as ONTOZRY® by Angelini Pharma S.p.A. in Europe, the UK, and Switzerland. Cenobamate is also being developed for commercialization by SK Biopharmaceuticals' partners in many other countries to meet the needs of patients living with epilepsy, including Dong-A ST Co., Ltd., Eurofarma Laboratórios S.A., Hikma MENA FZE, Ignis Therapeutics, Inc. and ONO Pharmaceutical Co., Ltd. IMPORTANT SAFETY INFORMATION AND INDICATION FOR XCOPRI® (cenobamate tablets) CV DO NOT TAKE XCOPRI IF YOU: Are allergic to cenobamate or any of the other ingredients in XCOPRI. Have a genetic problem (called Familial Short QT syndrome) that affects the electrical system of the heart. XCOPRI CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING: Allergic reactions: XCOPRI can cause serious skin rash or other serious allergic reactions which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away and go to the nearest emergency room if you have any of the following: swelling of your face, eyes, lips, or tongue, trouble swallowing or breathing, a skin rash, hives, fever, swollen glands, or sore throat that does not go away or comes and goes, painful sores in the mouth or around your eyes, yellowing of your skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, severe muscle pain, frequent infections, or infections that do not go away. Take XCOPRI exactly as your healthcare provider tells you to take it. It is very important to increase your dose of XCOPRI slowly, as instructed by your healthcare provider. QT shortening: XCOPRI may cause problems with the electrical system of the heart (QT shortening). Call your healthcare provider if you have symptoms of QT shortening including fast heartbeat (heart palpitations) that last a long time or fainting. Suicidal behavior and ideation: Antiepileptic drugs, including XCOPRI, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your health care provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempting to commit suicide; new or worse depression, anxiety, or irritability; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); or other unusual changes in behavior or mood. Nervous system problems: XCOPRI may cause problems that affect your nervous system. Symptoms of nervous system problems include: dizziness, trouble walking or with coordination, feeling sleepy and tired, trouble concentrating, remembering, and thinking clearly, and vision problems. Do not drive, operate heavy machinery, or do other dangerous activities until you know how XCOPRI affects you. Do not drink alcohol or take other medicines that can make you sleepy or dizzy while taking XCOPRI without first talking to your healthcare provider. DISCONTINUATION: Do not stop taking XCOPRI without first talking to your healthcare provider. Stopping XCOPRI suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). DRUG INTERACTIONS: XCOPRI may affect the way other medicines work, and other medicines may affect how XCOPRI works. Do not start or stop other medicines without talking to your healthcare provider. Tell healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. PREGNANCY AND LACTATION: XCOPRI may cause your birth control medicine to be less effective. Talk to your health care provider about the best birth control method to use. Talk to your health care provider if you are pregnant or plan to become pregnant. It is not known if XCOPRI will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking XCOPRI. You and your healthcare provider will decide if you should take XCOPRI while you are pregnant. If you become pregnantwhile taking XCOPRI, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888233-2334 or go to . Talk to your health care provider if you are breastfeeding or plan to breastfeed. It is not known if XCOPRI passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking XCOPRI. COMMON SIDE EFFECTS: The most common side effects in patients taking XCOPRI include dizziness, sleepiness, headache, double vision, and feeling tired. These are not all the possible side effects of XCOPRI. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at . DRUG ABUSE: XCOPRI is a federally controlled substance (CV) because it can be abused or lead to dependence. Keep XCOPRI in a safe place to prevent misuse and abuse. Selling or giving away XCOPRI may harm others and is against the law. INDICATION: XCOPRI is a prescription medicine used to treat partial-onset seizures in adults 18 years of age and older. It is not known if XCOPRI is safe and effective in children under 18 years of age. Please see additional patient information in the Medication Guide. This information does not take the place of talking with your healthcare provider about your condition or your treatment. Please see full Prescribing Information. About Epilepsy Epilepsy is the fourth most common neurological disorder. There are approximately 3.4 million people living with epilepsy in the United States, with 150,000 new cases each year in the country.1,2 Epilepsy is characterized by recurrent, unprovoked seizures. The seizures in epilepsy may be related to a brain injury or a family tendency, but often the cause is completely unknown. Having seizures and epilepsy can affect one's safety, relationships, work, driving, and much more.3,4 People with epilepsy are at risk for accidents and other health complications, including falling, drowning, depression and sudden unexplained death in epilepsy (SUDEP).3,4 Despite the availability of many antiepileptic therapies, almost 40 percent of people with epilepsy are not able to achieve seizure freedom, meaning they have epilepsy that remains uncontrolled.5 XCOPRI® and ONTOZRY® are registered trademarks of SK Biopharmaceuticals Co., Ltd. Media Contact: SK Biopharmaceuticals Public Relations Team [email protected] SOURCE SK Biopharmaceuticals. Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Bristol Myers Squibb's exit from a Chinese joint venture, two new biotechs with Chinese assets and reported deal talks by Roche and Johnson & Johnson with Shanghai Henlius Biotech made our news this week. Bristol Myers Squibb is exiting the first U.S.-China pharmaceutical joint venture. Kalexo Bio and Ollin Biosciences have launched with big venture capital backers and Chinese assets. Roche and Johnson & Johnson are reportedly eyeing an antibody-drug conjugate deal with Henlius. And more. 1. BMS sells controlling stake in historic US-China pharmaceutical joint ventureBristol Myers Squibb is exiting its 60% stake in Sino-American Shanghai Squibb Pharmaceuticals, which was established in 1982 as the first U.S.-China pharmaceutical joint venture. An internal email circulating online suggests Hillhouse Capital is on the other end of the deal, which also includes five old or over-the-counter products that the unit makes exclusively for the mainland China market.2. VC Aditum launches cardiovascular biotech, offers Mabwell up to $1B for siRNA assetCalifornia venture capital firm Aditum Bio has hatched another biotech by partnering up with China’s Mabwell Bioscience. Called Kalexo Bio, the startup carries a dual-target siRNA candidate after Aditum licensed the asset from Mabwell for $12 million in upfront and near-term payments. Kalexo will develop the drug for dyslipidemia and high-risk atherosclerotic cardiovascular disease.3. Eye disease biotech launches with $100M and sights set on Roche showdownOllin Biosciences has launched with two assets from Chinese biotechs: a VEGFxAng2 bispecific from Innovent Biologics and a TSHRxIGF-1R bispecific from VelaVigo. The eye-disease-focused startup is co-founded and headed by Jason Ehrlish, M.D., who supported the development of Roche’s Vabysmo, and counts Arch Venture Partners, Mubadala Capital and Monograph Capital among its backers.4. Fosun’s Henlius in talks with J&J, Roche on PD-L1 ADC (Bloomberg)Shanghai Henlius Biotech is in talks with Johnson & Johnson and Roche about a licensing deal around HLX43, a PD-L1 antibody-drug conjugate that’s in midstage testing in China, Bloomberg reports, citing people familiar with the matter. A deal could be worth several hundred million dollars upfront, the people said. Pfizer, already in phase 3, is currently the furthest in development with a PD-L1 ADC.5. GE HealthCare considering stake sale in China division: reportGE Healthcare is exploring options for its China unit, including the sale of a stake, people familiar with the matter told Bloomberg. A transaction may value the China assets at several billion dollars, the people said. GE’s China business has encountered some challenges thanks to U.S.-China tariffs.6. SK's blockbuster hopeful Xcopri reduces seizures in phase 3 trial, teeing up FDA expansion bidSK Biopharmaceutical reported a positive phase 3 readout for Xcopri in primary generalized tonic-clonic seizures. The 169-patient trial showed the drug reduced seizure frequency by 71.9% from baseline, versus 39.6% for placebo, over 28-day intervals. SK plans to file for an FDA label expansion on top of Xcopri’s existing focal seizures indication.Other News of Note:7. Dr. Reddy's India biologics plant issued FDA Form 4838. QL Biopharm links once-monthly GLP-1 to incumbent-rivaling weight loss in phase 29. Celltrion, Becton Dickinson team up to boost prefilled syringe manufacturing (release)