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]

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]

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。 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） 自願性公告 優替德隆治療乳腺癌腦轉移 美國關鍵臨床研究首例患者用藥 本公告由北京華昊中天生物醫藥股份有限公司（「本公司」）自願作出，以使本公司股東及潛 在投資者了解本集團的最新業務發展。 本 公 司 董 事（「 董 事 」）會（「 董 事 會 」）欣 然 宣 佈 ， 本 公 司 全 資 美 國 子 公 司 Biostar Pharma, Inc.（「US -Biostar」）已完成其一項重要海外臨床研究的首例患者給藥：UTD1聯合卡培他濱治 療HER2陰性乳腺癌腦轉移(BCBM)美國關鍵註冊臨床研究(NCT 06764940)。 該研究採用兩階段設計，共擬入組約120例受試者，主要研究終點為中樞 ...