Yuhan Corporation's developing allergy treatment, 'Resigercet,' has proven to be more effective than 'Xolair' (generic name: omalizumab), which has dominated the global market for over 10 years, emerging as a strong competitor. In recent clinical trials, it showed significant effects in patients who did not respond to existing treatments. Following the new lung cancer drug 'Lecraza', it remains to be seen whether the allergy drug will become another success story for Yuhan Corporation.
On the 13th (local time), Yuhan Corporation announced at the European Academy of Allergy and Clinical Immunology (EAACI) held in the UK that it demonstrated the effectiveness of Resigercet in chronic spontaneous urticaria patients who were not controlled by the established allergy drug Xolair, based on the results of its Phase 1b trial Part 2.
Resigercet is a new drug that Yuhan Corporation has been developing since 2020, having introduced it from the domestic biotech company GI Innovation. It is a drug that suppresses immunoglobulin E (IgE). IgE is an antibody that triggers allergic reactions by binding to an antigen on the surface of cells (FcεRIα) to elicit an immune response. Resigercet is a dual-action drug that removes both IgE antibodies and antigens simultaneously. Xolair, developed by Swiss Novartis and Roche, only blocks IgE antibodies. Although they belong to the same class, Resigercet has a broader scope of action.
In this clinical trial, Resigercet was additionally administered subcutaneously to 9 patients with chronic spontaneous urticaria not controlled by Xolair. As a result, it showed superior results in both the effectiveness of suppressing IgE remaining in the blood and safety compared to Xolair. Earlier data from the Phase 1b trial Part 1 presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) in March indicated that Resigercet demonstrated three times the efficacy of Xolair.
Chronic spontaneous urticaria, which is one of the allergic diseases, is a chronic skin disorder caused by type 2 inflammation, and antihistamines are the standard treatment. However, many patients remain uncontrolled with antihistamines alone, and the need for alternative medications has been continuously raised.
Yuhan Corporation expects that Resigercet could become a next-generation new drug capable of replacing the existing treatment Xolair. A Yuhan Corporation official noted, 'The market scope for Resigercet is significantly wide, especially if we include the patient group that does not respond to Xolair.'
Xolair received its first approval as an asthma treatment from the U.S. Food and Drug Administration (FDA) in 2003. It later received additional approval for the treatment of chronic spontaneous urticaria in 2014, dominating the global market for over 10 years. In 2020, it was also approved for allergic rhinitis and last year for food allergies, now used for a total of four diseases. Last year, Xolair generated approximately 6 trillion won in sales, with half coming from the U.S. market.
Yuhan Corporation has other potential competitors in the allergy treatment market. Dupixent (dupilumab), jointly developed by France's Sanofi and the U.S.'s Regeneron, was also approved in April as a treatment for chronic spontaneous urticaria, a decade after Xolair. Initially receiving its first FDA approval for eczema in 2017, it is now used for the treatment of seven allergic diseases, including moderate-to-severe atopic dermatitis, asthma, and urticaria. It generated approximately 20 trillion won in global sales last year.
Since Yuhan Corporation plans to develop Resigercet as a primary treatment for atopic dermatitis in addition to chronic spontaneous urticaria, a competitive landscape with Dupixent is expected. Although direct comparison clinical trials have not yet been conducted, the company stated that Resigercet has shown superiority over Dupixent in indirect comparisons. In this respect, Yuhan Corporation views Xolair as a stronger competitor than Dupixent.
According to the global market research firm Straits Research, the global allergy drug market is segmented by diseases such as urticaria, atopic dermatitis, and asthma, but the overall market size is expected to grow from approximately 50 trillion won in 2023 to 93 trillion won by 2033.
Kim Yeol-hong, the head of Yuhan Corporation's research and development, said, 'What stands out in this trial result is that it actually showed symptom improvement not only in patients with H1 antihistamine-refractory chronic spontaneous urticaria but also in those with chronic spontaneous urticaria not controlled by Xolair.' He noted, 'We are currently analyzing the final results of Phase 1b, which evaluate safety, pharmacokinetics, and pharmacodynamics in repeated dosing, and are reviewing the optimal strategy to enter the next development stage.'