Recently, the "Journey of Urticaria · Face-to-Face with Experts" tour conference on urticaria diagnosis and treatment guidelines was held in Yanji. Renowned authoritative experts in dermatology from across the country gathered to exchange views on cutting-edge advances in dermatology, relevant policies and regulations, and the latest guidelines in the field of urticaria.

During the conference, Professor Su Huichun from Fujian Medical University Union Hospital interpreted the *Guidelines for the Diagnosis and Treatment of Refractory Chronic Spontaneous Urticaria in China* issued in 2025. The guidelines state that clinical studies among Chinese CSU patients show that the overall response rate of omalizumab treatment reaches 87%–98.7% at week 12, with 65.2%–91.1% of patients achieving complete symptom relief, and approximately half of patients responding within one month. In addition, Professor Dong Qibin from Xilingol League Central Hospital delivered a keynote report titled *Omalizumab Ushered in a New Era in the Treatment of Chronic Spontaneous Urticaria*. He reviewed the relevant target‑based consensus for urticaria and the Phase III clinical data of Enyitan®. The Phase III clinical trial of CSPC Innovation’s omalizumab used the reference omalizumab as the control agent, and the results demonstrated that it was **bioequivalent** to the reference product with high robustness. Experts attending the meeting agreed that as China’s first omalizumab biosimilar, Enyitan® achieves full clinical efficacy comparable to the reference drug, and its lower treatment cost has greatly improved drug accessibility.

CSPC Innovation’s Omalizumab (Enyitan®) is the first biological agent approved in China for the treatment of chronic spontaneous urticaria. On September 26, 2024, it obtained the **Drug Registration Certificate** approved and issued by the National Medical Products Administration (NMPA), indicated for adult and adolescent patients (aged 12 years and older) with chronic spontaneous urticaria whose symptoms remain uncontrolled despite H1-antihistamine therapy. On January 26, 2025, a supplementary application was approved to add the indication for allergic asthma. It is indicated for adult, adolescent (aged 12 years and older) and pediatric patients (aged 6 to less than 12 years) with moderate to severe persistent allergic asthma whose symptoms are not adequately controlled despite treatment with inhaled corticosteroids and long-acting inhaled β2-adrenergic receptor agonists. It provides new treatment options for a large number of patients with chronic spontaneous urticaria and allergic asthma.