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 ...

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 - The core point of the article is that Zai Lab Limited (荃信生物-B) has seen its stock price increase by over 5% following the announcement of a licensing deal worth up to $700 million for the TSLPxIL-13 dual antibody drug with a subsidiary of Windward [1] - This marks the third overseas transaction for the company this year, following previous agreements granting global rights for QX030N to Caldera and licensing QX031N to Roche [1] - Zhongyou Securities highlights that the company is a leader in the domestic autoimmune innovative drug sector, with a solid foundation in this field [1] Group 2 - The company's mature pipeline is entering a monetization phase, enhancing its capital-raising capabilities [1] - The continuous overseas licensing of innovative pipelines provides further assurance for the company's stable operations [1] - Huachuang Securities expresses optimism about the company's ability to maintain its leading position in the autoimmune sector [1]

Core Viewpoint - The stock of Qianxin Biopharmaceuticals-B (02509) has risen over 5%, reflecting positive market sentiment following the announcement of a significant licensing deal in the autoimmune sector [1] Group 1: Company Developments - Qianxin Biopharmaceuticals announced a licensing agreement with a subsidiary of Windward for the TSLPxIL-13 dual antibody drug, with a total potential value of up to $700 million [1] - This marks the third overseas transaction for Qianxin Biopharmaceuticals this year, following the global rights grant of QX030N to Caldera and the licensing of QX031N to Roche [1] Group 2: Market Position and Analyst Sentiment - Zhongyou Securities highlighted that the company is a leader in the domestic innovative drugs for autoimmune diseases, with a solid foundation in this field [1] - The company's mature pipeline is entering a monetization phase, enhancing its revenue-generating capabilities, while the successful overseas licensing deals provide further assurance for stable operations [1] - Huachuang Securities expressed optimism about the company's ability to maintain its leading position in the autoimmune sector [1]

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].

Core Viewpoint - The Hong Kong innovative drug sector has experienced a significant rally this year, with the Hong Kong innovative drug index (CSI:931787) rising by 75% until October, but has since entered a cooling phase as investors digest previous gains [3][4]. Group 1: Market Performance - The innovative drug sector saw 23 companies listed in the Hong Kong healthcare sector this year, compared to only 8 last year [3]. - Despite the initial surge, many companies that have not yet entered the Stock Connect are experiencing a decline in stock prices, indicating a challenging path to inclusion [3][4]. Group 2: Stock Connect Mechanism - The Stock Connect allows mainland investors to trade Hong Kong-listed stocks, with significant contributions from southbound funds, accounting for 40%-50% of trading volume in some companies [3][4]. - Companies not included in the Stock Connect face liquidity challenges, as most mainland public funds cannot invest directly [4][5]. Group 3: Challenges for Inclusion - The threshold for entering the Stock Connect has increased due to rising market valuations, with the market capitalization requirement for inclusion in the Hang Seng Composite Index set at approximately HKD 9.32 billion [6]. - Companies previously included in the Stock Connect but later removed face significant hurdles to re-entry, as liquidity issues persist [7][8]. Group 4: Business Development (BD) Fatigue - The market has shown signs of "BD fatigue," where announcements of potential business developments no longer lead to significant stock price increases, as seen with recent collaborations that resulted in stock declines [9][10]. - Investors are now demanding more substantial evidence of project viability and commitment from partners before reacting positively to BD announcements [10]. Group 5: Future Outlook - The market is currently in a quiet phase, with investors waiting for clear signals of recovery before increasing their positions, reflecting a cautious sentiment as year-end approaches [10][11].

Industry Investment Rating - The industry investment rating is "Outperform the Market" and is maintained [1] Core Viewpoints - The report highlights significant clinical advancements in the dual-antibody sector, particularly focusing on the TSLP/IL-13 dual antibody Lunsekimig by Sanofi, which has entered Phase III clinical trials for COPD, with the first patient dosed on September 24 [4][5] - The report emphasizes the potential of dual antibodies in autoimmune diseases, particularly in respiratory conditions like asthma and COPD, indicating a substantial market opportunity [7] Summary by Relevant Sections Industry Basic Situation - The closing index level is 8665.0, with a 52-week high of 9323.49 and a low of 6764.34 [1] Clinical Progress Updates - Sanofi's Lunsekimig is in Phase II/III trials for COPD, aiming to enroll 1884 patients to evaluate its efficacy and safety compared to a placebo [4] - The CM512 dual antibody by Connoa shows promising results in atopic dermatitis, with EASI-75 and EASI-90 response rates of 58.3% and 41.7% respectively, compared to 21.4% and 0% in the placebo group [5] Market Activity and Collaborations - The report notes ongoing collaborations, such as the agreement between Qianxin Biotech and Roche for QX031N, which targets both TSLP and IL-33, with an upfront payment of $75 million and potential milestone payments up to $995 million [6] - The report also mentions the presentation of the CS2015 dual-specific antibody by Basestone Pharmaceuticals at the ACAAI conference, showcasing its therapeutic potential [6] Investment Recommendations - The report suggests focusing on companies like Connoa, Innovent Biologics, Qianxin Biotech, and Basestone Pharmaceuticals, as dual antibodies are expected to reshape treatment paradigms in autoimmune diseases [7][9]

Core Insights - The report from China Post Securities highlights the potential of dual antibodies in the field of autoimmune diseases, particularly in respiratory conditions like asthma and COPD, indicating significant room for improvement in existing therapies. The market potential for TSLP class dual antibodies is viewed positively [1]. Group 1: Clinical Progress of Dual Antibodies - Sanofi's lunsekimig (TSLP/IL-13 dual antibody) has entered Phase III clinical trials, with the first patient dosed on September 24. The trials aim to enroll 1,884 patients to evaluate the efficacy and safety of lunsekimig compared to placebo in adults with eosinophilic phenotype COPD [1]. - The primary endpoint of the studies is the annualized rate of moderate to severe COPD exacerbations from baseline to week 48. The company confirmed the completion of the first patient dosing during the Q3 earnings call on October 24 [1]. Group 2: Efficacy Data and Advantages - The first-phase data for Connoa's CM512 (TSLP x IL-13 dual antibody) in atopic dermatitis (AD) showed promising results, with EASI-75 and EASI-90 response rates of 58.3% and 41.7% respectively at the 300mg dose after 12 weeks, compared to 21.4% and 0% in the placebo group. This indicates a strong potential for deep relief and sustained stability [2]. - CM512's long half-life advantage suggests that it can effectively reduce dosing frequency in clinical use, thereby improving patient compliance [2]. Group 3: Ongoing Transactions and Research Activity - On October 28, Qianxin Biotech entered a global exclusive collaboration and licensing agreement with Roche for QX031N, a long-acting dual antibody targeting TSLP and IL-33, with an upfront payment of $75 million and potential milestone payments up to $995 million. This product is expected to be developed as a new treatment option for COPD and asthma [3]. - BGI Pharma showcased the OX40L/TSLP bispecific antibody CS2015 at the 2025 ACAAI, which demonstrated therapeutic potential in preclinical trials [3].

Core Viewpoint - The company, Qianxin Biopharmaceuticals-B (02509), has seen its stock price rise over 8% following the announcement of clinical trial approval for its long-acting dual antibody QX027N, aimed at treating asthma and atopic dermatitis [1] Group 1: Clinical Developments - Qianxin Biopharmaceuticals has received implied clinical trial approval from the National Medical Products Administration for its self-developed long-acting dual antibody QX027N [1] - The clinical approval marks the entry of the company's innovative dual antibody matrix into the clinical stage for autoimmune and allergic diseases [1] Group 2: Strategic Partnerships - On October 28, Qianxin Biopharmaceuticals announced a global exclusive collaboration and licensing agreement with Roche for its self-developed long-acting autoimmune dual antibody QX031N [1] - Under the agreement, Roche will have exclusive rights for research, development, registration, production, and commercialization of QX031N globally [1] - Qianxin Biopharmaceuticals will receive an upfront payment of $75 million, with potential milestone payments of up to $995 million and tiered royalties on future product sales [1]

Core Viewpoint - The stock of Zai Lab Limited (荃信生物-B) surged over 8% following the announcement of its long-acting dual antibody QX027N receiving clinical trial approval from the National Medical Products Administration, marking a significant advancement in the company's innovation pipeline for autoimmune and allergic diseases [1] Group 1: Clinical Developments - Zai Lab's QX027N injection is intended for the treatment of asthma and atopic dermatitis, indicating the company's commitment to addressing unmet medical needs in these areas [1] - The clinical trial approval signifies the official entry of the company's innovative dual antibody matrix into the clinical stage [1] Group 2: Strategic Partnerships - On October 28, Zai Lab announced a global exclusive collaboration and licensing agreement with Roche for its long-acting autoimmune dual antibody QX031N [1] - Under the agreement, Roche will gain exclusive rights for research, development, registration, production, and commercialization of QX031N globally [1] - Zai Lab will receive an upfront payment of $75 million, with potential milestone payments of up to $995 million, along with tiered royalties on future product sales [1]