Today, Shanghai JeYou Pharmaceutical Technology Co., Ltd. announced that the phase III clinical enrollment of the company's independently developed anti-IgE drug, oripazumab (JYB1904), for chronic spontaneous urticaria (CSU) has been completed three months ahead of schedule. This multicenter, randomized, double-blind, placebo-controlled clinical trial was led by Peking University People's Hospital and led by Professor Zhang Jianzhong. It mainly evaluated the efficacy and safety of JYB1904 injection in CSU patients with inadequate control of second-generation H1 antihistamines (administered every 12 weeks), and it is planned to enroll 240 CSU patients.

JYB1904

The results of CSU Phase II clinical trials completed before showed that JYB1904 was better than omazumab (administered every 4 weeks) at longer administration intervals (every 8 weeks and every 12 weeks). In terms of safety, JYB1904 was generally well tolerated. No serious adverse events related to the test drug was reported, and no new safety risk signal was observed compared with omazumab.

At the same time, JeYou Medicine also vigorously promotes clinical trials of allergic asthma, allergic rhinitis and other indications around this product. At present, JeYou Medicine has completed the phase II clinical trial of JYB1904 in patients with allergic asthma, and the phase II clinical trial in patients with perennial allergic rhinitis is being carried out smoothly. In addition, the phase Ib clinical trial in adolescent patients with allergic diseases has recently completed the patient enrollment, which is used to support the target population of multiple indications to expand from adults to adolescents.

Professor Zhang Jianzhong from Peking University People's Hospital said: "The burden of CSU in China is heavy, and the prevalence rate is as high as 2.6%. Although authoritative guidelines at home and abroad consistently list non-sedative H1 antihistamines as the first-line treatment, the clinical reality is not satisfactory. Under the standard dose, only less than half of patients can achieve complete control of symptoms; Even if the dosage is increased to four times of the routine dosage, there are still 10% ~ 50% patients with poor response and significant unmet treatment needs. At present, the diagnosis and treatment of CSU is moving from single symptom control to precise intervention based on immune mechanism. This time JYB1904 completed the enrollment of phase III patients ahead of schedule, which reflected the patients' urgent expectation for new therapy. I look forward to bringing new changes to CSU treatment with solid clinical evidence. "

JYB1904 is a new generation of ultra-long-acting recombinant humanized anti-IgE monoclonal antibody injected subcutaneously, which is intended to be used to treat chronic spontaneous urticaria, moderate and severe allergic asthma, allergic rhinitis, food allergy and other allergic inflammatory diseases. JYB1904 can specifically bind and block human IgE, reduce the level of free IgE in patients and down-regulate the expression of high affinity IgE receptor (FcεRI), so as to minimize the release of inflammatory mediators in the allergic inflammatory cascade. In phase I clinical trials, it has been proved that JYB1904 has significantly prolonged half-life (about 2.5 times) compared with the first generation anti-IgE drug omazumab with the same dose, and improved its pharmacokinetics and pharmacodynamics. In 2024, JeYou Pharmaceuticals authorized RAPT Therapeutics the right to develop, produce and commercialize the product outside Greater China, with the advance payment and milestone payment totaling 708 million US dollars, and will receive sales commission from high digits to low digits. In 2026, GSK announced the acquisition of RAPT Therapeutics with a total equity value of nearly $2.2 billion. At present, GSK is promoting the overseas clinical development of indications such as food allergy of this product.

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About JeYou Medicine

Shanghai JeYou Pharmaceutical Technology Co., Ltd. focuses on the "3+1" core treatment fields of tumor, nephropathy, pain and self-immunity, focusing on the research and development, manufacture and commercial transformation of innovative drugs. The company builds a differentiated product matrix with international competitiveness, covering various drug types such as monoclonal/monoclonal antibodies, TCE, ADC, small molecule drugs and PROTAC. At present, the self-developed product portfolio has reached 40+ items, and more than 10 items have entered the clinical stage. In February, 2026, Jilemei (Sosimerese Sulfate Tablets), an innovative anti-tumor drug independently developed by the company, was approved for listing in National Medical Products Administration.