JW THERAP(02126)
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药明巨诺(02126) - 自愿公告 - 研究及发展更新 - 中国国家药品监督管理局正式受理倍诺达使...
2025-10-09 08:57
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之內容概不負責,對其準確 性或完整性亦不發表任何聲明,並明確表示,概不就因本公告全部或任何部分內容而產生或 因倚賴該等內容而引致的任何損失承擔任何責任。 JW (Cayman) Therapeutics Co. Ltd 藥明巨諾(開曼)有限公司* (於開曼群島註冊成立的有限公司) (股份代號:2126) 關於瑞基奧侖賽注射液 瑞基奧侖賽注射液(簡稱relma-cel,其腫瘤適應症的商品名:倍諾達®)是藥明巨 諾在巨諾醫療(一家百時美施貴寶的公司)的CAR-T細胞工藝平台的基礎上,自 主開發的一款靶向CD19的自體CAR-T細胞免疫治療產品。作為藥明巨諾的首款 產品,瑞基奧侖賽注射液已被NMPA批准三項適應症,包括治療經過二線或以 上系統性治療後成人患者的復發或難治性大B細胞淋巴瘤(r/r LBCL)、治療經過 二線或以上系統性治療的成人難治性或24個月內復發的濾泡性淋巴瘤(r/r FL), 以及治療經過包括布魯頓酪氨酸激酶抑制劑(BTKi)治療在內的二線以及系統性 治療的成人復發或難治性套細胞淋巴瘤(r/r MCL),成為中國首個獲批為1類生 物製品的C ...
药明巨诺(02126) - 截至二零二五年九月三十日止月份之股份发行人的证券变动月报表
2025-10-08 10:14
FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年9月30日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: JW (Cayman) Therapeutics Co. Ltd 藥明巨諾(開曼)有限公司* 呈交日期: 2025年10月8日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02126 | 說明 | | | | | | | | | 已發行股份(不包括庫存股份)數目 | | 庫存股份數目 | | 已發行股份總數 | | | 上月底結存 | | | 416,437,544 | | 0 | | 416,437,544 | | 增加 / 減少 (-) | | | 35,706 | | 0 | | | | 本月底結存 | | | 416,473,250 | | 0 | | 416,473,250 | 第 2 頁 共 12 ...
药明巨诺(02126) - 延迟寄发通函
2025-09-30 08:30
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之內容概不負責,對其準確 性或完整性亦不發表任何聲明,並明確表示,概不就因本公告全部或任何部分內容而產生或 因倚賴該等內容而引致的任何損失承擔任何責任。 JW (Cayman) Therapeutics Co. Ltd 藥明巨諾(開曼)有限公司* 藥明巨諾(開曼)有限公司* 主席 劉敏 中國上海,2025年9月30日 (股份代號:2126) 延遲寄發通函 茲提述藥明巨諾(開曼)有限公司(「本公司」)日期為2025年9月16日有關根據首 次公開發售後激勵計劃授出購股權的公告(「該公告」)。除非另有界定,否則本 公告所用專有詞彙與該公告所界定者具有相同涵義。 按該公告所披露,一份載有(其中包括)有關根據首次公開發售後激勵計劃向 劉先生授出購股權的詳情及股東特別大會通告的通函(「通函」)將根據上市規 則寄發予股東。由於本公司需要額外時間編製及落實將載入通函的若干資料, 本公司目前預期將於2025年12月31日或之前寄發通函。 承董事會命 JW (Cayman) Therapeutics Co. Ltd (於開曼群島註冊成立的有限公司) 於本公告日期,本公司董事 ...
药明巨诺-B盘中涨近7% CAR-T产品集体通过专家评审 公司积极准备医保申报工作
Zhi Tong Cai Jing· 2025-09-29 07:44
Core Viewpoint - WuXi AppTec's CAR-T product, Benodida, along with four other CAR-T therapies, has successfully passed expert review for inclusion in the 2025 National Basic Medical Insurance Directory and Commercial Insurance Innovative Drug Directory, signaling a positive regulatory shift towards improving access to cutting-edge therapies [1] Group 1: Stock Performance - WuXi AppTec-B (02126) saw a nearly 7% intraday increase, currently up 6.1% at HKD 4.35, with a trading volume of HKD 7.2867 million [1] Group 2: Regulatory Developments - The National Healthcare Security Administration announced the completion of expert review for the 2025 National Basic Medical Insurance Directory and Commercial Insurance Innovative Drug Directory adjustments [1] - The inclusion of CAR-T therapies in the review indicates a commitment from regulators to enhance the accessibility of advanced treatments [1] Group 3: Market Context - CAR-T therapies have not been included in the basic medical insurance directory due to their high cost, often exceeding one million yuan per injection [1] - Currently, CAR-T therapy payment structures are diversified, relying primarily on commercial health insurance, supplemented by special disease insurance, financial installment plans, and various assistance programs [1] Group 4: Company Response - WuXi AppTec has stated that its CAR-T products will actively participate in the application process for the 2025 medical insurance and commercial insurance innovative drug directories [1] - Over 70 commercial health insurance products have already included WuXi AppTec's Benodida [1]
港股异动 | 药明巨诺-B(02126)盘中涨近7% CAR-T产品集体通过专家评审 公司积极准备医保申报工作
智通财经网· 2025-09-29 07:42
Core Viewpoint - WuXi AppTec's CAR-T product, Benauda, has passed expert review for inclusion in the 2025 National Basic Medical Insurance Directory and Commercial Insurance Innovative Drug Directory, signaling a positive regulatory shift towards improving access to advanced therapies [1] Group 1: Company Updates - WuXi AppTec's stock rose nearly 7% during trading, closing up 6.1% at HKD 4.35, with a trading volume of HKD 7.2867 million [1] - The company has confirmed that its CAR-T product, Benauda, is included in over 70 commercial health insurance products [1] - WuXi AppTec plans to actively participate in the application process for the 2025 medical insurance and commercial insurance innovative drug directories [1] Group 2: Industry Insights - The National Healthcare Security Administration has completed the expert review for five CAR-T drugs, including Benauda, which is seen as a positive signal for the accessibility of cutting-edge therapies [1] - CAR-T therapies have not yet entered the basic medical insurance directory due to their high pricing, often exceeding one million yuan per injection [1] - The current payment structure for CAR-T therapies is diverse, primarily relying on commercial health insurance, supplemented by special disease insurance, financial installment plans, and various assistance programs [1]
药明巨诺(02126) - 2025 - 中期财报
2025-09-25 08:50
股份代號:2126 (於開曼群島註冊成立的有限公司) JW (Cayman) Therapeutics Co. Ltd * 2025 中期報告 * * Stock Code: 2126 (Incorporated in the Cayman Islands with limited liability) JW (Cayman) Therapeutics Co. Ltd * 2025 INTERIM REPORT JW (Cayman) Therapeutics Co. Lt * d INTERIM REPORT 2025 中期報告 目錄 | 公司資料 | 2 | | --- | --- | | 財務摘要 | 4 | | 業務摘要 | 7 | | 管理層討論與分析 | 10 | | 企業管治及其他資料 | 28 | | 簡明綜合損益及其他全面收入表 | 50 | | 簡明綜合財務狀況表 | 51 | | 簡明綜合權益變動表 | 53 | | 簡明綜合現金流量表 | 54 | | 簡明綜合財務報表附註 | 55 | | 釋義及技術詞彙 | 75 | 公司資料 董事會 執行董事 劉敏先生 (主席) (1) 非執行董 ...
药明巨诺-B午后涨超7% 首版商保创新药目录完成专家评审 5款CAR-T药物均过评
Zhi Tong Cai Jing· 2025-09-25 06:24
Core Viewpoint - The approval of five CAR-T products, including WuXi AppTec's Benauda, by the National Healthcare Security Administration (NHSA) is seen as a positive signal indicating the regulatory body's commitment to improving access to cutting-edge therapies [1] Group 1: Company Specifics - WuXi AppTec's stock price increased by over 7% in the afternoon session, reaching 4.22 HKD with a trading volume of 19.47 million HKD [1] - The company's CAR-T product, Benauda, has been included in over 70 commercial health insurance products, indicating strong market acceptance [1] - WuXi AppTec has stated that it will actively participate in the application process for the 2025 National Basic Medical Insurance and commercial insurance innovative drug directories [1] Group 2: Industry Insights - The recent approval of CAR-T therapies reflects a shift towards a multi-faceted payment structure, primarily driven by commercial health insurance, supplemented by special disease insurance and various financial assistance programs [1] - Despite the high cost of CAR-T treatments, which can exceed one million yuan per injection, the industry is adapting to ensure broader access through innovative insurance solutions [1]
港股异动 | 药明巨诺-B(02126)午后涨超7% 首版商保创新药目录完成专家评审 5款CAR-T药物均过评
智通财经网· 2025-09-25 06:21
Core Viewpoint - WuXi AppTec's stock price increased by over 7% following the announcement that five CAR-T therapies, including its product Benodda, passed expert review for inclusion in the 2025 National Basic Medical Insurance Directory and Commercial Insurance Innovative Drug Directory, indicating a positive regulatory signal for advanced therapies [1] Group 1: Company Performance - WuXi AppTec's stock price rose by 5.76% to HKD 4.22, with a trading volume of HKD 19.47 million [1] - The company is actively participating in the application process for the 2025 medical insurance and commercial insurance innovative drug directories [1] Group 2: Industry Insights - The approval of five CAR-T products, including WuXi AppTec's Benodda, reflects a commitment from regulators to enhance the accessibility of cutting-edge therapies [1] - CAR-T therapies have not yet entered the basic medical insurance directory due to their high costs, often exceeding one million yuan per treatment [1] - The current payment structure for CAR-T therapies is diverse, primarily relying on commercial health insurance, supplemented by special disease insurance, financial installment plans, and various assistance programs [1]
药明巨诺-B(02126.HK)授出合共420.4万份购股权
Ge Long Hui· 2025-09-16 14:28
Group 1 - The company WuXi AppTec (02126.HK) announced the grant of a total of 4,204,490 stock options to its Chairman, CEO, and Executive Director Liu Min on September 16, 2025, in accordance with the incentive plan adopted after its initial public offering on October 14, 2020 [1]
药明巨诺-B(02126)授出合共420.45万份购股权
智通财经网· 2025-09-16 14:27
Group 1 - WuXi AppTec (02126) announced the grant of a total of 4.2045 million stock options to its Chairman, CEO, and Executive Director, Mr. Min Liu, on September 16, 2025, in accordance with the terms of the incentive plan adopted after its initial public offering on October 14, 2020 [1]