Maintain an “Overweight” rating. The company recently disclosed CMG901 Phase I data and announced CM310's Phase III 52-week follow-up data on the 2024ASCO. The data is excellent. Maintain the 2024-2026 revenue forecast at $1.56/5.26/$1,441 million, maintaining the “gain” rating.
Phase I of CMG901 showed initial efficacy, and multi-indication phase II/III clinical progress.
CMG901 authorized AZ in 2023.2 and received 10.1 month FDA fast-track review period for the treatment of G/GEJ. As of 2024.2.24, 133 patients with G/GEJ were included, 2.2 mg/kg, grade, and orphan drug eligibility. Phase I follow-up data was updated on 2024.6 at 2024 ASCO. The median group included 44, 50, and 19 patients in the 2.6 mg/kg and 3.0 mg/kg groups, respectively. The median number of subjects had 2 lines of treatment, and 74% had previously received PD-1/PD-L1 treatment. ① Effectiveness data:
89 evaluable patients with high expression of Claudin18.2 ORR = 33%, DCR = 70%, ORR= 48% (Zotuximab [CLDN18.2 mAb] +CAPOX treated ORR= 42.5%; ORR = 11.2% with navulizumab [PD-1 mAb] for 3LG/GEJ), showing some potential; the median follow-up time was 10.1mon, and all 93 patients with high Claudin18.2 expression MPFS = 4.8mon , MOS=11.8mon (median follow-up time of 8.87mon for navulizumab, m0S=5.26mon). ② Safety data:
Of the 113 patients, 55% G3TRAE was 55%, TRSAE was 32%, and 8% stopped taking the drug due to TRAE. The phase I trial showed controlled safety and initial efficacy. Currently, many phase II/III clinical trials for G/GEJ and pancreatic cancer have been carried out and are progressing steadily.
CM310 has excellent long-term efficacy and is expected to be approved by the end of 24. CM310 adult moderate to severe AD submitted an NDA in February '23 and was included in the CDE for priority review and approval. We expect it to be approved for marketing by the end of '24, and commercialization will officially begin in '25, making it the first domestically produced IL-4R monoclonal antibody and the second largest in the world. Phase III registered clinical follow-up data for AD was disclosed on EAACI in 2024.6. 476 patients were divided 1:1 into the CM310 group and control group. The 52W EasI-75 = 92.5% vs. 88.7%, IGA0/1 and decreased by ≥2 from baseline = 67.3% vs. 64.2%, and the weekly PP-NRS average decreased by at least 4 points from baseline = 67.3% vs. 60.5%. The data is excellent and the security is good. Other indications are progressing steadily: ① Phase II trials for moderate to severe AD in adolescents will be initiated in 2024.2: ② crSWNP is expected to submit NDAs within 2024; ③ Phase III of allergic rhinitis has been initiated; ④ Phase II/III of moderate to severe asthma responsible for Shiyao is progressing steadily.
Catalyst: CM310 approved for marketing, CMG901 rapid clinical progress risk warning: new drug development falls short of expected risk, new drug launch volume falls short of expected risk