Chong Kun Dang Receives Domestic Approval for Macular Degeneration Treatment Biosimilar 'Lucenbess'

Second Biosimilar Development Success Following 'Nesbel'

Jongkundang Headquarters Exterior (Photo by Jongkundang)

[Asia Economy Reporter Lee Chun-hee] Chong Kun Dang's 'Lucenbies Injection,' developed as a biosimilar (biopharmaceutical generic) of 'Lucentis (active ingredient ranibizumab),' has received domestic approval.

On the 20th, Chong Kun Dang announced that it received marketing authorization approval from the Ministry of Food and Drug Safety for Lucenbies Injection with the indication for the treatment of neovascular (wet) age-related macular degeneration. A Chong Kun Dang official stated, "We plan to launch the product after completing the National Health Insurance listing process."

With this, Lucenbies became Chong Kun Dang's second biosimilar after 'Nesvel,' a biosimilar of the anemia treatment drug 'Nesp.' Nesvel is currently marketed in domestic, Japanese, and Southeast Asian global markets.

In Phase 3 clinical trials, Lucenbies demonstrated therapeutic equivalence to the original drug Lucentis. Similarity was also confirmed in safety, immunogenicity, and pharmacokinetic properties.

Genentech's wet age-related macular degeneration treatment 'Lucentis' (Photo by Genentech)

Macular degeneration occurs when waste accumulates in the macula, the central part of the retina, causing dry macular degeneration, which can worsen into wet macular degeneration due to excessive blood vessel growth. If left untreated, it can lead to blindness, so treatment aims to slow disease progression by inhibiting blood vessel formation. Antibody drugs such as Genentech's (a Roche subsidiary) Lucentis or Regeneron's 'Eylea' are directly injected into the eye.

As the elderly population increases worldwide, data analysis firm GlobalData estimates that the market size for wet macular degeneration treatments in nine major countries including the U.S., Germany, Japan, China, and Australia will reach $18.7 billion (approximately 26.7691 trillion KRW) by 2028. The domestic Lucentis market size is estimated to be around 34 to 40 billion KRW annually.

Currently, besides Chong Kun Dang, Samsung Bioepis has also developed a Lucentis biosimilar. Under the product name 'Byooviz,' it received U.S. FDA approval in September last year and began sales in the U.S. in June. Domestically, it is expected to be launched next year as 'Amelibu' in partnership with Samil Pharmaceutical.

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