Incidents:

China's National Drug Administration (NMPA) has recently approved a new drug marketing application for sipcibalizumab (anti-IL-4Rα monoclonal antibody; trade name: Kang Yueda; R&D code: CM310). The indication is moderate to severe atopic dermatitis in adults.

Comment:

Long-term treatment with supibalizumab can provide continuous clinical benefits and is safe.

The approval for marketing of spoximab was based on a multi-center, randomized, double-blind, placebo-controlled phase III study. The common main end point was that the eczema area and severity index improved by at least 75% (EASI-75) at week 16 and that the overall evaluation method (IGA) score of the researcher reached 0 or 1 point and decreased by at least 2 points from the baseline. The results showed that the trial reached a common primary endpoint in week 16, long-term treatment can obtain continuous clinical benefits, and safety is good.

Sproximab is the first domestically produced IL-4Rα antibody drug approved for marketing by the NMPA.

Sproximab is a highly effective, humanized antibody targeting the interleukin 4 receptor alpha subunit (IL-4Rα). It is the first domestically produced IL-4Rα antibody drug approved for marketing by the NMPA. By targeting IL-4Rα, spoximab can double block the signal transduction of interleukin 4 (IL-4) and interleukin 13 (IL-13). IL-4 and IL-13 are two key cytokines that cause type II inflammation. As of September 12, 2024, the NMPA has accepted the application for marketing of a new drug with spoximab to treat seasonal allergic rhinitis and chronic sinusitis with nasal polyps.

Profit forecasting, valuation and ratings:

Taking into account changes in the company's product development schedule, the 2024-2025 net profit forecast was lowered to -7.04/ -0.737 billion yuan (the original forecast was -4.13/ -0.242 billion yuan), and the 2026 net profit forecast was added to -0.304 billion yuan. Based on the latest share capital, EPS was -2.51/ -2.63/ -1.09 yuan, respectively. The company's core product, spoximab, was approved for marketing. Given the large population of atopic dermatitis patients and the broad market, we maintain a “buy” rating.

Risk warning: risk of R&D progress falling short of expectations; risk of sales falling short of expectations; risk of international cooperation falling short of expectations.