Study Objectives:
Primary
° To evaluate the safety and tolerability of multiple vaginal doses of AZU-101 at 3 dose levels in postmenopausal women
Secondary
* To assess systemic pharmacokinetics (PK) of AZU-101
* To assess the efficacy of multiple vaginal doses of AZU-101 at 3 dose levels in postmenopausal women

开始日期2024-05-01

申办/合作机构

Azure Biotech, Inc.

100 项与 Lasofoxifene Tartrate 相关的临床结果

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100 项与 Lasofoxifene Tartrate 相关的转化医学

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100 项与 Lasofoxifene Tartrate 相关的专利（医药）

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214

项与 Lasofoxifene Tartrate 相关的文献（医药）

2025-06-16·JOURNAL OF EXPERIMENTAL & CLINICAL CANCER RESEARCH

PARP-1 as a novel target in endocrine-resistant breast cancer.

Article

作者: Lappano, Rosamaria ; Zicarelli, Azzurra ; Lainé, Muriel ; Talia, Marianna ; Maggiolini, Marcello ; Greene, Geoffrey L

BACKGROUND:

Several mechanisms are involved in the resistance to endocrine therapy (ET) in estrogen receptor (ERα)-positive breast cancer (BC), including acquired mutations of ERα gene (ESR1). For example, the frequent mutation, Y537S, was shown to trigger a constitutively active receptor leading to reduced affinity for both agonist and antagonist ligands. The development of more comprehensive therapies remains a challenge in BC patients exhibiting activating mutations in ERα. Here, we show that Poly (ADP-ribose) polymerase-1 (PARP-1) may be considered as a novel therapeutic target in ERα-positive BC.

METHODS:

ERα wild type or Y537S mutated MCF7 and T47D BC cell lines were used as model systems. Immunoblotting, immunofluorescence, gene silencing, real-time PCR, promoter assays, chromatin immunoprecipitation sequencing (ChIP-seq) as well as cell viability, colony and cell cycle assays served to investigate the involvement of PARP-1 in BC progression. The growth of MCF7 ERα Y537S cells injected into the mammary ducts of NSG mice and treated with the ERα antagonist lasofoxifene or the PARP-1 inhibitor niraparib was monitored by luminescence imaging, weight measurement, and histological analysis. RNA sequencing studies were performed on the above-described xenograft tumors. METABRIC dataset was used to evaluate the clinical significance of PARP-1 and the biological role of the PARP-1-associated genes in ERα-positive BC patients.

RESULTS:

We first demonstrated that the up-regulation of PARP-1 expression induced by estrogens is abrogated either by inhibiting or silencing ERα in MCF7 and T47D BC cells expressing ERα wild type or Y537S mutation. We then showed that PARP-1 is involved in the binding of ERα and its co-activator FoxA1 to the promoters of several target genes, as determined by ChIP-sequencing studies. Of note, the inhibition of PARP-1 prevented the proliferative effects mediated by ERα in BC cells expressing either wild type or Y537S ERα. In accordance with these findings, the growth of xenograft tumors derived from MCF7 ERα Y537S BC cells was significantly reduced using niraparib and lasofoxifene. Finally, RNA-sequencing analyses showed that ERα signaling is downregulated by niraparib compared to vehicle-treated tumors.

CONCLUSIONS:

Overall, our results suggest that PARP-1 should be explored as a potential target in comprehensive therapeutic approaches in ET-resistant BC.

2025-05-03·Future Oncology

ELAINE 3: phase 3 study of lasofoxifene plus abemaciclib to treat ER+/HER2-, ESR1 -mutated, metastatic breast cancer

Article

作者: Boruta, Gina ; Gal-Yam, Einav Nili ; de Nonneville, Alexandre ; Wander, Seth A. ; Twelves, Chris ; Goetz, Matthew P. ; Shen, Sherry ; Damodaran, Senthil ; Bachelot, Thomas ; Portman, David J. ; Sammons, Sarah L.

Endocrine therapy (ET) is recommended for patients with estrogen receptor-positive (ER+) metastatic breast cancer (mBC), but most patients will develop treatment resistance, often due to mutations in the ER-α-coding gene, ESR1. Therapeutic options are limited for endocrine-resistant mBC, particularly following treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i). Lasofoxifene had anti-tumor activity in two separate phase 2, open-label studies (ELAINE 1 and 2) when given as monotherapy or combined with abemaciclib. The phase 3, randomized ELAINE 3 trial will evaluate the efficacy and safety of lasofoxifene/abemaciclib versus fulvestrant/abemaciclib for locally advanced or metastatic, ER+/HER2- breast cancer with an ESR1 mutation that progressed after ET-CDK4/6i treatment. Enrollment is planned for up to 500 patients to evaluate progression-free survival as the primary endpoint.Clinical trial registration: www.clinicaltrials.gov identifier is NCT05696626.

2025-04-01·Clinical Breast Cancer

Effects of Lasofoxifene Versus Fulvestrant on Vaginal and Vulvar Symptoms in Patients With ESR1-Mutated, ER+/HER2-, Metastatic Breast Cancer From the ELAINE 1 Study

Article

作者: Goldfarb, Shari B ; Meisel, Jane L ; Portman, David J ; Carroll, Dominic ; Jenkins, Simon N ; Pluard, Timothy J ; Komm, Barry S ; Sammons, Sarah L

BACKGROUND:

Lasofoxifene, a novel endocrine therapy (ET), showed antitumor activity versus fulvestrant in women with ESR1-mutated, metastatic breast cancer (mBC) that progressed on prior ET (phase 2, ELAINE 1 study). We investigated changes in genitourinary syndrome of menopause (GSM) vulvar-vaginal symptoms with lasofoxifene and how patient/disease characteristics affect baseline vulvar-vaginal symptoms in ELAINE 1.

METHODS:

Women were randomized to oral lasofoxifene 5 mg/day or IM fulvestrant 500 mg (days 1, 15, and 29, then every 28 days) until disease progression/severe toxicity. Changes in mean vaginal (VAS) and vulvar (VuAS) assessment scales, and their composite (average of all symptom scores/patient), from baseline to week 16, and mean baseline VAS/VuAS scores by patient/disease characteristics, were descriptively summarized.

RESULTS:

Of 103 enrolled patients, 72 (70%) completed the VAS/VuAS (mean age 61.5 years). Vaginal (40%)/vulvar (25%) dryness and vaginal pain (22%) were the most frequently reported symptoms; 26% reported ≥1 moderate/severe symptom. Lasofoxifene decreased the mean composite VAS/VuAS, VAS, and VuAS from baseline to week 16 by 74%, 74%, and 79%, respectively; fulvestrant increased them by 36%, 15%, and 63%, respectively. Baseline vaginal/vulvar symptoms were more severe if patients were under age 40, had no visceral disease, used adjuvant tamoxifen previously, or had longer AI duration in the adjuvant/metastatic settings.

CONCLUSIONS:

Oral lasofoxifene (5 mg/day), but not fulvestrant, appears to improve GSM vaginal symptoms in women with mBC. These preliminary findings suggest further study is needed; such will be explored in the phase 3, registrational, ELAINE 3 trial in patients with ESR1-mutated, ER+/HER2- mBC.

项与 Lasofoxifene Tartrate 相关的新闻（医药）

2025-09-17

·复宏汉霖

复宏汉霖乳腺癌一线治疗再获突破！创新型CDK4/6抑制剂复妥宁®获批新适应症

近日，创新型CDK4/6抑制剂复妥宁®（枸橼酸伏维西利胶囊）新增适应症的药品注册申请获得国家药品监督管理局（NMPA) 批准。本次获批适应症为用于激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性（HR+/HER2-）局部晚期或转移性乳腺癌成人患者：与芳香化酶抑制剂联合使用作为初始内分泌治疗。此前，复妥宁®已获批联合氟维司群用于既往接受内分泌治疗后出现疾病进展的HR+/HER2-的复发或转移性乳腺癌。截至目前，复宏汉霖凭借全程全域的管线布局，已实现对乳腺癌所有亚型的覆盖，并持续夯实在HER2+及HR+领域的一线治疗优势，为乳腺癌患者带来更丰富治疗选择。乳腺癌是全球以及中国女性最常见的恶性肿瘤之一。HR+/HER2-是乳腺癌中最常见的分子亚型，约占所有乳腺癌的80% [1]。CDK4/6抑制剂可通过与CDK4 和CDK6激酶的三磷酸腺苷(ATP)结合位点结合，抑制其活性，干扰网膜母细胞瘤(Rb)的磷酸化，阻断细胞周期从G1 期到S 期的进程，抑制肿瘤细胞增殖。此外，CDK4/6 抑制剂还能抑制上游雌激素受体信号通路的表达，与内分泌治疗之间存在协同增效的作用，达到延缓和逆转内分泌耐药的目的[2]。CDK4/6抑制剂联合内分泌治疗已成为《CACA-CBCS（2025版）》《中国临床肿瘤学会乳腺癌诊疗（CSCO BC）指南（2025版）》及美国国立综合癌症网络（NCCN）等国内外权威指南一致推荐的HR+/HER2-晚期乳腺癌治疗标准疗法。复妥宁®为复星医药子公司奥鸿药业拥有自主知识产权的创新型小分子CDK4/6抑制剂，是一种口服、强效、高选择性、全新结构的创新小分子药物，于2018年被列入国家“重大新药创制”科技重大专项。该新药能够显著延长患者中位无进展生存期，降低疾病进展的风险，整体安全性可控，为患者提供了新的治疗选择。复妥宁®在中国的商业化推广由复宏汉霖负责，依托成熟的商业化体系，公司于9月高效完成产品的首批发货以及全国各地的首处方落地，并持续扩大市场覆盖，让创新治疗选择尽早惠及更多晚期乳腺癌患者。复宏汉霖深耕乳腺癌治疗领域，通过自主研发与合作引进，已建立覆盖乳腺癌全程全域治疗管线。公司乳腺癌核心产品曲妥珠单抗汉曲优®（美国商品名：HERCESSI™，欧洲商品名：Zercepac®）已在全球50多个国家和地区获批上市；早期强化辅助治疗药物汉奈佳®（奈拉替尼）与汉曲优®续贯协同，降低复发风险；帕妥珠单抗生物类似药HLX11的上市申请获中美欧监管机构受理, 有望于下半年在美国获得批准。新表位抗HER2单抗HLX22针对HER2低表达HR阳性乳腺癌的II期临床研究正在同步开展中。同时，复宏汉霖加速布局新型内分泌疗法拉索昔芬片HLX78、KAT6A/B抑制剂HLX97、LIV-1靶点ADC HLX41、HER2xHER2双表位ADC HLX49、HER2 ADC HLX87等多元类型高潜创新分子。未来，公司将持续强化管线协同，构建贯穿全病程的诊疗生态，为更多乳腺癌患者提供全面的解决方案。【参考文献】 [1] Jerzak KJ, Bouganim N, Brezden-Masley C, et al. HR+/HER2- Advanced Breast Cancer Treatment in the First-Line Setting: Expert Review. Curr Oncol. 2023;30(6):5425-5447. Published 2023 Jun 2. doi:10.3390/curroncol30060411 [2] CDK4/6抑制剂治疗激素受体阳性人表皮生长因子受体2阴性乳腺癌临床应用专家共识（2023版）关于复妥宁复妥宁®（枸橼酸伏维西利胶囊）是一款创新型小分子CDK4/6 抑制剂，于2025年5月正式获得国家药品监督管理局（NMPA）上市注册批准。目前已获批适应症包括：1）用于激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性局部晚期或转移性乳腺癌成人患者：与芳香化酶抑制剂联合使用作为初始内分泌治疗；2）联合氟维司群用于既往接受内分泌治疗后出现疾病进展的激素受体（HR）阳性、人表皮生长因子 2 (HER2) 阴性的复发或转移性成年乳腺癌患者。该产品在中国的商业化推广由复宏汉霖负责。关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在全球获批上市9款产品，5个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、国内首个生物类似药汉利康®（利妥昔单抗）、以及地舒单抗生物类似药Bildyos®和Bilprevda®。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。 Henlius Achieves Breakthrough in First-Line Breast Cancer Therapy: Innovative CDK4/6 Inhibitor FUTUONING Approved for New Indication Recently, the drug registration application for the additional indication of FUTUONING (fovinaciclib citrate capsules), a novel CDK4/6 inhibitor, has been approved by the National Medical Products Administration (NMPA). The approved indication is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor2 (HER2)-negative locally advanced or metastatic breast cancer: in combination with an aromatase inhibitor as initial endocrine therapy. Previously, in combination with fulvestrant, FUTUONING has been approved for the treatment of patients with HR+/HER2- recurrent or metastatic breast cancer with disease progression following endocrine therapy. With a pipeline that spans the entire treatment journey, Henlius has achieved comprehensive coverage across all breast cancer subtypes. The company continues to solidify its leadership in first-line treatment for both HER2+ and HR+ subtypes, bringing more diverse treatment options to patients. Breast cancer is the most common malignancy among women worldwide and in China, with HR+/HER2- accounting for about 80% of all breast cancer cases [1]. CDK4/6 inhibitors exert their therapeutic effect by binding to the adenosine triphosphate (ATP) sites of CDK4 and CDK6 kinases, thereby inhibiting their activity. This action disrupts the phosphorylation of retinoblastoma (Rb) protein and arrests cell cycle progression from the G1 to the S phase, effectively suppressing tumor cell proliferation. Furthermore, CDK4/6 inhibitors downregulate upstream estrogen receptor signaling pathways and demonstrate synergistic efficacy when combined with endocrine therapy, helping to delay and potentially reverse the development of endocrine resistance [2].The combination of CDK4/6 inhibitors with endocrine therapy is the recommended standard treatment for HR+/HER2- advanced breast cancer, as endorsed by major guidelines in China and internationally, including the "CACA-CBCS (2025 Edition)," the "Chinese Society of Clinical Oncology Breast Cancer Diagnosis and Treatment (CSCO BC) Guidelines (2025 Edition)," and the United States National Comprehensive Cancer Network (NCCN) guidelines. FUTUONING is an oral, potent, highly selective CDK4/6 inhibitor with a novel structure. It was included in China’s National Major New Drug Innovation Program in 2018. Clinical studies demonstrated that the drug significantly prolonged median progression-free survival (PFS), reduced the risk of disease progression, and showed a manageable safety profile, providing patients with a new treatment option. It is an innovative small-molecule CDK4/6 inhibitor with independent intellectual property rights, owned by Avanc Pharmaceutical Co., Ltd (“Avanc Pharma”), a member enterprise of Fosun Pharma. Its commercialization in China is led by Henlius, utilizing its robust and well-established commercialization platform. In September, the company efficiently completed the first batch of product shipments and the implementation of the first prescriptions nationwide, while continuously expanding market coverage to ensure that the innovative treatment option benefit more advanced breast cancer patients as soon as possible. Henlius has demonstrated a strong commitment to advancing breast cancer treatment, establishing a comprehensive pipeline that addresses all stages and types of breast cancer through both independent development and strategic collaborations. Its core product trastuzumab HANQUYOU (trade name: HERCESSI™ in the U.S., Zercepac® in Europe) has been approved in over 50 countries and regions. The extended adjuvant treatment HANNAIJIA (neratinib), can be sequenced with trastuzumab to further reduce recurrence risk. The pertuzumab biosimilar HLX11 has been accepted for review by regulatory agencies in China, the U.S., and the EU，with potential approval in the U.S. in the second half of this year. The company’s self-developed novel epitope anti-HER2 antibody HLX22 is under Phase 2 clinical trials in HR-positive/HER2-low breast cancer. In addition, Henlius is advancing next-generation molecules such as oral selective estrogen receptor modulator (SERM) lasofoxifene (HLX78), KAT6A/B inhibitor HLX97, LIV-1-targeting ADC HLX41, HER2×HER2 bispecific epitope ADC HLX49 and HER2 ADC HLX87 through its robust innovation platforms and collaborative R&D. Looking ahead, the company will continue to enhance synergy across its pipeline and develop an integrated diagnostic and therapeutic ecosystem spanning the entire disease continuum, striving to deliver comprehensive solutions to a broader population of breast cancer patients. About FUTUONING FUTUONING (Fovinaciclib), a novel CDK4/6 inhibitor, received approval from NMPA in May 2025. Its currently approved indications are as follows: 1) for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor2 (HER2)-negative locally advanced or metastatic breast cancer: in combination with an aromatase inhibitor as initial endocrine therapy; 2) in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative recurrent or metastatic breast cancer with disease progression following endocrine therapy. Henlius is responsible for the commercialization of FUTUONING in China. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 9 products have been approved for marketing worldwide, and 5 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, and denosumab Bildyos® and Bilprevda®. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets. 联系方式媒体：PR@Henlius.com 投资者：IR@Henlius.com 喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看

CSCO会议上市批准

2025-09-04

·复宏汉霖

复宏汉霖乳腺癌布局再添力将，复妥宁®全国各地首张处方落地

近日，复妥宁®（枸橼酸伏维西利胶囊）的首张处方由河北医科大学第四医院刘运江教授、哈尔滨医科大学附属肿瘤医院张清媛教授、中国医学科学院肿瘤医院袁芃教授、上海市第十人民医院盛湲教授、四川省肿瘤医院王浩教授、山东省肿瘤医院李永清教授等在全国各地陆续开出。该款CDK4/6抑制剂联合氟维司群用于既往接受内分泌治疗后出现疾病进展的激素受体（HR）阳性、人表皮生长因子 2 （HER2）阴性的复发或转移性成年乳腺癌患者。复妥宁®是一款由复星医药控股子公司锦州奥鸿药业有限责任公司（以下简称“奥鸿药业”）自主研发、拥有自主知识产权的创新型小分子CDK4/6抑制剂，其在中国的商业化推广由复宏汉霖负责。复宏汉霖首席商务官兼高级副总裁余诚先生表示此次首批发货标志着复妥宁®正式进入商业化阶段，全面供应全国市场。依托自身成熟的商业化体系，我们将全力推动复妥宁®的市场准入与终端覆盖，不断提升药品可及性，让更多患者早日从创新治疗中获益。乳腺癌是全球及中国女性最常见的恶性肿瘤。HR阳性/HER2阴性是乳腺癌中最常见的亚型，约占所有乳腺癌的65-70% [1]。以内分泌治疗为基础的综合方案是该亚型的标准治疗，显著改善了患者预后[2]，但30%~50%的患者在治疗中会发生内分泌耐药，最终导致疾病复发或转移[3]。研究发现，该类乳腺癌细胞的增殖高度依赖CDK4/6通路，CDK4/6抑制剂可通过特异性抑制CDK4/6激酶活性，抑制增殖并诱导肿瘤细胞凋亡。复妥宁®是一种口服、强效、高选择性、具有全新结构的CDK4/6抑制剂，于2018年被列入国家“重大新药创制”科技重大专项。该药物可显著延长患者的中位无进展生存期，降低疾病进展风险，且整体安全性可控。9月1日，奥鸿药业于辽宁锦州顺利完成复妥宁®首批发货。随后，复宏汉霖积极规划商业渠道与供应链管理，在公司全资子公司汉霖医贸的高效运作和战略合作经销商的紧密配合下，复妥宁®迅速发往全国各地，以最快速度入库上架，截至目前该产品已覆盖29个省份44座城市。此外，公司持续提升创新药物的可及性与可负担性，截至最新，复妥宁®已被成功纳入22个省（市）的医保目录。乳腺癌是复宏汉霖重点布局的核心治疗领域。公司已建立覆盖乳腺癌全病程、全分子亚型的多元化产品管线，通过自建商业化团队和携手海外合作伙伴，组建了覆盖全球的商业化网络，持续释放乳腺癌管线的商业价值。公司组建了逾600人的乳腺癌产品商业化团队，不仅全面覆盖了市场准入、渠道拓展、医学推广等关键环节，更凭借精细化运营和智能化管理，实现行业领先的商业化效率。目前，公司核心产品曲妥珠单抗汉曲优®（美国商品名：HERCESSI™，欧洲商品名：Zercepac®）已在全球50多个国家和地区获批上市，并进入中国、英国、法国、德国等多个国家的医保目录；HER2阳性早期乳腺癌强化辅助治疗药物汉奈佳®（奈拉替尼）可与汉曲优®形成序贯治疗降低复发风险；帕妥珠单抗生物类似药HLX11的上市申请也已获中美欧监管机构受理，有望下半年在美国获得批准，与汉曲优®联用实现双靶协同增效；公司自主研发的新表位抗HER2单抗HLX22正在HER2低表达HR阳性乳腺癌患者中开展II期临床研究。同时，依托强大的创新技术平台，以及通过与合作伙伴的创新协同，复宏汉霖加速ADC、小分子靶向药物等多元化分子的研发进程，布局新型内分泌疗法拉索昔芬片HLX78、KAT6A/B抑制剂HLX97、LIV-1靶点ADC HLX41、HER2xHER2双表位ADC HLX49等高潜创新分子。未来，复宏汉霖将继续聚焦未被满足的临床需求，加速推进乳腺癌全线治疗方案的落地，切实提升患者生存质量及长期获益。参考文献 [1] Huppert LA, Gumusay O, Idossa D, Rugo HS. Systemic therapy for hormone receptor-positive/human epidermal growth factor receptor 2-negative early stage and metastatic breast cancer. CA Cancer J Clin. 2023 Sep-Oct;73(5):480-515. doi: 10.3322/caac.21777. Epub 2023 Mar 20. PMID: 36939293. [2] 江泽飞. 乳腺癌内分泌治疗专家共识（2023版）. 中华医学杂志，2023，103(38):2993-3001. [3]Rozeboom B, et al. ER+ metastatic breast cancer: past, present, and a prescription for an apoptosis-targeted future. Am J Cancer Res. 2019, 9(12):2821-2831. 关于复妥宁复妥宁®（枸橼酸伏维西利胶囊）是一款创新型小分子CDK4/6 抑制剂，于2025年5月正式获得国家药品监督管理局（NMPA）上市注册批准，联合氟维司群用于既往接受内分泌治疗后出现疾病进展的激素受体（HR）阳性、人表皮生长因子 2 (HER2) 阴性的复发或转移性成年乳腺癌患者。该产品在中国的商业化推广由复宏汉霖负责。关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在全球获批上市9款产品，5个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、国内首个生物类似药汉利康®（利妥昔单抗）、以及地舒单抗生物类似药Bildyos®和Bilprevda®。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。 FUTUONING Sets Sail Commercially with First Prescriptions Across China These days, the first prescriptions of FUTUONING (fovinaciclib citrate capsules) were issued across China by leading oncologists including Professor Yunjiang Liu from the Fourth Hospital of Hebei Medical University, Professor Qingyuan Zhang from Harbin Medical University Cancer Hospital, Professor Peng Yuan from the Cancer Hospital of the Chinese Academy of Medical Sciences, Professor Yuan Sheng from Shanghai Tenth People’s Hospital, Professor Hao Wang from Sichuan Cancer Hospital & Institute and Professor Yongqing Li from Shandong Cancer Hospital. FUTUONING, a CDK4/6 inhibitor, is indicated in combination with fulvestrant, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative recurrent or metastatic breast cancer with disease progression following endocrine therapy. The drug was independently developed by Avanc Pharmaceutical Co., Ltd (“Avanc Pharma”), a subsidiary of Fosun Pharma, with full intellectual property rights. Its commercialization in China is led by Henlius. Mr. Kurt Yu, Chief Commercial Officer and Senior Vice President of Henlius, stated: “The first batch delivery of FUTUONING marks its official entry into the commercial stage, with full-scale supply nationwide. Leveraging our well-established commercialization system, we will spare no effort to accelerate market access and terminal coverage for FUTUONING, continuously improving its accessibility so that more patients can benefit from this innovative therapy as early as possible.” Breast cancer is the most common malignancy among women worldwide and in China. HR-positive/HER2-negative breast cancer is the most prevalent subtype, accounting for approximately 65–70% of all cases [1]. Endocrine therapy-based regimens are the standard of care and have significantly improved patient outcomes [2]. However, 30–50% of patients eventually develop endocrine resistance, leading to recurrence or metastasis [3]. Research shows that the proliferation of such cancer cells is highly dependent on the CDK4/6 pathway, and CDK4/6 inhibitors suppress tumor cell proliferation and induce apoptosis by specifically inhibiting CDK4/6 kinase activity. FUTUONING is an oral, potent, highly selective CDK4/6 inhibitor with a novel structure. It was included in China’s National Major New Drug Innovation Program in 2018. Clinical studies demonstrated that the drug significantly prolonged median progression-free survival (PFS), reduced the risk of disease progression, and showed a manageable safety profile. On September 1, Avanc Pharma successfully completed the first batch delivery of FUTUONING in Jinzhou, Liaoning Province, China. Henlius has since developed comprehensive commercialization and supply chain strategies to ensure swift nationwide coverage, spanning 29 provinces and 44 cities. Furthermore, the company is driving initiatives to enhance drug accessibility and affordability. As of now, FUTUONING has been successfully included in the reimbursement catalogues of 22 provinces (municipalities). Breast cancer is one of Henlius’ core therapeutic focuses. The company has built a diversified pipeline covering the full disease spectrum and all molecular subtypes of breast cancer. By combining its in-house commercialization team with global partnerships, Henlius has established a worldwide commercial network and continues to unlock the commercial value of its breast cancer portfolio. Henlius has built a 600+ member breast cancer commercialization team, covering key areas including market access, channel expansion, and medical promotion. Through refined operations and digitalized management, the company has achieved industry-leading commercialization efficiency. Its core product trastuzumab HANQUYOU (Hercsessi™ in the U.S., Zercepac® in Europe) has been approved in over 50 countries and regions and is reimbursed in China, the UK, France, Germany, and more.Neratinib HANNAIJIA, for extended adjuvant treatment of HER2-positive early breast cancer, can be sequenced with trastuzumab to further reduce recurrence risk. The pertuzumab biosimilar HLX11 has been accepted for review by regulatory agencies in China, the U.S., and the EU, and is expected to gain FDA approval in the second half of this year, enabling dual HER2-targeted synergy with trastuzumab.The company’s self-developed novel epitope anti-HER2 antibody HLX22 is under Phase 2 clinical trials in HR-positive/HER2-low breast cancer. In addition, Henlius is advancing next-generation molecules such as oral selective estrogen receptor modulator (SERM) lasofoxifene (HLX78), KAT6A/B inhibitor HLX97, LIV-1-targeting ADC HLX41, and HER2×HER2 bispecific epitope ADC HLX49 through its robust innovation platforms and collaborative R&D. Looking ahead, Henlius will continue to focus on unmet clinical needs, accelerate the rollout of comprehensive treatment solutions for breast cancer, and improve patients’ quality of life and long-term survival outcomes. About FUTUONING FUTUONING(Fovinaciclib), a novel CDK4/6 inhibitor, received approval from NMPA in May 2025. It is indicated in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative recurrent or metastatic breast cancer with disease progression following endocrine therapy. Henlius is responsible for the commercialization of FUTUONING in China. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 9 products have been approved for marketing worldwide, and 5 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, and denosumab Bildyos® and Bilprevda®. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets. 联系方式媒体：PR@Henlius.com 投资者：IR@Henlius.com 喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看

高管变更申请上市核酸药物

2025-08-27

·E药经理人

冲刺500亿！艾力斯点火，荣昌翻身，复宏汉霖加速，Bio六杰谁能稳住？

对于本土Biotech来说，500亿市值是门槛，也是分水岭，考验的是，谁能把讲故事变成真业绩，把单品逻辑升级为平台逻辑，把阶段性亮点拉成长坡厚雪的增长曲线。撰文| Erin 当艾力斯交出2025年上半年营收、净利润同增50%的答卷时，市场情绪瞬间被点燃。业绩公告次日，股价收盘涨17%，市值暴增百亿，一举跨过500亿元门槛。以此为界，“500亿线”被照亮为分水岭，估值的锚从“讲故事”切换到“凭业绩”。E药经理人据此将这条线附近、正回答同样考题的六家中国Biotech——艾力斯、荣昌生物、复宏汉霖、诺诚健华、君实生物、新诺威——合称“Bio六杰”。不过，“六杰”的划定，并非简单的市值罗列，而是一组具有代表性的样本：它们同时直面三道必答题：商业化现金流稳不稳、管线接不接得上、全球化与BD能否提供第二曲线。艾力斯之所以跨线，固然有伏美替尼在EGFR拥挤赛道中的份额与销售能力，但也把共同命题推到台前：创新纵深如何抵御同质化？第二发动机是否足够清晰？全球注册与商业化能否按节拍转化为现金回流？ 500亿不是终点，而是对“潜力与确定性”的优先级重排。谁能在这条新坐标上站稳，谁才能真正开启下一段的增长曲线。来源：公司财报跨越“500亿”市值门槛 8月26日收盘后，艾力斯发布2025年上半年业绩：营业收入23.74亿元，同比增长50.57%；归母净利润10.51亿元，同比增长60.22%。业绩的同步大幅提升迅速点燃市场情绪，艾力斯市值一夜抬升，直接跨过500亿元关口。至8月27日下午收盘，艾力斯报111.31元/股，涨幅17%，总市值500.90亿元，市场对其“由故事转向兑现”的拐点预期正在形成。 “500亿”市值门槛，现在对恒瑞、百济神州这样的“一哥”或许连起跑线都谈不上，但对一众“待爆帝”而言，却是从“讲故事”跨越到“凭业绩”的关键门槛。跨线与否，背后是估值逻辑的切换：在此之前，市值尚未触及500亿的公司，多由研发管线预期驱动，市场为“想象力”买单，波动难免；跨线之后，通常意味着至少有一款重磅单品进入稳定放量期，企业从能研发走向能兑现，生产、准入、渠道与学术推广的正向循环开始稳步运转，利润与现金流成为新的估值锚。就拿艾力斯来说，其营收、净利双增的背后，是基本面的稳健：第三代EGFR-TKI伏美替尼自2021年3月获批以来持续放量；2025年上半年，即便在与基石药业合作的普拉替尼因价格调整出现同比大幅下滑、且国内已有多款三代EGFR-TKI获批NSCLC适应证的竞争环境中，艾力斯的收入与净利仍呈现双位数高速增长。这意味着其单品份额具备韧性，更意味着公司在肺癌赛道的龙头地位已被坐实。把镜头拉远，“500亿线”已成为创新药企的重要分水岭。荣昌、复宏汉霖、诺诚健华、新诺威、君实等，皆在这一线附近，或稳住基本盘，或蓄力冲刺。荣昌生物当前A股市值约465.54亿元，距离门槛一步之遥。其2025年上半年营收10.98亿元，同比增加48.02%；亏损4.46亿元，同比收窄43.88%。长期压制定价的“增收难增利”局面已出现松动。来源是泰它西普、维迪西妥单抗两大核心产品的持续放量。更进一步的是，今年5月两款核心产品分别新增重症肌无力与肝转移乳腺癌适应证，下半年增量可期。复宏汉霖的“临门一脚”则来自“第二曲线”的落地。目前，公司总市值约430.18亿港元，2025年上半年营收28.2亿元，净利润3.9亿元，皆实现同比提升。更值得一提是，海外产品利润同比激增逾200%，BD合同现金流入超10亿元，同比增幅达280%。当海外商业化放量与BD变现形成“现金+里程碑”，复宏汉霖距离“500亿”市值门槛也更近一步。诺诚健华已经越线，A股市值约503.1亿元。两款上市新药、一个年销10亿元级单品、两个生产基地、10多款成梯队的在研管线、近80亿元现金储备，以及覆盖研发、生产、商业化及BD的千人团队，构成其“稳”的底座。最新半年报显示，得益于奥布替尼持续放量，公司上半年营收同比大涨74%至7.3亿元，亏损同比收窄87%，盈利路径愈发清晰。对已跨过门槛的公司而言，接下来更重要的是把业绩数字与管线接力的节奏做“顺”，让估值锚从“单品逻辑”转向“平台逻辑”。君实生物则处于“重估窗口”。公司A股市值约445.38亿元，2025年上半年营业收入11.68亿元，同比增加48.64%。核心产品特瑞普利单抗国内销售收入达9.47亿元，同比增长42%，成为少数双位数高速增长的国产PD-1。市场对君实定价的关键在于：在优化费用结构、稳住现金流的同时，加速“第二发动机”的明确化与落地。新诺威的路径不仅是背靠石药集团，还兼具BD驱动与产品放量。2025年上半年，除PD-1恩朗苏拜单抗注射液与注射用奥马珠单抗带来9351.02万元收入外，其716.34亿元的市值中也包含了市场对其BD里程碑的期待。据悉，今年2月，巨石生物与美国Radiance Biopharma达成合作，授予后者SYS6005在北美、欧盟及日本等主要市场的独家开发及商业化权益，交易总金额最高可达12.4亿美元。不难看出，“500亿”市值其实并不是终点线，而是“由潜力到可持续”的分水岭：它要求创新药企证明单品能“卖得好”、费用与现金流结构稳定、管线能接得上、海外BD能贡献新增长。相对应的是，真正的考题是如何把这条曲线拉长、拉稳，让市场在下一个估值锚点前，看到更确定的兑现。推荐阅读 * 从“稳扎稳打”到“全速奔跑”：详解诺诚健华2.0阶段创新成长密码 * 百济盈利，再鼎环比翻倍，信达收入52亿，股价却齐跌？创新七君进入重估时刻能否守住当“500亿”市值成为分水岭，真正的考题不再是能不能跨过去，而是能不能站稳。前人的经验已给出答案：要么把业绩数字做漂亮、把现金流做厚、把单品做深；要么用一个个有节奏的里程碑，把管线从时间表兑现为收入表。例如头部Biopharma信达的来时路，回望过去几年，其“500亿市值”拐点就发生在2023年年中。彼时，信达生物的H1财报显示，总收入约27亿元、产品收入就达到24.6亿元，研发投入同比下降、亏损大幅收窄、现金储备充裕，同时两大重磅产品——GLP-1R/GCGR双激动剂玛仕度肽和PCSK9单抗托莱西单抗，都给出了明确预期，由此形成了公司“商业化基本盘＋新增长曲线”的双支点。此后信达市值一路飙升，如今已经接近1600亿港元。这背后也是信达生物稳健的基本面：2025年上半年产品收入已超52亿元，玛仕度肽已获批，再添放量抓手。如今市值超1400亿港元的康方，在2024年用PD-1/VEGF双抗依沃西单药“打败“K药在全球范围内重塑预期、缔造爆点；2025年上半年，在凭借商业化收入超14亿元，同比近五成增长，以及依沃西单抗联合化疗的III期研究达到总生存期（OS）终点将继续把“爆点”转化为兼顾底盘。两条路径都指向同一件事：资本最终为可持续兑现的价值定价。回到“Bio六杰”，能否守住“500亿”上下的市值，也要把“当期兑现力”和“中长期接力”同时做实。艾力斯的当期兑现力毋庸置疑：伏美替尼的一、二线适应证已全部进医保，肺癌领域销售网络纵深覆盖，戈来雷塞与普拉替尼协同巩固，肺癌赛道形成多产品矩阵。不过，艾力斯要守住甚至抬升市值，还需回答两大问题：其一，核心管线仍集中于已验证靶点，创新纵深与差异化何以建立？其二，伏美替尼外的其他管线能否形成真正的第二发动机？荣昌正在用“两张底牌”修复估值：泰它西普与维迪西妥带动收入增长、亏损收窄，新适应证增强了当期确定性；中程来看，VEGF双靶点眼科新药的海外授权交易增厚现金流，叠加RC88新ADC实体瘤临床试验拓展，以及PD-1双抗RC148获突破性治疗认定等连续节点支撑收入曲线。但荣昌的考验却不止于此，他还需要回答，面对自免与肿瘤双线商业化对费用的挑战，利润改善能否持续？诺诚健华的近岸清晰、远期雄心明确：奥布替尼精准卡位前三市场，适应证迅速进医保，商业化队伍升级后放量与现金流质量同步增强；中程是奥布替尼在自免领域新适应证即将迎来上市节点，另一端是新产品接力，ICP-723已递交上市申请、ICP-248获突破性疗法认定、两款差异化TYK2抑制剂持续突破；远期以“2.0战略”拉长节奏，力争至2028年实现5–6款新产品及适应证商业化、3–5款国际化，持续产出源头创新产品，平台化色彩更浓。复宏汉霖的“近岸”主线，则凭借6款已获批产品，聚焦于持续盈利与海外放量；中程以新型内分泌疗法HLX78、新表位抗HER2单抗HLX22、HER2 ADC HLX87等把新增长曲线从预期推向价值兑现；远期借约50个分子与10余技术平台、全球化供应体系迭代，把“研产销一体化”能力在全球打开收入天花板。君实的国际化布局同样如此，其近岸靠特瑞普利单抗的大适应证在国内扩围，国际化布局广，成为少数真正形成出海规模化的Biotech之一。但守住与再上台阶的瓶颈在于：除PD-1外，BTLA、IL-17与双抗管线何时给出能撬动业绩增长的“硬结果”？海外商业化的成果何时反哺业绩，其估值天花板也将取决于第二发动机的速度与质量。新诺威的未来，则更偏“交易+平台”特性：新药收入起量、功能食品与原料提供现金流缓冲，BD大单为远期增加潜力。然而市场对其“产品价值兑现”的路径仍存疑：mRNA与ADC从临床到商业化的“窗口期”偏长，BD交易的里程碑能否按是市场预期节拍落地？只有把“交易的故事”落到实打实的收入上，第二曲线才会变得可计算。总体来看，对于“Bio六杰”来说，守住“500亿”从来不是一次性的速度竞赛，而是一场节奏的比拼，当商业化底盘足够扎实、管线接力清晰可见、全球化里程碑不断加码，估值锚才会从短线爆点进化为可持续增长的曲线。一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐大事件 | IPO | 融资&交易 | 财报季 | 新产品 | 研发日 | 里程碑 | 行业观察 | 政策解读 | 深度案例 | 大咖履新 | 集采&国谈 | 出海 | 高端访谈 | 技术&赛道 | E企谈 | 新药生命周期 | 市值 | 新药上市 | 商业价值 | 医疗器械 | IND | 周年庆大药企 | 竞争力20强 | 恒瑞 | 石药 | 中生制药 | 齐鲁 | 复星 | 科伦 | 翰森 | 华润 | 国药 | 云南白药 | 天士力 | 华东 | 上药创新药企 | 创新100强 | 百济 | 信达 | 君实 | 复宏汉霖 | 康方 | 和黄 | 荣昌 | 亚盛｜康宁杰瑞｜贝达｜微芯｜再鼎｜亚虹跨国药企｜ＭＮＣ卓越｜辉瑞｜AZ｜诺华｜罗氏｜BMS｜默克｜赛诺菲｜GSK｜武田｜礼来｜诺和诺德｜拜耳供应链｜赛默飞｜药明｜凯莱英｜泰格｜思拓凡｜康龙化成｜博腾｜晶泰｜龙沙｜三星启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 中国医药手册

财报

100 项与 Lasofoxifene Tartrate 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Lasofoxifene Tartrate	G03	DB06202

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
绝经期后骨质疏松	欧盟	Dr. Friedrich Eberth Arzneimittel GmbH	2009-02-24
绝经期后骨质疏松	冰岛	Dr. Friedrich Eberth Arzneimittel GmbH	2009-02-24
绝经期后骨质疏松	列支敦士登	Dr. Friedrich Eberth Arzneimittel GmbH	2009-02-24
绝经期后骨质疏松	挪威	Dr. Friedrich Eberth Arzneimittel GmbH	2009-02-24

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
萎缩性阴道炎	申请上市	美国	Sermonix Pharmaceuticals LLC	-
ER阳性/HER2阴性/ESR1突变乳腺癌	临床3期	美国	上海复宏汉霖生物技术股份有限公司	2023-11-14
ER阳性/HER2阴性/ESR1突变乳腺癌	临床3期	澳大利亚	上海复宏汉霖生物技术股份有限公司	2023-11-14
ER阳性/HER2阴性/ESR1突变乳腺癌	临床3期	加拿大	上海复宏汉霖生物技术股份有限公司	2023-11-14
ER阳性/HER2阴性/ESR1突变乳腺癌	临床3期	法国	上海复宏汉霖生物技术股份有限公司	2023-11-14
ER阳性/HER2阴性/ESR1突变乳腺癌	临床3期	以色列	上海复宏汉霖生物技术股份有限公司	2023-11-14
ER阳性/HER2阴性/ESR1突变乳腺癌	临床3期	新加坡	上海复宏汉霖生物技术股份有限公司	2023-11-14
ER阳性/HER2阴性乳腺癌	临床3期	美国	Sermonix Pharmaceuticals LLC	2023-10-31
ER阳性/HER2阴性乳腺癌	临床3期	中国	Sermonix Pharmaceuticals LLC	2023-10-31
ER阳性/HER2阴性乳腺癌	临床3期	澳大利亚	Sermonix Pharmaceuticals LLC	2023-10-31

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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


NCT01042379 (I-SPY2 endocrine optimization pilot (EOP), ASCO2025)	临床2期	HR阳性/HER2阴性乳腺癌新辅助 MammaPrint (MP) low risk \| Ki-67 \| ctDNA+	20	Lasofoxifene 5 mg	窪醖鑰製窪鑰餘鏇網餘(鹽淵鹽醖夢艱醖淵艱網) = 50% 餘夢築壓廠窪膚範憲廠 (醖鏇繭構廠構鹽衊積壓 ) 更多	积极	2025-05-30
				Placebo
NCT01042379 (I-SPY 2, Company_Website) 人工标引	临床2期	HR阳性/HER2阴性乳腺癌新辅助 HR Positive \| HER2 Negative	20	Lasofoxifene	壓遞齋繭淵壓鹹襯製窪(願淵範蓋範繭選鏇築廠) = Adverse events (AEs) were all grade 1-2. Most common AEs include hot flushes (65%), constipation (40%), fatigue (40%) and nausea (25%). 願夢艱選鑰遞憲廠壓繭 (顧餘鑰鏇蓋糧繭艱願築 )	积极	2025-04-11
NCT03781063 (ELAINE 1, Pubmed \| Ann Oncol)	临床2期	ER阳性/HER2阴性/ESR1突变乳腺癌 ESR1 mutation	103	Lasofoxifene 5 mg	衊鏇築鏇願醖觸鹹構窪(廠淵鏇繭膚膚繭顧構醖) = 鏇壓範夢積獵獵鏇壓壓鏇鹽鹽範餘遞顧糧製艱 (壓壓廠襯願鑰製廠積鏇 ) 更多	积极	2023-12-01
				Fulvestrant 500 mg	衊鏇築鏇願醖觸鹹構窪(廠淵鏇繭膚膚繭顧構醖) = 繭網淵淵壓鹹製繭憲鬱鏇鹽鹽範餘遞顧糧製艱 (壓壓廠襯願鑰製廠積鏇 ) 更多
NCT04432454 (ELAINE 2, Pubmed \| Ann Oncol)	临床2期	ER阳性/HER2阴性/ESR1突变乳腺癌 ESR1 mutation	-	Lasofoxifene 5 mg/day + Abemaciclib 150 mg b.i.d	鏇衊齋鹽製夢構築鹽廠(膚廠糧壓鹹蓋廠獵壓蓋) = 顧鏇網鏇製獵鹽構鹹鬱觸鹽齋餘襯廠齋糧觸鹹 (遞觸廠網糧顧醖願製餘, 47.3% ~ 80.1%) 更多	积极	2023-12-01
NCT04432454 (ELAINE 2, ASCO2023) 人工标引	临床2期	ER阳性/HER2阴性/ESR1突变乳腺癌 ESR1 \| ER Positive \| HER2 Negative	29	Lasofoxifene 5 mg/day + Abemaciclib 150 mg	簾窪衊網廠顧構繭憲窪(願製鏇醖範餘艱憲製齋) = LAS/Abema was well tolerated with primarily grade 1/2 treatment-emergent adverse events (most commonly diarrhea, nausea, fatigue, and vomiting) 遞築鑰製簾襯鬱衊齋選 (簾製築鏇鏇範齋簾網鬱 )	积极	2023-05-31
NCT03781063 (ELAINE 1, SABCS2023)	临床2期	ER阳性/HER2阴性乳腺癌 mutESR1	103	Lasofoxifene 5 mg daily	鬱選鏇網夢築範餘繭簾(積網築簾鑰夢醖廠醖廠) = 選鏇獵選壓鹽餘獵顧窪製鏇築襯鹽糧醖窪廠夢 (衊積簾獵窪鏇憲製淵願 ) 更多	积极	2023-03-01
				Fulvestrant 500 mg on days 1, 15, and 29, then every 4 wks	鬱選鏇網夢築範餘繭簾(積網築簾鑰夢醖廠醖廠) = 鬱鏇襯鑰鑰膚製遞鹽膚製鏇築襯鹽糧醖窪廠夢 (衊積簾獵窪鏇憲製淵願 ) 更多
NCT03781063 (ELAINE 1, ESMO2022) 人工标引	临床2期	ER阳性/HER2阴性乳腺癌二线 ER+/HER2-/ESR1-mutated	103	lasofoxifene	膚壓獵獵鑰醖淵遞鬱遞(構獵製襯鹹選遞顧襯繭) = 壓獵鹹鹹範繭製夢醖餘鏇餘築觸積衊醖鏇繭壓 (憲齋築選膚鑰簾夢選鏇, 2.82 ~ 8.04) 更多	优效	2022-09-10
				fulvestrant	膚壓獵獵鑰醖淵遞鬱遞(構獵製襯鹹選遞顧襯繭) = 範壓選衊膚願積繭製構鏇餘築觸積衊醖鏇繭壓 (憲齋築選膚鑰簾夢選鏇, 2.93 ~ 6.04) 更多
NCT04432454 (ELAINE 2, ASCO2022)	临床2期	ER阳性/HER2阴性乳腺癌 \| 转移性乳腺癌	29	Lasofoxifene 5 mg/day + Abemaciclib 150 mg BID	簾積繭膚蓋壓憲製顧憲(壓淵簾繭齋製鏇艱製廠) = 鏇網糧艱積憲獵獵願範範衊餘鹽齋顧齋願觸廠 (壓繭鬱繭鑰襯醖網築糧, 44.0–77.3) 更多	-	2022-06-02
NCT00141323 (PEARL, Pubmed \| Circulation)	临床3期	绝经期后骨质疏松	8,556	Lasofoxifene 0.5 mg/d	獵製製製願襯膚網選淵(艱積醖憲願願鏇壓窪夢): hazard ratio = 0.56 (95% CI, 0.32 ~ 0.98) 更多	-	2010-10-26
				Placebo
NCT00141323 (Pubmed \| N Engl J Med)	临床3期	绝经期后骨质疏松	8,556	Lasofoxifene 0.25 mg	艱築衊觸選糧餘廠構鬱(淵鑰窪鹹憲壓築鹹襯遞) = 製衊顧窪簾餘蓋襯繭選壓壓築顧獵獵淵襯積構 (壓膚膚鹹觸鹽襯築齋憲 ) 更多	-	2010-02-25
				Lasofoxifene 0.5 mg	艱築衊觸選糧餘廠構鬱(淵鑰窪鹹憲壓築鹹襯遞) = 簾構窪鹽窪構鑰鹹遞鹽壓壓築顧獵獵淵襯積構 (壓膚膚鹹觸鹽襯築齋憲 ) 更多