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 [2] - 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 [2] - The adjusted loss for the period was 5.221 million RMB, significantly reduced by 96% compared to the same period last year, with cash and cash equivalents amounting to approximately 559 million RMB as of June 30, 2025 [2] Product Development - Qianxin Biotech's first commercialized product is the biosimilar drug Seluxin, which received approval from the National Medical Products Administration in October 2024 [3] - As of June 2025, over 60,000 doses of Seluxin have been shipped to Huadong Medicine, with additional applications for pediatric plaque psoriasis and Crohn's disease under review [3] Pipeline Advancements - The lead product QX005N (IL-4Rα monoclonal antibody) has obtained IND approval for seven indications, making it one of the most advanced products targeting IL-4Rα in China [4] - QX002N (IL-17A monoclonal antibody) has reached the primary endpoint in its Phase III clinical trial for ankylosing spondylitis, with plans to submit a BLA within the year [4] - QX004N (IL-23p19 monoclonal antibody) and QX008N (TSLP monoclonal antibody) are in Phase III and Phase II clinical stages, respectively, with development progress among the top in China [4] Strategic Partnerships and Market Expansion - Qianxin Biotech's second-largest shareholder is Huadong Medicine, which has a nationwide sales network, facilitating faster commercialization of products [6] - The company has entered into a global rights agreement for QX030N with Caldera, receiving a $10 million upfront payment and potential milestone payments totaling up to $545 million [7] - The CDMO business and external research services contributed approximately 22 million RMB in revenue in the first half of 2025, with expectations for continued growth [7] Investment and Market Confidence - Qianxin Biotech recently received significant investment from TruMed Health Innovation Fund, enhancing its market credibility and long-term value perception [8]
从单抗到双抗，从国内到海外：荃信生物如何成为自免赛道新标杆？