该适应症的获批主要基于CULMINATE-1研究，显示库莫西利联合氟维司群较氟维司群取得了显著的中 位无进展生存期(PFS)改善，大幅降低了HR+/HER2-晚期乳腺癌疾病进展或死亡风险。 乳腺癌已成为全球及中国女性群体中的"第一大癌种"，HR+/HER2-乳腺癌是最主要的亚型。对于晚期 HR+乳腺癌，国内外指南目前均推荐CDK4/6抑制剂作为治疗选择，但CDK4/6抑制剂本身的耐药问题、 骨髓抑制问题也亟待解决。 作为新一代CDK2/4/6抑制剂，库莫西利独特分子结构设计：既能精准靶向抑制CDK4，又能显著增强对 CDK2的结合能力，同时对CDK6的抑制作用较弱，能有效降低骨髓抑制的用药风险。临床前数据显 示，库莫西利对CDK2、CDK4的抑制活性显著优于传统CDK4/6抑制剂。 库莫西利此次获批主要基于CULMINATE-1研究，该研究充分验证了产品的疗效与安全性。安全性方 面，库莫西利联合氟维司群组治疗相关不良事件(TRAEs)多为1-2级，较传统CDK4/6抑制剂具有更低的 骨髓抑制风险，为长期治疗的依从性提供了有效保障。 有券商在近期报告中将库莫西利列为潜在的"重磅炸弹"药物，仅在中国的峰值销售额便 ...

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 - Xuan Bamboo Biotech-B (02575) has seen its stock price increase by nearly 70% since its listing, with a recent rise of over 9% following the announcement of clinical trial results for its drug, Pyrocilin, in treating HR+/HER2- advanced breast cancer [1][2] Group 1: Stock Performance - As of the latest update, Xuan Bamboo Biotech-B's stock price is reported at 49.28 HKD, with a trading volume of 12.67 million HKD [1] - The stock has experienced a cumulative increase of approximately 70% since its initial public offering [1] Group 2: Clinical Trial Results - On October 22, 2025, Xuan Bamboo Biotech-B announced the presentation of mid-term analysis results from the Phase III clinical trial (BRIGHT-3) at the 2025 European Society for Medical Oncology (ESMO) [1] - The mid-term data from the BRIGHT-3 study has led to the acceptance of a new drug application by the National Medical Products Administration of China for Pyrocilin in combination with aromatase inhibitors for HR+/HER2- advanced breast cancer [1] Group 3: Drug Approval and Mechanism - Pyrocilin (brand name: Xuan Yuening) is a novel CDK2/4/6 inhibitor that exhibits a unique multi-target synergistic mechanism, effectively inhibiting tumor cell proliferation while significantly reducing common hematological toxicities associated with traditional CDK4/6 inhibitors [2] - On May 13, 2025, Pyrocilin received approval from the National Medical Products Administration of China for use in patients with disease progression after prior endocrine therapy, making it the first and only CDK4/6 inhibitor approved for single-agent indication in China [2]

Group 1 - Xuan Bamboo Biotech-B (02575) has seen its stock price increase by nearly 70% since its listing, with a recent rise of over 9% to HKD 49.28, and a trading volume of HKD 12.6681 million [1] - On October 22, 2025, Xuan Bamboo Biotech-B announced the presentation of mid-analysis results from the clinical III phase (BRIGHT-3) study on the combination of palbociclib with letrozole or anastrozole for HR+/HER2- advanced breast cancer at the 2025 European Society for Medical Oncology (ESMO) [1] - The China National Medical Products Administration accepted the new drug application for palbociclib combined with aromatase inhibitors (AI) for HR+/HER2- advanced breast cancer on May 14, 2025, based on the mid-term data from the BRIGHT-3 study [1] Group 2 - Palbociclib (brand name: Xuan Yue Ning) is a novel CDK2/4/6 inhibitor with a unique multi-target synergistic mechanism, effectively inhibiting tumor cell proliferation and significantly reducing the hematological toxicity commonly associated with traditional CDK4/6 inhibitors [2] - On May 13, 2025, palbociclib was approved by the China National Medical Products Administration for use in combination with fulvestrant for patients who have progressed after prior endocrine therapy, and as a monotherapy for patients who have progressed after receiving two or more endocrine therapies and one chemotherapy, making it the first and only CDK4/6 inhibitor approved for monotherapy indications in China [2]

Core Viewpoint - Xuan Bamboo Biotech has presented interim analysis results of the BRIGHT-3 clinical trial at the 2025 ESMO, demonstrating the efficacy and safety of Pyrotinib combined with letrozole or anastrozole in treating HR+/HER2- advanced breast cancer [1][2] Group 1: Clinical Trial Overview - The BRIGHT-3 study is a randomized, double-blind Phase III clinical trial conducted at 58 centers in China, involving 397 HR+/HER2- advanced breast cancer patients [1] - The trial aims to evaluate the effectiveness and safety of Pyrotinib in combination with letrozole or anastrozole as a first-line treatment [1] Group 2: Efficacy Results - As of January 10, 2025, with a median follow-up of 20.7 months, the mPFS for the Pyrotinib group has not yet been reached, while the control group reported mPFS of 18.43 months and 19.55 months [2] - The Pyrotinib regimen reduces the risk of disease progression or death by 47% compared to the placebo combined with endocrine therapy, with a notable 64% reduction in patients with liver metastases [2] - The overall response rate (ORR) in the intention-to-treat population for the Pyrotinib group is 63.5%, significantly higher than the control group's 42.5% [2] Group 3: Safety Profile - Common adverse events associated with the Pyrotinib combination therapy are mostly grade 1-2, including diarrhea and neutropenia, which can be effectively managed through supportive care or dose adjustments [2] Group 4: Regulatory Status - Based on the interim data from the BRIGHT-3 study, the National Medical Products Administration of China accepted the new drug application for Pyrotinib combined with aromatase inhibitors for HR+/HER2- advanced breast cancer on May 14, 2025 [2] Group 5: Product Information - Pyrotinib (brand name: XuanYueNing) is a novel CDK2/4/6 inhibitor with a unique multi-target synergistic mechanism, significantly reducing the hematological toxicity commonly associated with traditional CDK4/6 inhibitors [3] - It received approval from the National Medical Products Administration of China on May 13, 2025, for use in patients who have progressed after prior endocrine therapy, making it the first and only CDK4/6 inhibitor approved for monotherapy indications in China [3]

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]