迪哲医药(688192) - 2025 Q4 - 年度业绩预告

Financial Projections - The company expects to achieve approximately CNY 800 million in revenue for 2025, an increase of about CNY 440.1 million or 122.28% year-on-year[3]. - The estimated R&D expenses for 2025 are around CNY 860 million, an increase of approximately CNY 136.31 million or 18.84% year-on-year[3]. - The net loss attributable to the parent company is projected to be around CNY 770 million, a reduction of approximately CNY 75.96 million or 8.98% year-on-year[3]. - The net loss attributable to the parent company, excluding non-recurring gains and losses, is expected to be about CNY 850 million, a decrease of approximately CNY 48.89 million or 5.44% year-on-year[3]. - The company anticipates continued negative net profit due to high R&D investments, despite significant revenue growth and successful product development[7]. - There are no major uncertainties affecting the accuracy of this performance forecast[8]. Product Development and Approvals - The company has successfully included two products, Shuwozhe® and Gaoruizhe®, in the national medical insurance drug list, which is expected to significantly enhance patient accessibility and market share[4]. - Shuwozhe® received FDA approval for treating adult patients with locally advanced or metastatic NSCLC with EGFR Exon20ins mutations, marking it as the first and only EGFR Exon20ins NSCLC innovative drug approved in the U.S.[5]. - The company is actively advancing its core R&D products, including Shuwozhe® and Gaoruizhe®, with ongoing clinical studies presented at major international conferences[6]. - The company’s wholly-owned subsidiary obtained a drug production license, ensuring qualifications for future commercial production[7].