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天风证券:首予荃信生物-B“买入”评级 目标价40.25港元
Zhi Tong Cai Jing· 2025-09-30 03:08
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]
天风证券:首予荃信生物-B(02509)“买入”评级 目标价40.25港元
智通财经网· 2025-09-30 03:04
公司兔抗体开发平台兼具高活性抗体筛选和早期商业可行性评估功能,并始终聚焦自免疾病信号通路上 下游核心靶点:(1)银屑病上游细胞因子IL12/IL-23p40与IL-23p19;(2)哮喘上游警报分子TSLP;(3)2型炎症 反应的上游受体IL-4Rα;(4)关键促炎效应分子IL-17A;(5)肥大细胞主要调节因子c-kit。 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化基础 公司在自免单抗管线上有丰富的产品布局,其中,QX001S(IL-23p40)是国内首个获批的乌司奴单抗生物 类似药,可显著提高银屑病治疗的临床可及性;QX008N(TSLP)完成慢性阻塞性肺疾病II期入组 ...
荃信生物-B(02509):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
Tianfeng Securities· 2025-09-29 11:58
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 ...
荃信生物完成TruMed基金约1亿港元新H股配售,自免领域实力获专业投资者认可
IPO早知道· 2025-08-26 04:04
Core Viewpoint - The article discusses the recent share placement by Zhaoxin Biotech, focusing on fundraising and attracting long-term investors, highlighting the company's strategic partnerships and growth potential in the biopharmaceutical sector [2][3]. Group 1: Fundraising and Investor Engagement - Zhaoxin Biotech completed a placement of 5 million shares at HKD 20.0 per share, raising approximately HKD 100 million [2]. - TruMed Health Innovation Fund, a significant player in biopharmaceutical investments, participated in this placement, indicating strong industry influence and potential for future collaborations [2]. Group 2: Company Overview and Market Potential - Zhaoxin Biotech specializes in biotherapies for autoimmune and allergic diseases, with a pipeline covering skin, respiratory, digestive, and rheumatic treatment areas [2]. - The global market for autoimmune and allergic disease drugs is projected to grow rapidly, reaching USD 271 billion by 2030, with significant unmet clinical needs in China [2]. Group 3: Strategic Partnerships and R&D Focus - The company has formed strategic collaborations with leading domestic pharmaceutical firms to advance clinical development and commercialization of multiple products [3]. - Funds raised will be used for financial structure optimization and advancing R&D pipelines, including innovative dual-antibody projects [3]. - The placement will enhance the company's financial health and support ongoing research activities, ensuring sustainable development [3].
从单抗到双抗,从国内到海外:荃信生物(02509)如何成为自免赛道新标杆?
智通财经网· 2025-08-20 02:56
Industry Overview - The self-immune field is becoming one of the hottest sectors for innovative drug investment, with both primary and secondary market transactions heating up [1] - In the first half of 2025, the total transaction amount for License-out of innovative drugs in China approached $66 billion, surpassing the total BD transaction scale for the entire year of 2024, setting a historical record [1] - The proportion of BD transactions for tumor pipeline licensing has decreased from 72% in 2023 to 61% in 2024, while the proportion for metabolism and self-immune has increased from 12% to 25%, nearly doubling [1] Company Performance - Qianxin Biotech, established in 2015, focuses on biotherapies for self-immune and allergic diseases, covering four major areas: skin, respiratory, digestive, and rheumatology [1] - In the first half of 2025, Qianxin Biotech reported revenue of 206 million RMB, a year-on-year increase of 359.69%, primarily driven by upfront payments, milestone payments, clinical research service fees, and CDMO revenue [1] - The adjusted loss for the period was 5.22 million RMB, significantly reduced by 96% compared to the same period last year [2] Product Development - Qianxin Biotech's flagship product QX005N (IL-4Rα monoclonal antibody) has obtained IND approval for seven indications, making it one of the products with the most indications targeting IL-4Rα in China [3] - The company has completed patient enrollment for the Phase III clinical trial of QX005N for nodular prurigo and is nearing completion for atopic dermatitis, with results expected by the end of this year and early next year [3] - QX002N (IL-17A monoclonal antibody) achieved its primary endpoint in Phase III clinical research for ankylosing spondylitis in February 2025, with plans to submit a BLA within the year [3] Strategic Partnerships and Market Expansion - Qianxin Biotech's second-largest shareholder is Huadong Medicine, which has a nationwide sales network, allowing the company to accelerate its commercialization efforts [5] - The company has commercialized its first product, the biosimilar drug Seluxin®, which has been prescribed in over 1,200 hospitals, with sales accelerating [6] - In April 2025, Qianxin Biotech granted global rights for its long-acting self-immune dual antibody QX030N to Caldera, receiving a $10 million upfront payment and potential milestone payments totaling up to $545 million [6] Financial Backing - Qianxin Biotech recently received significant investment from TruMed Health Innovation Fund LP, providing strong institutional backing and enhancing market confidence in the company's long-term value [7]
荃信生物-B(02509)2025年上半年收入同比大增359.69%,创新研发与商业化并进成果超预期
Sou Hu Wang· 2025-08-18 07:36
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]
荃信生物-B早盘涨超6% 上半年收入同比增超近3.6倍 公司配股筹资近1亿港元
Zhi Tong Cai Jing· 2025-08-18 03:24
Group 1 - The core viewpoint of the article highlights that Zai Lab Limited (荃信生物-B) experienced a significant increase in its stock price, rising over 6% following the release of its interim financial results [1] - The company reported a revenue of RMB 206 million, representing a year-on-year increase of 359.69% [1] - The net loss for the period was RMB 30.93 million, which is a reduction of 83.11% compared to the previous year [1] Group 2 - The revenue primarily consisted of income from licensing agreements, including an upfront payment related to the overseas licensing of QX030N and a non-cash consideration for approximately 24.88% equity in Caldera Therapeutics, totaling RMB 181 million [1] - Additional revenue was generated from CDMO services and R&D services for projects QX004N and QX008N, amounting to approximately RMB 22 million [1] - The company announced a placement of 5 million new shares to TruMed Health Innovation Fund LP at a price of HKD 20 per share, raising approximately HKD 99 million, with about 60% allocated for repaying existing interest-bearing bank loans [1][1]
港股异动 | 荃信生物-B(02509)早盘涨超6% 上半年收入同比增超近3.6倍 公司配股筹资近1亿港元
智通财经网· 2025-08-18 03:17
Core Viewpoint - Zai Lab Limited (荃信生物-B) reported significant revenue growth and reduced losses in its interim results, indicating strong operational performance and strategic developments [1] Financial Performance - The company achieved revenue of RMB 206 million, representing a year-on-year increase of 359.69% [1] - The net loss for the period was RMB 30.93 million, a decrease of 83.11% compared to the previous year [1] Revenue Breakdown - Revenue primarily included income from licensing agreements, which accounted for RMB 181 million, including upfront payments related to QX030N and a non-cash consideration for approximately 24.88% equity in Caldera Therapeutics [1] - Additional revenue of approximately RMB 22 million was generated from CDMO services and R&D services for projects QX004N and QX008N [1] Capital Raising - The company announced a placement of 5 million new shares to TruMed Health Innovation Fund LP at a price of HKD 20 per share, raising approximately HKD 99 million [1] - Approximately 60% of the net proceeds will be used to repay existing interest-bearing bank loans, 30% for the development of new pipelines including QX027N, QX031N, and QX035N, and 10% for working capital and other corporate purposes [1]
荃信生物-B发布中期业绩,收入2.06亿元 同比增长359.69%
Zhi Tong Cai Jing· 2025-08-15 14:38
Core Insights - The company reported a revenue of RMB 206 million for the six months ending June 30, 2025, representing a year-on-year increase of 359.69% [1] - Research and development (R&D) expenses amounted to RMB 151 million, reflecting a year-on-year increase of 4.25% [1] - The net loss for the period was RMB 30.93 million, a significant reduction of 83.11% compared to the previous year [1] - The loss per share was RMB 0.13 [1] Revenue Breakdown - The revenue of RMB 206 million primarily included income from licensing agreements, which accounted for RMB 181 million, derived from upfront payments related to the overseas licensing of QX030N and a non-cash consideration for approximately 24.88% equity in Caldera Therapeutics, Inc., as well as milestone fees from the Phase III trial of QX004N [1] - Additionally, revenue from CDMO services and R&D services for projects QX004N and QX008N contributed approximately RMB 22 million [1] R&D Expenses Analysis - R&D expenses increased from RMB 145 million for the six months ending June 30, 2024, to RMB 151 million for the same period in 2025, marking a rise of 4.25% [1] - The increase in R&D spending was primarily due to higher clinical trial costs associated with the advancement of the company's clinical trials, despite a reduction of RMB 5.87 million in equity-settled share-based payment amortization [1]
荃信生物-B(02509)发布中期业绩,收入2.06亿元 同比增长359.69%
智通财经网· 2025-08-15 14:11
Group 1 - The company reported a revenue of RMB 206 million for the six months ending June 30, 2025, representing a year-on-year increase of 359.69% [1] - Research and development (R&D) expenses increased by 4.25% to RMB 151 million compared to RMB 145 million for the same period last year [1] - The net loss for the period was RMB 30.93 million, a significant reduction of 83.11% year-on-year, with a loss per share of RMB 0.13 [1] Group 2 - Revenue primarily came from licensing agreements, including upfront payments related to the overseas licensing of QX030N and a non-cash consideration for approximately 24.88% equity in Caldera Therapeutics, Inc., totaling RMB 181 million [1] - Additional revenue was generated from CDMO services and R&D services for projects QX004N and QX008N, amounting to approximately RMB 22 million [1] - The increase in R&D expenses was mainly due to higher clinical trial costs associated with the advancement of the company's clinical trials [1]