Chong Kun Dang Receives Approval for Macular Degeneration Biosimilar 'Lucenbiese' (Comprehensive)

Second Biosimilar Development Following 'Nesvel'

Lucentis Secures Full Label for Domestic Indications

Jongkundang Headquarters Building Exterior (Photo by Jongkundang)

[Asia Economy Reporter Lee Chun-hee] Chong Kun Dang has received domestic approval for 'Lucenbies (development name CKD-701),' a biosimilar (biopharmaceutical generic) developed based on 'Lucentis (active ingredient ranibizumab).'

Chong Kun Dang announced on the 21st that it received product approval for Lucenbies injection from the Ministry of Food and Drug Safety yesterday, with indications for the treatment of neovascular (wet) age-related macular degeneration. This came about 1 year and 3 months after applying for product approval in July last year.

In addition to wet macular degeneration, Lucenbies also received simultaneous approval for all currently approved indications (full-label) of Lucentis in Korea, including ▲treatment of vision loss due to diabetic macular edema ▲treatment of proliferative diabetic retinopathy ▲treatment of vision loss due to retinal vein occlusion macular edema ▲treatment of vision loss due to choroidal neovascularization. A Chong Kun Dang official stated, "We plan to launch the product after completing the National Health Insurance registration process."

With this, Lucenbies became Chong Kun Dang's second biosimilar following 'Nesvel,' a biosimilar of the anemia treatment 'Nesp' launched in 2019. Nesvel is currently marketed in domestic, Japanese, Southeast Asian, and Middle Eastern global markets.

Lucenbies demonstrated equivalent therapeutic efficacy to the original drug Lucentis in a Phase 3 clinical trial conducted from September 2018 to March last year. The trial involved 312 patients with wet macular degeneration at 25 institutions, including Seoul National University Hospital.

As a result, equivalence with the original was confirmed in efficacy indicators such as the proportion of patients with less than 15 letters of vision loss and vision improvement at 3, 6, and 12 months after drug administration, mean changes in best-corrected visual acuity, and changes in central retinal thickness. Clinical equivalence was also demonstrated in safety, immunogenicity, and pharmacokinetic characteristics.

A Chong Kun Dang official said, "Lucenbies is a high-purity biosimilar product developed purely with Chong Kun Dang's independent technology, securing all indications of the original drug," adding, "We will expand the global market targeting not only the domestic market but also Southeast Asia and the Middle East."

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 worsens into wet macular degeneration with 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, wet macular degeneration is becoming a major cause of blindness among the elderly. Data analysis firm GlobalData estimated 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 32 billion KRW annually.

Currently, besides Chong Kun Dang, Samsung Bioepis has also developed a Lucentis biosimilar. Under the product name 'Byooviz,' it received FDA approval in the U.S. last September and began sales in the U.S. from June. In Korea, 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.