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Chong Kun Dang Expands Global Push with New Drugs

It also launched Nesbell, a biosimilar to the anemia treatment Nesp, after obtaining product... which it launched in January of the following year. It is currently conducting a range of clinical...

Chong Kun Dang Expands Global Push with New Drugs

Invests 9–11% of Sales in R&D, First-Quarter Revenue and Profit Rise

Chong Kun Dang Chairman Lee Jang-han (Photo provided by Chong Kun Dang)

Chong Kun Dang is accelerating its push into global markets on the back of steady research and development investment and new drug development. The company is expanding clinical trials across a range of fields, including anticancer drugs, biosimilars, and innovative new medicines based on antibody-drug conjugates, or ADCs.

According to the Financial Supervisory Service’s electronic disclosure system, Chong Kun Dang posted first-quarter sales of 447.7 billion won ($322.34 million) and operating profit of 17.6 billion won ($12.67 million) this year. Those figures were up 12.2% and 36.9%, respectively, from the same period a year earlier. Chong Kun Dang accounts for about 5% of sales in the overall domestic pharmaceuticals market.

The company invests about 9-11% of its annual sales in research and development. Its achievements in new drug development to date include Camtobell, the country’s eighth domestically developed new anticancer drug in 2004, and Duvie Tab, a diabetes treatment that became the 20th domestically approved new drug in 2013. It also launched Nesbell, a biosimilar to the anemia treatment Nesp, after obtaining product approval in South Korea and Japan.

In addition, in July 2022, the company obtained domestic product approval for G-Tec, a natural product medicine for gastritis, and in October 2022 secured domestic product approval for Lucenivis, a biosimilar to Lucentis, which it launched in January of the following year. It is currently conducting a range of clinical trials in targeted anticancer therapies and biopharmaceutical new drugs. At the same time, it is also preparing future growth engines by developing new combination drugs and launching over-the-counter medicines.

In a recent speech marking the company’s 85th anniversary at its headquarters in Chungjeongno, Chong Kun Dang Chairman Lee Jang-han said, “The pharmaceutical industry is facing a graver situation than ever amid changes in the internal and external environment and uncertainty,” adding, “At times like this, we must devote all our efforts to securing future growth engines with bolder and more precise strategies.”

In January last year, Chong Kun Dang received its first European Phase 1 clinical trial approval for ‘CKD-706,’ a biosimilar to Dupixent (ingredient name: dupilumab), from the European Medicines Agency and the U.K. Medicines and Healthcare products Regulatory Agency. With the approval, the company plans to demonstrate the pharmacokinetic equivalence of CKD-706 and the original product Dupixent in healthy adults in Europe, while comparing pharmacodynamics, safety, and immunogenicity.

Dupilumab is a human monoclonal antibody. It is a biopharmaceutical that works by binding to IL-4Rα, the receptor commonly used by interleukin-4 and interleukin-13, which are involved in type 2 inflammatory responses, thereby inhibiting the relevant signaling pathway. The drug is currently approved by the U.S. Food and Drug Administration for eight indications, including atopic dermatitis, asthma, chronic rhinosinusitis, eosinophilic esophagitis, and chronic obstructive pulmonary disease.

Then in April, Chong Kun Dang began enrolling the first patient in the United States for a global Phase 1/2a clinical trial of ‘CKD-703,’ a new ADC-based anticancer drug candidate.

The trial is being conducted in about 12 institutions in South Korea and the United States, including MD Anderson Cancer Center, targeting patients with non-small cell lung cancer and various solid tumors. Beginning with the first patient enrollment at Gabrail Cancer Center in Ohio, the goal is to confirm the safety and maximum tolerated dose of CKD-703 and derive the optimal dose based on proof of concept.

CKD-703 is a drug under development by Chong Kun Dang that applies next-generation ADC platform technology to a c-Met-targeting monoclonal antibody developed independently by the company. It is an innovative anticancer drug candidate designed to selectively kill only cancer cells. After receiving approval from the U.S. Food and Drug Administration last year for a Phase 1/2a clinical trial, it also obtained approval for its clinical trial plan from the Ministry of Food and Drug Safety in February this year. The company plans to expand clinical trial countries to Europe and other regions in the future.

Kim Eun-jin

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