每经AI快讯，荃信生物-B(02509.HK)高开逾6%，截至发稿，涨6.49%，报26.9港元，成交额240.49万港 元。 （文章来源：每日经济新闻） ...

Core Viewpoint - The company, Qianxin Biologics-B (02509), has entered into a global exclusive collaboration and licensing agreement with F. Hoffmann-La Roche Ltd for its self-developed long-acting dual antibody QX031N, which is expected to be a new treatment option for respiratory diseases such as COPD and asthma [1] Financial Summary - The company will receive a one-time, non-refundable, and non-deductible upfront payment of $75 million [1] - The agreement includes potential milestone payments of up to $995 million related to product development, regulatory approval, and commercialization [1] - The company may also receive tiered royalties on future product sales [1] Product Development - QX031N is an injectable solution that targets TSLP and IL-33, with the potential to become a first-in-class and best-in-disease therapy [1] - The collaboration with Roche is seen as a significant recognition of the company's self-developed platform and aims to maximize the global value of QX031N [1] Strategic Goals - The company’s founder and chairman, Qiu Jiwan, emphasized that international expansion is a steadfast strategic goal for the company [1]

Investment Rating - The report maintains a "Buy" rating for the stock, expecting a relative increase of over 20% compared to the benchmark index within six months [14]. Core Insights - The report highlights a global exclusive collaboration and licensing agreement between the company and F. Hoffmann-La Roche Ltd for the self-developed long-acting dual antibody QX031N, which targets TSLP and IL-33, potentially offering new treatment options for respiratory diseases like COPD and asthma [4][5]. - The agreement includes an upfront payment of $75 million and up to $995 million in milestone payments, reflecting the company's innovative capabilities and the market potential of the self-immune field [5][6]. - The company is recognized as a leader in domestic self-immune innovative drugs, with a mature pipeline entering a monetization phase and ongoing collaborations with global giants to expand market reach [8]. Company Overview - Latest closing price: HKD 25.26 - Total shares: 2.27 billion, with a market capitalization of HKD 57 billion - 52-week high/low: HKD 36.50 / HKD 5.95 - Debt-to-asset ratio: 80.94% - Price-to-earnings ratio: -27.3 [3]. Financial Projections - Expected revenue growth rates for 2025-2027 are 123%, 98%, and -33%, respectively, with EPS projected at -0.72, 0.48, and -0.72 CNY per share [8][10]. - The company anticipates a significant increase in operating income, with projections of HKD 354 million in 2025 and HKD 703 million in 2026, before a decline to HKD 473 million in 2027 [10][11].

Core Insights - The company announced a global exclusive collaboration and licensing agreement with F. Hoffmann-La Roche Ltd for the development, production, and commercialization of QX031N [1] Financial Details - The company will receive a one-time, non-refundable, and non-deductible upfront payment of $75 million [1] - The company is eligible for up to $995 million in milestone payments related to product development, regulatory approval, and commercialization [1] - There are potential future sales royalties based on product sales [1]

Core Viewpoint - The company, Qianxin Biotechnology-B (02509), has entered into a global exclusive collaboration and licensing agreement with F. Hoffmann-La Roche Ltd, granting Roche exclusive rights to develop, manufacture, and commercialize the product QX031N [1] Financial Summary - The company will receive a one-time, non-refundable, and non-deductible upfront payment of $75 million [1] - The company is eligible for up to $995 million in milestone payments related to product development, regulatory approval, and commercialization [1] - Additionally, the company may receive tiered royalties on future product sales [1]

Core Viewpoint - The company announced the results of its Phase III clinical trial for QX002N, a monoclonal antibody for ankylosing spondylitis, which showed significant efficacy compared to the placebo group [1] Group 1: Clinical Trial Details - The Phase III clinical study was led by Professor Zeng Xiaofeng from Peking Union Medical College Hospital and involved 641 patients across 58 centers in China [1] - The study design was multi-center, randomized, double-blind, and placebo-controlled, with a treatment period of 48 weeks and a safety follow-up of 4 weeks [1] - Patients were randomly assigned in a 1:1 ratio to receive either 160mg of QX002N or a placebo, administered subcutaneously every four weeks [1] Group 2: Efficacy Results - At week 16, the ASAS40 response rate for the QX002N group was 40.4%, significantly higher than the 18.9% in the placebo group (P<0.0001) [1] - The ASAS20 response rate for the QX002N group was 65.2%, also significantly higher than the placebo group (P<0.0001) [1] - These results indicate that QX002N effectively alleviates symptoms and signs of ankylosing spondylitis across multiple dimensions, including pain and spinal function [1]

Core Viewpoint - The clinical trial results of QX002N (Lusacitinib) for treating ankylosing spondylitis (AS) show significant efficacy, indicating a potential new treatment option for AS patients [1][2] Group 1: Clinical Trial Overview - The Phase III clinical trial was led by Professor Zeng Xiaofeng from Peking Union Medical College Hospital and involved 641 patients across 58 centers in China [1] - The study design was a multi-center, randomized, double-blind, placebo-controlled trial with a treatment period of 48 weeks and a safety follow-up of 4 weeks [1] Group 2: Efficacy Results - At week 16, the ASAS40 response rate for the Lusacitinib group was 40.4%, significantly higher than the placebo group's 18.9% (P<0.0001) [1] - The ASAS20 response rate for the Lusacitinib group was 65.2%, also significantly higher than the placebo group (P<0.0001) [1] Group 3: Imaging and Inflammation Assessment - MRI assessments showed that the spinal score for the Lusacitinib group changed by -8.1, while the sacroiliac joint score changed by -6.2, both significantly better than the placebo group's -1.4 and -2.3 [2] - These results provide objective imaging evidence that Lusacitinib effectively alleviates edema and inflammation in the spine and sacroiliac joints [2] Group 4: Safety Profile - The incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in the Lusacitinib group was similar to that of the placebo group, with most TEAEs being mild to moderate [2] - The overall safety profile of Lusacitinib is considered good, supporting its potential as a new treatment option for AS patients [2] Group 5: Future Prospects - The company plans to accelerate the registration application process for Lusacitinib to seek early approval for market launch [2]

Core Viewpoint - Company announced a global exclusive collaboration and licensing agreement with F. Hoffmann-La Roche Ltd for the development, production, and commercialization of QX031N, a long-acting bispecific antibody targeting TSLP and IL-33, which are involved in respiratory diseases like COPD and asthma [1] Financial Summary - Company will receive a one-time, non-refundable, and non-deductible upfront payment of $75 million [1] - Company is eligible for up to $995 million in milestone payments related to product development, regulatory approval, and commercialization [1] - Potential future sales will generate tiered royalties for the company [1] Product Overview - QX031N is a research-stage long-acting bispecific antibody targeting TSLP and IL-33 [1] - TSLP and IL-33 are proteins released in response to allergens, viruses, pollution, and mechanical stimuli, playing a significant role in the development of chronic obstructive pulmonary disease (COPD) and asthma [1] - QX031N has the potential to be developed as a treatment option for COPD and asthma, with prospects of being a "First-in-class" and "Best-in-disease" therapy [1]

Core Insights - The company announced the results of its Phase III clinical trial for QX002N (Lusacitinib) in treating ankylosing spondylitis (AS), which will be presented at the ACR Convergence 2025 in Chicago [1] Group 1: Clinical Trial Details - The Phase III trial was led by Professor Zeng Xiaofeng from the Peking Union Medical College Hospital and involved 641 patients across 58 centers in China [1] - The study was a multi-center, randomized, double-blind, placebo-controlled trial with a treatment period of 48 weeks, including a 16-week double-blind phase and a 32-week open-label phase [1] - Patients were randomly assigned in a 1:1 ratio to receive either 160mg Lusacitinib or a placebo, administered subcutaneously every four weeks [1] Group 2: Efficacy Results - At week 16, the ASAS40 response rate for the Lusacitinib group was 40.4%, significantly higher than the placebo group's 18.9% (P<0.0001) [1] - The ASAS20 response rate for the Lusacitinib group was 65.2%, also significantly higher than the placebo group (P<0.0001) [1] - The results indicate that Lusacitinib effectively alleviates symptoms and signs of AS from multiple dimensions, including pain and spinal function [1] Group 3: Imaging and Safety Assessment - MRI assessments showed that the Lusacitinib group had a change in spinal score of -8.1 and a change in sacroiliac joint score of -6.2, both significantly better than the placebo group's -1.4 and -2.3 [2] - The findings provide objective imaging evidence that Lusacitinib can effectively reduce edema and inflammation in the spine and sacroiliac joints [2] - The incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in the Lusacitinib group was similar to that of the placebo group, with most TEAEs being mild to moderate, indicating good overall safety [2] Group 4: Future Prospects - The promising clinical efficacy and clear imaging evidence position Lusacitinib as a potential new treatment option for AS patients [2] - The company plans to expedite the registration application process to seek early approval for market launch [2]

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. 本 公 司 將 獲 得 一 次 性、不 可 退 還 且 不 可 抵 扣 的 首 付 款7,500萬 美 元，並 有 資 格 獲 得 與產品開發、監管批准及商業化相關的至多9.95億 美元里程碑付款，以及潛在未來 產品銷售的梯度特許權使用費。 關 於QX031N QX031N是一款研究中的長效 雙特異性抗體，同時靶向人胸腺基質淋巴細胞生成素 （TSLP）和 人 白 細 胞 介 素33（IL-33）。 TSLP和IL-33是 被 稱 為 警 報 素 的 蛋 白 質，機 體 受 到 過 敏 原、病 毒、污 染、機 械 刺 激 等外界因素誘導時將會釋 放，其 參 與 慢 性 阻 塞 性 肺 病（「COPD」）及 哮 喘 等 呼 吸 系 統 疾病的發生，在炎症進程中發揮重要作用。QX031N有望被 ...