Korea UCB Pharma has achieved significant milestones this year, securing South Korean regulatory approval for two innovative therapies: Bimzelx (bimekizumab) for plaque psoriasis and Zilbrysq (zilucoplan) for myasthenia gravis. Building on this momentum, the company aims to continue expanding its portfolio in 2024 with additional drug approvals anticipated.

In 2023, the Ministry of Food and Drug Safety (MFDS) approved Bimzelx on August 29 and Zilbrysq on November 21. Bimzelx represents a breakthrough in plaque psoriasis treatment as the first dual-action inhibitor targeting interleukin-17A (IL-17A) and interleukin-17F (IL-17F), two cytokines critical to the inflammatory processes underlying the disease. The drug is indicated for adults with moderate to severe plaque psoriasis requiring phototherapy or systemic therapy. Zilbrysq, meanwhile, is a complement C5 inhibitor approved as an add-on therapy for generalized myasthenia gravis in adults who test positive for anti-acetylcholine receptor antibodies. This treatment offers a significant advance as the first self-administered subcutaneous injection for this condition available in Korea.

Looking ahead, UCB Pharma is actively pursuing the approval of two additional drugs in South Korea. The first, Fintepla (fenfluramine), is being reviewed as a treatment for seizures associated with Dravet syndrome and Lennox-Gastaut syndrome. Dravet syndrome has been prioritized, with Fintepla receiving orphan drug designation in March 2023 based on promising phase 3 trial results involving children and adolescents aged 2 to 18. The drug was further recognized under the GIFT (Global Innovative Product Fast Track) program in June, signaling the potential for expedited approval in 2024, barring any unforeseen regulatory delays. Already approved in major markets, including the United States, Europe, the UK, and Japan, Fintepla is expected to seek separate orphan drug designation in Korea for Lennox-Gastaut syndrome.

Another promising candidate is Rystiggo (rozanolixizumab), a humanized IgG4 monoclonal antibody designed to treat 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, the drug 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.

Meanwhile, industry attention is turning to Bimzelx as it prepares to compete in Korea’s highly 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 underscore the company’s commitment to addressing unmet medical needs while solidifying its position in the Korean pharmaceutical market.