Chong Kun Dang recently announced plans to invest KRW 2.2 trillion in establishing a state-of-the-art biopharmaceutical complex research and development cluster in Baegot District, Siheung City. In May 2024, it established CKD USA, a U.S. subsidiary in Boston, as a global R&D hub, and in June 2022, it opened the Gen2C gene therapy research center at Seoul St. Mary's Hospital to develop treatments for rare and intractable diseases, securing a bridgehead for global new drug development.

Within its cutting-edge R&D infrastructure, Chong Kun Dang is significantly expanding its new drug pipeline and accelerating next-generation drug development. The company is exploring new modalities such as cell and gene therapies (CGT) and antibody-drug conjugates (ADC) for cancer treatment, focusing on developing unprecedented new drugs and medicines for unmet needs.

The bold R&D strategy led to a record-breaking technology export deal in November 2023, exporting an innovative new drug candidate to a global pharmaceutical company. Chong Kun Dang signed a technology export contract worth USD 1.305 billion (approximately KRW 1.73 trillion) for the development and commercialization of CKD-510, a histone deacetylase 6 (HDAC6) inhibitor. In May, Novartis submitted a Phase 2 clinical trial plan to the U.S. FDA, resulting in a milestone payment of USD 5 million.

CKD-510, a new drug candidate developed by Chong Kun Dang, is an HDAC6 inhibitor utilizing a highly selective non-hydroxamic acid (NHA) platform technology. Preclinical studies confirmed its efficacy in various HDAC6-related diseases, including cardiovascular diseases. Phase 1 clinical trials conducted in Europe and the U.S. demonstrated its safety and tolerability.

Securing Future Growth Engines with a Broad New Drug Pipeline

In February 2023, Chong Kun Dang signed a contract with Synaffix in the Netherlands to introduce ADC technology, securing rights to use three ADC platform technologies for developing ADC cancer treatments. In February 2022, it signed a memorandum of understanding (MOU) with Encell, a company specializing in CDMO for cell and gene therapies and next-generation stem cell therapy development, for strategic investment and joint research. The company plans to strengthen academic-industry collaboration and exchange related to research and clinical trials and pursue joint development through open innovation with domestic and international companies.

CKD-508, under development by Chong Kun Dang as a treatment for dyslipidemia, is a new drug candidate that inhibits the activity of cholesterol ester transfer protein (CETP), which promotes the transport of cholesterol esters (CE) and triglycerides (TG) among lipoproteins in the blood. It lowers low-density cholesterol (LDL-C) levels and raises high-density cholesterol (HDL-C) levels. Preclinical efficacy tests conducted by the Hyojong Research Institute confirmed CKD-508's effects on reducing LDL-C and increasing HDL-C, and significantly decreased apolipoprotein (Apo-B), a key indicator of dyslipidemia.

CKD-508 is a second-generation drug that overcomes the issues of off-target effects, adipose tissue accumulation, weak efficacy, and low stability associated with first-generation CETP inhibitors. It demonstrated efficacy and safety in healthy adults in a Phase 1 clinical trial in the UK, and in November last year, it received approval from the U.S. FDA for a Phase 1 clinical trial in the U.S. to confirm CKD-508's safety and lipid-improving effects while exploring the optimal dosage for Phase 2 trials.

A Chong Kun Dang representative stated, “CKD-508 is an innovative drug expected to be effective at low doses by resolving the issues of drug accumulation and blood pressure increase that led to the discontinuation of previous CETP inhibitors. If successfully developed, it is anticipated to provide a new treatment option for patients with statin-resistant dyslipidemia that cannot be controlled with statin drugs.”

CKD-702, currently under development for non-small cell lung cancer, is an anti-cancer bispecific antibody biopharmaceutical. In September 2022, at the European Society for Medical Oncology, Chong Kun Dang announced the recommended Phase 2 dosage for CKD-702 and presented the results of Phase 1 Part 1, which evaluated its pharmacokinetic characteristics, safety, and anti-tumor effects, confirming its potential as an anti-cancer drug. The company is currently conducting Phase 1 Part 2 trials for CKD-702 with non-small cell lung cancer as the indication. Future plans include expanding the scope of application to various cancers with high unmet needs by confirming treatment effects in patients selected based on biomarkers.

CKD-703, which is expected to become a new modality for Chong Kun Dang, is an antibody-drug conjugate-based anti-cancer new drug targeting the hepatocyte growth factor receptor (c-MET). In July, it received approval from the U.S. FDA for a Phase 1/2a clinical trial to confirm safety and maximum tolerated dose in patients with non-small cell lung cancer and solid tumors in the U.S., and to derive the optimal dosage through proof of concept (PoC). The trial will also comprehensively evaluate pharmacokinetics, immunogenicity, and early efficacy.

CKD-703 is expected to improve safety by inhibiting the indiscriminate separation of drugs in the bloodstream while selectively delivering cytotoxic drugs into cancer cells to induce cell death and suppressing downstream signaling of c-Met. Preclinical studies conducted in Korea confirmed its excellent cell death-inducing effects, and research is currently underway to expand indications for various solid tumors.

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