Group 1 - Tianfeng Securities initiates coverage on Qianxin Biologics-B (02509) with a "Buy" rating, projecting revenue of RMB 3.22 billion, RMB 4.41 billion, and RMB 5.93 billion for 2025-2027 respectively, and sets a target price of RMB 36.85, equivalent to HKD 40.25 for 2025 [1] - The autoimmune disease biopharmaceutical market in China is expected to reach RMB 36.3 billion by 2024, with biologics' market share projected to increase to 65.6% by 2030. The psoriasis market is anticipated to reach RMB 30.65 billion by 2030, while the ankylosing spondylitis market is expected to reach approximately RMB 46.3 billion by 2030 [1] - Current first-line treatments for autoimmune diseases like psoriasis and ankylosing spondylitis primarily involve corticosteroids, immunosuppressants, and non-steroidal anti-inflammatory drugs, which have limitations such as short treatment duration and systemic side effects [1] Group 2 - The company has a robust pipeline in monoclonal antibodies for autoimmune diseases, with QX001S being the first approved biosimilar of ustekinumab in China, significantly improving accessibility for psoriasis treatment [2] - QX008N has completed Phase II enrollment for chronic obstructive pulmonary disease, leading the domestic market, while QX005N has received breakthrough therapy designation and completed Phase III enrollment for nodular prurigo [2] - QX002N has completed Phase III trials for ankylosing spondylitis, with a BLA submission expected in H2 2025, and QX004N has shown significant efficacy and safety for psoriasis, initiating Phase III trials [2] Group 3 - The company is advancing differentiated long-acting bispecific antibodies and actively pursuing overseas business development and licensing collaborations [3] - The rabbit antibody development platform enables high-activity antibody screening and early commercial feasibility assessments, focusing on key signaling pathways in autoimmune diseases [3] - The company has multiple bispecific antibody pipelines, including QX030N, which has completed its first overseas New Co transaction, and QX027N and QX035N, which are set for IND submissions in China and the U.S. [3] Group 4 - The company is diversifying its commercialization efforts through strategic partnerships, including collaborations with Huadong Medicine for QX001S and QX005N, and exclusive licensing agreements with Hansoh Pharmaceutical and Health元 for various products [4] - An exclusive licensing agreement has been signed with Caldera Therapeutics for the global development and commercialization of long-acting bispecific antibody QX030N [4]

港股公司报告 | 首次覆盖报告 荃信生物-B（02509） 证券研究报告 自身免疫赛道东风已至，高效研发平台构建差异化管 线新格局 荃信生物：十年突破，立足技术平台优势，专注自免领域全产品线布局 荃信生物于 2015 年在江苏泰州成立，是一家专注于自身免疫及过敏性疾 病生物疗法的生物医药企业，覆盖皮肤、呼吸、消化和风湿四大疾病领域， 公司创始人裘总在生物医药研发领域具备近 30 年从业经验。2025H1 公司 实现营业收入 2.06 亿元，同比增长 359.69%，归母净利润-3093.3 万元。 自身免疫性疾病生物药市场代开发潜力广阔 2024 年中国自身免疫性疾病药物市场规模达 363 亿元，生物制剂占比逐年 提升，预计 2030 年提升至 65.6%，其中：中国银屑病市场规模 2030 年预 计达 306.5 亿元；2022 年中国强直性脊柱炎患者人数为 390 万人，预计到 2030 年市场规模达约 463 亿元。目前，银屑病与强直性脊柱炎等自身免疫 性疾病的一线治疗以糖皮质激素、免疫抑制剂和非甾体抗炎药为主，存在 疗程持续性较短与全身性副作用等问题。 深度聚焦自免领域生物制剂研发，夯实公司研发与商业 ...

Core Viewpoint - The company, 荃信生物-B, has shown significant growth in its mid-year performance, with a substantial increase in revenue and a notable reduction in losses, indicating strong potential for future development in the biopharmaceutical sector [1][2]. Financial Performance - The company reported a revenue of RMB 206 million for the first half of the year, representing a year-on-year increase of 359.69% [1]. - The net loss for the period was RMB 30.93 million, which is a decrease of 83.11% compared to the previous year [1]. Revenue Sources - The revenue growth was primarily driven by upfront payments from licensing agreements, milestone payments, clinical research service fees, and CDMO (Contract Development and Manufacturing Organization) income [1]. Product Pipeline - The company has five key pipeline products: QX001S, QX005N, QX002N, QX004N, and QX008N, targeting various therapeutic areas with established drug approval in the global market, indicating a high probability of successful commercialization [1]. - Except for QX002, the remaining products have established partnerships with domestic pharmaceutical companies for commercialization, which is expected to accelerate market potential realization [1]. Internationalization Strategy - The company aims to internationalize its dual-antibody pipeline, with QX027N and QX031N expected to submit IND applications simultaneously in China and the U.S. in Q3 2025 and H2 2025, respectively [2]. - QX035 is projected to submit its IND application in H2 2026, with no significant competing dual-antibody products currently available in the autoimmune field, suggesting a strong opportunity for clinical value realization [2].

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]

Group 1 - The core viewpoint of the news is that Zai Lab Limited (荃信生物-B) has seen a significant increase in its stock price, rising over 22% to reach a new high since September of the previous year, driven by strong financial performance and positive developments in its product pipeline [1] - For the six months ending June 30, 2025, the company reported revenue of RMB 206 million, a year-on-year increase of 359.69%, with R&D expenses of RMB 151 million, up 4.25%, and a significant reduction in losses by 83.11% [1] - The revenue primarily came from licensing agreements, including upfront payments related to QX030N and a non-cash consideration for approximately 24.88% equity in Caldera Therapeutics, totaling RMB 181 million, along with revenue from CDMO services and R&D services for projects QX004N and QX008N amounting to approximately RMB 22 million [1] Group 2 - The company has one commercialized product, the first biosimilar of Ustekinumab in China, named Seluixin® [2] - Two core products are progressing well in development: QX005N (IL-4Rα monoclonal antibody) is expected to complete patient enrollment for its Phase III trials in China for nodular prurigo (PN) and atopic dermatitis (AD) by the end of this year and early next year, respectively [2] - QX002N (IL-17A monoclonal antibody) has achieved its primary endpoint in the Phase III trial for ankylosing spondylitis (AS) in China and plans to submit a Biologics License Application (BLA) within this year [2]

Core Insights - The article discusses the innovative approach of Quanxin Biopharmaceuticals in the biopharmaceutical industry, breaking the "double ten rule" by developing five promising clinical-stage products with an investment of less than 1.3 billion yuan [2][3] - The company focuses on autoimmune diseases and has established a collaborative ecosystem to enhance its research, clinical, and commercialization processes, aiming for international market entry by 2025 with a projected overseas licensing deal worth $555 million [3][5] Group 1: Company Strategy - Quanxin Biopharmaceuticals has successfully created five clinical-stage innovative products with over 1 billion yuan in R&D investment, including one drug already on the market and two in phase III clinical trials [4][5] - The company emphasizes efficient use of funds and time, focusing on a clear development direction in antibody drug research for autoimmune and allergic diseases [4][6] - The company has formed deep collaborations with major pharmaceutical companies, leveraging their sales networks and resources to accelerate clinical trials and commercialization [5][6] Group 2: Market Expansion - In 2025, Quanxin Biopharmaceuticals plans to make significant strides in international markets, having signed a licensing agreement with Caldera Therapeutics for its long-acting dual antibody QX030N, which could yield up to $545 million in additional payments [7][8] - The company aims to target autoimmune disease markets with real clinical demand and high success rates, particularly in the respiratory and digestive fields, anticipating rapid growth in antibody drug applications [8]

今年将加速产品的国际化拓展。 本文为IPO早知道原创 作者｜ 罗宾 微信公众号｜ipozaozhidao 据 IPO 早知道消息， 3 月 29 日，荃信生物（ 2509.HK ）公布了 2024 年全年业绩。 2024 年， 公司实现收入人民币 1.59 亿元，首次实现营业收入。毛利达到 9219 万元 。 公司行政支出同比下 降 29.57% 至 1.16 亿元；研发支出下降 8.27% 至 3.34 亿元。现金储备上升 47.63% 至 5.56 亿 元，年内净亏损缩窄 33% 。 QX005N 是一种阻断 IL-4R α的单克隆抗体（ mAb ）。 QX005N 在中国针对特应性皮炎（ AD ） 的 III 期临床试验的患者入组工作接近完成，且在 2025 年 3 月 19 日， QX005N 治疗结节性痒疹 （ PN ）的中国 III 期临床试验已完成患者入组。 此前， QX005N 于 2024 年 1 月被药审中心纳入 突破性治疗品种（ BTD ）名单。 2024 年，荃信生物收入主要来自： QX008N 及 QX004N 的对外授权交易产生的授权费收入 1 亿 元，就 QX008N 及 QX0 ...