端到端的创新药开发能力，自免领域深度布局 荃信生物成立于2015年，作为国内少数几家专注于自身免疫及过敏性疾病研发的Biotech，公司已搭建 了从早研、生产到临床和商业化的端到端创新药开发体系。截至目前公司已构建了覆盖皮肤/风湿/呼吸/ 消化科四大协同治疗领域的全面研发管线，已拥有了1款获批产品，10款在研产品，以及20余项IND批 准。QX001S是国内首个获批上市的乌司奴单抗生物类似药，QX005N(IL-4Rα单抗)、QX002N(IL-17A单 抗)、QX004N(IL-23p19单抗)均已处于III期临床阶段，有望未来1-2年也将上市贡献业绩。 中金发布研报称，预计荃信生物-B(02509)2025~2027年EPS分别为1.61元、0.88元、0.55元。该行首次覆 盖给予跑赢行业评级，基于DCF估值，该行给予目标价33.0港元，较公司当前股价存在41.6%的上行空 间。该行认为公司现有成熟管线国内合作伙伴实力强劲，销售确定性强，双抗价值正逐步被海外药企所 认可。 中金主要观点如下： 潜在催化剂：QX005N III期数据读出及申报BLA，QX002N申报BLA，双抗产品逐步启动国内和海外临 床 ...

Core Viewpoint - CICC has initiated coverage on Zai Lab (02509) with an outperform rating, projecting EPS of 1.61, 0.88, and 0.55 CNY for 2025-2027, respectively, and a target price of HKD 33.0, indicating a 41.6% upside from the current stock price [1] Group 1: Company Overview - Zai Lab, established in 2015, is one of the few domestic biotech companies focused on the research and development of autoimmune and allergic diseases, having built an end-to-end innovative drug development system from early research to commercialization [2] - The company has developed a comprehensive R&D pipeline covering four major therapeutic areas: dermatology, rheumatology, respiratory, and gastroenterology, with one approved product, ten products in development, and over twenty IND approvals [2] Group 2: Product Development and Partnerships - Zai Lab has efficiently developed a series of long-acting bispecific antibodies (bsAbs) in the autoimmune field, with significant overseas licensing agreements for products QX030N, QX031N, and QX027N, indicating recognition from multinational corporations and investment institutions [3] - Potential catalysts for growth include the Phase III data readout and BLA submission for QX005N, BLA submission for QX002N, and the gradual initiation of domestic and overseas clinical trials for bispecific products [3]

Investment Highlights - Company is initiating coverage on Qianxin Biologics-B (02509) with an "outperform" rating and a target price of HKD 33.00, citing its end-to-end innovative drug development capabilities and deep focus in the autoimmune sector [1] - Established in 2015, Qianxin Biologics is one of the few domestic biotech firms specializing in the research and development of autoimmune and allergic diseases, having built a comprehensive drug development system from early research to commercialization [1] - The company has developed a pipeline covering four major therapeutic areas: dermatology, rheumatology, respiratory, and gastroenterology, with one approved product, ten products in development, and over twenty IND approvals [1] Product Pipeline and Collaborations - QX001S is the first approved biosimilar of ustekinumab in China, while QX005N (IL-4Rα monoclonal antibody), QX002N (IL-17A monoclonal antibody), and QX004N (IL-23p19 monoclonal antibody) are in Phase III clinical trials and expected to contribute to revenue in the next 1-2 years [1] - The company has efficiently developed a series of long-acting bispecific antibodies (bsAbs) in the autoimmune field, with overseas licensing agreements for QX030N, QX031N (TSLP/IL-33), and QX027N (TSLP/IL-13) signed with Caldera, Roche, and Windward, respectively, indicating recognition from multinational corporations and investment institutions [2] - The existing mature pipeline has strong domestic partners, ensuring sales certainty, and the value of bispecific antibodies is gradually being recognized by overseas pharmaceutical companies [2] Financial Projections - Earnings per share (EPS) forecasts for the company are projected at CNY 1.61, CNY 0.88, and CNY 0.55 for the years 2025 to 2027 [2] - The target price of HKD 33.00 represents a 41.6% upside potential from the current stock price, based on discounted cash flow (DCF) valuation [2]

Core Viewpoint - The company, Qianxin Biotech, has established itself as a leading player in the field of biopharmaceuticals, particularly focusing on autoimmune diseases, with a commitment to making high-quality therapies accessible to the general public [1][2]. Group 1: Company Overview - Qianxin Biotech was founded by Qiu Jiwan, who has decades of experience in biopharmaceutical research and development, and has grown into a national high-tech enterprise with over a hundred domestic and international patents [1]. - The company's mission emphasizes scientific innovation and the provision of affordable, high-quality therapies, aiming to meet the needs of ordinary patients [1][2]. Group 2: Product Development Strategy - The company focuses on a single domain of autoimmune diseases to concentrate resources and avoid distraction, capitalizing on the large patient base and diverse disease types within this field [1][2]. - Qianxin Biotech has successfully launched QX001S (brand name: Sailixin), the first approved biosimilar of ustekinumab in China, addressing the urgent needs of psoriasis patients [1][2]. Group 3: Innovation and Market Position - The company adopts a "combination innovation" approach, developing both biosimilars to lower drug costs and innovative drugs to overcome treatment bottlenecks, thereby making medications more accessible [2]. - Qianxin Biotech's pipeline includes QX002N and QX005N, targeting different autoimmune diseases with a differentiated strategy to build competitive advantages [3][4]. Group 4: Global Expansion and Partnerships - Recently, Qianxin Biotech entered a global exclusive collaboration with Roche for its long-acting dual antibody QX031N, receiving an upfront payment of $75 million and potential milestone payments of up to $995 million [5]. - The company aims to establish a global presence by entering overseas markets early and leveraging partnerships to accelerate product development [5]. - Qianxin Biotech's strategy includes building a global cooperation network and exploring various collaboration models to enhance its international footprint [5].

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]

Investment Rating - The report assigns a "Buy" rating for the company with a target price of 40.25 HKD, based on a 26x PS for 2025 [6]. Core Insights - The company, established in 2015, focuses on autoimmune and allergic diseases, with a comprehensive product pipeline covering skin, respiratory, digestive, and rheumatic diseases. The founder has nearly 30 years of experience in biopharmaceutical research [1][14]. - The autoimmune disease drug market in China is projected to reach 363 billion CNY by 2024, with a significant increase in the share of biological agents, expected to rise to 65.6% by 2030 [2][29]. - The company has a robust pipeline of monoclonal antibodies targeting key autoimmune disease pathways, with several products in advanced clinical stages [3][50]. Summary by Sections 1. Company Overview - The company has established a strong presence in the autoimmune and allergic disease sectors, with a focus on innovative therapies and a fully integrated production capability [14][17]. - The company has successfully integrated R&D, production, and sales through strategic partnerships, enhancing its market position [14][25]. 2. Market Potential - The global autoimmune disease drug market is expected to grow from 833.7 billion CNY in 2019 to 1,260.2 billion CNY by 2030, with biological agents gaining a larger market share [29][30]. - The Chinese market for autoimmune disease drugs is also expanding rapidly, with projections indicating a market size of 1,355 billion CNY by 2030 [29][30]. 3. R&D and Product Pipeline - The company has developed a comprehensive R&D platform that includes high-throughput antibody discovery and dual-antibody design capabilities, which significantly shortens development timelines [42][43]. - The company’s lead products include QX001S, the first approved biosimilar of ustekinumab in China, and QX002N, which is in the final stages of clinical trials for ankylosing spondylitis [3][25][50]. 4. Clinical Progress and Collaborations - The company has made significant progress in clinical trials, with multiple products entering critical phases, including QX005N and QX004N, which are advancing in their respective indications [25][50]. - Strategic collaborations with major pharmaceutical companies have been established to enhance the commercialization of key products [5][25]. 5. Financial Performance - In the first half of 2025, the company reported revenues of 206 million CNY, a year-on-year increase of 359.69%, although it recorded a net loss of 30.93 million CNY [1][25].

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]