On April 28, the company revealed that the phase III clinical trial of spiqibizumab for SAR reached the main end point. On April 28, the company revealed that the phase III clinical trial of spiqibimab for SAR treatment reached the main end point. Among the 108 subjects, the drug's rTNSS improvement was significantly superior to that of the placebo group, making it the first IL-4Rα monoclonal antibody in the world to complete phase III SAR clinical trials. We continue to be optimistic about the sales prospects of supuximab: 1) the number of SAR patients is huge, there is significant unmet demand, and the competitive landscape is showing a blue ocean trend; 2) we expect adult AD indications to be approved by the end of 24, and CRSWnP is expected to submit an NDA in 3Q24; 3) the company is actively building a commercial team, which will reach 200 people by the end of 24, and has expanded production capacity to 186,000 liters. We expect EPS for 24-26 to be (3.06)/(3.33)/(1.71), and the target price based on DCF is HK$55.36 (WACC: 11.4%, sustainable growth rate 2.5%). Maintain a “buy” rating.
Pioneering indications for allergic rhinitis
We expect the company to submit an NDA for treating SARs in the near future, and is expected to be approved in 25 years to seize market opportunities: 1) There are about 250 million domestic AR patients, of which SAR accounts for about 20%; 2) AR patients with poor first-line regimens have significantly unmet their needs. The 2022 edition of the “Guidelines for the Diagnosis and Treatment of Allergic Rhinitis” indicates that oral glucocorticoids and decongestants may have obvious systemic or local side effects, and there is no innovative treatment plan; 3) No biologics have been approved in China to treat AR; 3) No biologics have been approved in China to treat AR. complete As for the phase III trial products, only 7 biologics were developed in China, and the highest progress of competing products is still in phase II clinical; 4) From a global perspective, dupriumab is in the phase II clinical stage, and spiquibimab is in the first tier of progress in the AR field and is highly competitive.
Approval for moderate to severe AD is imminent, and development of multiple indications is progressing steadily
The development of other indications for sipqibimab is also progressing steadily: 1) We expect the treatment of moderate to severe AD in adults to be approved by the end of 24, and the 52-week efficacy data will be read out at the EAACI in May; 2) Phase III clinical trials for severe AD in adolescents achieved FPI in 3M24 and are currently successfully enrolled; the PK trial for treating moderate to severe AD in children completed FPI at the end of 23; 3) We expect to submit an NDA for treatment of CRSwnP 3Q24 and is expected to be approved in 1H25; 4) The IND for treating one PN in 4 Approved by the CDE on January 28, we anticipate that the company may launch phase III clinical trials; 5) Asthma registration clinical trials will be promoted by Shiyao. Additionally, the injectable dosage form is undergoing BE clinical trials, and we expect to receive approval and improve compliance within 25 years.
Early pipelines continued to move forward, and many catalysts can be expected to be realized
The company's development in the research pipeline is progressing in an orderly manner: 1) CMG901 will disclose phase I updated data for a longer observation period on ASCO 2024; AstraZeneca has initiated phase III clinical trials of CMG901 to treat 2L+CLDN 18.2+ GC in 3M24, making the drug the world's first CLDN18.2 ADC to enter a registered clinical trial; 2) CM313 has reached 100% ORR for ITP treatment in an IIT clinical trial. We expect phase I/II clinical 3Q24 for SLE to be completed Climbing; 3) CM336 is expected to read early clinical data for the treatment of MM within the year; 4) The company's second-generation AD treatment products are expected to be declared IND within the year.
Risk warning: 1) The drug has not achieved the expected positive clinical results; 2) Drug commercialization uncertainty.