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同源康医药(02410) - 自愿性公告 - TY-302、TY-2699a及TY-0540的I期临...
2025-07-24 14:41
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意見,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。 TYK Medicines, Inc 浙江同源康醫藥股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:2410) 自願性公告 TY-302、TY-2699a及TY-0540的I期臨床試驗結果獲2025年 歐洲腫瘤內科學會(ESMO)大會以壁報形式收錄 浙江同源康醫藥股份有限公司(「本公司」),連同其附屬公司統稱(「本集團」)自願 刊發,以告知本公司股東及潛在投資者有關本集團最新業務發展的資料。 本公司董事會(「董事會」)欣然宣佈,公司自主研發的三款臨床產品TY-302、 TY-2699a及TY-0540的I期臨床試驗結果,正式獲2025年歐洲腫瘤內科學會 (ESMO)大會以壁報形式收錄。相關詳細數據將於會議期間展示,並同步發表於 ESMO官方期刊《Annals of Oncology》。 關於CDK4/6抑制劑TY-302 TY-302是一種為治療乳腺癌及前列腺癌等晚期實體瘤而開發的強 ...
四环医药(00460.HK):吡洛西利片联合芳香化酶抑制剂一线治疗HR+╱HER2-晚期乳腺癌新适应症NDA获NMPA受 理
Ge Long Hui· 2025-06-09 09:50
Group 1 - The core point of the article is that Sihuan Pharmaceutical's subsidiary, Xuan Bamboo Biotech, has received acceptance for a new drug application (NDA) for the innovative drug Palbociclib (brand name: Xuan Yue Ning®) for a new indication in treating HR+/HER2- advanced breast cancer patients [1][2] - The new indication involves using Palbociclib in combination with aromatase inhibitors as initial endocrine therapy and as subsequent treatment for patients who have progressed after tamoxifen or toremifene adjuvant therapy [1] - Palbociclib is a CDK4/6 inhibitor with a unique multi-target synergistic mechanism that significantly reduces hematological toxicity compared to traditional CDK4/6 inhibitors, enhancing patient tolerance to treatment [1] Group 2 - Breast cancer is the most common malignant tumor among women globally, with 2.3 million new cases reported in 2022, and projections indicate 3.2 million new cases by 2050, with approximately 70% being HR+/HER2- subtype, indicating a substantial treatment demand [2] - The global market for CDK4/6 inhibitors is expected to reach nearly $13 billion in 2024, reflecting an approximate 18% year-on-year growth [2] - The acceptance of the NDA for the new indication of Palbociclib demonstrates the company's strong innovative research capabilities and commitment to providing more effective treatment options for breast cancer patients [2]
复星医药:控股子公司获枸橼酸伏维西利胶囊药品注册批准
news flash· 2025-05-29 09:06
Group 1 - The core point of the article is that Fosun Pharma's subsidiary, Jinzhou Aohong Pharmaceutical, has received approval from the National Medical Products Administration for the registration of a new drug, Citrate Vofopitant Capsules, for specific breast cancer treatment [1] - The approved indication is for the use of the drug in combination with Fulvestrant for adult patients with hormone receptor-positive and HER2-negative recurrent or metastatic breast cancer who have previously undergone endocrine therapy [1] - The new drug is a novel small molecule CDK4/6 inhibitor, and the total R&D investment for this drug is approximately RMB 601 million, expected to be completed by April 2025 [1]
四环医药(00460):创新药吡洛西利联合氟维司群治疗HR+/HER2-晚期乳腺癌临床III期期中分析结果在《Nature Communications》学术期刊发表
智通财经网· 2025-04-10 04:51
智通财经APP讯,四环医药(00460)发布公告,本集团旗下非全资附属公司轩竹生物科技股份有限公司 (轩竹生物)研发的创新药吡洛西利(Bireociclib)取得了重大科研突破,其联合氟维司群治疗HR+/HER2-晚 期乳腺癌临床III期研究( BRIGHT-2,NCT05077449)期中分析结果,已正式刊登于顶级期刊Nature子刊 《Nature Communications》。 BRIGHT-2研究是由中国医学科学院肿瘤医院徐兵河院士牵头开展的随机双盲 III期试验。该试验聚焦中 国乳腺癌患者,他们普遍诊断年龄小、分期晚,Luminal B型比例高,晚期化疗应用多,复发风险大。 研究从国内64个中心招募305例经内分泌治疗后进展的HR+/HER2-晚期乳腺癌患者。这些患者中位年龄 55岁, 37.0%绝经前,68.2%有内脏转移,25.6%原发耐药,23.9%晚期接受过化疗,91.5% 在治疗期病 情进展,整体病情复杂棘手。 在此次试验里,吡洛西利联合氟维司群疗效显著。中位随访8.7个月时,联合组中位PFS达12.94个月, 远超氟维司群组的7.29个月。各亚组患者均有PFS获益,尤其是内分泌原发耐药 ...