Mecoxcuremed "Oral Anticancer Drug 'Mekbentu' Phase 1 Clinical Trial, IND Approval by MFDS"

[Asia Economy Reporter Jang Hyowon] New drug development company Mecox Curemed announced on the 6th that its orally administered anticancer drug ‘Mecbentu’ has received approval for its Phase 1 clinical trial plan (IND) from the Ministry of Food and Drug Safety.

A Mecox Curemed official stated, “Mecbentu is the first blood cancer treatment developed in an easy-to-take pill form of Bendamustine, which has already been verified for its anticancer function,” adding, “Unlike the existing treatment method that required hospitalization to receive anticancer drugs for two consecutive days, Mecbentu enables anticancer treatment through simple oral administration, which is expected to reduce patient side effects and, above all, greatly enhance patient convenience.”

The anticancer drug ‘Mecbentu,’ for which Mecox Curemed has initiated clinical trials, is a new drug that changes the administration route by developing the existing injectable anticancer drug Bendamustine into an oral form. It primarily targets a wide range of blood cancers such as follicular lymphoma, lymphocytic leukemia, and multiple myeloma. According to market research firm Polaris Market Research, the global blood cancer treatment market size is expected to grow to approximately $87 billion (about 107 trillion KRW) by 2025.

Mecox Curemed applied its proprietary drug delivery platform technology, DDS (Drug Delivery System), in the development process of ‘Mecbentu.’ The company expects that ‘Mecbentu,’ as the first orally developed blood cancer treatment applying platform technology that increases drug stability, absorption, and penetration, will improve safety and medication convenience compared to the existing intravenous Bendamustine.

Mecox Curemed will conduct clinical trials of ‘Mecbentu’ involving 30 representative lymphoma patients at Seoul St. Mary’s Hospital, one of the world’s top five hospitals in the blood cancer field, as well as Yeouido St. Mary’s Hospital. The trial will assess drug safety and pharmacokinetic characteristics by comparing with the existing injectable Bendamustine.

The company plans to accelerate global clinical trials sequentially in the United States, Europe, Australia, and other regions following this IND approval. Mecox Curemed began production of ‘Mecbentu’ for global clinical trials last year through Haupt Pharma Amareg GmbH, a global pharmaceutical manufacturing company based in Germany, and is preparing for global clinical trials in line with the progress of domestic clinical trials of Mecbentu.

Mecox Curemed, a new drug development specialist company with KOSDAQ-listed Medicox as its largest shareholder, holds key pipelines including Mecbentu, which is entering domestic Phase 1 clinical trials with this IND approval, the arthritis treatment ‘Bozanics,’ which recently entered domestic Phase 1 clinical trials, and the COVID-19 treatment ‘M002-A,’ which recently completed preclinical trials at the University of Padua research institute in Italy.

This content was produced with the assistance of AI translation services.