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2023年报点评:CM310预计年底获批,多管线持续推进

Investment Rating - The report maintains a "Buy" rating for the company [4]. Core Insights - The core product CM310 for moderate to severe AD has submitted its NDA and is expected to be approved by the end of 2024, becoming the first domestically produced IL-4R monoclonal antibody [2][3]. - The company reported a revenue of 354 million in 2023, a 254% increase, primarily driven by upfront payments from the licensing of CMG901 to AstraZeneca [2]. - Adjusted net loss for the year was 318 million, with R&D expenses amounting to 596 million, reflecting an 18% increase due to rising employee costs and depreciation of new equipment [2]. - Cash and cash equivalents totaled 2.719 billion as of December 31, 2023, a decrease of 456 million from the end of 2022, indicating high capital utilization [2]. Financial Summary - Revenue projections for 2024 and 2025 have been revised down to 156 million and 526 million respectively, from previous estimates of 231 million and 697 million [2]. - The new revenue forecast for 2026 is set at 1.441 billion [2]. - The company is expected to initiate commercialization of CM310 in 2025 following its anticipated approval [2]. Clinical Development - CM310's Phase III trial data presented at EADV in October 2023 showed significant efficacy, with 66.9% of patients achieving EASI-75 compared to 25.8% in the control group [2]. - The company plans to start a Phase III double-blind trial for adolescents with moderate to severe AD in February 2024 [2]. - CMG901 has shown promising early data, with an overall response rate of 33% in a recent study, and is currently undergoing multiple Phase II clinical trials [2]. Pipeline Progress - The company has multiple products in its pipeline, including CM313 for ITP and CM326 for AD and asthma, both showing promising early results [2]. - The clinical data for CM350, CM355, and CM336 are also progressing steadily [2].