经济观察网华昊中天医药-B(02563.HK)近期在资本运作、产品研发及法律事务方面取得多项进展。 股票近期走势 截至2026年2月13日，华昊中天医药-B(02563.HK)近期有以下值得关注的事件进展。 近期事件 关于公司全资附属US-Biostar认购的LFM Stable Income Fund SP基金投资款回收问题，开曼群岛法院已 于2025年12月3日批准委任接管人对该基金进行接管和清盘程序。资金回收进度可能对公司现金流产生 影响。 公司项目推进 公司已向上交所科创板递交上市申请材料，拟募资15亿元用于创新药研发及产业化项目。该进程的后续 审核结果将对公司资本路径产生重要影响。 以上内容基于公开资料整理，不构成投资建议。 公司首个创新药注射用亚胺西福预计将于2026年实现国内获批上市。此外，XNW5004、XNW27011及 XNW28012等3款药品已获CDE突破性治疗药物认定，预计在2027年至2028年间陆续上市。产品管线进 展是影响公司营收拐点的核心变量。 业绩经营情况 公司通过对外授权合作已实现累计协议交易金额超20亿美元，其中2025年收到1.30亿美元(税前)不可撤 销首付款，并预 ...

华昊中天医药-B(02563)发布公告，本公司已接获中国证监会就申请于2026年2月5日发出的备案通知 书。根据备案通知书，本公司已就实施H股全流通完成向中国证监会备案。备案通知书将自其发出日期 起12个月内有效。本公司将向联交所申请转换及上市。 于本公告日期，转换及上市的实施计划详情尚未最终确定。本公司将根据上市规则及适用法律的规定于 适当时候就转换及上市的进展及详情作出进一步公告。 ...

于本公告日期，转换及上市的实施计划详情尚未最终确定。本公司将根据上市规则及适用法律的规定于 适当时候就转换及上市的进展及详情作出进一步公告。 智通财经APP讯，华昊中天医药-B(02563)发布公告，本公司已接获中国证监会就申请于2026年2月5日发 出的备案通知书。根据备案通知书，本公司已就实施H股全流通完成向中国证监会备案。备案通知书将 自其发出日期起12个月内有效。本公司将向联交所申请转换及上市。 ...

格隆汇2月6日丨 华昊中天医药-B(02563.HK)公告，公司已接获中国证监会就申请于2026年2月5日发出 的备案通知书。根据备案通知书，公司已就实施H股全流通完成向中国证监会备案。备案通知书将自其 发出日期起12个月内有效。公司将向联交所申请转换及上市。于本公告日期，转换及上市的实施计划详 情尚未最终确定。 ...

Beijing Biostar Pharmaceuticals Co., Ltd. 北 京 華 昊 中 天 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：2563） 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。 茲提述本公司日期為2025年5月2日內容有關股東特別大會的通函（「該通函」）、日期為2025 年5月23日的投票表決結果公告及本公司日期為2025年5月26日內容有關向中國證監會提交 H 股全流 通申請的 公告（「該等 公告」）。除文義 另有所指 外，本公告 所用詞彙 與該通函 及該 等公告所界定者具有相同涵義。 董事會欣然宣佈，本公司已接獲中國證監會就申請於2026年2月5日發出的備案通知書（「備 案通 知書」）。根 據備 案通 知書 ，本 公司 已就實 施H 股 全流 通完 成向 中國 證監 會備 案。備 案 通知書將自其發出日期起12個月內有效。本公司將向聯交所申請轉換及上市。 於本公告日 ...

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: 2026年1月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 北京華昊中天生物醫藥股份有限公司 呈交日期: 2026年2月4日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02563 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 216,720,857 | RMB | | 1 | RMB | | 216,720,857 | | 增加 / 減少 (-) | | | | | | | RMB | | | | 本月底結存 | | | 216,720,857 | RMB | | 1 | RMB | | 216,720,857 | | 2. 股份分類 | 普通 ...

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12月31日 狀態: 新提交 致：香港交易及結算所有限公司 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02563 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 216,720,857 | RMB | | 1 RMB | | 216,720,857 | | 增加 / 減少 (-) | | | | | | RMB | | | | 本月底結存 | | | 216,720,857 | RMB | | 1 RMB | | 216,720,857 | | 2. 股份分類 | 普通股 | 股份類別 | 其他類別 (請註明) | | | 於香港聯交所上市 (註1) | | 否 | | | -- ...

Core Viewpoint - Huahao Zhongtian Pharmaceutical-B (02563) announced that its wholly-owned U.S. subsidiary, Biostar Pharma, Inc. (US-Biostar), has completed the first patient dosing in a significant overseas clinical study for UTD1 combined with capecitabine to treat HER2-negative breast cancer brain metastases (BCBM) in a pivotal registration trial in the U.S. (NCT06764940) [1] Group 1 - The study employs a two-stage design, aiming to enroll approximately 120 subjects, with the primary endpoint being the central nervous system objective response rate (CNS-ORR) [2] - Nearly 20 leading research centers across the U.S., including MD Anderson Cancer Center and Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, are participating in the study [2] Group 2 - UTD1's unique physicochemical properties and insensitivity to P-glycoprotein-mediated efflux allow it to penetrate the blood-brain barrier (BBB) and combat solid tumor brain metastases, contrasting sharply with taxane drugs [3] - A clinical phase II study presented at the 2025 ASCO conference involving UTD1 combined with bevacizumab and chemotherapy for HER2-negative BCBM included 34 patients, showing a CNS-ORR of 67.6% and a CNS clinical benefit rate (CNS-CBR) of 88.2%, with a median CNS progression-free survival (CNS-PFS) of 15 months [3] - Another phase II study published in the 2025 JAMA Oncology journal included 47 patients, reporting a CNS-ORR of 42.6%, a median CNS-PFS of 10.6 months, and a median overall survival of 15.1 months, with most treatment-related adverse events (TRAEs) being grade 1-2 and manageable [3] Group 3 - Approximately 20-50% of advanced breast cancer patients experience brain metastases, with poor prognosis for HER2-negative BCBM patients, who have a median progression-free survival of only 2-6 months [4] - There is a significant and urgent unmet clinical need for effective drug treatments for HER2-negative BCBM, as no drugs have been approved globally for this condition [4] - UTD1 is expected to change the current treatment landscape and provide new therapeutic options and survival hope for these patients [4]

Group 1 - The core point of the news is that Huahao Zhongtian Pharmaceutical-B (02563.HK) announced the completion of the first patient dosing in a significant overseas clinical study for UTD1 combined with capecitabine to treat HER2-negative breast cancer brain metastases (BCBM) in the United States [1] Group 2 - The study is designed in two phases, aiming to enroll approximately 120 subjects, with the primary endpoint being the central nervous system objective response rate (CNS-ORR) [2] - The research involves nearly 20 leading research centers across the United States, including MD Anderson Cancer Center, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, City of Hope-Duarte, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, University of Colorado Hospital, Augusta University, and University of California Los Angeles [2]

Core Viewpoint - Huahao Zhongtian Pharmaceutical-B (02563) announced that its wholly-owned U.S. subsidiary, Biostar Pharma, Inc. (US-Biostar), has completed the first patient dosing in a significant overseas clinical study for UTD1 combined with capecitabine to treat HER2-negative breast cancer brain metastases (BCBM) in a key U.S. registration clinical trial (NCT06764940) [1] Group 1 - The study employs a two-stage design, aiming to enroll approximately 120 subjects, with the primary endpoint being the central nervous system objective response rate (CNS-ORR) [2] - Nearly 20 leading research centers across the U.S., including MD Anderson Cancer Center and Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, are participating in the study [2] Group 2 - UTD1's unique physicochemical properties and insensitivity to P-glycoprotein-mediated efflux allow it to penetrate the blood-brain barrier (BBB) and combat solid tumor brain metastases, contrasting sharply with taxane drugs [3] - A clinical phase II study presented at the 2025 ASCO conference showed a CNS-ORR of 67.6% and a median CNS-PFS of 15 months for UTD1 combined with bevacizumab and chemotherapy [3] - Another phase II study published in the 2025 JAMA Oncology journal reported a CNS-ORR of 42.6% and a median CNS-PFS of 10.6 months for UTD1 combined with bevacizumab [3] Group 3 - Approximately 20-50% of advanced breast cancer patients experience brain metastases, with HER2-negative BCBM patients having particularly poor prognoses, with a median progression-free survival of only 2-6 months [4] - There is a significant and urgent unmet clinical need for effective treatment options for HER2-negative BCBM, as no drugs have been approved globally for this condition [4] - UTD1 is expected to change the current treatment landscape and provide new therapeutic options and hope for survival for these patients [4]