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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?
Zhi Tong Cai Jing· 2025-08-20 03:00
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(02509)如何成为自免赛道新标杆?
智通财经网· 2025-08-20 02:56
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]