Workflow
2023年报点评:司普奇拜单抗递交NDA,商业化在即

Investment Rating - The report does not specify a clear investment rating for the company [1]. Core Insights - The company reported a revenue of 350 million HKD in 2023, representing a significant increase of 254% year-on-year, primarily due to the upfront payment from the licensing agreement for CMG901 [2]. - Research and development expenses reached 590 million HKD, an increase of 18% compared to the previous year [2]. - The company has successfully submitted a New Drug Application (NDA) for CM310 for the treatment of moderate to severe atopic dermatitis, with expectations for another NDA submission for CRSwNP in 2024 [2]. - CMG901 has shown promising safety and tolerability in late-line gastric cancer, with a licensing deal with AstraZeneca worth up to 1.125 billion USD [2]. - The company anticipates revenues of 100 million HKD in 2024, 600 million HKD in 2025, and 2.169 billion HKD in 2026, driven by the commercialization of CM310 and CMG901 [3][7]. Summary by Sections Financial Performance - 2023 revenue was 350 million HKD, with a growth rate of 253.87% [4]. - The net profit attributable to the parent company was -359.36 million HKD, with a decrease of 16.63% [4]. - Earnings per share (EPS) for 2023 was -1.28 HKD [4]. - The return on equity (ROE) was -12.03% [4]. Revenue Forecast - The company forecasts revenues of 1 billion HKD in 2024, 6 billion HKD in 2025, and 21.7 billion HKD in 2026 [8]. - The expected revenue from CM310 in 2025 is 500 million HKD and 1.5 billion HKD in 2026 [7]. - CMG901 is projected to contribute 570 million HKD in 2026 [7]. Clinical Development - CM310 has completed a Phase III clinical trial for moderate to severe atopic dermatitis and has submitted an NDA [2]. - CMG901 has shown a confirmed objective response rate (ORR) of 33% in late-line gastric cancer patients [2]. - Other potential products, such as CM338 and CM313, are expected to read out data in 2024 [3].