Shanghai Hengrui Pharmaceutical Co., Ltd.

精彩内容日前，河北省医用药品器械集中采购中心发布通知，拟对乳果糖口服液体剂、七氟烷吸入剂2种化学药品开展集中带量采购。米内网数据显示，上述2个品种2023年在中国公立医疗机构终端的销售额分别超过17亿元、30亿元。据悉，此次集采所有原研药（含参比制剂），通过一致性评价药品（含视同过评药品），普通仿制药均可自愿参加，标期为两年。中选规则为：同质量层次药品有1至3家企业申报的，拟中选企业为1家，按规则差比后价格最低的拟中选；同质量层次药品有4家及以上企业申报的，按规则差比后从低到高排名，最低价与最高价在1.1倍（含）以内的药品中最低价和次低价的2家企业拟中选；普通质量层次药品申报价格需低于过评质量层次拟中选药品最低价的10%及以上；过评质量层次拟中选药品价格需不高于普通质量层次拟中选药品最高价的2倍。采购品种及周期第一年约定量来源：河北省医用药品器械集中采购中心国内在销的七氟烷吸入剂仅吸入用七氟烷一种，该产品适用于成年人和儿童的全身麻醉的诱导和维持。米内网数据显示，吸入用七氟烷已被纳入国家医保乙类目录，2023年在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端的销售额超过30亿元。从厂家格局看，上海恒瑞医药、日本丸石制药、鲁南贝特制药依次位列前三，市场份额分别超过62%、18%、11%。近年来中国公立医疗机构终端吸入用七氟烷销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局含进口厂家在内，目前有11家企业拥有吸入用七氟烷生产批文，其中上海恒瑞医药、鲁南制药集团、福建海西联合药业、四川百利药业、山东新时代药业、河北一品生物、河北山姆士药业的产品已过评或视同过评。乳果糖口服溶液是一种渗透性泻药，适用于：1、慢性或习惯性便秘：调节结肠的生理节律；2、肝性脑病：治疗和预防肝昏迷或昏迷前状态。该产品为国家医保乙类、OTC甲类（双跨）品种，近年来在中国公立医疗机构终端的销售额均超过17亿元。从2023年厂家格局看，雅培、韩美、费森尤斯卡比依次位列前三，市场份额分别超过43%、28%、13%。近年来中国公立医疗机构终端乳果糖口服溶液销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局含进口厂家在内，目前有40余家企业拥有乳果糖口服溶液生产批文，其中江中药业、福元药业、山东新华制药、山东京卫制药、石药银湖制药、健民药业等33家企业的产品已过评或视同过评。乳果糖口服溶液过评企业来源：米内网一致性评价进度数据库注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至4月30日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

Since its launch in 2015, it has been prescribed to more than 200,000 patients globally. The drug is currently approved for use in both men and women, expanding its market potential. Despite facing competition from other CDK4/6 inhibitors like Novartis' KISQALI and Eli Lilly's VERZENIO, IBRANCE maintains a strong position in the metastatic setting. LAS VEGAS, April 24, 2025 /PRNewswire/ -- DelveInsight's " IBRANCE Market Size, Forecast, and Market Insight Report" highlights the details around IBRANCE, a CDK4/6 inhibitor. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of IBRANCE. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Pfizer's IBRANCE (palbociclib) Overview IBRANCE is an oral medication that inhibits CDKs 4 and 6, which are crucial regulators of the cell cycle that drive cellular progression. In the U.S., IBRANCE is approved for treating adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. It is used in combination with an aromatase inhibitor as a first-line endocrine therapy for postmenopausal women or men or with fulvestrant for patients whose disease has progressed after endocrine treatment. IBRANCE is currently authorized in over 90 countries and has been prescribed to more than 200,000 patients worldwide. Learn more about IBRANCE projected market size for metastatic HR+/HER2− breast cancer @ IBRANCE Market Potential The HR+ HER2- subtype is the most commonly found type of breast cancer, characterized by cancer cells that have estrogen and progesterone receptors but do not overexpress HER2. A patient's journey typically begins with the onset of concerning symptoms, leading to a comprehensive clinical evaluation and various imaging tests. DelveInsight estimates that approximately 211K new cases of HR+/HER2– breast cancer occurred in the US in 2024. CDK4/6 inhibitors currently dominate the first-line treatment market and represent a significant advancement in the management of HR+/HER2-ve breast cancer. The data from large, randomized clinical trials are both strong and consistent. While single-agent endocrine therapies have shown limited benefits in the first and subsequent treatment lines for women with ER-positive metastatic breast cancer (mBC), combination therapies have emerged as a more effective option for many patients. In recent years, the treatment landscape for HR+/HER2−ve breast cancer has been transformed with the introduction of highly active targeted therapies, including CDK4/6 inhibitors, mTOR inhibitors, PARP inhibitors, new oral SERDs, and PI3K inhibitors. These advances have expanded the range of treatment options and improved survival outcomes for these patients. The market for metastatic HR+/HER2− breast cancer in the 7MM is projected to grow during the forecast period (2025–2034) due to the introduction of several novel therapies in the market. Discover more about the metastatic HR+/HER2− breast cancer market in detail @ Metastatic HR+/HER2− Breast Cancer Market Report Emerging Competitors of IBRANCE Some of the drugs in the pipeline include Gedatolisib (Celcuity), ARV-471 (Arvinas and Pfizer), OP-1250 (Olema Pharmaceuticals), KEYTRUDA (Merck), and Rupitasertib (Evexta Bio), among others. In December 2024, Arvinas and Pfizer presented preliminary data from the ongoing Phase 1b portion of the TACTIVE-U sub-study of vepdegestrant in combination with abemaciclib among patients with locally advanced or metastatic ER+/HER2- breast cancer at the San Antonio Breast Cancer Symposium (SABCS) 2024. In December 2024, Olema Pharmaceuticals presented clinical results from the ongoing Phase Ib/II study of palazestrant in combination with ribociclib in patients with ER+/HER2- advanced or metastatic breast cancer at SABCS 2024. To know more about the number of competing drugs in development, visit @ IBRANCE Market Positioning Compared to Other Drugs Key Milestones of IBRANCE In February 2021, Pfizer Inc. announced that the U.S. Patent and Trademark Office (USPTO) has granted a U.S. Patent Term Extension (PTE) certificate for IBRANCE. This extension prolongs the validity of U.S. Patent No. RE47,739 ('739) by over four years, now lasting until March 5, 2027. In April 2019, Pfizer announced that the FDA has approved a supplemental New Drug Application (sNDA) to broaden the uses of IBRANCE in combination with an aromatase inhibitor or fulvestrant, now including men with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced or metastatic breast cancer. In March 2017, Pfizer Inc. revealed that the FDA has approved a supplemental New Drug Application (sNDA) for IBRANCE, its pioneering cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor, following the positive outcomes from the confirmatory Phase 3 trial PALOMA-2. In September 2016, Pfizer Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive recommendation for the marketing authorization of IBRANCE® (palbociclib) in the European Union (EU). This recommendation is for its use in treating women with hormone receptor-positive, HER2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. In February 2016, Pfizer announced that the FDA has approved a new indication for IBRANCE 125mg capsules, expanding its use. The approval allows IBRANCE to be used in combination with fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in women whose disease has progressed after endocrine therapy. In February 2015, Pfizer announced that the FDA granted accelerated approval for IBRANCE in combination with letrozole to treat postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer as the initial endocrine-based therapy for their metastatic disease. Discover how IBRANCE is shaping the metastatic HR+/HER2− breast cancer treatment landscape @ IBRANCE Drug IBRANCE Market Dynamics IBRANCE is a targeted therapy that has revolutionized the treatment of hormone receptor-positive, HER2-negative breast cancer, particularly in combination with aromatase inhibitors or letrozole. Developed by Pfizer, IBRANCE was one of the first CDK4/6 inhibitors approved by the FDA for metastatic breast cancer, and its approval has significantly changed the treatment landscape. The drug works by inhibiting cyclin-dependent kinases 4 and 6, which are key regulators of the cell cycle, thus preventing cancer cells from proliferating. Its market dynamics have been shaped by the growing demand for targeted therapies, as well as the increasing focus on precision medicine and improved patient outcomes. The global market for IBRANCE has been positively impacted by its proven efficacy in clinical trials and its ability to extend progression-free survival in breast cancer patients. The drug's market dominance is underpinned by its widespread acceptance and adoption by oncologists worldwide. However, competition is intensifying, with other CDK4/6 inhibitors such as VERZENIO (abemaciclib) and KISQALI (ribociclib) entering the market, offering similar benefits but with some distinct clinical profiles. This competitive landscape has led to strategic pricing and marketing strategies by Pfizer, aiming to maintain IBRANCE's market leadership while managing pressures from generic alternatives. Additionally, the evolving reimbursement landscape and regulatory policies around oncology drugs are crucial factors influencing the market dynamics. Health insurers and government healthcare programs often scrutinize the cost-effectiveness of cancer treatments, which can impact the pricing and accessibility of IBRANCE in different markets. Another factor is the rising focus on combination therapies, as IBRANCE is often used in conjunction with other drugs like letrozole, which boosts its efficacy and market potential. The shift toward personalized cancer treatment regimens is expected to continue fueling demand for CDK4/6 inhibitors like IBRANCE, especially in more advanced stages of breast cancer. In terms of geographical markets, IBRANCE has seen significant uptake in North America and Europe, where the healthcare infrastructure supports innovative cancer therapies. However, emerging markets, where the economic barriers to accessing expensive cancer treatments can be higher, present a challenge to the widespread use of IBRANCE. Pfizer's ongoing efforts to expand in these regions, through partnerships and pricing adjustments, will be key to ensuring continued growth in global market share. Overall, the IBRANCE market is poised for steady growth, driven by clinical advancements, increasing breast cancer diagnoses, and the continual push toward more targeted, effective therapies. Dive deeper to get more insight into IBRANCE's strengths & weaknesses relative to competitors @ IBRANCE Market Drug Report Table of Contents Related Reports Metastatic HR+/HER2− Breast Cancer Market Metastatic HR+/HER2− Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic HR+/HER2− breast cancer companies, including Merck, Arvinas, Olema Pharmaceuticals, Celcuity, Roche, AstraZeneca, Daiichi Sankyo, Eli Lilly, Sermonix Pharmaceuticals, Genentech, Veru Pharma, DualityBio, BioNtech, Evgen Pharma, Carrick Therapeutics, EQRx, G1 Therapeutics, Immutep, among others. HR+/HER2− Breast Cancer Pipeline HR+/HER2− Breast Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HR+/HER2− breast cancer companies, including Regor Therapeuics, Seagen Inc., CytomX Therapeutics, Taizhou EOC Pharma, Chia Tai Tianqing Pharmaceutical Group, AstraZeneca, Daiichi Sankyo, Inc., Tyme, Inc., Seagen Inc., Context Therapeutics, Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., Jiangsu Simcere Pharmaceutical Co., Kind Pharmaceuticals, Merus N.V., Atossa Therapeutics, Roche, among others. Breast Cancer Market Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key breast cancer companies including Veru, Sanofi, Roche, AstraZeneca, Eli Lilly, EQRx, Gilead, Sermonix Pharmaceuticals, Evgen Pharma, Tyme, Genentech, Daiichi Sankyo, among others. Metastatic Breast Cancer Pipeline Metastatic Breast Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key metastatic breast cancer companies, including Roche, RemeGen, SynCore Biotechnology, Allarity Therapeutics, Daiichi Sankyo Company, Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Byondis B.V., Jiangsu Hansoh Pharmaceutical Co., Ltd., Shanghai Miracogen Inc., Ambrx, Inc., Daehwa Pharmaceutical Co., Ltd., Phoenix Molecular Designs, GlycoMimetics Incorporated, Rhizen Pharmaceuticals SA, Menarini Group, Samus Therapeutics, Inc., Hanmi Pharmaceutical Company Limited, Jiangxi Qingfeng Pharmaceutical Co. Ltd., Immutep Limited, Arvinas Inc., G1 Therapeutics, Mirati Therapeutics Inc., Chia Tai Tianqing Pharmaceutical, Shanghai Pharmaceuticals Holding Co., Ltd, Pfizer, OncoTherapy Science, Inc., Eisai Inc., Dizal Pharmaceuticals, Jiangsu Hengrui Medicine Co., Tyme, Inc, Orion Pharma, HiberCell, Inc., Rhizen Pharmaceuticals SA, Hutchison Medipharma Limited, OncoPep Inc., Taizhou Hanzhong biomedical co. LTD, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . 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新的恒瑞，来了！3月30日，恒瑞医药发布2024年年报，其营收，净利，创新药收入占比以及研发投入均创下新高：净利明显大增，反映其盈利能力提升。归母净利润达63.37亿元，同比增47.28%，扣非净利润为61.78亿元，同比增49.18%。同期，恒瑞营业收入达279.85亿元，同比增长22.63%。创新药成绩再跨里程碑。创新药销售收入达138.92亿元（含税，不含对外许可收入），同比增30.60%，占公司总销售收入（不含对外许可收入）一半以上。研投创历史新高。2024年研发投入达82.28亿元，其中，费用化研发投入65.83亿元，研发投入占销售收入比重达到29.4%。至今，恒瑞累计研发投入超440亿元，全球研发团队达5500余人。国际化表现很是漂亮。目前，恒瑞已实现13笔创新药海外授权合作，近三年对外授权就达8笔。居于行业前列的BD成绩，验证了巨头的创新成色，且成为了恒瑞净利润大增的关键驱动力。近期，恒瑞脂蛋白(a)[Lp(a)]口服小分子药HRS-5346授权给默沙东一事也重磅官宣。仅这1款处在临床II期的小分子药，对应首付款便达到了2亿美元，交易总额约20亿美元。市场不仅能直观看到，从去年将GLP-1组合高额“NewCo”，到打响国产DLL3 ADC出海第一枪，再到今年Lp（a）降脂药成功授权给MNC，恒瑞总能成为某靶点、赛道、模式的“火炬手”，更是能让市场从质疑、审视到重估大药企创新转型能力的“带头人”。而从集采冲击下走出财报低谷，到在“创新+国际化”主线上找到多元化的利润增长点，恒瑞的创新药及在研管线带来的价值增量愈发凸显。一直以来，恒瑞是中国医药创新带着历史去探索未来的一大锚点。当恒瑞实现了困境反转，在压力下跑出了一条不断上扬的曲线，某种程度上印证了，中国的医药创新又抵达了一个全新高点。01创新大丰收未来3年预计47项创新成果获批创新药销售收入占公司总销售收入（不含对外许可收入）一半以上，这是恒瑞创新迈入新阶段的关键印证。截至目前，恒瑞已在国内获批上市19款新分子实体药物（1类创新药）、4款其他创新药（2类新药）。2024年至今，恒瑞共9项创新成果获批上市，其中4款为1类创新药（富马酸泰吉利定、夫那奇珠单抗、瑞卡西单抗、硫酸艾玛昔替尼），覆盖神经科学、自免、心血管等近两年备受市场关注的疾病领域。另外，在研管线储备丰富，已经形成上市一批、临床一批、开发一批的良性循环，发展后劲充足。在研管线正加速推进。截至目前，恒瑞共有18项上市申请（含新增适应症）获NMPA受理，90多个自主创新产品正在临床开发，约400项临床试验在国内外开展。值得注意的是，此次年报中，恒瑞披露了未来三年预计获批上市的47项创新成果，覆盖肿瘤、代谢及心血管疾病、免疫和呼吸系统疾病等治疗领域，包括HER2 ADC、GLP-1药物等重磅产品。根据公告，2025年预计上市项目11项，明星产品HER2 ADC瑞康曲妥珠单抗（SHR-A1811）有望获批用于非小细胞肺癌，该产品已有8个适应症获国家药监局突破性疗法认定，另有6项Ⅲ期临床在研。此外，NK1/5-HT3双通道止吐复方制剂HR20013、干眼病产品SHR8058滴眼液，也有望造福患者健康；已上市产品中，中国首个自主研发JAK1抑制剂艾玛昔替尼（艾速达）用于类风湿关节炎、特应性皮炎2个适应症，重组抗IL-17A人源化单克隆抗体夫那奇珠单抗（安达静）用于强直性脊柱炎也有望获批，值得期待。2026年，预计上市项目13项，如重磅产品PD-L1/TGF-βRⅡ双靶点融合蛋白瑞拉芙普-α（SHR-1701）有望获批胃癌适应症，经查询，目前国内外尚无同类产品获批上市，具备First-in-Class潜力。新型口服EZH2抑制剂SHR2554用于淋巴瘤，PD-1单抗和小分子TKI联合疗法卡瑞利珠单抗联合苹果酸法米替尼用于二线宫颈癌也有望上市。2027年，预计上市项目23项，热门的GLP-1药物或将迎来上市，具备同类最佳潜力的GLP-1/GIP双受体激动剂HRS9531用于2型糖尿病和超重/肥胖2个适应症，口服小分子GLP-1受体激动剂HRS-7535用于2型糖尿病均有望获批。此外有望上市的还有：具备First-in-Class潜力的HER3 ADC创新药SHR-A2009用于非小细胞肺癌、URAT1抑制剂SHR4640用于痛风伴高尿酸血症。02BD大爆发，国际化稳步推进截至目前，恒瑞已实现13笔创新药海外授权合作，其中近三年对外授权8笔，包括将自主研发的Lp(a)抑制剂、DLL3 ADC、PARP1抑制剂等许可给包括默沙东、IDEAYA Biosciences、德国默克在内的多家海外药企。尤其值得一提的是，2024年5月，恒瑞将其3款自研GLP-1产品组合（HRS-7535、HRS9531、HRS-4729）在全球（大中华区除外）开发、生产、商业化的独家权利有偿许可给Kailera公司，首付款加里程碑付款累计可高达60亿美元，并取得Kailera公司19.9%的股权。于行业而言，这笔迄今为止国内最大一笔金额的“Newco”交易，一举助燃了“Newco”这一新的出海模式。另外，国际临床试验也在稳步开展。目前，恒瑞已在美国、欧洲、澳大利亚、日本及韩国等国家和地区启动超20项海外临床试验；SHR-A2009、SHR-A1912、SHR-A1921、SHR-A2102四款ADC创新药获得美国FDA快速通道资格认定。同时，恒瑞创新实力持续赢得国际认可。2024年，已有与公司产品相关的386项重要研究成果相继在BMJ（英国医学杂志）、JAMA（美国医学会杂志）、Lancet Oncology（柳叶刀·肿瘤学）等全球顶级期刊发表。此外，公司超百项抗肿瘤创新研究成果被2024美国临床肿瘤学会（ASCO）年会、欧洲肿瘤内科学会（ESMO）大会、欧洲肺癌大会（ELCC）、世界肺癌大会（WCLC）等国际知名学术会议录用为口头报告/会议壁报；多项慢病产品研究亮相国际学术舞台，被美国血液学会（ASH）、美国肾脏病学会（ASN）、美国心脏病学会科学年会（ACC）、美国皮肤科学会年会（AAD）等国际会议录用为口头报告。通过多年积累，恒瑞已打下全球一体化能力的基础，目前公司产品已进入超40个国家，在欧美日获得包括注射剂、口服制剂和吸入性麻醉剂在内的20余个注册批件。在此基础上，恒瑞医药在持续稳步推进国际化战略，坚持自主研发与开放合作并重，在内生发展的基础上着力加强国际合作。而且能明显看到，恒瑞的“创新+国际化”已经取得显著成效，国际化路径走到了引领新模式阶段，交易屡创纪录，未来的收益预期在不断提升。03持续优化运营，国际化人才蓄力2024年，恒瑞一方面优化组织结构，促进运营提效。夯实医学、市场双引擎驱动机制，打造公司创新药品牌。同时，持续强化商业化体系建设，并致力于拓展DTP药房等渠道，从战略层面深入布局零售市场，加快创新药销售渠道覆盖。公司还加强推动应用AI等新兴技术赋能公司研发、生产及各类经营管理活动。持续完善质量管理体系，公司上市产品的所有生产线均通过GMP检查，建立了拥有一流生产设备、国际标准化的生产车间。公司聘请拥有丰富制药行业质量管理经验的徐学健博士担任首席质量官，全面负责质量管理工作。2024年，恒瑞顺利通过了国内药品监管部门以及欧盟等国际官方药品监管部门对各分子公司进行的各类官方检查共计59次，今年1月上海恒瑞顺利通过美国FDA现场检查，公司质量管理体系再获国际权威认可。在人才建设方面，恒瑞始终坚持“人才是第一资源”理念，推进人才转型升级，持续引入具备国际视野的领军人才。公司全球研发团队达5500余人，其中接近60%的成员拥有硕士及以上学位，许多成员拥有在跨国制药企业和知名研究机构工作的经验。截至2024年年底，公司超过30%的中层及以上管理人员拥有海外教育或工作经验。通过不断精密缝合、调整创新与国际化的战略、人才、资金资源配置组合，恒瑞在创新转型过程中一步一步实现了进阶。五十余年来，恒瑞从一家地处苏北大地的小药厂，向着一家根植中国、全球领先的创新型制药企业蜕变，在此过程中，恒瑞用“继续做下去”的决心和实际应变行动，证明了其创新转型路径的可持续性。一审| 黄佳二审| 李芳晨三审| 李静芝