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]

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]

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]

Investment Rating - The report does not explicitly state an investment rating for the skin disease drug industry Core Insights - The skin disease drug industry focuses on treating various skin conditions, with a strong market demand driven by increasing patient needs and innovative treatment methods [5][6] - The market size for skin disease drugs is projected to grow from 2.076 billion RMB in 2019 to 2.575 billion RMB in 2023, with a compound annual growth rate (CAGR) of 5.54%. It is expected to reach 3.551 billion RMB by 2028, with a CAGR of 6.32% [9][10] - The industry has evolved from the use of natural substances to synthetic drugs and innovative biopharmaceuticals, with significant advancements in drug formulations and delivery systems [8] Market Background - The skin disease drug industry is characterized by high regulatory barriers and significant policy impacts, but the growing patient demand is driving market expansion [5] - The prevalence of skin diseases in China is high, with estimates indicating that 40%-70% of the population is affected, leading to a strong treatment willingness and a growing market for topical medications [13] Market Status - The market supply is constrained by the complexity of developing topical formulations, with only five new topical drugs approved in the last five years compared to 80 oral formulations [11] - The demand for skin disease treatments is increasing due to rising incidence rates and the convenience of topical medications, which patients can self-administer [13] Market Competition - The competitive landscape features a tiered structure, with leading companies like Huabang Pharmaceutical and ZhiYuan Pharmaceutical dominating the market [18][19] - The online sales channel for skin disease drugs has grown significantly, with its share increasing from 9.0% in 2019 to 22.9% in 2023, reflecting a CAGR of 24.3% [18] Development Trends - Technological innovations, particularly in biopharmaceuticals and AI-driven drug development, are expected to be key growth drivers in the industry [32] - Local companies are likely to strengthen their market positions through channel advantages and innovation, while foreign companies may deepen their local presence through partnerships [33] - Policy changes and capital investments are anticipated to accelerate industry upgrades, enhancing the accessibility of innovative drugs [34]