Zheng Quan Shi Bao Wang·2025-11-13 10:29Core Insights - Nuo Cheng Jian Hua reported a significant revenue increase of 59.8% year-on-year for the first three quarters of 2025, reaching 1.12 billion yuan, primarily driven by the sales growth of its core product, the BTK inhibitor Aobutini (Yinokai®) [2][5] - The company expects to achieve breakeven for the entire year of 2025, two years ahead of its profitability target, supported by strong revenue growth and improved cost efficiency [2][5] Financial Performance - Aobutini's revenue for the first three quarters increased by 45.8% year-on-year, totaling 1.01 billion yuan, surpassing the total revenue for the previous year [2] - The company's loss narrowed significantly by 74.8%, down to 70 million yuan, due to rapid revenue growth and enhanced cost management [2] Globalization Strategy - Nuo Cheng Jian Hua is accelerating its globalization efforts, having completed two major licensing agreements this year, including a significant deal with Zenas for Aobutini and other autoimmune pipeline products [3][4] - The agreement with Zenas includes an upfront payment of 100 million USD and potential milestone payments, with the total deal value exceeding 2 billion USD [3] Product Pipeline and Market Position - The company is strengthening its leadership in the hematological oncology market with Aobutini, Tanshizhu Single Antibody (Mingnuokai®), and Mesutoclax, covering multiple indications [6] - Aobutini has been approved for first-line treatment of CLL/SLL, enhancing its market position [6][7] - Tanshizhu Single Antibody has been fully commercialized in China, providing a new treatment option for R/R DLBCL patients [8] Clinical Development - Mesutoclax is undergoing multiple clinical trials, showing significant potential in treating CLL/SLL and AML, with promising efficacy and safety data [9][10] - The company is advancing several Phase III clinical trials for autoimmune diseases, including Aobutini for primary progressive multiple sclerosis (PPMS) and immune thrombocytopenic purpura (ITP) [12][14] Innovation and R&D - Nuo Cheng Jian Hua is committed to innovation, with a 9.9% increase in R&D expenses, reaching 680 million yuan in the first three quarters of 2025 [19] - The company plans to submit 5 to 7 clinical trial applications for new drug candidates in 2026, focusing on oncology and autoimmune diseases [20]