Chong Kun Dang's Biosimilar 'Lucenbace' Clinical Results Published in SCI-Level International Journal

Proving the Equivalence of Lucentis, a Treatment for Macular Degeneration

Exterior view of Chong Kun Dang headquarters. [Photo by Chong Kun Dang]

[Asia Economy Reporter Lee Gwan-joo] Chong Kun Dang announced on the 23rd that the Phase 3 clinical trial results of the Lucentis biosimilar 'Lucenbies' have been published in the SCI-level international journal 'PLoS One'.

Lucenbies is a high-purity Lucentis biosimilar with ranibizumab as its main ingredient. It is mass-produced using Chong Kun Dang's proprietary antibody fragment raw material manufacturing technology and is an ophthalmic disease treatment used for macular degeneration and diabetic macular edema. It received product approval from the Ministry of Food and Drug Safety on the 20th of last month and is scheduled to be launched in January next year.

From September 2018 to March last year, Chong Kun Dang conducted a Phase 3 clinical trial of Lucenbies on a total of 312 patients with neovascular (wet) age-related macular degeneration (nAMD) at 25 hospitals, including Seoul National University Hospital.

In the primary efficacy endpoint comparing best-corrected visual acuity (BCVA) at 3 months after drug administration, the proportion of patients with less than 15 letters of vision loss was analyzed. The Lucenbies group showed 97.95%, and the original drug group showed 98.62%, confirming that the equivalence range between the two drugs was met.

The change in best-corrected visual acuity (BCVA) also improved by 7.14 letters in the Lucenbies group and 6.28 letters in the original drug group, showing no significant difference between the two drugs. At 3, 6, and 12 months after drug administration, the efficacy, safety, immunogenicity, and pharmacokinetic characteristics of the drug were confirmed to be clinically equivalent to the original drug through indicators such as the proportion of patients with less than 15 letters of vision loss and vision improvement, as well as changes in central retinal thickness.

Professor Yoo Hyung-gon, the corresponding author of the clinical paper on Lucenbies, said, "Lucenbies is a drug whose clinical equivalence to the original drug Lucentis has been verified in major indicators, including the primary endpoint of best-corrected visual acuity. In particular, it is expected to stabilize the condition of macular degeneration diseases through selective administration therapy (PRN) tailored to the patient's condition, as well as reduce the treatment burden on patients caused by fixed drug administration."

Macular degeneration is a serious disease in which the macula, the tissue in the retina of the eye that receives light, loses function due to aging and inflammation, and in severe cases leads to blindness. The number of patients is continuously increasing due to the global aging phenomenon.

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