The company's recent situation
On April 28, the company announced that the phase III clinical trial of allergic rhinitis (SAR) during the CM310 treatment season has completed the disclosure and statistical analysis of double-blind treatment period data, and the clinical data has reached the main end.
reviews
CM310 allergic rhinitis phase III clinical success, differentiated layout SAR. A total of 108 patients were enrolled in the CM310 phase III clinical study on allergic rhinitis (NCT05908032). The enrolled patients were adult seasonal allergic rhinitis patients with poor control of nasal glucocorticoids or other treatments. The treatment group and control group were treated with CM310 as a single agent and placebo respectively. The patients were given the drug once every 2 weeks, and observed for 8 weeks during the safety period. The main end point of this clinical study was the average change in the total daily retrospective nasal symptom score (rTNSS) for 2 weeks of treatment compared to baseline. Dupriumab is currently not approved as an indication for allergic rhinitis. The domestic allergic rhinitis patient base is about 240 million people. The main treatment method for patients is hormone therapy, and the penetration rate of biological agents is low. We expect CM310 to submit an allergic rhinitis NDA in the near future and is expected to be approved in 25 years. We expect sales of allergic rhinitis indications to be impressive.
We expect the impact on the JAK inhibitor market to be limited, and we are still optimistic about the domestic sales volume of IL4Rα products. Recently, AbbVie announced the results of a phase IIIb/IIIII study of upatinib in the treatment of severe atopic dermatitis (AD). Upatinib was superior to dupliumab at the main endpoint PASI90 and WP-NRS scores of 0/1. Previously, phase III clinical Heads UP had similar results but did not change the competitive pattern of AD overseas products. There is still a black box warning on the current use label of upatinib. We believe IL4Rα is still an important variety in the current AD field. CM310 is leading in domestic progress. The company expects 2H24 to be approved for domestic listing. In addition to AD and allergic rhinitis, the company is expected to submit a CRSwnP listing application within the year and is expected to be approved for listing within 25 years. Currently, the company is actively building a sales team to prepare for the product launch. We recommend actively paying attention to the asset value of CM310.
Other pipeline assets are progressing clinically in an orderly manner. According to the official website of the 2024 ASCO conference, 1 the company will disclose CMG901 phase I follow-up data. In March '24, the partner AstraZeneca initiated phase III clinical trial of CMG901 as a single agent to treat 2L Claudin18.2 positive advanced gastric cancer. In addition, clinical trials of assets such as CM313, CM338, and CM335 within the pipeline are progressing in an orderly manner.
Profit forecasting and valuation
We keep our revenue and profit forecasts unchanged for 24 and 25. Maintaining an outperforming industry rating, due to the positive clinical progress of CM310 and the increase in the long-term asset value of the pipeline, we maintained our target price of HK$57 unchanged (corresponding to 63.3% upward space) using the DCF valuation method.
risks
New product launches, clinical trial data and sales fell short of expectations; competition intensified.