On December 23, Conoya announced that its independently developed Class 1 new drug Kangyueda® (Sepkibaimab Injection) was approved for marketing by the National Medical Products Administration for the treatment of chronic sinusitis with nasal polyps (CRSwNP). Previously, this indication was included in the priority review.

The prevalence of chronic sinusitis in my country is 8%, of which about one-third are patients with chronic sinusitis with nasal polyps. The pathogenesis of chronic sinusitis with nasal polyps is complex, and the clinical symptoms such as nasal congestion, hyposmia and runny nose caused by it seriously affect the quality of life of patients.

Clinically, the treatment of this disease faces difficulties such as refractory and recurrent, and innovative treatment methods are urgently needed. Kangyueda® (sipkizumab) is a highly effective, humanized monoclonal antibody targeting the interleukin-4 receptor α subunit (IL-4Rα). It is the first IL-4Rα antibody drug approved for marketing in China and the second in the world. By targeting IL-4Rα, sipkizumab can double block the signal transduction of interleukin 4 (IL-4) and interleukin 13 (IL-13), inhibit Th2 cell differentiation, and thus effectively reduce the inflammatory response, achieving effective treatment of chronic sinusitis with nasal polyps.

Phase III clinical data for this drug showed that after receiving sipkizumab treatment, patients' nasal polyps can shrink rapidly and significantly, nasal congestion symptoms are relieved, and the sense of smell is effectively improved. Long-term treatment for more than 6 months can bring sustained clinical benefits, almost achieving clinical cure, and comprehensively improving the quality of life of patients. Specifically, nasal polyps were significantly reduced in size two weeks after the first use of the drug; four weeks after the drug was used, the sense of smell was significantly restored, and nasal comprehensive symptoms (including nasal congestion, runny nose, decreased or loss of smell) were significantly improved; after 24 weeks of treatment, 81% of patients achieved at least 50% reduction in nasal polyps (NPS score improved by ≥2 points compared with baseline), 42% of patients could achieve "drug-induced polypectomy" (NPS score = 0 or 1), 70% of patients achieved nasal ventilation after treatment (NCS score improved by ≥1 point compared with baseline), and 76% of patients had significantly improved quality of life (SNOT-22 score improved by ≥8.9 points compared with baseline). After 52 weeks of medication, 90% of patients achieved at least 50% reduction in nasal polyps (NPS score improved by ≥2 points from baseline), 62% of patients achieved "drug-induced polypectomy" (NPS score = 0 or 1), 86% of patients achieved nasal ventilation after treatment (NCS score improved by ≥1 point from baseline), and 85% of patients had significantly improved quality of life (SNOT-22 score improved by ≥8.9 points from baseline). In terms of safety, during the treatment period, the incidence of adverse events (TEAEs) during treatment in the Kangyueda® (Sipkibaimab) and placebo groups was comparable, and the vast majority of TEAEs were mild or moderate, with good long-term safety.

Public information shows that Kangyueda® (Sipkibaimab) was approved for marketing in September 2024, and has been approved for two indications of moderate to severe atopic dermatitis and chronic sinusitis with nasal polyps in adults so far.

According to information on Conoya's official website, the drug's treatment prospects for more autoimmune diseases are also being explored. Its application for marketing authorization for seasonal allergic rhinitis has been accepted by the National Medical Products Administration, and clinical research on multiple indications such as asthma, nodular pruritus, chronic obstructive pulmonary disease, and atopic dermatitis in children and adolescents is also progressing rapidly.

https://mp.weixin.qq.com/