诺诚健华(09969):上调2025年销售指引,自免管线加速推进
Shenwan Hongyuan Securities·2025-11-17 12:12

Investment Rating - The report maintains a "Buy" rating for the company [1][7][15] Core Insights - The company has raised its 2025 sales target from a year-on-year growth of over 35% to over 40% due to strong sales performance of its key product, orelabrutinib, which saw a 46% year-on-year increase in sales to RMB 1.01 billion in the first three quarters of 2025 [4][5][12] - The company reported a revenue of RMB 1.12 billion for the first nine months of 2025, reflecting a 60% year-on-year growth, with a net loss of RMB 64 million, which is a 77% reduction compared to the previous year [4][11] - The company has a robust pipeline in both oncology and autoimmune diseases, with several products in various stages of development, including orelabrutinib and ICP-332 [5][6][13][14] Financial Performance - For the first three quarters of 2025, the company recorded a revenue of RMB 1.12 billion, with a net loss of RMB 64 million, and a third-quarter revenue of RMB 384 million, marking a 38% year-on-year increase [4][11] - Research and development expenses for the first three quarters were RMB 676 million, a 10% increase year-on-year, while selling expenses rose by 41% to RMB 386 million [4][11] - The company had approximately RMB 7.76 billion in cash as of September 2025, providing a solid financial foundation for ongoing and future projects [4][11] Sales and Product Development - Orelabrutinib's sales reached RMB 373 million in the third quarter of 2025, with a year-on-year growth of 35% and a quarter-on-quarter growth of 14% [5][12] - The company is advancing its autoimmune pipeline, with plans to submit a new drug application for orelabrutinib for ITP in the first half of 2026 and to read out phase IIb data for SLE by the end of 2025 [6][13] - The company expects to submit 5-7 IND applications targeting malignant tumors and autoimmune diseases in 2026, indicating a strong early-stage pipeline [14]