MA-ICURE-PHARMACEUTICAL
16.11.2021 15:03:14 CET | Business Wire | Press release
Icure Pharmaceutical Inc. (KOSDAQ: 175250), a biopharmaceutical company in Korea, announced today that its donepezil patch, a treatment of Alzheimer’s-type dementia, received a drug product approval from the Ministry of Food and Drug Safety of Korea.
The drug product approval process took 7 months after it filed an application in April 2021. With the approval, Icure marks the first commercialization of the donepezil patch in the world.
Donepezil is a current typical treatment that has been widely prescribed for the longest period for Alzheimer’s disease patients in severity ranging from mild to moderate and severe ones among FDA-approved Alzheimer's treatments. Due to difficulty in the development of its formulations, donepezil has been commercialized for only oral administration to date.
With successful completion of a Phase III clinical trial for the first time in the world, the donepezil patch of Icure is expected to significantly improve the quality of life of patients with Alzheimer’s-type dementia and their caregivers by enhancing the convenience in its use from orally taking once daily to putting a patch on skin twice a week.
With nearly 400 mild and moderate dementia patients in Korea, Taiwan, Australia and Malaysia, Icure successfully conducted a Phase III clinical study for its donepezil patch. Specifically, the study demonstrated noninferiority compared to oral donepezil in Alzheimer's disease assessment scale cognitive subscale (ADAS-cog), a typical standard tool for evaluating abilities of memory, language, reorganization, action and orientation in patients with mild and moderate Alzheimer’s-type dementia.
“Based on outstanding efficacy and marketability of donepezil along with our technological prowess, we expect our donepezil patch will sufficiently take over the market of donepezil oral products as we have seen a high conversion rate of rivastigmine patches in the past,” said CEO YoungKweon Choi, Ph.D. of Icure, who led donepezil patch development. “We reported results of the Phase III clinical trial of donepezil patch at the Conference on Clinical Trials of Alzheimer’s Disease (CTAD) that was held on November 9~12, 2021 in Boston, Massachusetts.” He attended the CTAD Conference to present the results of the clinical study while making consultations on potential global transactions.
Now that its donepezil patch received FDA approval for Phase I clinical trial as an investigational new drug in April 2021, Icure will start to administer it to patients in the latter part of 2022. The company expects to begin in 2025 to provide the donepezil patch in the global market by reducing the period of clinical trials through the 505(b)2 clinical study track. Today, the global dementia treatments market is estimated to reach around USD 3 billion, and it is anticipated to increase to roughly USD 5 billion by 2024 as the world transforms into an aging society. Icure plans to expand the global business of transdermal drug delivery system (TDDS) as its production facilities in Wanju, Korea obtained the cGMP certification.
Starting with the donepezil patch, Icure diversifies pipelines by developing a variety of DDS-based incrementally modified drugs and new drugs. Following the donepezil patch, the company is developing a pramipexole patch that will be used for treating Parkinson’s disease. And Icure BNP, a subsidiary of Icure, is currently developing oral liraglutide peptide formulation from injectable liraglutide peptide product that is being used for treating diabetes and obesity while accelerating the development of microneedles and lipid-based nanoparticle (LNP) drugs through CuRsuS Bio and EBA BIO. In addition, Icure is also in the development of the world’s first oral peptide-based anticancer drug and a new drug based on PROTAC through oneCureGen and Dandi Cure, attracting attention on the potentiality of growing into a global pharmaceutical company by developing varied DDS-based new drugs.
For more information on Icure Pharmaceutical Inc., visit https://icure.co.kr .
View source version on businesswire.com: https://www.businesswire.com/news/home/20211116005684/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Humanoids Dominate the Headlines, but Specialized Physical AI Captures Value in $18 Billion Market, Arthur D. Little’s Blue Shift Finds3.9.2026 12:07:00 CEST | Press release
Arthur D. Little’s (ADL) Blue Shift, its forward-looking institute exploring the impact of emerging technologies on business and society, today published I, Robot. Despite the hype around humanoid robots, this report finds they are still immature, compared to other areas of physical AI (autonomous and versatile robots that can perceive, decide, and act in the physical world). ADL analysis shows that humanoid robots only account for $2-3 billion of today’s overall $18 billion physical AI market. Many demonstrations are pre-programmed, remotely operated or even totally AI-generated. The study highlights that specialized physical AI offers the real opportunity for innovation and value in the short-to-medium term, and that businesses should take action now. The overall market could reach $60-$100 billion by 2030, thanks to drivers including labor shortages, shifting work preferences, increasing needs for operational resilience and productivity pressures. Countries and regions are competing
LITEON Announces Strategic Investment in Liquid Cooling Technology Company DCX3.9.2026 12:05:00 CEST | Press release
Advancing AI Infrastructure Value Chain Through Integrated Power Management and Cooling Technologies LITEON Technology (2301.TW) today announced a strategic investment in DCX POLSKA Sp. z o.o. (“DCX Liquid Cooling Systems”), a Warsaw, Poland-based provider of advanced liquid cooling systems for AI and High-Performance Computing (HPC) data centers. Upon closing of the transaction, LITEON will hold approximately 25% equity ownership in DCX Liquid Cooling Systems with a total transaction value of approximately US$176 million. The investment brings together DCX's deep expertise in liquid cooling technologies, including coolant distribution units (CDUs), facility coolant distribution units (FDUs), cold plates and immersion cooling systems, with LITEON's strengths in AI server power management, rack-level power delivery and 800VDC power architectures. Together, the two companies are positioned to deliver highly integrated power and thermal management solutions for the rapidly evolving AI inf
The Untold Story ‘NEW YORK IN MONCLER’3.9.2026 12:00:00 CEST | Press release
A Retrospective of Pioneering New York Moments Some love stories take time. After decades of shared moments, Moncler reveals the story of its enduring relationship with New York through an expansive city-wide declaration of love. The untold story of New York in Moncler began when snow met concrete. What could have melted instead endured, forging a love built on pioneering moments and strengthened with every chapter. They found each other, again and again. Decades later, their story is finally ready to be shared. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260903671495/en/ NEW YORK IN MONCLER MIDTOWN MOUNTAINS Revealed through one of the largest open-air public exhibitions the city has ever seen, New York in Monclerunveils the peak moments that capture the bond between New York and Moncler, transforming communal spaces across the city into a powerful retrospective gallery from September 9-13. New York in Moncleris a very p
Chiesi Advances Its Carbon Minimal Inhaler Journey as European Submissions for Its Single Inhaler Triple Therapy (SITT) and ICS/LABA Combination Next-Generation Propellant pMDIs Are Validated3.9.2026 11:00:00 CEST | Press release
Key Highlights Regulatory submissions for next-generation propellant pMDIs (pressurized metered-dose inhalers) across Chiesi’s Single Inhaler Triple Therapy (SITT; or ICS/LABA/LAMA) and fixed double ICS/LABA combination (inhaled corticosteroid with a long-acting bronchodilator) range have been validated by Regulatory Agencies in Europe. Transition to HFA‑152a, a next‑generation propellant classified as non‑PFAS* and with low global warming potential (GWP),aimsto reduce the carbon footprint of Chiesi’s pMDIs by up to 90% compared to current ones.1-3 Designed for a seamless transition for patients and HCPs, maintaining established efficacy, safety and usability and supporting continuity of care.4-8 The validation supports Chiesi’s ambition to reach Net Zero† across its full value chain by 20359, following MHRA approval of Chiesi’s beclometasone pMDIs formulated with HFA-152a. Chiesi Group, an international research-focused biopharmaceutical company and certified B Corp, today announces a
Belkin præsenterer nye løsninger til at strømforsyne, lokalisere og personalisere hverdagens teknologi3.9.2026 10:00:00 CEST | Pressemeddelelse
Belkin International kan findes på IFA-messen i udstillingshal 3.2, stand nr. 117 Belkin, der i mere end 40 år har været globalt førende inden for forbrugerelektronik, annoncerede i dag en ny kollektion af tilsluttet tilbehør, enhedsbeskyttelse og livsstilsløsninger, der er designet til at hjælpe forbrugerne med at holde styr på og personalisere de enheder, de er afhængige af. Den nye portefølje omfatter SureFind-kollektionen, BoostCharge Slim Magnetic Ring Stand, UltraCharge Smart Display-powerbanks og nye farvevarianter af Belkins populære BoostCharge Compact USB-C-oplader 30 W. De nyligt annoncerede produkter bliver præsenteret på IFA 2026, hvor Belkin udstiller på IFA-messen i hal 3.2, stand nr. 117. Der er multimedier i denne pressemeddelelse. Se hele meddelelsen her: https://www.businesswire.com/news/home/20260903932800/da/ Product lineup showcasing Belkin's newest mobile power accessories De nye produkter bygger på idéen om, at teknologi skal passe problemfrit ind i en moderne l
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom