A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 Combined With Letrozole/Anastrozole Versus Placebo Combined With Letrozole/Anastrozole in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer

This is a Phase III clinical trial designed to evaluate the efficacy and safety of XZP-3287 in combination with Letrozole/Anastrozole versus placebo in combination with Letrozole/Anastrozole in patients with HR-positive and HER2-negative recurrent/metastatic breast cancer who have not received systemic anticancer therapy.

开始日期2022-03-14

申办/合作机构

轩竹生物科技股份有限公司

NCT05077449

/ Active, not recruiting临床3期

A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 in Combination With Fulvestrant Versus Placebo Combined With Fulvestrant in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer

This is a phase III clinical trial to evaluate the efficacy and safety of XZP-3287 in combination with Fulvestrant versus placebo combined with Fulvestrant in Patients who have HR positive and Her2 negative recurrent/metastatic breast cancer and have received prior endocrine therapy are eligible for study.

开始日期2021-11-16

申办/合作机构

轩竹生物科技股份有限公司

100 项与吡洛西利相关的临床结果

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100 项与吡洛西利相关的转化医学

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100 项与吡洛西利相关的专利（医药）

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项与吡洛西利相关的文献（医药）

2025-12-01·BREAST

Associations between dynamic hematological indicators and outcomes in HR-positive, HER2-negative metastatic breast cancer treated with bireociclib or placebo plus fulvestrant: Findings from the BRIGHT-2 trial

Article

作者: Hu, Yan ; Tan, Xinxin ; Bai, Jing ; Li, Qiao ; Ma, Fei ; Xu, Binghe ; Yang, Fan ; Cai, Ruigang ; Wang, Yan ; Zhang, Pin ; Fan, Ying ; Cui, Liang ; Lan, Bo ; Wang, Jiani ; Xu, Hangcheng ; Wang, Jiayu ; Duan, Xianghui ; Sa, Qiang ; Zhou, Yiran

BACKGROUND:

Cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors combined with endocrine therapy have revolutionized the treatment landscape of hormone receptor (HR)-positive advanced breast cancer. However, reliable biomarkers for CDK4/6 inhibitors remain limited. This study investigated dynamic peripheral blood indicators as potential prognostic biomarkers for survival outcomes and therapeutic efficacy.

METHODS:

This post-hoc analysis included patients with HR-positive, HER2-negative metastatic breast cancer treated with bireocilib or placebo with fulvestrant from BRIGHT-2 trial. Peripheral blood samples collected at baseline and on-treatment were used to calculate absolute lymphocyte count (ALC), neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR), platelet-to-lymphocyte ratio (PLR), systemic immune-inflammation index (SII) and prognostic nutritional index (PNI). Kaplan-Meier analysis and Cox proportional hazards models assessed survival outcomes, while dynamic changes in indicators were compared using paired Wilcoxon signed-rank test.

RESULTS:

A total of 305 patients was included in this analysis. Bireociclib significantly improved PFS versus placebo regardless of MLR, PLR, and PNI levels (all p < 0.05). In multivariate Cox analysis, NLR, MLR, SII and PNI were independent prognostic factors for both PFS and overall survival (OS). None of the hematological indicators demonstrated significant predictive value across different treatment arms. In experimental group, PLR remained stable during treatment in the response group but increased significantly in the non-response group (p = 0.003). In control group, none of the indicators demonstrated significant changes from baseline to on-treatment point.

CONCLUSIONS:

Peripheral blood-derived indicators are prognostic markers for HR-positive, HER2-negative metastatic breast cancer. Elevated PLR during treatment indicates poor response to CDK4/6 inhibitors.

2025-07-01·JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Development and validation of an LC-MS/MS method for simultaneous determination of XZP-3287(bireociclib) and its metabolites in human plasma, and its clinical pharmacokinetics application

Article

作者: Wang, Li ; Liang, Bohan ; Xu, Lingmei ; Fan, Huirong ; Dong, Shiqi ; Zhuang, Quankun ; Li, Yanjie

XZP-3287(bireociclib) is a novel and selective inhibitor of the cell cyclin-dependent kinases 4/6 (CDK4/6), which is primarily employed for the treatment of breast cancer in clinical trials. In this study, a novel and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated for the simultaneous determination of XZP-3287 and its metabolites XZP-5286, XZP-3584 and XZP-5736 in human plasma in accordance with international conference on harmonization of technical requirements for registration of Pharmaceuticals for Human use (ICH) guideline R3 (M10) guideline. The multiple reaction monitoring mode (MRM) of mass spectrometer was used and all compounds were monitored in electrospray ionization (ESI+) mode. The correlation coefficients (R²) of all calibration curves for linear regression were greater than 0.99. The intra- and inter-day precision of XZP-3287 and its metabolites XZP-5286, XZP-3584 and XZP-5736 were determined to be 5.2 %-5.5 %, 14.9 %-10.1 %, 6.9 %-13.8 % and 7.3 %-5.6 %, and their accuracy were determined to be 5.2 %-6.0 % 6.9 %-4.4 %, 11.1 %-5.0 % and 7.4 %-5.6 %, respectively. In conclusion, a method for the simultaneous detection of the pharmacokinetic profiles of XZP-3287 and its metabolites in human plasma had been successfully developed. The results demonstrated the efficacy, sensitivity, and reliability of this method.

2025-06-01·Cancer Communications

An open‐label, single‐arm, multicenter, phase II trial of bireociclib as monotherapy for heavily pretreated HR‐positive, HER2‐negative advanced breast cancer patients: BRIGHT‐1 trial

Article

作者: Wu, Xinhong ; Cheng, Jing ; Zhu, Zhengqiu ; Li, Wei ; Xu, Binghe ; Li, Huihui ; Chen, Zhendong ; Teng, Yuee ; Zhang, Qingyuan ; Tong, Zhongsheng ; Duan, Xianghui ; Xu, Lingmei ; Sun, Tao ; Liu, Mingming ; Wang, Jingfen ; Cheng, Ying ; Wang, Li ; Li, Huiping ; Wang, Jiayu

Abstract:

Background:

Bireociclib (XZP‐3287) is a novel selective cyclin‐dependent kinase 4 and 6 (CDK4/6) inhibitor, with a favorable safety profile demonstrated in preclinical and phase I studies. BRIGHT‐1 aimed to further explore the efficacy and safety of bireociclib monotherapy in patients with locally advanced, recurrent or metastatic, hormone receptor‐positive and human epidermal growth factor receptor 2‐negative (HR + /HER2 − ) breast cancer who had progressed on or after prior chemotherapy and endocrine therapy in advanced settings, without previous exposure to CDK4/6 inhibitors.

Methods:

In this open‐label phase II trial, eligible patients received bireociclib 480 mg twice daily (BID) until disease progression or intolerable toxicities. The primary endpoint was the confirmed objective response rate (ORR) assessed by an independent review committee (IRC). The secondary endpoints included progression‐free survival (PFS), investigator‐assessed ORR, disease control rate (DCR), clinical benefit rate (CBR), duration of response (DoR), overall survival (OS), safety and the pharmacokinetic properties of bireociclib.

Results:

A total of 131 patients were enrolled. At data cutoff (July 31, 2023), the IRC‐assessed ORR was 29.8% (95% confidence interval [CI], 22.1% to 38.4%), with a DCR of 73.3% (95% CI, 64.8% to 80.6%), CBR of 42.0% (95% CI, 33.4% to 50.9%) and a median DoR of 15.2 months (95% CI, 9.5 months to not reached). The median PFS was 11.0 months (95% CI, 7.3 months to 12.9 months) assessed by the IRC, and the median OS was 29.0 months (95% CI, 24.9 months to not reached). The most frequently reported treatment‐emergent adverse events (TEAEs) of any grade were diarrhea (93.1%), neutrophil count decreased (87.0%), white blood cell decreased (86.3%), vomiting (78.6%), anemia (72.5%), and platelet count decreased (72.5%). The grade ≥3 TEAEs occurred in 109 (83.2%) patients. The most common grade ≥3 TEAEs were neutrophil count decreased (43.5%), white blood cell decreased (32.8%), hypokalemia (20.6%), and diarrhea (19.1%).

Conclusions:

Bireociclib monotherapy at 480 mg BID exhibited promising and sustained clinical activity, with no unexpected and acceptable toxicity in patients with recurrent or metastatic HR + /HER2 − breast cancer who had progressed on or after previous therapy.

Trial registration:

Clinicaltrials.gov ID, NCT04539496.

207

项与吡洛西利相关的新闻（医药）

23 小时之前

·医药健闻

玛氏CEO加入诺和诺德董事会；GSK撤回被特朗普吹捧为自闭症潜在疗法的药物申请；辉瑞撤出南旧金山办公场所 | 日报

全球医疗行业每日重点资讯文 | 苏丁企业动态诺和诺德将任命玛氏（Mars）首席执行官Poul Weihrauch担任董事会观察员，同时选举H&M董事会成员Helena Saxon进入董事会。Poul Weihrauch自2022年起担任玛氏首席执行官，此前已在公司任职超过20年，长期负责全球业务运营与战略管理工作。诺和诺德引入其作为董事会观察员，有助于公司从更广泛的消费行业视角审视减重药物的市场化路径。美国国家综合癌症网络（NCCN）宣布，任命Nancy L. Lewis（拥有医学博士、MBS、FACP身份）为新首席科学官（CSO）。该机构由多家领先癌症中心组成，致力于患者护理、科研与教育。Lewis博士是一位资深生物医学研究专家，专注于实体瘤及血液系统恶性肿瘤治疗相关的临床试验研究。在此之前，她曾在Novartis Pharmaceuticals担任高级临床项目负责人，并于多家知名学术癌症中心担任副教授多年。辉瑞正在对其在美国加州的布局进行进一步调整，将撤出位于南旧金山的一处办公场所。该处曾是其2022年收购的Global Blood Therapeutics公司的总部所在地。辉瑞一位发言人表示，位于Oyster Point Blvd的这栋164,150平方英尺的办公楼即将关闭，原因是该办公空间“目前利用率不足”。该办公地点的所有员工将转为远程办公。辉瑞在加州仍保持着强大的业务布局，包括位于圣地亚哥的设施。 Sidewinder Therapeutics宣布完成1.37亿美元超额认购的B轮融资。本轮融资由Frazier Life Sciences和Novartis Venture Fund共同领投，A轮唯一投资方OrbiMed继续参与，同时吸引了多家新投资者加入。本轮资金将用于推进其双特异性抗体偶联药物（ADC）研发管线。蔚程医药有限公司宣布完成超额认购的5400万美元A轮融资。启明创投联合领投。本轮融资资金将主要用于公司核心肝外递送技术平台的迭代优化、多条管线的临床推进，以及团队扩充与全球研发网络搭建。康德莱子公司浙江康德莱与浙药集团签署战略合作协议。双方将以此次战略合作为契机，在省内流通与终端协同、国际市场共建、资本与基金合作等领域开展广泛合作，共同推动医疗器械产业高质量发展。心血管介入领域专家金泽宁教授正式加入上海德达心血管医院，出任医疗副院长兼心内科主任。金泽宁教授在心血管介入领域有近30年临床经验，曾任首都医科大学心脏病学系副主任及北京天坛医院心脏及大血管病中心学科带头人。他是欧洲心脏病学会委员（FESC），北京医学会心血管病分会常务委员，同时担任日本CCT及美国TCT年会国际主席团成员、中国介入心脏病学大会（CIT）主席团成员。他专注于复杂冠心病介入、慢性完全闭塞病变（CTO）及结构性心脏病介入治疗，累计完成各类介入手术逾万例。产业动态葛兰素史克(GSK)已于4月9日撤回了其叶酸类药物Wellcovorin(亚叶酸钙)的一项申请。该药物曾被特朗普政府及卫生与公众服务部部长小罗伯特·F·肯尼迪吹捧为自闭症的潜在治疗选择。上月，美国食品药品监督管理局(FDA)批准了Wellcovorin标签的更新，允许该药物的仿制药版本用于治疗一种名为“脑叶酸缺乏症”的罕见遗传性神经系统疾病。该病会影响脑叶酸的转运，患者常表现出类似自闭症的症状。然而，FDA明确表示，该批准不适用于自闭症的治疗。拜耳宣布，公司影像诊断业务旗下MEDRAD Mark 7 Arterion高压造影注射系统于2026年4月3日正式获得北京市药品监督管理局颁发的国产医疗器械注册证，标志着拜耳影像诊断设备本地化生产取得新里程碑。作为北京市药监局项目制管理支持的进口转国产项目之一，MEDRAD Mark 7 Arterion在28个工作日内取得了检测报告，并通过“零发补”于8个工作日完成注册审评审批，加速该产品实现国产化。罗氏与C4 Therapeutics（C4T）达成合作。罗氏将支付2000万美元预付款，并承诺超10亿美元的里程碑付款，双方将围绕两个未公开的肿瘤靶点，联合开发DAC候选药物，加码下一代精准抗癌创新疗法。DAC是抗体偶联药物（ADC）与靶向蛋白降解剂（TPD）的交叉创新技术，兼具两大领域核心优势。由百济神州与安进公司（Amgen）共同负责在中国大陆开发和商业化的靶向DLL3和CD3的双特异性T细胞衔接器（TCE）抗体安泰适（注射用塔拉妥单抗），经优先审评程序获得国家药品监督管理局（NMPA）附条件批准，用于既往接受过至少2种系统性（包括含铂化疗）失败的广泛期小细胞肺癌（ES-SCLC）成人患者。轩竹生物与Boston Oncology CGT Holding Co. Limited就吡洛西利、地罗阿克订立许可及供货协议。轩竹生物将允许被许可人在授权区域（中东及北非区域21个国家及地区）开发、注册并商业化吡洛西利与地罗阿克。轩竹生物将获得首付款和后续可能累计超过壹亿美元的监管和商业里程碑付款，以及授权区域内销售总额的固定比例特许权使用费。日本盐野义制药宣布，通过美国生物医学高级研究与发展局（BARDA）签署了一项新合同，旨在加强Fetroja（头孢地罗）在美国的国内供应，并可能将该抗生素的应用范围扩展至应对鼠疫和蜜蜂病等“高生物威胁病原体”。BARDA已为该合同提供1.19亿美元的初始资金，并表示如果“多年期选项”被行使，盐野义制药最终可获得高达4.82亿美元的资金。盐野义制药将利用这笔资金在美国建立专门的Fetroja生产基地。人福医药控股子公司宜昌人福药业近日收到德国联邦药品和医疗器械管理局（BfArM）核准签发的注射用盐酸瑞芬太尼的上市许可批准信。宜昌人福于2022年4月以DCP程序向德国联邦药品和医疗器械管理局（BfArM）递交注射用盐酸瑞芬太尼上市许可申请并获得受理，现获得德国BfArM上市批准，有效期五年。映恩生物宣布，DB-1303（美国药品通用名称USAN：Trastuzumab Pamirtecan/T-Pam，拟定中文药品通用名称：帕康曲妥珠单抗）基于III期关键临床研究所获得的积极结果和与国家药监局药品审评中心的新药上市申请前沟通交流反馈，提交的生物制品新药上市申请已获得国家药品监督管理局受理。凌科药业宣布其核心产品泽普昔替尼胶囊用于治疗中重度特应性皮炎（AD）的新药上市申请（NDA）已获中国国家药品监督管理局（NMPA）药品审评中心（CDE）正式受理。本次受理标志着公司在炎症性皮肤疾病领域的临床开发迈入关键阶段。未来，泽普昔替尼胶囊有望为广大特应性皮炎患者提供新的治疗选择。爱科百发自主研发的首款抗流感长效药物-Fc偶联物新药（ADFC，Antiviral Drug-Fc Conjugate）AK0406注射液获得澳大利亚人类研究伦理委员会（HREC）的批准，开展I期临床试验，并成功完成首个队列健康成人受试者的入组给药。汇宇制药公告，子公司Seacross (Europe) Pharma Ltd.和Seacross Pharmaceuticals Ltd.近期获德国、西班牙、比利时、巴基斯坦相关部门核准，公司注射用替考拉宁、注射用紫杉醇（白蛋白结合型）、醋酸奥曲肽注射液获上市许可。联系美通社 +86-10-5953 9500 info@prnasia.com

2026-04-09

·EndPoints

FDA lifts MacroGenics hold; Oxford and Bristol Myers team up

Plus, news about Boston Oncology, Garda and Assertio, an Everest deal and Forte’s raise: 🟢 FDA ends partial hold on MacroGenics cancer drug: In February, the agency stopped a Phase 2 trial of lorigerlimab after one patient died and three others experienced life-threatening side effects. The drug is a bispecific antibody that targets PD-1 and CTLA-4 in certain forms of ovarian and gynecological cancers. MacroGenics said it has implemented a “revised protocol” to enroll new patients to try to prevent additional “hematologic and cardiac toxicities,” and said the regulator will let the trial continue. — Max Gelman 🤝 Oxford BioTherapeutics secures third big pharma pact: The UK biotech signed a collaboration deal with Bristol Myers Squibb to develop next-generation T cell engagers for solid tumors. Oxford will use its OGAP-Verify platform for discovery and validation purposes. Financial terms weren’t disclosed. The company has previously announced deals with GSK and Roche . — Ayisha Sharma 🌏 Boston Oncology licenses Chinese cancer medicines: The US biotech is committing an undisclosed upfront amount and more than $100 million in milestones, to tap Xuanzhu Biopharmaceutical’s breast cancer treatment bireociclib and its lung cancer drug dirozalkib. Both medicines are currently approved in China. — Ayisha Sharma 🔀 Garda’s $125M Assertio deal: Garda Therapeutics will pay $18 per share to acquire Assertio $ASRT , plus a contingent value right for potential future milestones related to its nasal spray pain drug, Sprix. Garda is a specialty pharma company run by former Secura Bio CEO Joseph Limber. The sale price is roughly half the $248 million Assertio paid in 2023 to acquire Spectrum Pharmaceuticals and its drug Rolvedon, which is used to reduce infections in chemotherapy patients. As part of the Garda deal, Assertio will sell all “non-Rolvedon” assets to Cosette Pharmaceuticals. “These transactions provide our shareholders with a certain path to value realization amid a rapidly evolving regulatory, reimbursement, and macroeconomic environment,” Assertio CEO Mark Reisenauer said in a press release . — Kyle LaHucik 🏔️ Everest Medicines also did an acquisition: The Shanghai biotech signed an agreement to buy a Hasten Biopharmaceuticals subsidiary for $150 million upfront and up to $100 million across two additional installments. The deal gives Everest 14 chronic disease drugs that are marketed across the Asia Pacific region. — Kyle LaHucik 💰 Forte’s money moves: The Dallas biotech priced a $150 million offering at $26.27 per share $FBRX . The drug developer is testing a celiac disease treatment in Phase 2 . The asset, called FB102, is also being explored for alopecia areata and vitiligo . Forte Biosciences last did a $75 million offering in June. — Kyle LaHucik

并购临床2期免疫疗法上市批准

2026-04-09

·药圈头条

超1亿美元！轩竹生物2款自研新药授权出海中东及北非地区

今日（4月9日），轩竹生物宣布，与Boston Oncology CGT Holding Co. Limited （总部位于美国马萨诸塞州剑桥市，在沙特利雅得设有区域中心）就轩竹生物自主研发的两款1类创新药吡洛西利片（Bireociclib Tablet, 商品名：轩悦宁®）及地罗阿克片（Dirozalkib Tablet，商品名：轩菲宁®）达成独家授权许可及供货协议。根据双方正式签署的协议条款，Boston Oncology将获授独家许可，以于中东及北非地区超20个国家开发、注册及商业化（包括进口、出口、营销、推广、分销等商业活动）两款产品。轩竹生物将获得来自Boston Oncology支付的首付款和后续可能累计超过1亿美元的监管和商业里程碑付款，以及授权区域内销售总额的固定比例特许权使用费。轩竹生物将根据双方约定的产品供应价格向Boston Oncology供货，以满足两款药品未来在授权区域内的商业开发活动。吡洛西利片（商品名：轩悦宁®）是国内首个获批的CDK2/4/6抑制剂，其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。吡咯西利片已分别于2025年5月、2026年3月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激素受体阳性（HR+）、人表皮生长因子受体2阴性（HER2-）局部晚期或转移性乳腺癌患者；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HR+/HER2-晚期或转移性乳腺癌患者；联合芳香化酶抑制剂（AI）一线治疗HR+/HER2-晚期乳腺癌，成为中国首个且唯一获批单药适应症的CDK2/4/6抑制剂。地罗阿克片（商品名：轩菲宁®）是新一代ALK抑制剂，其与ALK激酶结构域内的ATP结合位点亲和力更强，对包括一代及多数二代ALK-TKI常见耐药突变如G1202R、I1171N在内表现出强效抑制活性，且可通过高效穿透血脑屏障实现显著的颅内抗肿瘤效果。地罗阿克片已于2025年8月获得中国国家药品监督管理局批准单药适用于未经过间变性淋巴瘤激酶（ALK）抑制剂治疗的 ALK 阳性的局部晚期或转移性非小细胞肺癌（NSCLC）患者的治疗。欢迎加入交流群

100 项与吡洛西利相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
HR阳性/HER2阴性乳腺癌	中国	轩竹生物科技股份有限公司	2025-05-13

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
晚期乳腺癌	临床3期	中国	轩竹生物科技股份有限公司	2021-11-16
晚期恶性实体瘤	临床1期	中国	山东轩竹医药科技有限公司	2018-04-27
晚期恶性实体瘤	临床1期	中国	吉林四环制药有限公司	2018-04-27
前列腺癌	临床申请批准	中国	轩竹生物科技股份有限公司	2023-06-28

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05257395 (BRIGHT-3, ESMO2025) 人工标引	临床3期	HR阳性/HER2阴性乳腺癌二线 \| 一线 HR Positive \| HER2 Negative	397	Bireociclib plletrozoleoanastrozoleole	網憲醖遞製鬱構鹽壓獵(遞齋憲衊鹽窪製鏇淵簾) = 壓襯糧壓膚範淵襯醖憲願鑰廠遞淵顧蓋鑰簾膚 (鬱觸簾選網醖選壓鑰壓 ) 更多	积极	2025-10-17
				Placebo plletrozoleoanastrozoleole	網憲醖遞製鬱構鹽壓獵(遞齋憲衊鹽窪製鏇淵簾) = 糧鹹觸構鹽齋糧餘築顧願鑰廠遞淵顧蓋鑰簾膚 (鬱觸簾選網醖選壓鑰壓 ) 更多
NCT05077449 (BRIGHT-2, ESMO2025)	临床2期	HR阳性/HER2阴性乳腺癌二线 HR+/HER2-	325	Bireociclib plus fulvestrant	獵範願齋壓淵醖醖淵廠(積鹽廠積鏇獵範齋獵鑰) = 築淵顧窪醖齋鑰鏇齋觸鹽顧壓艱簾鬱衊範齋顧 (鹽鑰齋壓壓鬱壓觸積遞 ) 更多	积极	2025-10-17
				Dalpiciclib plus fulvestrant	獵範願齋壓淵醖醖淵廠(積鹽廠積鏇獵範齋獵鑰) = 選選夢醖鏇夢醖餘繭鹹鹽顧壓艱簾鬱衊範齋顧 (鹽鑰齋壓壓鬱壓觸積遞 ) 更多
NCT04539496 (ESMO2025)	临床2/3期	HR阳性/HER2阴性乳腺癌二线 \| 一线 HR+ \| HER2-	832	Bireociclib plus anastrozole/letrozole/fulvestrant	齋顧憲壓餘顧壓鏇遞夢(糧餘鹽網醖築網衊願淵) = 願範壓襯願窪淵鏇製鑰觸網選繭簾顧網積願獵 (鹽憲鏇齋網窪網鹽網襯 ) 更多	积极	2025-10-17
				anastrozole/letrozole/fulvestrant alone	齋顧憲壓餘顧壓鏇遞夢(糧餘鹽網醖築網衊願淵) = 艱糧襯壓餘衊願衊衊積觸網選繭簾顧網積願獵 (鹽憲鏇齋網窪網鹽網襯 ) 更多
NCT04539496 (Pubmed \| BMC Med)	临床1期	晚期恶性实体瘤 \| 乳腺癌	41	Bireociclib 480 mg BID	衊顧淵觸糧醖繭鹹艱壓(窪鹽醖觸夢廠鹽獵糧壓) = 顧獵願鬱網鑰繭窪淵壓糧膚蓋鹹衊鬱鏇膚選壓 (簾壓窪積鑰膚範鹽膚襯 )	积极	2025-10-08
				Bireociclib plus non-steroidal aromatase inhibitor	選餘鏇憲醖蓋選窪艱鏇(範鏇衊鹽夢獵鹽憲壓築) = 壓艱艱網繭鏇觸構夢糧壓夢構網憲鏇膚觸餘選 (醖鏇顧壓鬱簾糧顧醖積 ) 更多
NCT04539496 (BRIGHT-1, Pubmed \| Cancer Commun (Lond)) 人工标引	临床2期	HR阳性/HER2阴性乳腺癌 HER2 Negative \| HR Positive	131	Bireociclib 480 mg BID	鏇壓積鹹顧鏇網鑰餘繭(鹹餘齋範積憲夢願膚繭) = 鹽糧壓鏇餘範範淵壓衊選遞範選夢鏇衊餘遞顧 (齋顧範顧廠膚襯襯構鑰, 22.1 ~ 38.4) 更多	积极	2025-06-01
BRIGHT-1 and BRIGHT-2 (ASCO2025)	N/A	HR阳性/HER2阴性乳腺癌一线	697	Bireociclib containing regimens	壓蓋鏇簾憲鏇壓膚襯艱(憲鑰觸網顧製窪簾構製) = 鏇憲醖觸願餘衊觸糧顧觸鹹醖壓簾鹹壓廠遞鹽 (膚構鬱觸構簾觸壓壓壓 ) 更多	积极	2025-05-30
				Bireociclib (Heavily pretreated MBC pts)	壓蓋鏇簾憲鏇壓膚襯艱(憲鑰觸網顧製窪簾構製) = 築蓋鹹夢鹽構簾醖齋鹹觸鹹醖壓簾鹹壓廠遞鹽 (膚構鬱觸構簾觸壓壓壓 )
NCT05077449 (BRIGHT-2, AACR2025) 人工标引	临床3期	HR阳性/HER2阴性乳腺癌二线	305	Bireociclib + Fulvestrant	衊繭齋窪憲範製廠顧觸(膚鹹憲築窪獵積艱齋築) = 繭餘鹽鹽憲觸衊鹹廠築顧積鹹衊艱鬱糧淵醖窪 (鹹觸製壓繭顧窪夢網廠, 13.83 ~ 23.06) 更多	积极	2025-04-28
				Placebo + Fulvestrant	衊繭齋窪憲範製廠顧觸(膚鹹憲築窪獵積艱齋築) = 鑰壓積憲糧膚選憲鏇壓顧積鹹衊艱鬱糧淵醖窪 (鹹觸製壓繭顧窪夢網廠, 5.49 ~ 9.46) 更多
ESMO2019	临床1期	-	16	XZP-3287	觸觸糧築觸願齋願構壓(積鹽願製繭顧壓顧壓膚) = 願範壓廠鹹繭鏇衊構蓋製繭淵範構積艱選淵衊 (網膚夢膚顧衊窪鹽顧廠 ) 更多	-	2019-09-29