Following the successful approval of two innovative therapies in South Korea this year, UCB Pharma is setting its sights on further expanding its presence in the region. The company recently gained approval for Bimzelx (bimekizumab) for plaque psoriasis and Zilbrysq (zilucoplan) for myasthenia gravis, and is now pursuing approval for two additional drugs in 2024.
Recent Approvals: Bimzelx and Zilbrysq
In 2023, South Korea's Ministry of Food and Drug Safety (MFDS) approved Bimzelx on August 29 and Zilbrysq on November 21. Bimzelx marks a significant advancement in plaque psoriasis treatment as the first dual-action inhibitor targeting interleukin-17A (IL-17A) and interleukin-17F (IL-17F). These cytokines are critical to the inflammatory processes underlying the disease. The drug is indicated for adults with moderate to severe plaque psoriasis who require phototherapy or systemic therapy.
Zilbrysq, a complement C5 inhibitor, is approved as an add-on therapy for generalized myasthenia gravis in adults who test positive for anti-acetylcholine receptor antibodies. It represents a notable advancement as the first self-administered subcutaneous injection available in Korea for this condition.
Potential Approvals: Fintepla and Rystiggo
UCB Pharma is actively seeking approval for Fintepla (fenfluramine) as a treatment for seizures associated with Dravet syndrome and Lennox-Gastaut syndrome. Fintepla has received orphan drug designation for Dravet syndrome in March 2023, based on promising phase 3 trial results involving children and adolescents aged 2 to 18. Further recognition under the GIFT (Global Innovative Product Fast Track) program in June suggests the potential for expedited approval in 2024, pending regulatory review. Fintepla is already approved in major markets, including the United States, Europe, the UK, and Japan, and the company plans to seek separate orphan drug designation in Korea for Lennox-Gastaut syndrome.
Rystiggo (rozanolixizumab), a humanized IgG4 monoclonal antibody, is another promising candidate for treating generalized myasthenia gravis in patients positive for anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibodies. Approved in the United States, Europe, and Japan, Rystiggo received FDA approval in June 2022 for use as an add-on therapy alongside corticosteroids or non-steroidal immunosuppressants. While it has not yet been included in Korea’s GIFT program, its designation early next year could accelerate the approval process.
Bimzelx in the Korean Market
Industry attention is now focused on Bimzelx as it prepares to enter Korea’s competitive plaque psoriasis market in 2024. In head-to-head phase 3 trials, Bimzelx demonstrated superior efficacy and safety compared to established biologics such as Humira (adalimumab), Stelara (ustekinumab), and Cosentyx (secukinumab). If UCB Pharma successfully secures reimbursement and launches the drug in the latter half of 2024, it could significantly reshape the biologics market for plaque psoriasis treatment.
UCB Pharma’s strategic efforts to introduce new treatments in South Korea highlight the company’s commitment to addressing unmet medical needs and strengthening its position in the Korean pharmaceutical market.
