"Confirmed Clinical Equivalence with Lucentis in Phase 3 Trial"
[Asia Economy Reporter Kim Ji-hee] Chong Kun Dang announced on the 28th that it has completed Phase 3 clinical trials of the biosimilar of the macular degeneration treatment drug Lucentis, ‘CKD-701 (active ingredient ranibizumab),’ and has applied for product approval from the Ministry of Food and Drug Safety.
From September 2018 to March of this year, Chong Kun Dang conducted Phase 3 clinical trials of CKD-701 on 312 patients with neovascular age-related macular degeneration (nAMD) at 25 hospitals, including Seoul National University Hospital. As a result, clinical equivalence with the original drug Lucentis was confirmed.
Macular degeneration is a disease in which the macula, the tissue in the retina of the eye that receives light, loses its 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. In particular, wet macular degeneration, caused by exudates or blood leaking from abnormally formed blood vessels (neovascularization) that cause structural changes and damage to the retina and macula, is considered one of the top three causes of blindness among the elderly population aged 65 and over.
In the Phase 3 clinical trial, CKD-701 and the original drug were administered respectively to patients with wet macular degeneration, and the best corrected visual acuity (BCVA) was compared and analyzed after three months. The evaluation showed that the proportion of patients who lost fewer than 15 letters of vision was 97.95% (143 out of 146) in the CKD-701 group and 98.62% (143 out of 145) in the original drug group, meeting the equivalence range. The mean change in BCVA also improved by 7.14 letters in the CKD-701 group and 6.28 letters in the original drug group, showing no statistical difference between the drugs.
At 3, 6, and 12 months after drug administration, indicators such as the proportion of patients with less than 15 letters of vision loss or vision improvement, mean change in BCVA, and central retinal thickness change confirmed that the drug efficacy, pharmacokinetics, immunogenicity, and safety showed no statistically significant difference compared to the original drug.
A Chong Kun Dang official stated, “If the product approval for CKD-701 is granted, it is expected to expand the product lineup in the ophthalmic treatment field and broaden treatment options for patients. Starting with the domestic market worth 37 billion KRW, we will expand the market to Southeast Asia and the Middle East following Chong Kun Dang’s first biosimilar Nesvel.”
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