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康诺亚-B(02162):CM512初战告捷,BIC潜力初步验证
KEYMED BIOKEYMED BIO(HK:02162) HTSC·2025-11-05 08:53

Investment Rating - The investment rating for the company is maintained as "Buy" with a target price of HKD 91.08 [1][5]. Core Insights - The Phase I clinical results of CM512, a dual antibody targeting TSLP/IL-13 for treating atopic dermatitis (AD), show promising efficacy and safety, outperforming the placebo group significantly [2][3]. - CM512 demonstrates a long half-life of 70 days, indicating potential for extended dosing intervals, and has shown rapid onset of action with a 50% EASI-75 response at 6 weeks in the 300mg dose group [2][4]. - The clinical data suggests that CM512 has competitive advantages over current standard therapies and other monoclonal antibodies, particularly in achieving deep remission [3][4]. Summary by Sections Clinical Results - The Phase I trial included 64 healthy participants and 46 moderate to severe AD patients, showing comparable rates of treatment-emergent adverse events (TEAE) and serious adverse events (SAE) between the trial and control groups [2]. - The 300mg dose group achieved EASI-75/90 rates of 58.3% and 41.7% at 12 weeks, significantly better than the placebo's 21.4% and 0% [2][3]. Competitive Landscape - CM512's EASI-90 response rate of 41.7% is superior to other treatments, including IL-4Rα monoclonal antibodies and small molecule drugs, indicating its potential as a best-in-class (BIC) therapy [3][4]. - Comparatively, other therapies like dupilumab and lebrikizumab have lower EASI-90 rates, reinforcing CM512's competitive edge [3][4]. Future Development - The company is expanding CM512's indications beyond AD, with ongoing Phase II trials for asthma, COPD, and chronic spontaneous urticaria, leveraging its long-acting profile [4]. - The potential for collaboration and further development in international markets is promising, given the initial efficacy data and competitive advantages [4]. Financial Projections - Revenue forecasts for the company have been adjusted, with expected revenues of RMB 570.96 million in 2025 and RMB 1,554 million by 2027, reflecting a significant growth trajectory [5][9]. - Net profit estimates for 2025-2027 have been revised to -679.40 million, -669.87 million, and -282.40 million respectively, indicating ongoing investment in R&D and market expansion [5][11].