Core Viewpoint - XuanZhu Bio-B (02575) experienced a significant stock price increase, reaching a new high of 71.6 HKD, following the announcement of FDA's Fast Track designation for its product NG-350A, aimed at treating locally advanced rectal cancer [1][1][1] Company Developments - XuanZhu Bio-B's stock rose over 9% at the close, with a current trading price of 69.7 HKD and a trading volume of 38.59 million HKD [1][1][1] - The company has exclusive rights for the development, production, and commercialization of NG-350A in the Greater China region [1][1][1] Regulatory Updates - The National Healthcare Security Administration (NHSA) is conducting negotiations for the 2025 National Basic Medical Insurance Drug List, which includes price negotiations for innovative drugs [1][1][1] - XuanZhu Bio-B's product, Pyrocil, has successfully passed the preliminary review for inclusion in the national medical insurance list, which is crucial for its market access [1][1][1]

Core Viewpoint - Four Seasons Pharmaceutical (00460) announced that its non-wholly owned subsidiary, Xuan Zhu Bio-Tech Co., Ltd., has received Fast Track designation from the FDA for the product NG-350A, aimed at treating locally advanced rectal cancer (LARC) with proficient mismatch repair (pMMR) [1] Group 1 - Xuan Zhu Bio-Tech holds exclusive rights for the development, production, and commercialization of NG-350A in Greater China [1] - The Fast Track designation is a method to expedite the development and approval of potential drugs that address serious conditions and unmet medical needs [1] - NG-350A is currently being tested in the Phase Ib FORTRESS clinical trial (NCT06459869) in combination with chemoradiotherapy for adult patients with pMMR locally advanced rectal cancer [1]

Core Viewpoint - The company XuanZhu Bio-B (02575) has received Fast Track designation from the FDA for its product NG-350A, which is intended for the treatment of locally advanced rectal cancer (LARC) with proficient mismatch repair (pMMR) [1] Group 1: Product Development - NG-350A is licensed from the clinical-stage oncology company Akamis Bio Ltd. [1] - The company holds exclusive rights for the development, production, and commercialization of NG-350A in the Greater China region [1] Group 2: Regulatory Significance - The Fast Track designation is a method to expedite the development and review of potential drugs [1] - Drugs granted Fast Track designation are aimed at treating serious conditions and addressing unmet medical needs, potentially being the first therapy for a specific disease or offering significant clinical advantages over existing therapies [1]

Core Viewpoint - The company XuanZhu Bio-B (02575) has received Fast Track designation from the FDA for its product NG-350A, which is intended for the treatment of locally advanced rectal cancer (LARC) with proficient mismatch repair (pMMR) [1] Group 1: Product Development - NG-350A is licensed from the clinical-stage oncology company Akamis Bio Ltd. [1] - The company holds exclusive rights for the development, production, and commercialization of NG-350A in the Greater China region [1] Group 2: Regulatory Significance - The Fast Track designation is a method to expedite the development and review of potential drugs [1] - Drugs granted Fast Track designation are aimed at treating serious conditions and addressing unmet medical needs, potentially being the first therapy for a specific disease or offering significant clinical advantages over existing therapies [1]

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 全部或任何部份內容而產生或因倚賴該等內容而引致之任何損失承擔任何責 任。 （股份代號：2575） 自願性公告 NG-350A獲授美國FDA快速通道資格認定 軒 竹 生 物 科 技 股 份 有 限 公 司（「本公司」或「軒竹生物」，連 同 其 附 屬 公 司，統 稱 為 「本集團」）董 事 會（「董事會」）欣 然 宣 佈，本 集 團 從 臨 床 階 段 腫 瘤 公 司Akamis Bio Ltd.（「Akamis」）授 權 引 進 的 產 品NG-350A獲 得 美 國 食 品 藥 品 監 督 管 理 局（「FDA」） 授予快速通道資格(Fast Track designation)，用 於 治 療 錯 配 修 復 功 能 完 整(pMMR)的 局部晚期直腸癌(LARC)。本 集 團 擁 有NG-350A產 品 的 大 中 華 區 開 發、生 產 與 商 業 化 的 獨 家 權 利。有 關 與Akamis的授權協議及NG- ...