Chong Kun Dang pharmaceutical(185750) is strengthening domestic and overseas research and development (R&D) infrastructure and accelerating global innovative new drug development.
The company established the new drug development specialist Archela in Oct. last year and, this month, set up NURATEON, a research and development subsidiary. NURATEON serves as a research and development platform, while Archela is structured to handle development and technology commercialization of core new drug pipelines.
Also, last year it announced a plan to invest 2.2 trillion won in the Baegot district of Siheung, Gyeonggi Province, to build a state-of-the-art biopharmaceutical complex research and development (R&D) campus.
It is also strengthening its global research base. In 2024, it established U.S. subsidiary CKD USA in Boston to secure a global research and development hub, and in 2022 it opened the Gen2C gene therapy research center at Seoul St. Mary's Hospital to begin research on treatments for rare and intractable diseases.
Chong Kun Dang pharmaceutical is expanding new modalities such as cell and gene therapy (CGT) and Antibody-Drug Conjugate (ADC) based on its research and development infrastructure, and is focusing on first-in-class new drugs and the unmet needs sector.
This strategy is also translating into technology export results.
In Nov. 2023, Chong Kun Dang pharmaceutical out-licensed the HDAC6 inhibitor "CKD-510," a candidate for inflammatory diseases, to Novartis in a deal worth a total of $1.305 billion. After Novartis submitted an investigational new drug (IND) application for a phase 2 trial to the U.S. FDA in May last year, Chong Kun Dang pharmaceutical also received a $5 million milestone under the contract.
◇ "R&D advancement" research by NURATEON, development by Archela
NURATEON is a research and development platform company that, based on Chong Kun Dang pharmaceutical Hyojong Research Institute's capabilities, conducts work ranging from new drug formulations, improved new drugs, generics, and over-the-counter (OTC) products to analytical research, formulation research, and drug delivery system (DDS) research. In addition to in-house product development, it plans to expand technology transfer and research and development services for external clients.
The new drug development specialist Archela operates under the NRDO (No Research, Development Only) model. NRDO is a new drug development model that focuses capabilities on candidate development, clinical trials, and technology commercialization rather than basic research. Archela is responsible for development, technology out-licensing, and commercialization of core pipelines.
Archela's core pipelines currently include ▲ CETP inhibitor CKD-508 ▲ oral GLP-1 agonist CKD-514 ▲ HDAC6 inhibitor CKD-513.
CKD-508 is a second-generation CETP inhibitor in development as a treatment for dyslipidemia. It is characterized by improvements over existing CETP inhibitors in off-target effects, adipocyte accumulation, and low stability. In a phase 1 trial in the U.K., it demonstrated safety and efficacy, and in 2024 it received U.S. FDA approval for a U.S. phase 1 investigational new drug application.
CKD-514 is an oral GLP-1 class treatment for obesity and diabetes. In nonclinical studies, it showed significant weight loss effects at lower doses than the competing drug Orforglipron from Eli Lilly and Company, and at the same dose it also showed superior blood glucose-lowering effects. The goal is to secure oral formulation competitiveness in a global obesity treatment market led by injectables.
CKD-513 is an HDAC6 inhibitor that crosses the blood-brain barrier (BBB) and is being developed as a treatment for neurodegenerative diseases such as Alzheimer's disease, tauopathies, and Charcot-Marie-Tooth (CMT). In nonclinical results released at the Society for Neuroscience in the U.S. last year, it showed high BBB permeability, restoration of axonal transport, and improved cognitive function.
◇ Expanding the oncology pipeline with ADCs and bispecific antibodies
In oncology, it is fostering ADCs and bispecific antibodies as future growth pillars.
In Feb. 2023, Chong Kun Dang pharmaceutical signed an agreement with Dutch biotech Synaffix to secure licenses to three ADC platform technologies. Based on this, it is pursuing development of next-generation ADC anticancer drugs.
Lead pipeline CKD-702 is a bispecific antibody biologic in development with an indication for Non-small cell lung cancer (NSCLC). At the European Society for Medical Oncology (ESMO) in 2022, it presented phase 1 Part 1 results confirming the recommended phase 2 dose, safety, and antitumor activity, and phase 1 Part 2 is underway.
CKD-703 is a candidate that applies ADC technology to a c-Met–targeting monoclonal antibody developed in-house by Chong Kun Dang pharmaceutical. In July last year, it received U.S. FDA approval for phases 1 and 2a and is conducting trials in patients with Non-small cell lung cancer (NSCLC) and solid tumors. In nonclinical studies, it demonstrated strong cancer cell–killing effects, and it is pursuing expansion of indications to various solid tumors.