Industry Overview - The self-immune field is becoming one of the hottest sectors for innovative drug investment, with both primary and secondary market transactions heating up [1] - In the first half of 2025, the total transaction amount for License-out of innovative drugs in China approached $66 billion, surpassing the total BD transaction scale for the entire year of 2024, setting a historical record [1] - The proportion of BD transactions for tumor pipeline licensing has decreased from 72% in 2023 to 61% in 2024, while the proportion for metabolism and self-immune has increased from 12% to 25%, nearly doubling [1] Company Performance - Qianxin Biotech, established in 2015, focuses on biotherapies for self-immune and allergic diseases, covering four major areas: skin, respiratory, digestive, and rheumatology [1] - In the first half of 2025, Qianxin Biotech reported revenue of 206 million RMB, a year-on-year increase of 359.69%, primarily driven by upfront payments, milestone payments, clinical research service fees, and CDMO revenue [1] - The adjusted loss for the period was 5.22 million RMB, significantly reduced by 96% compared to the same period last year [2] Product Development - Qianxin Biotech's flagship product QX005N (IL-4Rα monoclonal antibody) has obtained IND approval for seven indications, making it one of the products with the most indications targeting IL-4Rα in China [3] - The company has completed patient enrollment for the Phase III clinical trial of QX005N for nodular prurigo and is nearing completion for atopic dermatitis, with results expected by the end of this year and early next year [3] - QX002N (IL-17A monoclonal antibody) achieved its primary endpoint in Phase III clinical research for ankylosing spondylitis in February 2025, with plans to submit a BLA within the year [3] Strategic Partnerships and Market Expansion - Qianxin Biotech's second-largest shareholder is Huadong Medicine, which has a nationwide sales network, allowing the company to accelerate its commercialization efforts [5] - The company has commercialized its first product, the biosimilar drug Seluxin®, which has been prescribed in over 1,200 hospitals, with sales accelerating [6] - In April 2025, Qianxin Biotech granted global rights for its long-acting self-immune dual antibody QX030N to Caldera, receiving a $10 million upfront payment and potential milestone payments totaling up to $545 million [6] Financial Backing - Qianxin Biotech recently received significant investment from TruMed Health Innovation Fund LP, providing strong institutional backing and enhancing market confidence in the company's long-term value [7]
从单抗到双抗，从国内到海外：荃信生物（02509）如何成为自免赛道新标杆？