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
ISC 2026: KAYTUS Unveils Gigawatt-Scale AI Infrastructure and Intelligent Management to Empower Europe’s AI Future25.6.2026 09:02:00 CEST | Press release
End-to-end, fully factory-prefabricated modular AI Factory deployment in just a few months, with full-stack intelligent management from GPU to rack, to the entire data center. KAYTUS, a leading provider in AI infrastructure and liquid cooling solutions, unveiled two core solutions at ISC 2026, designed for next-generation AI data centers: a gigawatt-scale, fully prefabricated containerized liquid-cooled data center solution and KSManage Ultra, an intelligent operations management platform for AI Factories. Together, the solutions target the escalating efficiency, performance, scalability, and reliability requirements of AI-era infrastructure, enabling faster deployment, optimized thermal management, and unified operations across large-scale AI computing environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260625809392/en/ KAYTUS prefabricated containerized liquid cooled data center solution The KAYTUS gigawatt-scale
LR Health & Beauty SE Successfully Completes Financial Realignment – Strong Foundation for Growth and Long-Term Partnerships25.6.2026 09:00:00 CEST | Press release
Successful completion of the financial realignment enables full focus on growth and further strengthening operational excellence Planned investments in production and logistics will enhance efficiency, flexibility, and delivery capabilities Further international growth, including expansion into new markets, targeted LR Health & Beauty SE, Europe’s leading social commerce company for high-quality nutritional supplements and beauty products, has successfully completed its financial realignment, establishing the foundation for the company’s stable and forward-looking development. With the achievement of the final milestone, an intensive and demanding process has been successfully concluded. LR has fundamentally realigned its financing structure and significantly strengthened its capital base. An initial financing tranche of EUR 10 million was provided at the end of March, followed by a second tranche of the same amount in June. Jörg Körfer, CEO of LR Health & Beauty SE, comments: “The pas
YesWeHack Launches Agentic Pentest for AI Security Testing25.6.2026 09:00:00 CEST | Press release
New on-demand solution rapidly tests attack surfaces and centralises findings within YesWeHack’s offensive security platform YesWeHack, the offensive security and exposure management platform, announces Agentic Pentest, an on-demand solution using autonomous AI agents to test organisations' assets and deliver same-day findings. Shaped by YesWeHack’s extensive offensive security experience, Agentic Pentest helps organisations identify vulnerabilities, test their real-world exploitability and uncover attack paths across in-scope assets. The solution supports black box, grey box and white box testing of web applications, mobile apps, APIs and other internet-facing assets. YesWeHack, leader in offensive security in Europe and APAC, leverages the best available frontier models for offensive testing, including open-weight models. This flexible approach enables organisations to use models developed and/or hosted anywhere in the world, such as in EU or APAC. Agents operate within guardrails de
H2SITE Secures New Strategic Investment to Accelerate Industrial Deployment of Hydrogen Production and Separation Solutions25.6.2026 06:00:00 CEST | Press release
H2SITE, a leading industrial company in hydrogen production and separation solutions, has completed a second closing of its Series B round. The transaction brings in EIC Fund with a private investor who will support the company’s next phase of growth and increases H2SITE’s total funding raised in this round to more than €42 million. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260624444396/en/ H2SITE These new partners, join BEV, Suma Capital, Hy24, Crane, Enagás Emprende, Calderion and CRPV who participated in the first closing, further validating the confidence of the European innovation ecosystem in H2SITE’s ability to industrialize and deploy key hydrogen solutions at commercial scale. Over the past years, H2SITE has successfully demonstrated the maturity and scalability of its technology, achieving more than 50,000 operating hours with its membrane reactors and separators, establishing advanced manufacturing capabilit
FPT Expands Strategic Collaboration with Microsoft to Advance AI Frontier Innovation Across Asia25.6.2026 04:00:00 CEST | Press release
FPT Corporation today announced an expanded strategic collaboration with Microsoft aimed at accelerating enterprise AI adoption and co‑innovation across Asia, with a strong focus on ASEAN, Japan, and South Korea. The collaboration brings together Microsoft’s global AI platforms with FPT’s large‑scale delivery and regional market capabilities to support organizations as they move from AI experimentation to real‑world, scalable impact, with measurable business outcomes. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260624200416/en/ Representatives of FPT and Microsoft at the signing ceremony, formalizing an expanded strategic collaboration to advance AI Frontier innovation across Asia The collaboration aligns with FPT’s AI‑First strategy and Microsoft’s vision for human‑agent collaboration, with the goal of enabling enterprises to redesign how work is done across engineering, operations, and business functions. Positioning FP
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