据介绍，吡洛西利片(商品名：轩悦宁)作为新型CDK2/4/6抑制剂，具有独特的多靶点协同作用机制，具 有强效抑制肿瘤细胞增殖，显著降低传统CDK4/6抑制剂常见的血液学毒性等优势。吡洛西利已于2025 年5月13日获得中国国家药品监督管理局批准与氟维司群联合用于既往接受内分泌治疗后出现疾病进展 的患者;单药用于既往转移性阶段接受过两种及以上内分泌治疗和一种化疗后出现疾病进展的患者，成 为中国首个且唯一获批单药适应症的CDK4/6抑制剂。 消息面上，10月22日，轩竹生物-B发布公告，其已于德国当地时间2025年10月20日在2025年欧洲肿瘤内 科学会(2025年ESMO)上以壁报的形式展示了吡洛西利联合来曲唑或阿那曲唑在HR+/HER2-晚期乳腺癌 一线治疗的临床III期(BRIGHT-3)期中分析结果。 基于BRIGHT-3研究中期数据，中国国家药品监督管理局已于2025年5月14日正式受理吡洛西利联合芳香 化酶抑制剂(AI)治疗HR+/HER2-晚期乳腺癌的新药上市申请。 轩竹生物-B(02575)再涨超9%，上市至今股价累计涨幅近七成。截至发稿，涨8.31%，报49.28港元，成 交额1266.81万 ...

据介绍，吡洛西利片(商品名：轩悦宁)作为新型CDK2/4/6抑制剂，具有独特的多靶点协同作用机制，具 有强效抑制肿瘤细胞增殖，显著降低传统CDK4/6抑制剂常见的血液学毒性等优势。吡洛西利已于2025 年5月13日获得中国国家药品监督管理局批准与氟维司群联合用于既往接受内分泌治疗后出现疾病进展 的患者;单药用于既往转移性阶段接受过两种及以上内分泌治疗和一种化疗后出现疾病进展的患者，成 为中国首个且唯一获批单药适应症的CDK4/6抑制剂。 消息面上，10月22日，轩竹生物-B发布公告，其已于德国当地时间2025年10月20日在2025年欧洲肿瘤内 科学会(2025年ESMO)上以壁报的形式展示了吡洛西利联合来曲唑或阿那曲唑在HR+/HER2-晚期乳腺癌 一线治疗的临床III期(BRIGHT-3)期中分析结果。 智通财经APP获悉，轩竹生物-B(02575)再涨超9%，上市至今股价累计涨幅近七成。截至发稿，涨 8.31%，报49.28港元，成交额1266.81万港元。 基于BRIGHT-3研究中期数据，中国国家药品监督管理局已于2025年5月14日正式受理吡洛西利联合芳香 化酶抑制剂(AI)治疗HR+/HER2- ...

轩竹生物-B(02575)发布公告，其已于德国当地时间2025年10月20日在2025年欧洲肿瘤内科学会(2025年 ESMO)上以壁报的形式展示了吡洛西利联合来曲唑或阿那曲唑在HR+/HER2-晚期乳腺癌一线治疗的临 床III期(BRIGHT-3)期中分析结果。 BRIGHT-3研究是一项在中国58家中心开展的随机、双盲的III期临床试验，旨在评估吡洛西利联合来曲 唑或阿那曲唑一线治疗HR+/HER2-晚期乳腺癌的有效性和安全性。本研究共纳入397例HR+/HER2-晚期 乳腺癌患者，其中在意向治疗人群中，55.7%患者有内脏转移，41.3%为新发晚期。 截至2025年1月10日，中位随访时间为20.7个月。本次期中分析结果显示，在疗效方面，吡洛西利组由 研究者和独立评审委员会评估的mPFS均暂未达到，对照组分别为18.43个月和19.55个月。mPFS尚未达 到，提示吡洛西利组有更多患者仍未发生疾病进展，反映出其持久的疗效优势。与安慰剂联合内分泌治 疗相比，吡洛西利方案可降低47%的疾病进展或死亡风险，且尤其在预后较差的肝转移患者中，疾病风 险大幅降低64%，显示出其在难治人群中的突出潜力。在意向治疗人群 ...

Xuanzhu Biopharmaceutical Co., Ltd. 軒竹生物科技股份有限公司 （一家於中華人民共和國註冊成立的股份有限公司） （股份代號：2575） 自願公告 吡洛西利一線治療HR+/HER2-晚期乳腺癌臨床III期研究數據 於2025年ESMO公佈 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。 1 關於吡洛西利 吡洛西利片（商品名：軒悅寧）作為新型CDK2/4/6抑製劑，具有獨特的多靶點協 同作用機制，具有強效抑制腫瘤細胞增殖，顯著降低傳統CDK4/6抑製劑常見的血 液學毒性等優勢。吡洛西利已於2025年5月13日獲得中國國家藥品監督管理局批 准與氟維司群聯合用於既往接受內分泌治療後出現疾病進展的患者；單藥用於既 往轉移性階段接受過兩種及以上內分泌治療和一種化療後出現疾病進展的患者， 成為中國首個且唯一獲批單藥適應症的CDK4/6抑製劑。 關於軒竹生物 軒竹生物是四環醫藥控股集團有限公司（「四環醫藥」）旗下的創新藥子公司，是 ...

Core Insights - China Biopharmaceutical announced the interim analysis results of the Phase III clinical trial (CULMINATE-2) for its innovative drug, Kumosili capsules, presented at the 2025 European Society for Medical Oncology (ESMO) [1] - CULMINATE-2 is the first global Phase III trial demonstrating positive results for an oral CDK2/4/6 inhibitor combined with endocrine therapy for HR+/HER2- advanced breast cancer [1] Group 1 - Kumosili is a novel oral CDK2/4/6 inhibitor with varying degrees of inhibition on CDK2, CDK4, and CDK6, showing strong selectivity against CDK4, which may help delay clinical resistance and reduce bone marrow suppression [2] - The China National Medical Products Administration (NMPA) accepted the marketing application for Kumosili combined with Fulvestrant for previously treated HR+/HER2- locally advanced or metastatic breast cancer in July 2024, with a second indication application expected in July 2025 [2] - The company is actively advancing a Phase III clinical trial for Kumosili in adjuvant therapy for breast cancer, having completed patient enrollment, with plans to submit a marketing application in the next two years [2] Group 2 - Kumosili is expected to comprehensively cover the treatment cycle for HR+/HER2- breast cancer, including first-line, subsequent lines, and adjuvant therapy, providing innovative treatment options for more patients [2]

Core Insights - China Biologic Products (01177) announced the mid-analysis results of the Phase III clinical trial (CULMINATE-2) for its innovative drug, Kumosili capsules (CDK2/4/6 inhibitor), for first-line treatment of HR+/HER2- advanced breast cancer at the 2025 European Society for Medical Oncology (ESMO) [1] - CULMINATE-2 is the first global Phase III trial demonstrating positive results for an oral CDK2/4/6 inhibitor combined with endocrine therapy in HR+/HER2- advanced breast cancer [1] - Kumosili shows selective inhibition of CDK4 kinase, which may help delay clinical resistance and reduce bone marrow suppression, potentially positioning it as a Best-in-Class therapy [1] Regulatory Developments - The Center for Drug Evaluation (CDE) of the National Medical Products Administration has accepted the marketing application for Kumosili combined with Fulvestrant for previously treated HR+/HER2- locally advanced or metastatic breast cancer, expected to be reviewed by July 2024 [2] - A second indication for initial endocrine treatment in HR+/HER2- locally advanced or metastatic breast cancer is also under review, with an expected decision by July 2025 [2] - The company is advancing a Phase III clinical trial for Kumosili in adjuvant therapy, with all participants enrolled and a marketing application anticipated within the next two years [2] Market Potential - Kumosili is expected to comprehensively cover the treatment cycle for HR+/HER2- breast cancer, including first-line, subsequent lines, and adjuvant therapy, providing innovative treatment options for more patients [2]

Core Viewpoint - The company has submitted a new indication application for its self-developed CDK2/4/6 inhibitor TQB3616 in combination with Fulvestrant for previously untreated HR-positive, HER2-negative locally advanced or metastatic breast cancer to the National Medical Products Administration of China, which has been accepted [1] Group 1 - The application for the first-line indication further confirms the broad potential of this combination therapy in different treatment stages of advanced breast cancer [1] - The study has achieved its primary endpoint, with detailed data expected to be presented at an upcoming international academic conference [1]