[Translation] An open-label, single-dose phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of lasofoxifene 5 mg tablets in healthy Chinese adult female subjects

主要目的：评估在中国健康成人女性受试者中单次给予5 mg拉索昔芬片的药代动力学（PK）特征。次要目的：评估在中国健康成人女性受试者中单次给予5 mg拉索昔芬片的安全性和耐受性。

[Translation]

Primary objective: To evaluate the pharmacokinetic (PK) characteristics of a single dose of 5 mg lasofoxifene tablets in healthy Chinese female adult subjects. Secondary objective: To evaluate the safety and tolerability of a single dose of 5 mg lasofoxifene tablets in healthy Chinese female adult subjects.

Start Date05 Nov 2024

Sponsor / Collaborator

Shanghai Henlius Biotech, Inc.

[+1]

CTR20242519

/ RecruitingPhase 3

一项比较阿贝西利联合拉索昔芬或氟维司群用于雌激素受体阳性（ER+）、人表皮生长因子受体2阴性（HER2-）、雌激素受体1（ESR1）突变的绝经前/后女性和男性局部晚期或转移性乳腺癌患者的有效性和安全性的开放标签、随机、多中心研究

[Translation] An open-label, randomized, multicenter study comparing the efficacy and safety of abemaciclib combined with lasofoxifene or fulvestrant in premenopausal and postmenopausal women and men with locally advanced or metastatic breast cancer who are estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), and have an estrogen receptor 1 (ESR1) mutation

针对既往接受过瑞波西利或哌柏西利治疗、ER+、HER2-、ESR1突变的绝经前/后女性和男性局部晚期或转移性乳腺癌患者，评估分别使用阿贝西利联合拉索昔芬或氟维司群治疗的无进展生存期（PFS）情况。

[Translation]

To evaluate the progression-free survival (PFS) of abemaciclib combined with lasofoxifene or fulvestrant in premenopausal/postmenopausal women and men with locally advanced or metastatic breast cancer who were ER+, HER2-, and ESR1 mutated and had received prior treatment with ribociclib or palbociclib.

Start Date29 Oct 2024

Sponsor / Collaborator

Shanghai Henlius Biotech, Inc.

[+1]

NCT06197568

/ Not yet recruitingPhase 1/2

An Open-Label, Safety, Tolerability and Efficacy Study of Vaginal AZU-101 in Postmenopausal Women

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

Start Date01 May 2024

Sponsor / Collaborator

Azure Biotech, Inc.

100 Clinical Results associated with Lasofoxifene Tartrate

100 Translational Medicine associated with Lasofoxifene Tartrate

100 Patents (Medical) associated with Lasofoxifene Tartrate

271

Literatures (Medical) associated with Lasofoxifene Tartrate

03 May 2025·Future Oncology

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

Article

Author: Boruta, Gina ; Gal-Yam, Einav Nili ; Wander, Seth A. ; de Nonneville, Alexandre ; 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.

01 Apr 2025·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

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

01 Mar 2025·JOURNAL OF HAZARDOUS MATERIALS

A genetically encoded fluorescent whole-cell biosensor for real-time detecting estrogenic activities in water samples

Article

Author: Chen, Ling ; Yang, Junyi ; Ren, Hongqiang ; Yuan, Shengjie ; He, Ruonan ; Wu, Bing

Real-time monitoring of estrogenic activity in the aquatic environment is a challenging task. Current biosensors face difficulties due to their limited response speed and environmental tolerance, especially for detecting wastewater, the major source of estrogenic compounds in aquatic environments. To address these difficulties, this study developed a single fluorescent protein (FP) -based whole-cell bacterial biosensor named ER-Light, which was achieved by inserting the sensing domain of the estrogen receptor (ER) into the FP Citrine and expressing it in the periplasm of Escherichia coli. As designed, ER-Light enables the detection of net estrogenic activity in mixtures, represented by estradiol equivalent concentration (EEQ). ER-Light detects EEQ in 40 s with a detection limit of 4.55 × 10^-7 μM and a maximum working range of 1.1 × 10^-4 μM, demonstrating sufficient response speed, sensitivity, and working range. In addition, the ER-Light can survive and tolerate wastewater effluent. Satisfactory recoveries (91.0 % to 102.1 %) eliminated concerns about the matrix effect of wastewater. EEQs (Not detected-2.9 ×10^-5 µM) measured by ER-Light from the effluent of 9 wastewater treatment plants validate its practicality in detecting wastewater. This is the first attempt to integrate ER into FP-based biosensors for environment monitoring. Our findings provide valuable design rules for real-time detection of bioactivity effects in the environment, contributing to the safeguarding of ecological and human health.

News (Medical) associated with Lasofoxifene Tartrate

11 Apr 2025

·sermonixpharma.com

Sermonix Pharmaceuticals’ Lasofoxifene Is Well Tolerated, Demonstrates Promising Ki67 Suppression in Phase 2 I-SPY 2 Arm Evaluating Therapy in Neoadjuvant Breast Cancer Setting

COLUMBUS, Ohio, and SAN FRANCISCO, Nov. 02, 2024 (GLOBE NEWSWIRE) — Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), and Quantum Leap Healthcare Collaborative™ today broadly announced that in the Phase 2 clinical trial evaluating lasofoxifene as a neoadjuvant endocrine therapy in molecularly selected HR+/HER2-, locally advanced breast cancer, the investigational drug was well tolerated and demonstrated promising early activity in suppressing the Ki67 protein in both premenopausal and postmenopausal patients. Results from the study, an arm of the Endocrine Optimization Pilot Protocol (EOP), a sub-study of Quantum Leap’s ongoing I-SPY 2 TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2), were initially shared yesterday in a poster presentation at RISE UP for Breast Cancer. Twenty patients (10 pre- and nine postmenopausal women, and one male) were enrolled in the lasofoxifene arm of the study, during which early Ki67 suppression in premenopausal patients was seen in the absence of ovarian function suppression (OFS). Ki67 is a marker that measures how fast cancer cells are dividing. “Lasofoxifene continued to demonstrate a strong tolerability profile while showing promising Ki67 suppression in this Phase 2 study, supporting our plans to further explore its potential in the neoadjuvant setting,” said Dr. David Portman, Sermonix founder and chief executive officer. “We are currently studying lasofoxifene in the ELAINE-3 Phase 3 combination study with abemaciclib in the ESR1-mutated metastatic breast cancer setting. We are excited to see it continue to demonstrate broad potential while offering unique quality of life benefits for people confronted with breast cancer.” Patients were enrolled in the I-SPY 2 arm from March 2023 to May 2024. Median total days of treatment was 154 days. At the time of data analysis, three patients were still on treatment and two discontinued treatment due to physician or patient preference. Median Ki67 expression went from 10% at baseline (range 1.0-40%) to 4% (1.0-18.0%) at Week 3. At three weeks, Ki67 expression was suppressed to <10% in 14 out of 16 (88%) patients, and to <2.7% in 6 out of 16 (38%) patients. Adverse events (AEs) were all grade 1-2. Most common AEs include hot flushes (65%), constipation (40%), fatigue (40%) and nausea (25%). “The I-SPY 2 EOP provides a biomarker-rich platform to test novel endocrine agents in the neoadjuvant setting in a molecularly selected group of patients with tumors that are predicted to have little to no benefit from chemotherapy,” said Dr. Jo Chien, principal investigator of the sub-study. “Lasofoxifene has demonstrated significant activity based on early Ki67 suppression, not only in postmenopausal women, but also in 10 premenopausal women without concomitant ovarian function suppression, with baseline Ki67 of 12.5% (1.0-40.0%) going to 3.0% (1.0-15%) at Week 3. It is exciting to see that lasofoxifene is well-tolerated even in our youngest patients who are often most impacted by the debilitating side effects of current standard endocrine therapy options.” Quantum Leap partners with a consortium that includes the U.S. Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors and clinicians from 41 major U.S. cancer research centers. About LasofoxifeneLasofoxifene is an investigational novel endocrine therapy in clinical development which has demonstrated robust target engagement as an ESR1 antagonist in the breast, particularly in the presence of ESR1 mutations. Lasofoxifene has demonstrated anti-tumor activity as monotherapy and in combination with a CDK4/6 inhibitor in Phase 2 studies and has unique tissue selectivity distinguishing it from other current and investigational endocrine therapies, with beneficial effects seen on vagina and bone in previous clinical studies. Lasofoxifene, which Sermonix licensed globally from Ligand Pharmaceuticals Inc., has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a novel targeted and tissue selective oral endocrine therapy, could, if approved, play a critical role in the precision medicine treatment of advanced ER+ breast cancer. About SermonixSermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific oncology products and is currently undertaking a Phase 3 clinical study of lasofoxifene, its lead investigational drug. The Sermonix management team, led by founder Dr. David Portman, has significant experience in all stages of the drug development, regulatory and commercialization processes. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience at AstraZeneca in the breast cancer drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in nuclear receptor biology. Miriam Portman, M.D., is co-founder and chief operating officer, with expertise in clinical trial conduct and patient recruitment. Elizabeth Attias, M.M.Sc., Sc.D., chief strategy and development officer, has extensive experience in pharmaceutical drug commercialization. Simon Jenkins, Ph.D., vice president of operations, has over 30 years of experience in global drug development leadership. Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lambert’s Pharmaceutical Division. Learn more at SermonixPharma.com. To learn more about the ELAINE studies, visit DiscoverElaine.com. About Quantum Leap Healthcare CollaborativeQuantum Leap Healthcare Collaborative (QLHC) is a 501c(3) nonprofit pioneer that designs, implements, and succeeds at building and iterating creative and nimble solutions that drive meaningful results for patients. Our mission is to better serve patients by accelerating and innovating health care through approaches that challenge the status quo of science and care. All our efforts focus on achieving our long-term vision to improve human health for all through personalized medicine by bridging the gap between research and care. QLHC provides operational, financial, and regulatory oversight to I-SPY. For more information, visit https://www.quantumleaphealth.org/. About the I-SPY TRIALsThe I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2) (I-SPY 2 TRIAL) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 30 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit www.ispytrials.org. Quantum Leap Healthcare Collaborative Media Contact:Jacqueline MurrayDirector, Marketing and Communications(415) 839-8082j.murray@quantumleaphealth.org

Phase 2Phase 3Clinical Result

27 Mar 2025

·sermonixpharma.com

Sermonix and Regor Announce Strategic Collaboration to Optimize Regor’s Proprietary rCARD Platform for Identification of Novel Targets and Therapeutics

COLUMBUS, Ohio and CAMBRIDGE, Mass., March 24, 2025 (GLOBE NEWSWIRE) — Sermonix Pharmaceuticals, a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), and Regor Therapeutics Group, a clinical-stage global biopharmaceutical company, today announced a strategic collaboration to optimize Regor’s proprietary, cutting-edge rCARD™ (Regor Computer Accelerated Rational Discovery) platform for identification of novel targets and therapeutics that fulfill unmet patient clinical needs and preferences in the breast oncology arena. The partnership will unite the key core competencies of both organizations to leverage expertise from early discovery through preclinical, clinical, and commercial launch, resulting in treatments that deliver on the promise of fulfilling on efficacy but also developing therapies with tolerability and quality of life profiles that are aligned with patient priorities and concerns. With a Phase 3 asset – oral lasofoxifene – in development for the treatment of ESR1-mutated ER+ HER2- mBC, the Sermonix team has expertise within the clinical drug development and commercialization arena and understands the landscape and value proposition of new treatments, which are requirements for launch success and adoption by both patients and health care providers. Patient insights and unmet needs within the arena of onco-sexuality and cardio oncology, in addition to patient concerns with respect to bone health, have been increasing in importance and are areas for which Sermonix also has expertise and interest in exploring. These areas are currently gaps within the breast cancer treatment patient arena and hold great concern for patients as breast cancer potentially evolves from a lethal to a chronic disease. Regor’s leading rCARD™ platform empowers drug discovery and development from target identification and validation, molecular design and optimization, to translational research and clinical development with unprecedented speed, efficiency, and success rate. “Regor’s translational to clinical approach – and then confirmation of clinical impact – is one we greatly admire and is producing molecules for development that will be best in class from both an efficacy and tolerability perspective,” said Dr. David Portman, Sermonix founder and chief executive officer. “At Sermonix, we believe patients deserve not only highly efficacious treatments, but also ones that are well tolerated and potentially improve quality of life for breast cancer patients. Deep patient insights and the potential to develop targets that can ultimately provide efficacy while addressing areas of key concerns to patients such as vaginal, bone, and cardiovascular health would be fulfilling on the promise of optimized drug development. It is an honor to collaborate with Regor in that shared mission.” Sermonix is currently enrolling its Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE-3) study, comparing targeted lasofoxifene in combination with the CDK 4/6 inhibitor abemaciclib versus fulvestrant plus abemaciclib in pre- and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation. About Regor Therapeutics GroupRegor Therapeutics Group is a clinical-stage biotechnology company, headquartered in Cambridge, MA and with operations in Houston, TX, San Diego, CA, and Shanghai, China. Regor is developing innovative and clinically differentiated medicines to address large unmet needs in oncology, metabolism, and auto-immunity. Regor is powered by the highly efficient drug discovery engine rCARD™ (Regor Computer Accelerated Rational Discovery) that enables rapid prototyping and validation of candidate molecules. This rapid approach to developing small molecules against high-profile targets is the creation of the four cofounders who collectively brought decades of experience in leading US biopharma and were previously the named inventors of 4 FDA-approved medicines. The power of the rCARD™ platform and approach has been highlighted by out-licensing deals with top companies, including Roche/Genentech on next-gen CDK oncology agents RGT-419B and RGT-587 (now GDC-4198 and GDC-0587) in late 2024.To learn more about Regor, please visit us at www.regor.com.

Phase 3

26 Mar 2025

·www.prnewswire.com

Fosun Pharma Announces 2024 Annual Results

Accelerates Globalization of Innovative Products with Operating Cash Flow Surging 31.13% YoY SHANGHAI, March 25, 2025 /PRNewswire/ -- On March 25, 2025, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"or "the Group"; Stock Code: 600196.SH, 02196.HK), a leading global pharmaceutical and healthcare company driven by innovation, announced its annual results for the year ended 31 December 2024 ("the Reporting Period"). In 2024, Fosun Pharma further focused on the business development of innovative drugs and high-value devices, achieving operating revenue of RMB41.07 billion and net profit attributable to shareholders of RMB2.77 billion, representing an increase of 16.08% YoY. Fosun Pharma continuously optimize supply chain management to enhance operational efficiency, recording an operating cash flow of RMB4.48 billion with an increase of 31.13% YoY, surpassing the growth rate of operating profit. In addition, Fosun Pharma continues to advance lean management across quality enhancement, cost control, efficiency improvement, cycle management, and innovation R&D, driving operational efficiency and expanding profitability. During the Reporting Period, the gross margin minus the selling and distribution expense ratio improved by 2.45 percentage points YoY; and, excluding the impact of newly acquired enterprises during the Reporting Period and the same period last year, administrative expenses declined by RMB355 million. Fosun Pharma always takes innovation as a core driving force in its development. Fosun Pharma has established an open and globally integrated pharmaceutical R&D ecosystem, focusing on core therapeutic areas including oncology (solid tumors and hematologic malignancies) and Immune-inflammatory disorders. The company is strategically enhancing its technological leadership in antibody/ADC platforms, cell therapies, and small molecule development, while collaborating with industry funds to pioneer next-generation modalities such as radiopharmaceuticals, RNA therapeutics, gene editing, and AI-powered drug discovery. During the Reporting Period, Fosun Pharma continuously optimized its innovative R&D system while maintaining stable R&D investment, focusing on key pipeline strengths and enhancing efficiency through system integration. In 2024, Fosun Pharma's total R&D expenditure amounted to RMB5.55 billion, with R&D expenses totaling RMB3.64 billion. The R&D expenditure in the pharmaceutical manufacturing segment amounted to RMB4.91 billion, accounting for 16.98% of pharmaceutical business revenue. There are over 80 major pipeline projects on innovative drugs and biosimilars (calculated by indications). In addition, during the Reporting Period, the pharmaceutical manufacturing segment of Fosun Pharma submitted 220 patent applications, including 3 American patent applications, 18 PCT applications, and Fosun Pharma has obtained 66 licensed invention patents authorization. Accelerating Innovation Transformation and the Internationalization of Innovative Products Focusing on unmet clinical needs, Fosun Pharma continuous to push forward its innovation transformation and the development and commercialization of innovative products, expanding into regulatory markets such as the U.S. and the EU. During the Reporting Period, 7 innovative products/biosimilars with a total of 16 indications independently developed and licensed-in by Fosun Pharma were approved for launch, and 8 innovative products/biosimilars had entered the pre-launch approval/critical clinical stage. Fosun Pharma also had 18 innovative products/biosimilar projects (calculated by indications) initiated clinical trials. In the field of lung cancer, Fosun Pharma has developed a comprehensive layout in innovative drugs and precision diagnostics and treatment to benefit patients globally. Fosun Pharma's self-developed innovative anti-PD-1 monoclonal antibody, Han Si Zhuang (Serplulimab Injection), is the world's first anti-PD-1 monoclonal antibody (mAb) approved for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), and it remains the first and only anti-PD-1 mAb approved in the EU for the treatment of ES-SCLC. During the Reporting Period, Han Si Zhuang also received approval in Chinese mainland for the treatment of non-squamous non-small cell lung cancer (nsNSCLC), and this also marked its third indication in the field of lung cancer, further expanding its reach. To date, Han Si Zhuang has been approved for marketing in over 30 countries and regions, including China, the European Union, and several Southeast Asian nations, benefiting more than 100,000 patients. In addition, to help more lung cancer patients obtain early diagnosis and treatment in a more minimally invasive way, the Ion Bronchial Navigation Operation Control System (Ion System) of Intuitive Fosun, Fosun Pharma's associated company, received NMPA approval in March 2024 and has been commercially deployed. In high-incidence cancers such as breast and gastric cancers, Fosun Pharma's self-developed monoclonal antibody(mAb) biosimilar Han Qu You (Trastuzumab Injection) has been approved for launch in over 50 countries and regions, including China, the European Union, the U.S., Canada and Australia, and has been included in the health insurance directories in countries such as China, UK, France, and Germany. To date, Han Qu You has benefited over 240,000 patients. The HER2-targeted innovative monoclonal antibody HLX22 for gastric cancer treatment and the novel endocrine therapy HLX78 (lasofoxifene) for breast cancer are currently under international multi-center Phase III clinical trials. Additionally, the biosimilar candidate HLX11 (pertuzumab) has had its new drug applications submitted and accepted in both China and the U.S., injecting new momentum into global expansion. In addition, Fosun Pharma is also advancing the development of rare disease drugs. Its self-developed MEK1/2 selective inhibitor Luvometinib tablets, (Project Code: FCN-159), has had its new drug applications for two indications—treatment of adult dendritic cell and histiocytic tumors, and treatment of plexiform neurofibromas (PN) associated with Neurofibromatosis Type 1 (NF1) in children aged 2 years and older—accepted by the NMPA and placed in the priority review process . In the non-oncology field, during the Reporting Period, Fosun Pharma's self-developed and licensed-in rabies vaccine (Vero cell) for human use (freeze dried), Pu Rui Ni (Pretomanid Tablets), Han Da Yuan (Adalimumab Injection) received approval for four new indications, and Su ke Xin (Avatrombopag Malate Tablets) was approved for its second indication in China; meanwhile, the new drug applications for a biosimilar of denosumab HLX14 under development were accepted by the European Medicines Agency (EMA), Health Canada and the FDA, respectively. Continuously Enhancing Global Operations and Bilateral Licensing Cooperation Fosun Pharma continues to uphold the internationalization strategy in multiple dimensions, such as innovative R&D, licensing, manufacturing and operations as well as commercialization. In 2024, overseas revenue reached RMB11.30 billion, accounting for 27.51% of total revenue. During the reporting period, Fosun Pharma continues to promote the building of production system with international quality standard, laying a solid foundation for the overseas distribution of preparations. As of the end of 2024, all production lines of the domestic subsidiaries under the pharmaceutical manufacturing segment of Fosun Pharma obtained domestic GMP certifications and 10 production lines had passed GMP certification in major regulatory markets such as the U.S. and the EU. Fosun Pharma's pharmaceuticals and medical devices businesses now primarily cover major overseas markets, including the United States, Europe, Africa, India, and Southeast Asia, with an overseas commercialization team of over 1,000 employees. In the U.S., Fosun Pharma's in-house generic drug team has continued to grow, establishing partnerships with major distributors and group purchasing organizations (GPOs) to drive the sales of formulation products. Meanwhile, Fosun Pharma has established its innovative drug team in the U.S. and is preparing for the commercialization of its anti-PD-1 monoclonal antibody (mAb), serplulimab injection. In Europe, Gland Pharma has built localized manufacturing capabilities through its subsidiary, Cenexi. Sisram Medical has expanded its global direct sales offices to 12, with its marketing network now covering over 110 countries and regions. The share of direct sales revenue has further increased to 87%. Meanwhile, Breas Medical's marketing network has expanded across key mature markets, including Europe, the United States, Japan, and Australia. In emerging markets, Fosun Pharma's sales network in Africa now covers over 40 countries and regions. The company continues to advance the Côte d'Ivoire park project to establish localized pharmaceutical manufacturing and supply in Africa. In February 2025, Fosun Pharma launched a new pharmaceutical and medical device sales platform in Nanning, gradually enhancing its registration and commercialization capabilities in Southeast Asia to expand its presence in the region. Fosun Pharma is also actively expanding into the Middle East market. During the reporting period, Henlius, a subsidiary of Fosun Pharma, entered into a strategic partnership with SVAX to establish a joint venture in Saudi Arabia. This collaboration aims to enhance the accessibility of innovative and high-value products in the MENAT region (Middle East, North Africa, and Turkey). Fosun Pharma continues to strengthen its global licensing collaboration, further enhancing its international influence and competitiveness. On the out-licensing front, Henlius, a subsidiary of Fosun Pharma has forged deep partnerships with over 20 leading global biopharmaceutical companies, including Accord, Abbott, Eurofarma, KGbio, Organon, and Dr. Reddy's, to jointly expand global markets. These collaborations comprehensively cover major biologics markets in Europe and the U.S., as well as numerous emerging markets. To date, its approved biologics have benefited more than 750,000 patients worldwide. Fosun Pharma continues to expand its product pipeline in core therapeutic areas through strategic global collaborations. Licensed-in products such as the antiemetic Akynzeo® (netupitant/palonosetron capsules), long-lasting recombinant human granulocyte colony-stimulating factor product (Pei Jin) and the drug for heart failure and hypertension treatment (Yi Xin Tan) have been included in the National Medical Insurance Drugs Catalogue, benefiting a wide range of patients. Fosun Pharma has obtained exclusive development and commercialization rights for Tenapanor Hydrochloride Tablets (Wan Ti Le), a first-in-class phosphate-lowering drug with a novel mechanism. In February 2025, the drug received approval from the National Medical Products Administration (NMPA) in China for the treatment of hyperphosphatemia in adult dialysis patients with chronic kidney disease (CKD). This approval marks a new era of multi-mechanism phosphate control, bringing new hope to dialysis patients with hyperphosphatemia. During the reporting period, Fosun Pharma's licensed product Daxxify® (DaxibotulinumtoxinA-lanm) became the first of its kind approved in China. The product received NMPA approval for the improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. Accelerating Localization of Innovative Products in China to Achieve High-quality Development As a global innovation-driven pharmaceutical and healthcare company, Fosun Pharma actively introduces internationally advanced technologies and products to the Chinese market, benefiting patients and customers. During the reporting period, Fosun-Insightec, a joint venture established with Insightec in China, successfully achieved sales of magneticresonance image guided focused ultrasound brain therapy system ("MRgFUS brain therapy system") for brain treatment. Additionally, the headquarters and industrial base of Intuitive Fosun, an associated company, was officially inaugurated in the Zhangjiang International Medical Park in Shanghai. This facility integrates R&D, manufacturing, and training, further accelerating the localization of the da Vinci Robotic surgical systems in China. To further enhance its leading position in tumor immunotherapy, Fosun Pharma increased its stake in its cell therapy platform, Fosun Kairos, to 100% during the reporting period. The company will continue to collaborate with Kite Pharma to advance the development and commercialization of its licensed products, Axi-Cel (marketed as Yi Kai Da ) and Brexu-Cel (investigational project FKC889), in Chinese mainland, Hong Kong S.A.R and Macao S.A.R. Yi Kai Da became the first in China to introduce an innovative outcome-based payment model. As of the end of 2024, Yi Kai Da has benefited over 800 lymphoma patients, been included in more than 110 provincial and municipal government-backed insurance programs and over 80 commercial insurance plans, and has been registered in more than 180 treatment centers across 28 provinces and municipalities nationwide. While maintaining steady operations, Fosun Pharma remains committed to its corporate social responsibilities. In 2024, the company received multiple domestic and international accolades for its significant progress in ESG, including recognition as one of China's ESG Listed Company Pioneer 100, Deloitte's China Best Managed Companies, Charity Star, and Forbes 2024 China ESG 50 list. Additionally, Fosun Pharma's MSCI ESG rating remained at A. "Fosun Pharma will continue to adhere to innovation-driven and global development strategies, actively embrace AI, concentrate resources on core businesses, and persistently advance lean management and enhance operational efficiency." Wu Yifang, Chairman of Fosun Pharma said, "We aim to grow in tandem with China's biopharmaceutical industry and stride into a new phase of high-quality development. Upholding our mission to 'create better health for families worldwide', we will maintain a patient-centric approach, address unmet clinical needs, deepen innovation transformation and global expansion, and strive to become a global leader in healthcare innovation and integration." About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"; SSE: 600196, HKEX: 02196) is a leading innovation-driven global healthcare company operating in the fields of pharmaceuticals, medical devices & diagnostics, and healthcare services. Through its strategic alliance with Sinopharm Group Co., Ltd., Fosun Pharma further extends its capabilities in pharmaceutical commerce. Over the past 30 years since its establishment, Fosun Pharma has maintained deep roots in China while strategically expanding its global presence. The company has been actively implementing its "4IN" strategy -Innovation, Internationalization, Intelligentization, and Integration, with core business operations now spanning major overseas markets including the United States, Europe, Africa, India, and Southeast Asia. At present, Fosun Pharma has established an open and globally integrated pharmaceutical R&D ecosystem, focusing on core therapeutic areas including oncology (solid tumors and hematologic malignancies) and Immune-inflammatory disorders. The company is strategically enhancing its technological leadership in antibody/ADC platforms, cell therapies, and small molecule development, while collaborating with industry funds to pioneer next-generation modalities such as radiopharmaceuticals, RNA therapeutics, gene editing, and AI-powered drug discovery. This multidimensional approach accelerates the translation of innovative therapies into clinical practice, systematically addressing critical unmet medical needs worldwide. Looking ahead, Fosun Pharma remains anchored in its core values of "Care for life, Continuous innovation, Pursuit of excellence and Sustainable partnership". By advancing its global innovation engine and operational excellence, the company strives to be a global leader to integrate pharmaceutical and healthcare innovations, creating better health for families worldwide. SOURCE Fosun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalPhase 3VaccineLicense out/in

100 Deals associated with Lasofoxifene Tartrate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Lasofoxifene Tartrate	G03	DB06202

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Osteoporosis, Postmenopausal	European Union	Dr. Friedrich Eberth Arzneimittel GmbH	24 Feb 2009
Osteoporosis, Postmenopausal	Iceland	Dr. Friedrich Eberth Arzneimittel GmbH	24 Feb 2009
Osteoporosis, Postmenopausal	Liechtenstein	Dr. Friedrich Eberth Arzneimittel GmbH	24 Feb 2009
Osteoporosis, Postmenopausal	Norway	Dr. Friedrich Eberth Arzneimittel GmbH	24 Feb 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Atrophic Vaginitis	NDA/BLA	United States	Sermonix Pharmaceuticals LLC	-
ER-positive/HER2-negative/ ESR1-mutated breast cancer	Phase 3	United States	Shanghai Henlius Biotech, Inc.	14 Nov 2023
ER-positive/HER2-negative/ ESR1-mutated breast cancer	Phase 3	Australia	Shanghai Henlius Biotech, Inc.	14 Nov 2023
ER-positive/HER2-negative/ ESR1-mutated breast cancer	Phase 3	Canada	Shanghai Henlius Biotech, Inc.	14 Nov 2023
ER-positive/HER2-negative/ ESR1-mutated breast cancer	Phase 3	France	Shanghai Henlius Biotech, Inc.	14 Nov 2023
ER-positive/HER2-negative/ ESR1-mutated breast cancer	Phase 3	Israel	Shanghai Henlius Biotech, Inc.	14 Nov 2023
ER-positive/HER2-negative/ ESR1-mutated breast cancer	Phase 3	Singapore	Shanghai Henlius Biotech, Inc.	14 Nov 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	United States	Sermonix Pharmaceuticals LLC	31 Oct 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	China	Sermonix Pharmaceuticals LLC	31 Oct 2023
ER-positive/HER2-negative Breast Cancer	Phase 3	Australia	Sermonix Pharmaceuticals LLC	31 Oct 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01042379 (I-SPY 2, Company_Website) Manual	Phase 2	Hormone receptor positive HER2 negative breast cancer Neoadjuvant Hormone Receptor Positive \| HER2 Negative	20	Lasofoxifene	rhmgafyhkg(okpzcozjtd) = Adverse events (AEs) were all grade 1-2. Most common AEs include hot flushes (65%), constipation (40%), fatigue (40%) and nausea (25%). jzneaveamg (yqqrmogznk )	Positive	11 Apr 2025
NCT04432454 (ELAINE 2, Pubmed \| Ann Oncol)	Phase 2	ER-positive/HER2-negative/ ESR1-mutated breast cancer ESR1 mutation	-	Lasofoxifene 5 mg/day + Abemaciclib 150 mg b.i.d	lkdbfwbaqc(rdsiythpwm) = srgnzpmymd jtalenhigr (ymcbmrdmeg, 47.3% - 80.1%) View more	Positive	01 Dec 2023
NCT03781063 (ELAINE 1, Pubmed \| Ann Oncol)	Phase 2	ER-positive/HER2-negative/ ESR1-mutated breast cancer ESR1 mutation	103	Lasofoxifene 5 mg	sodzhcovif(wgydfnssoo) = fgxjyzwpsm qtwpkxqwfy (nlgotvmslq ) View more	Positive	01 Dec 2023
				Fulvestrant 500 mg	sodzhcovif(wgydfnssoo) = zhyezdrsfz qtwpkxqwfy (nlgotvmslq ) View more
NCT04432454 (ELAINE 2, ASCO2023) Manual	Phase 2	ER-positive/HER2-negative/ ESR1-mutated breast cancer ESR1 \| ER Positive \| HER2 Negative	29	Lasofoxifene 5 mg/day + Abemaciclib 150 mg	nsgqyffpbe(uubohjtsob) = LAS/Abema was well tolerated with primarily grade 1/2 treatment-emergent adverse events (most commonly diarrhea, nausea, fatigue, and vomiting) vptgcppujf (vftfewfanc )	Positive	31 May 2023
NCT03781063 (ELAINE 1, SABCS2023)	Phase 2	ER-positive/HER2-negative Breast Cancer mutESR1	103	Lasofoxifene 5 mg daily	ytibhnnufa(afgkvqxamu) = jvyhbqxcwd yegqozvbxu (cfccqrfxuq ) View more	Positive	01 Mar 2023
				Fulvestrant 500 mg on days 1, 15, and 29, then every 4 wks	ytibhnnufa(afgkvqxamu) = psozfioqlt yegqozvbxu (cfccqrfxuq ) View more
NCT03781063 (ELAINE 1, ESMO2022) Manual	Phase 2	ER-positive/HER2-negative Breast Cancer Second line ER+/HER2-/ESR1-mutated	103	lasofoxifene	eqmxxratsb(oysynzxfre) = ithfagnbcn uxrgtxpwyr (hcuufiqvel, 2.82 - 8.04) View more	Superior	10 Sep 2022
				fulvestrant	eqmxxratsb(oysynzxfre) = gizmjzpmve uxrgtxpwyr (hcuufiqvel, 2.93 - 6.04) View more
NCT04432454 (ELAINE 2, ASCO2022)	Phase 2	ER-positive/HER2-negative Breast Cancer \| Metastatic breast cancer	29	Lasofoxifene 5 mg/day + Abemaciclib 150 mg BID	flepowsxmh(vfzhaizhbl) = koxcvczywz zrqtmqnhqy (hqojqirwsu, 44.0–77.3) View more	-	02 Jun 2022
NCT00141323 (PEARL, Pubmed \| Circulation)	Phase 3	Osteoporosis, Postmenopausal	8,556	Lasofoxifene 0.5 mg/d	astfjxvewe(zmpnrcqfps): hazard ratio = 0.56 (95% CI, 0.32 - 0.98) View more	-	26 Oct 2010
				Placebo
NCT00141323 (Pubmed \| N Engl J Med)	Phase 3	Osteoporosis, Postmenopausal	8,556	Lasofoxifene 0.25 mg	zoabydvdee(adzmwfpyca) = ihbwruwjmg bcpsdcrfnw (gmrqqtskgc ) View more	-	25 Feb 2010
				Lasofoxifene 0.5 mg	zoabydvdee(adzmwfpyca) = unjvycuxmo bcpsdcrfnw (gmrqqtskgc ) View more

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