According to the intelligence financial APP, GTJA released a research report stating that Kangnuoya-B (02162) recently updated CMG901's Phase I follow-up data, demonstrating preliminary efficacy and controllable safety. CM310's 52-week follow-up data shows good improvement in indicators such as EASI-75, and is expected to be approved by the end of the year, contributing to future performance. The rating remains at 'shareholding', and 2024-2026 revenue is predicted to remain at 1.56/5.26/14.41 billion yuan.

The main points of the report are as follows:

CMG901 Phase I showed preliminary efficacy, and Phase II/III clinical trials for multiple indications are in progress.

CMG901 was authorized by AZ in February 2023, and obtained FDA fast track qualification and orphan drug qualification for the treatment of G/GEJ. The I-phase follow-up data was updated at 2024ASCO in June 2024. A total of 133 G/GEJ patients were included as of February 24, 2024, with 44, 50, and 19 patients in the 2.2mg/kg, 2.6mg/kg, and 3.0mg/kg groups, respectively. The median previous line of treatment was 2 lines and 74% have previously received PD-1/PD-L1 therapy.

①Efficacy data: ORR=33%, DCR=70% for 89 evaluable patients with Claudin18.2 high expression; ORR=48% for the low dose 2.2mg/kg group (ORR=42.5% for the treatment of 1L G/GEJ with [CLDN18.2 monoclonal antibody]+CAPOX; ORR=11.2% for the treatment of 3L G/GEJ with [PD-1 monoclonal antibody] ); demonstrating certain potential; median follow-up time of 10.1 months, mPFS=4.8 months and mOS=11.8 months for all 93 patients with Claudin18.2 high expression( the median follow-up time and mOS for treatment with Naduliou monoclonal antibody[Pembrolizumab] were 8.87 mon and 5.26 mon, respectively). ②Safety data: ≥G3TRAE was 55% among the 113 patients, TRSAE was 32%, and 8% of the subjects stopped using the drug due to TRAE. The Phase I study showed controllable safety and preliminary efficacy. Multiple Phase II/III clinical trials for G/GEJ and pancreatic cancer are currently underway.

CM310 has excellent long-term efficacy and is expected to be approved by the end of 2024.

CM310 adult moderate to severe AD submitted NDA in December 2023 and was included in CDE's priority review and approval. The company expects to be approved for listing by the end of 2024 and begin commercialization in 2025. It is China's first and the world's second IL-4R monoclonal antibody. The III-stage registration clinical follow-up data for AD will be disclosed at EAACI in June 2024. A total of 476 patients were 1:1 divided into the CM310 group and the control group. The EASI-75 at 52 weeks was 92.5% vs 88.7%, the proportion of IGA0/1 and a decrease of ≥2 compared to baseline was 67.3% vs 64.2%, and the proportion of PP-NRS weekly averages decreased by ≥4 points compared to baseline was 67.3% vs 60.5%. The data is excellent and safety is good. Other indications are steadily advancing: ①Started Phase III testing for moderate to severe AD in teens in February 2024; ②Expected to submit NDA for CRSwNP within 2024; ③III-phase clinical trials have been initiated for allergic rhinitis; ④II/III trials for moderate to severe asthma are progressing steadily under the responsibility of Shi Yao.