香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責， 對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明，並 明 確 表 示，概 不 對 因 本 公 告 全 部 或 任 何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 Qyuns Therapeutics Co., Ltd. 江蘇荃信生物醫藥股份有限公司 （ 於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司 ） （股份代號：2509） 自願公告 QX004N進 入III期臨床試驗及 收到翰森製藥的付款 本 公 告 乃 由 江 蘇 荃 信 生 物 醫 藥 股 份 有 限 公 司（「本公司」）自 願 刊 發，以 向 股 東 及 潛 在投資者提供本公司最新的業務發展狀況。 本 公 司 正 在 開 發 用 於 治 療 銀 屑 病（「Ps」）及 克 羅 恩 病（「CD」）的 白 介 素23p19亞 基（「IL- 23p19」）抑制劑QX004N。於2024年4月，本公司與翰森製藥集團有限公司（「翰森製藥」， 股 份 代 號：3692.HK）的 全 資 附 屬 公 司 翰 森（上 海）健 康 科 ...

格隆汇8月5日丨荃信生物-B(02509.HK)公布，公司董事会会议将于2025年8月15日（星期五）举行，藉 以（其中包括）考虑及批准集团截至2025年6月30日止的六个月中期业绩及其发布，考虑建议派发中期 股息（如有），以及处理其他事项。 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責， 對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明，並 明 確 表 示，概 不 對 因 本 公 告 全 部 或 任 何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 Qyuns Therapeutics Co., Ltd. 江蘇荃信生物醫藥股份有限公司（「本公司」）連 同其附屬公司統稱（「本集團」）董 事 會（「董事會」）謹此公佈，本公司董事會會議將於2025年8月15日（星期五）舉行，藉以（其 中包括）考慮及批准本集團截至2025年6月30日 止 的 六 個 月 中 期 業 績 及 其 發 佈，考 慮建議派發中期股息（如 有），以及處理其他事項。 承董事會命 江蘇荃信生物醫藥股份有限公司 董事會主席及執行董事 裘霽宛先生 香港，2025年8月5日 於 本 公 告 日 期，本 公 司 董 事 會 成 員 包 括 主 席 及 執 行 董 事 裘 霽 宛 先 生、執 行 董 事 吳 亦 亮 先 生 及 林 偉 棟 先 生、非 執 行 董 事 余 熹 先 生 及 吳 志 強 先 生 以 及 獨 立 非 執 行 董 ...

Group 1 - The stock price of Zai Lab Limited (02509) has increased by over 8%, reaching a high of 22.15 HKD, the highest since October of last year, with a nearly 40% increase in the past month [1] - As of the latest update, the stock is up 5.42%, trading at 21.4 HKD with a trading volume of 5.7078 million HKD [1] - Zai Lab is a biopharmaceutical company focused on therapies for autoimmune and allergic diseases, with a fully self-developed drug pipeline and mature commercial-scale production capabilities [1] Group 2 - Zai Lab has a diverse product pipeline with multiple innovative candidates, including one approved product, two in Phase III clinical trials, and four in Phase II and I trials, targeting diseases such as psoriasis, atopic dermatitis, ankylosing spondylitis, systemic lupus erythematosus, asthma, and inflammatory bowel disease [1] - In April, Zai Lab signed a licensing agreement with Caldera Therapeutics for its clinical-stage long-acting dual antibody QX030N, granting Caldera global exclusive rights for development and commercialization [2] - The agreement includes a one-time upfront payment of 10 million USD, approximately 24.88% equity in Caldera, and potential additional payments up to 545 million USD under specific conditions, along with tiered royalties on net sales [2] - Zai Lab's product Selinexor has entered the medical insurance directory, with projected sales of 300 million CNY in 2025 and peak sales estimated between 1.5 billion to 2 billion CNY, contributing to the company's revenue through profit-sharing [2]

Group 1 - The stock of Qianxin Biopharmaceuticals-B (02509) rose over 8% during trading, reaching a new high of 22.15 HKD, with a cumulative increase of nearly 40% in the past month [1] - Qianxin Biopharmaceuticals focuses on biopharmaceutical therapies for autoimmune and allergic diseases, with a fully self-developed drug pipeline and mature commercial-scale production capabilities [1] - The company has a diverse product pipeline, including one product approved for market, two in Phase III clinical trials, and four in Phase II and I trials, targeting diseases such as psoriasis, atopic dermatitis, ankylosing spondylitis, systemic lupus erythematosus, asthma, and inflammatory bowel disease [1] Group 2 - In April, Qianxin Biopharmaceuticals signed a licensing agreement with Caldera Therapeutics for its long-acting dual antibody QX030N, granting Caldera global exclusive rights for development and commercialization [2] - The agreement provided Qianxin Biopharmaceuticals with a one-time payment of 10 million USD, approximately 24.88% equity in Caldera, and potential additional payments up to 545 million USD under specific conditions, along with tiered royalties on net sales [2] - The company expects significant revenue from its biosimilar product, Sailixin, which has entered the medical insurance directory, with projected sales of 300 million RMB in 2025 and peak sales of 1.5 billion to 2 billion RMB [2]

Group 1 - The stock price of Qianxin Biopharmaceuticals-B (02509) has risen over 8% during trading, reaching a new high of 22.15 HKD, marking a nearly 40% increase in the past month [1] - Qianxin Biopharmaceuticals focuses on biopharmaceuticals for autoimmune and allergic diseases, with a fully self-developed drug pipeline and mature commercial-scale production capabilities [1] - The company has a diverse product pipeline, including one product approved for market, two in Phase III clinical trials, and four in Phase II and I trials, targeting diseases such as psoriasis, atopic dermatitis, ankylosing spondylitis, systemic lupus erythematosus, asthma, and inflammatory bowel disease [1] Group 2 - In April, Qianxin Biopharmaceuticals signed a licensing agreement with Caldera Therapeutics for its clinical-stage long-acting dual antibody QX030N, granting Caldera global exclusive rights for development and commercialization [2] - The agreement includes a one-time payment of 10 million USD, approximately 24.88% equity in Caldera, and potential additional payments up to 545 million USD along with tiered royalties on net sales [2] - The company anticipates that its biosimilar product, Sailixin, will enter the medical insurance directory in 2024, with projected sales of 300 million CNY in 2025 and peak sales of 1.5 billion to 2 billion CNY, contributing to the company's revenue through profit sharing [2]

Group 1 - Hong Kong biopharmaceutical stocks have strengthened again, with Lepu Biopharma (02157.HK) and Genscript Biotech (01672.HK) both rising by 9% [1] - Other companies such as Kintor Pharmaceutical (01167.HK) and Qianxin Biopharma (02509.HK) have seen increases of over 7% [1]

Financial Performance - Jiangsu Qunxin Biopharmaceutical Co., Ltd. achieved a revenue of approximately RMB 158.8 million in 2024, marking a significant increase compared to 2023[14]. - The company reported a net loss of RMB 349.7 million for the year, an improvement from a loss of RMB 521.3 million in 2023, indicating a reduction in losses by approximately 32.9%[14]. - Cash and cash equivalents increased by 47.6% to RMB 556.1 million, up from RMB 376.7 million in 2023, reflecting a strong liquidity position[14]. - The adjusted net loss under non-IFRS measures was RMB 274.2 million, down from RMB 390.0 million in 2023, indicating improved operational efficiency[14]. - For the fiscal year ending December 31, 2024, the company's revenue was RMB 158.8 million, primarily from licensing fees of RMB 100.9 million from QX008N and QX004N, and RMB 55.7 million from R&D and CDMO services[15]. - The company's CDMO service revenue increased from RMB 12.1 million in 2023 to RMB 23.8 million in 2024, reflecting a growth of RMB 11.7 million[15]. - The cost of sales for the fiscal year ending December 31, 2024, was RMB 66.6 million, which includes costs associated with R&D services for QX004N and QX008N, as well as CDMO services[16]. - The company achieved a gross profit of RMB 92.2 million for the fiscal year ending December 31, 2024, with a gross margin reflecting strong R&D capabilities[55]. - The company's total employee costs, including director remuneration, amounted to approximately RMB 168.8 million for the year ending December 31, 2024, a decrease from RMB 222.4 million for the previous year[51]. - Administrative expenses decreased significantly from RMB 164.6 million in 2023 to RMB 115.9 million in 2024, mainly due to a reduction in equity-settled share payment expenses[61]. - Other income increased by 15.63% from RMB 24.9 million in 2023 to RMB 28.8 million in 2024, driven by government subsidies and interest income[59]. - Financial costs rose by 39.3% to RMB 23.4 million in 2024, attributed to increased bank borrowings to meet operational needs[63]. - The company recorded a net loss of RMB 349.7 million for the year ending December 31, 2024, an improvement of 33% compared to a net loss of RMB 521.3 million in 2023[64]. - The company has generated significant operating losses since its inception and expects to continue incurring losses for the foreseeable future[164]. Research and Development - The company’s R&D expenses decreased to RMB 334.3 million from RMB 364.4 million in the previous year, showing a focus on cost management[14]. - R&D expenses decreased by 8.3% from RMB 364.4 million in 2023 to RMB 334.3 million in 2024, mainly due to reclassification of clinical costs and a reduction in equity-settled share payment expenses[17]. - The total R&D costs for the year ended December 31, 2024, amounted to approximately RMB 334.3 million, a decrease from RMB 364.4 million in 2023[46][47]. - The company has achieved 20 IND approvals over the past 9 years, with 19 from the National Medical Products Administration and 1 from the FDA[45]. - QX002N for AS is progressing to Phase III clinical trial, with primary endpoint data expected in February 2025[27]. - QX005N for adult moderate-to-severe AD and PN has initiated Phase III trials, with first patient in (FPI) achieved in May 2024[27]. - QX001S received drug registration certificate from the National Medical Products Administration in October 2024, branded as "Sailuxin®"[27]. - QX004N completed Phase II primary endpoint data readout in August 2024, with further clinical trial plans announced[27]. - QX006N for SLE completed Phase Ib clinical trial as of the last feasible date[27]. - QX005N has received IND approvals for seven indications, including adult and adolescent moderate-to-severe AD, PN, and asthma[28]. - QX013N for CSU achieved the last patient in (LPI) for Phase I clinical trial in September 2024[27]. - The company has established a collaboration agreement with East China Pharmaceutical for the development and commercialization of QX001S in China[27]. - QX008N is under development for COPD in China, with Health元 leading the clinical trials[27]. - The company retains exclusive rights for QX001S outside of China, while collaborating with East China Pharmaceutical for its commercialization[27]. - QX005N was included in the Breakthrough Therapy Designation (BTD) list in January 2024, indicating superior clinical efficacy compared to current treatments[29]. - The Phase II clinical trial for QX005N in treating CRSwNP was completed in February 2025, with a collaboration agreement established with China Meheco in July 2024 for joint development[30]. - The Phase III clinical trial for QX002N in treating AS enrolled 641 patients, with a 40.4% ASAS40 response rate in the treatment group compared to 18.9% in the placebo group (P<0.0001)[32]. - QX001S, a biosimilar to ustekinumab, was approved in October 2024, with global sales of Stelara® reaching $10.361 billion in 2024[34]. - China Meheco submitted a BLA for QX001S in July 2023, which was approved in October 2024, and additional applications for pediatric indications are underway[35]. - QX004N showed a 76.9% improvement in PASI scores after 16 weeks of treatment in the Phase II trial, indicating strong efficacy[37]. - QX008N completed its Phase Ib clinical trial for moderate to severe asthma in January 2025, with a licensing agreement signed with Health元 for development in specific regions[39]. - QX013N received clinical trial approval from the National Medical Products Administration for the treatment of CSU on May 9, 2024, marking it as the first c-kit targeted candidate biologic in China[40]. - QX006N, an IFNAR1 targeted monoclonal antibody for SLE, successfully completed its Ib phase clinical trial in October 2024[43]. Strategic Collaborations and Partnerships - Strategic collaborations with major pharmaceutical companies were established to enhance clinical research and commercialization potential, including partnerships for QX008N and QX004N[9]. - The company entered into a strategic collaboration with Health Yuan for the development and commercialization of QX008N, receiving an upfront payment of RMB 75.0 million[20]. - A collaboration agreement was established with Han Sen (Shanghai) for QX004N, which includes potential milestone payments of up to RMB 1,032.0 million[21]. - The company will share the costs of the Phase III clinical trial for QX005N with China Medical East on a 50/50 basis, enhancing its commercialization potential[22]. - The company has a strategic focus on product licensing and mergers and acquisitions, as highlighted by Mr. Yu's previous role in business development at Heplisav-B[113]. - The company aims to enhance its market presence through strategic partnerships and collaborations in the biopharmaceutical sector[117]. Market and Operational Strategies - Future strategies will focus on maintaining clinical progress of existing products and expanding into domestic and international markets for innovative drugs[11]. - The company plans to strengthen its core competitive advantages by expanding its pipeline and seeking overseas opportunities[52][53]. - The company aims to enhance production efficiency and capacity utilization while continuing to recruit and develop talent[53]. - The company has a mission to address the vast unmet medical needs in the autoimmune and allergic disease market through its innovative therapies[157]. - The company has a strong focus on expanding its market presence and enhancing its product development capabilities[157]. - The company is positioned for future growth with a focus on innovation and market expansion, supported by its experienced leadership team[123]. Governance and Management - The board currently consists of three executive directors, two non-executive directors, and three independent non-executive directors[155]. - The independent directors are tasked with providing oversight and strategic guidance, ensuring the company's governance aligns with best practices[121][126]. - The management team emphasizes the importance of financial reporting and analysis in driving business decisions and strategies[110]. - The company is committed to ensuring no actual conflicts of interest exist between its directors and stakeholders[116]. - The company has a diverse board with members experienced in finance, investment management, and biopharmaceuticals, enhancing its strategic oversight[136]. - The management team has a diverse background in pharmaceuticals, biotechnology, and clinical research, contributing to strategic growth[142]. Risks and Compliance - The company faces significant risks related to its financial condition, drug development, clinical trials, and regulatory approvals, with no guarantee of successfully commercializing its core products[163]. - The company is committed to maintaining compliance with environmental protection and occupational health and safety regulations in China[166]. - The group regularly monitors liquidity needs and adheres to borrowing covenants to maintain sufficient cash reserves[87]. - The group conducts impairment assessments based on expected credit loss models to ensure adequate provisions for credit losses[86]. Employee and Operational Metrics - As of December 31, 2024, the company employed 339 staff members, all located in China, and is focused on providing a safe working environment[171]. - The internal R&D team consists of 125 members, with approximately 59% holding master's degrees or higher in relevant fields[45]. - The production facility has passed GMP compliance inspection by the National Medical Products Administration in November 2024, ensuring adherence to quality standards[48]. - The production facility has a therapeutic antibody production capacity of approximately 300 kg per year, with specific production lines for vials and pre-filled syringes[48]. Financial Position and Investments - Current assets increased from RMB 418.3 million in 2023 to RMB 616.7 million in 2024, reflecting a significant growth in liquidity[66]. - Trade and other receivables surged by 95.8% from RMB 26.5 million in 2023 to RMB 51.8 million in 2024, driven by increased receivables from licensing agreements[71]. - Non-current liabilities rose by 37.0% from RMB 242.9 million in 2023 to RMB 332.7 million in 2024, mainly due to an increase in bank loans with a term of 2 to 3 years[69]. - The company's operating cash flow improved, with net cash used in operating activities decreasing from RMB 300.7 million in 2023 to RMB 186.1 million in 2024[76]. - Financing activities generated net cash of RMB 351.8 million in 2024, a significant increase from RMB 61.2 million in 2023, largely due to IPO proceeds and increased bank borrowings[77]. - The current ratio decreased from 1.7 in 2023 to 1.4 in 2024, attributed to rising current liabilities associated with ongoing clinical trials[82]. - The debt-to-asset ratio increased from 42.5% in 2023 to 74.7% in 2024, primarily due to higher bank borrowings[83]. - The company has an unused credit line of RMB 161.7 million available for working capital as of December 31, 2024[75]. - The group has implemented a cautious investment strategy, focusing on low-risk financial products provided by reputable banks[96].

就授权协议而言，公司与Caldera Therapeutics亦已于授权协议的同一日订立股份收购协议，集团同意收 购Caldera Therapeutics的上述股权。 荃信生物-B(02509)发布公告，于2025年4月23日，公司与Caldera Therapeutics订立一项对外授权协议(授 权协议)。授权协议授予Caldera Therapeutics开发及商业化QX030N的全球独家许可。 根据授权协议的条款及条件，Caldera Therapeutics获授独家、须支付特许权使用费、可转让、可再授权 的权利，以在全球范围内研究、开发、注册、生产及商业化QX030N。作为回报，公司或其指定联属公 司(统称"集团")将有权获得一次性、不可退还及不可抵扣的预付款1000万美元，以及获得Caldera Therapeutics约24.88%的股权。在达成特定临床开发、监管及商业里程碑的前提下，集团亦可获得最高 5.45亿美元的额外付款。在QX030N首次商业销售后的一段特定时间内，集团亦将有权从Caldera Therapeutics的销售净额中收取分级特许权使用费。 董事会相信，订立授权协议将非常有助 ...

Company and Industry Summary Company Overview - The company, 全信生物 (Quanxin Bio), specializes in the field of autoimmune diseases and has been innovating in drug development for nearly a decade, focusing on monoclonal antibodies and bispecific antibodies [1][3]. Key Points and Arguments Innovation and R&D - The company emphasizes its strong capability for continuous innovation and R&D, with all products being developed in-house [1]. - It has established a GMP-certified production facility to ensure product supply and support the development of innovative antibodies [1]. Market Position and Strategy - Management views the company as having strong certainty in both R&D and commercial aspects, aiming to maximize product value in the market [2]. - The company is focusing on four main therapeutic areas: dermatology, rheumatology, respiratory, and digestive diseases, with dermatology being the core area [2]. Product Pipeline and Development - The company expects to complete Phase III trials for its VGF product within the year and has initiated a second round of development [3]. - In 2024, the company plans to launch its first product, 乌斯乌丹康 (Usumudan), which has already been approved and is being promoted nationwide [4]. Financial Performance - The company reported significant revenue growth, with a target of 300 million yuan for sales and a peak sales expectation of 1.5 to 2 billion yuan for its products [8]. - The financial outlook is positive, with a nearly 50% increase in cash reserves compared to the previous year [23]. Collaborations and Partnerships - The company has partnered with 华东医药 (East China Pharmaceutical) to leverage its strong sales channels in the domestic autoimmune market [8][9]. - The collaboration is expected to enhance patient management and drive sales growth for the company's products [9]. Competitive Landscape - The company acknowledges the competitive landscape in the autoimmune drug market, with several players developing similar products [12]. - However, it believes that effective commercialization strategies will be crucial for success in this rapidly growing market [12]. Future Outlook - The company plans to expand its product offerings in the respiratory disease market, which is seen as a significant growth opportunity [6]. - It aims to diversify its commercial partnerships and explore international markets for its innovative products [25]. Additional Important Information - The company has a robust pipeline with multiple products in various stages of development, including several bispecific antibodies targeting different diseases [41][45]. - The management is optimistic about the potential for significant revenue generation from its CDMO (Contract Development and Manufacturing Organization) business, which has already secured substantial external orders [20][48]. - The company is focused on maintaining a strong financial position to support its R&D and operational needs over the next few years [53]. This summary encapsulates the key aspects of the company's operations, market strategy, financial performance, and future outlook, providing a comprehensive overview of its current status and potential in the industry.