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益方生物:2024年三季报点评:稳步推进临床进度,D-1553获批上市在即

Investment Rating - The report maintains a "Buy" rating for the company, indicating a positive outlook based on the potential of its technology platform and leading strategic positioning [2]. Core Insights - The company is steadily advancing its clinical development pipeline, with significant progress on existing products and collaborations, particularly with D-1553, which is nearing approval for market launch [1][2]. - Research and development expenditures totaled 296 million yuan in the first three quarters of 2024, reflecting a year-on-year decrease of 15.28%, with Q3 2024 expenditures at 87 million yuan, down 22.39% year-on-year [1]. - D-1553 has shown promising results in clinical trials, including a Phase II study for KRAS G12C mutation non-small cell lung cancer, which was presented at the AACR annual meeting and published in a prestigious journal [2]. - The company reported a significant decline in revenue, with Q3 2024 revenue at 4.28 million yuan, down 90.92% year-on-year, and a net loss of 910 million yuan for the same period [3]. Summary by Sections Clinical Development Progress - The company is advancing its clinical projects, including collaborations with Betta Pharmaceuticals for postoperative adjuvant therapy and ongoing Phase I studies for D-1553 in combination with other treatments [1]. - D-1553 has been included in the breakthrough therapy program by the CDE for two new indications, indicating regulatory support for its development [1]. Financial Performance - For the first three quarters of 2024, the company reported total revenue of 19 million yuan, a decrease of 84.94% year-on-year, and a net loss of 305 million yuan [3]. - The net profit forecast for 2024 and 2025 has been revised down to -360 million yuan and -191 million yuan, respectively, with a new forecast for 2026 at -150 million yuan [2]. Market Outlook - The commercial prospects for D-1553 post-approval are considered promising, with expectations for significant market potential once it is launched [2].