The first domestic IL-4R monoclonal antibody has been approved for listing!

On September 12th, the NMPA official website showed that Kangnoah's Sipuchibaixi monoclonal antibody was approved for listing, used to treat moderate to severe atopic dermatitis in adults with poor control or unsuitability for topical treatment (acceptance number: CXSS2300090). This is the first domestically approved IL-4R antibody drug and the second globally.

Sipuchibaixi monoclonal antibody (CM310) is a high-affinity, humanized antibody developed by Kangnoah targeting IL-4Rα. By targeting IL-4Rα, it can dual-block the signaling of IL-4 and IL-13, thereby inhibiting inflammatory reactions, and is used for indications such as moderate to severe asthma, COPD, and atopic dermatitis.

In March 2021, Simcere Pharmaceutical Group reached a cooperation agreement with Kangnoah to develop and commercialize Sipuchibaixi monoclonal antibody in China (excluding Hong Kong, Macau, and Taiwan) for respiratory diseases such as moderate to severe asthma and chronic obstructive pulmonary disease, becoming the Marketing Authorization Holder (MAH). The upfront payment for this transaction is 70 million RMB, with milestone payments of up to 100 million RMB, and there is also the possibility of receiving sales milestone payments and royalties in the future.

This approval is based on a multicenter, randomized, double-blind, placebo-controlled Phase III study (CM310AD005), with the achievement of at least 75% improvement in Eczema Area and Severity Index (EASI-75) and Investigator Global Assessment (IGA) score reaching 0 or 1 and a decrease of ≥2 points from baseline at week 16 as the co-primary endpoints.

The results showed that at 16 weeks of treatment with Sipuchibaixi monoclonal antibody, the proportion of subjects achieving EASI-75 was 66.9%, and the proportion of subjects achieving an IGA score of 0 or 1 (IGA 0/1, meaning complete or almost complete clearance of skin lesions) and a decrease of ≥2 points from baseline was 44.2%, both superior to the placebo group (25.8% and 16.1% respectively), with significant statistical differences (P<0.0001) between the two groups.

In June 2024, Kangnoah announced data for the 52nd week of treatment, with EASI-75 response rates of 92.5% and 88.7% for the Sipuchibaixi monoclonal antibody group and the placebo to Sipuchibaixi monoclonal antibody group respectively; EASI-90 response rates of 77.1% and 65.6% respectively; IGA scores of 0 or 1 and a decrease of ≥2 points from baseline response rates of 67.3% and 64.2% respectively; and the weekly average reduction in PP-NRS scores by ≥4 points from baseline response rates of 67.3% and 60.5% respectively

In terms of safety, the incidence of treatment-emergent adverse events (TEAE) with Siponimod monoclonal antibody therapy is comparable to the placebo group, with most TEAEs being mild to moderate in severity.

According to the Insight database, Siponimod monoclonal antibody currently has two indications that have been reported for marketing, namely chronic rhinosinusitis with nasal polyps and seasonal allergic rhinitis.

According to the Insight database, the world's first approved IL-4R monoclonal antibody is Dupilumab, developed by Sanofi in collaboration with Regeneron. In March 2017, it was FDA approved for the treatment of moderate to severe atopic dermatitis in adults, marketed under the brand name Dupixent®.

In its first year on the market, it achieved sales of $251 million. Subsequently, Dupixent was also approved for asthma and nasal polyp indications. By 2023, the global sales of the drug had reached $11.589 billion, a year-on-year increase of approximately 33%, and it entered the TOP 10 list of global drug sales in 2023. In the first half of 2024, Dupilumab sales were approximately $6.66 billion, surpassing AbbVie's Adalimumab ($5.084 billion) and Johnson & Johnson's Ustekinumab ($5.336 billion), becoming the new generation of "drug king" in the field of self-immunity.

Article Source: Insight Database, Original Title: "Just In! The first domestically produced IL-4R monoclonal antibody has been approved for marketing"