证券研究报告 自免行业报告（一）：双靶协同拓展治疗边界， 重视TSLP类双抗迭代潜力 中邮证券研究所 医药团队 行业投资评级：强大于市|维持 盛丽华（首席分析师） SAC编号：S1340525060001 徐智敏（研究助理） SAC编号：S1340125080012 1 1 发布时间：2025-09-29 投资要点 前言：下一个自免领域的blockbuster的潜在分子在于理解现有疗法下自免领域亟待解决的未满足需求是什么。 自免的药物明显的特征在于人数多、DOT长（长期用药），往往能诞生多个blockbuster，如度普利尤单抗、丽生奇珠单抗、 乌司奴单抗等销售超过100亿美元的分子，本系列报告想探讨下一个自免领域的blockbuster的潜在分子会是什么？而关于 这一问题我们认为思考的核心方向在于，现有疗法下自免领域亟待解决的未满足需求是什么以及什么样的药物最有可能率先 满足这些需求。 高患病基数人群孕育大市场，大市场催生药物新需求。 回顾来看，Dupi的成功在于"一药治多症"，进一步来看其覆盖的核心适应症特应性皮炎（AD）、哮喘、COPD患病人数 庞大，均为千万人数级别。在现有疗法下上述适应症仍未满足的关 ...

Group 1 - The core viewpoint of the news highlights the significant revenue growth and reduced losses for Qianxin Biologics, with a reported revenue of RMB 206 million, a year-on-year increase of 359.69%, and a loss of RMB 30.93 million, a decrease of 83.11% [1] - The revenue increase is primarily attributed to upfront payments from licensing projects, milestone payments, clinical research service fees, and CDMO income [1] - The company has five pipeline products with advanced clinical progress, which have established partnerships with domestic pharmaceutical companies for commercialization, enhancing market potential [1] Group 2 - The company aims to internationalize its dual-antibody pipeline, with QX027N and QX031N expected to submit IND applications simultaneously in the US and China in Q3 2025 and H2 2025, respectively [2] - QX035N is projected to submit its IND application in H2 2026, indicating a strategic timeline for product development [2] - There are currently no major dual-antibody products in the autoimmune field globally, suggesting that the company's innovative pipeline has the potential for rapid clinical value realization [2]

Core Insights - Jiangsu Quanxin Biopharmaceutical Co., Ltd. (stock code: 02509.HK) reported a significant revenue increase of 359.69% year-on-year, reaching 206 million yuan for the first half of 2025, while losses were reduced by 83.11% to 30.93 million yuan [1] - The revenue growth was primarily driven by income from licensing agreements and CDMO services, highlighting the company's progress in innovation and commercialization [1][5] Financial Performance - For the six months ending June 30, 2025, the company achieved a revenue of 206 million yuan, a substantial increase of 359.69% compared to the previous year [1] - The net loss for the same period was 30.93 million yuan, significantly reduced by 83.11% year-on-year [1] - As of June 30, 2025, the company had cash and cash equivalents totaling 559 million yuan, providing a solid foundation for future development [1] Product Development - The company has made significant progress in its core product pipeline, with multiple products achieving key milestones [2][3] - QX005N (IL-4Rα monoclonal antibody) has received IND approval for seven indications, making it one of the most advanced candidates in China for this target [3] - QX002N (IL-17A monoclonal antibody) has reached the primary endpoint in its Phase III clinical trial for ankylosing spondylitis and plans to submit a BLA within the year [3] Innovation and R&D - The company is developing a series of long-acting dual antibodies, with four innovative dual antibody pipelines disclosed, three of which are expected to file IND applications within the year [4] - The focus of these dual antibodies is on respiratory and skin diseases, aiming to fill existing treatment gaps [4] Commercialization Strategy - Quanxin Biopharmaceutical has established a diversified commercialization path, utilizing a "self-research + strategic cooperation" model [5] - The company’s first commercial product, Seluxon® (Ustinumab injection), has seen successful commercialization since its approval in October 2024, with over 60,000 units shipped by June 30, 2025 [5][6] - The company has also initiated international expansion, successfully completing its first overseas NewCo transaction with Caldera Therapeutics, Inc. in April 2025 [6] Future Outlook - The company completed a placement of 5 million shares, raising 99 million HKD, which will be used for debt repayment and accelerating the development of new pipelines [7] - With strong innovation capabilities, diversified revenue structures, and a steadily advancing international strategy, the company is positioned to achieve greater development in the global biopharmaceutical market [7]