Group 1 - XuanZhu Bio-B (02575) saw a significant increase in stock price, rising over 9% to reach a new high of 71.6 HKD, with a current price of 69.7 HKD and a trading volume of 38.59 million HKD [1] - The company announced that its product NG-350A, licensed from clinical-stage oncology company Akamis, received Fast Track designation from the FDA for the treatment of locally advanced rectal cancer (LARC) with proficient mismatch repair (pMMR) [1] - XuanZhu Bio holds exclusive rights for the development, production, and commercialization of NG-350A in the Greater China region [1] Group 2 - From October 30 to November 3, 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] - XuanZhu Bio's drug Pyrocil has successfully passed the preliminary review for inclusion in the national medical insurance list, making its final inclusion critical for the company [1]

Group 1 - XuanZhu Bio-B (02575) saw a significant increase in stock price, rising over 9% to reach a new high of 71.6 HKD, with a current price of 69.7 HKD and a trading volume of 38.59 million HKD [1] - The company announced that its product NG-350A, licensed from clinical-stage oncology company Akamis, received Fast Track designation from the FDA for the treatment of locally advanced rectal cancer (LARC) with proficient mismatch repair (pMMR) [1] - XuanZhu Bio holds exclusive rights for the development, production, and commercialization of NG-350A in the Greater China region [1] Group 2 - From October 30 to November 3, 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] - XuanZhu Bio's drug Pyrocil has successfully passed the preliminary review for inclusion in the national medical insurance list, making its final inclusion critical for the company [1]

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 - 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]

Core Viewpoint - XuanZhu Bio-B (02575.HK) has received Fast Track designation from the FDA for its product NG-350A, aimed at treating locally advanced rectal cancer with proficient mismatch repair (pMMR) [1] Group 1 - The product NG-350A is licensed from the clinical-stage oncology company Akamis [1] - The company holds exclusive rights for the development, production, and commercialization of NG-350A in the Greater China region [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- ...

Core Viewpoint - Xuan Zhu Bio-B (02575.HK) has seen a significant increase in its stock price, rising over 5% to reach 62.65 HKD with a trading volume of 23.5573 million HKD [2] Company Summary - The stock price of Xuan Zhu Bio-B increased by 5.12% [2] - The current trading price is 62.65 HKD [2] - The total trading volume reported is 23.5573 million HKD [2]

Core Viewpoint - XuanZhu Biotech-B (02575) has seen a stock increase of over 5%, currently trading at 62.65 HKD with a transaction volume of 23.56 million HKD, following the announcement of positive interim results from the BRIGHT-3 clinical trial for its drug, Pyrotinib, in treating HR+/HER2- advanced breast cancer [1][1][1] Group 1 - XuanZhu Biotech presented interim analysis results of the Phase III BRIGHT-3 trial at the 2025 European Society for Medical Oncology (ESMO), showcasing the efficacy of Pyrotinib in combination with letrozole or anastrozole for first-line treatment of HR+/HER2- advanced breast cancer [1][1][1] - The China National Medical Products Administration officially accepted the new drug application for Pyrotinib combined with aromatase inhibitors (AI) for HR+/HER2- advanced breast cancer on May 14, 2025, based on the interim data from the BRIGHT-3 study [1][1][1] Group 2 - Pyrotinib is a novel CDK2/4/6 inhibitor with a multi-target synergistic mechanism that effectively suppresses tumor cell proliferation and significantly reduces common hematological toxicities associated with traditional CDK4/6 inhibitors [1][1][1] - In May 2023, Pyrotinib was approved in China for use in adult patients with HR+/HER2- advanced or metastatic breast cancer, either in combination with fulvestrant for patients with disease progression after prior endocrine therapy or as a monotherapy for patients who have experienced disease progression after two or more endocrine therapies and one chemotherapy [1][1][1]

Core Viewpoint - XuanZhu Biotech-B has seen a significant increase in its market capitalization, surpassing HKD 30 billion within a week of its Hong Kong listing, driven by positive clinical trial results for its drug, Pyrocilin, in breast cancer treatment [2][5][6]. Company Performance - On October 22, XuanZhu Biotech-B's stock price reached a high of HKD 61.500, doubling from its opening price on the first trading day, with a closing price of HKD 60.000, reflecting a 31% increase on that day and a 417% rise from the issue price [2][4]. - The company reported a trading volume of HKD 278 million on October 22, with a slight decline of 0.83% on October 23 [2]. Clinical Trial Results - XuanZhu Biotech presented interim analysis results of the BRIGHT-3 clinical trial at the 2025 European Society for Medical Oncology (ESMO), showcasing the potential of Pyrocilin in treating HR+/HER2- advanced breast cancer [2][5]. - The BRIGHT-3 trial involved 397 patients and indicated that the Pyrocilin group had a 63.5% objective response rate (ORR), significantly higher than the control group's 42.5% [6]. Market Context - The Hong Kong biotech sector is currently experiencing a correction, with the biotech index declining over the past three weeks, indicating a challenging environment for innovation drugs [7]. - Despite the overall market downturn, XuanZhu Biotech's stock performance stands out, alongside other companies like Yaojie Ankang and Boan Biotech, which also saw price increases [7]. Financial Health - XuanZhu Biotech reported revenues of HKD 17.893 million in the first half of the year, with a total loss of approximately HKD 111 million, highlighting the financial challenges faced by many biotech firms in the Hong Kong market [9].