Trastuzumab

特约作者 | 张自然博士责任编辑 | 郑瑶哪些品种、企业销售额最大，一直是业界比较感兴趣的话题。本文即对最近一整年（23.7.1～24.6.30）时间内，全国院内、院外终端销售额最大的品种、企业做一排名分析。01Top20品种一、销售额：人血白蛋白最大23.7.1～24.6.30，全国院内外终端Top20品种销售额在50～370亿元之间。包括化学药11个（占55%）、生物药9个（占45%），中药暂无一上榜。其中，销售额最大的是人血白蛋白，卖了372亿元，也是唯一超300亿的品种。共有26家企业，杰特贝林（澳大利亚）的安博灵最大，占了近1/4（24.2%）；＞200亿的有1个，即氯化钠注射液239亿，因无参比制剂不能做一致性评价而免被集采降价，故仍居高位。共有96家企业，其中，科伦的最大，占了29%；＞100亿的有2个，即静注人免疫球蛋白（pH4）133亿元、贝伐珠单抗注射液132亿元。前者有16家企业，国药集团的占了近1/4（23%），后者有11家企业，齐鲁的安可达占了近半（46%）市场，安可达也是我国销售额最大的生物类似药；70～100亿的有3个，即阿托伐他汀钙片96亿（原研辉瑞的立普妥占68%）、注射用曲妥珠单抗82亿（原研罗氏的赫赛汀仍占51%）、葡萄糖注射液79亿（科伦的占1/3）；60～70亿的有4个，即硫酸氢氯吡格雷片69亿（原研赛诺菲的波立维仍占58%）、达格列净片68亿（阿斯利康的安达唐独霸市场，占97%）、甲磺酸奥希替尼片65亿（阿斯利康的泰瑞沙独占100%市场）、他克莫司胶囊64.6亿（安斯泰来的普乐可复占49%）；55～60亿的有3个，即苯磺酸氨氯地平片59亿（原研辉瑞的络活喜仍占51%）、注射用头孢哌酮钠舒巴坦钠(2：1)58亿（原研辉瑞的舒普深占95%）、利妥昔单抗注射液55亿（复星的汉利康占45%）；50～55亿的有6个，即硝苯地平控释片54亿（拜耳的拜新同仍占64%）、替雷利珠单抗注射液53亿（百济神州的PD-1百泽安独家）、丁苯酞氯化钠注射液52亿（石药独家）、重组人血小板生成素注射液51.9亿（三生制药独家）、司美格鲁肽注射液51.7亿（诺和诺德独家）、聚乙二醇化重组人粒细胞刺激因子注射液50亿（石药占51%）。（详见下图）二、增速：司美格鲁肽最快如上图所示，上述Top20品种与上年同期相比，销售额升降各半。其中，增长最快的是司美格鲁肽注射液，同比增长了43%，也是增速唯一超过40%的品种；增速20%～40%的有3个，即替雷利珠单抗注射液增长37%、贝伐珠单抗注射液增长29%、达格列净片增长27%。降幅最大的是硝苯地平缓释片，下降了25%。其次是注射用头孢哌酮钠舒巴坦钠(2：1)（-17%）、聚乙二醇化重组人粒细胞刺激因子注射液（-7%）。02Top20企业一、销售额：华润最大23.7.1～24.6.30，全国院内外终端销售额Top20企业的销售额分布在170～450亿元之间，本土（12家）：外企（8家），之比为3:2。其中，销售额最大的是华润医药，卖了443亿元，也是唯一超过400亿的企业，华润医药最大的品种是感冒灵颗粒。300～400亿元的有5家，即阿斯利康397亿（最大单品：安达唐，达格列净片）、辉瑞370亿（最大单品：立普妥，阿托伐他汀钙片）、国药集团350亿（最大单品：静注人免疫球蛋白（pH4））、扬子江312亿（最大单品：地佐辛注射液）、恒瑞302亿（最大单品：碘佛醇注射液）；250～300亿元的有4家，即诺华286亿（最大单品：诺欣妥，沙库巴曲缬沙坦钠片）、齐鲁279亿（最大单品：安可达，贝伐珠单抗注射液）、石药278亿（最大单品：恩必普，丁苯酞氯化钠注射液）、正大天晴药业集团250亿（最大单品：福可维，盐酸安罗替尼胶囊）；    200～250亿元的有6家，即拜耳235亿（最大单品：拜糖平）、复星医药230亿（最大单品：汉曲优）、默沙东215亿（最大单品：K药）、上海医药214亿（最大单品：麝香保心丸）、远大医药212亿（最大单品：福美欣）、科伦209亿（最大单品：氯化钠注射液）；100～200亿元的有4家，即赛诺菲195亿（最大单品：波立维）、罗氏193亿（最大单品：帕妥珠单抗）、诺和诺德177亿（最大单品：诺和泰）、步长169亿（最大单品：脑心通胶囊）。（详见下图）二、增速：诺华最快如上图所示，上述Top20企业与上年同比，只有1/4（5家）增长，3/4(15家)销售下滑。其中，增长最快的是诺华，同比增长了8.9%。其他4家的增长率依次是齐鲁（+8%）、恒瑞（+2.8%）、赛诺菲（+2.5%）、复星医药（+1.4%）。降幅最大的4家都是本土药企。Top品种、Top企业的规模和分布一定程度上反映了行业的发展状况和基本趋势，集采使老药规模缩水，国谈使新药尤其生物药排名跃升，腾笼换鸟成效初显，为《国务院办公厅关于全面深化药品医疗器械监管改革促进医药产业高质量发展的意见》提出的“打造具有全球竞争力的创新生态，推动我国从制药大国向制药强国跨越”奠定了基础。注：欢迎转载！但在转载或引用本文图片时，除公众号外，还请标明作者。谢谢！   END内容沟通：郑瑶（13810174402）

TOKYO, Japan & BASKING RIDGE, NJ, USA I April 21, 2025 I Positive topline results from a planned interim analysis of the DESTINY-Breast09 phase 3 trial showed ENHERTU ® (trastuzumab deruxtecan) in combination with pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to taxane, trastuzumab and pertuzumab (THP) as a first-line treatment for patients with HER2 positive metastatic breast cancer. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN). The PFS improvement was seen across all pre-specified patient subgroups with ENHERTU in combination with pertuzumab. The key secondary endpoint of overall survival (OS) was not mature at the time of this planned interim analysis; however, interim OS data showed an early trend favoring the ENHERTU combination compared to THP. The second arm assessing ENHERTU monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis. HER2 positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer. 1 While HER2 targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade. 2,3,4,5 Further, approximately one in three patients never go on to receive treatment following first-line therapy due to disease progression or death. 6,7 “The results of DESTINY-Breast09 reinforce the importance of effectively targeting HER2 to achieve durable disease control early in the treatment of HER2 positive metastatic breast cancer,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “Building on the positive results seen with ENHERTU in the second-line setting, these new findings suggest that starting treatment with ENHERTU in combination with pertuzumab at the time of metastatic diagnosis delays disease progression, postponing the time until additional treatment may be needed.” “This is the first trial in more than a decade to demonstrate superior efficacy across a broad HER2 positive metastatic breast cancer patient population compared to the current first-line standard of care,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology R&D, AstraZeneca. “This is a significant milestone for patients and sets the foundation for ENHERTU in combination with pertuzumab as an important treatment option in the first-line HER2 positive setting.” The safety profile of ENHERTU in combination with pertuzumab was consistent with the known profiles of each individual therapy. Data from the combination arm of DESTINY-Breast09 will be presented at an upcoming medical meeting and shared with regulatory authorities. About DESTINY-Breast09 DESTINY-Breast09 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP (a taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab) as a first-line treatment in patients with HER2 positive metastatic breast cancer. Patients were randomized 1:1:1 to receive either ENHERTU monotherapy with a pertuzumab matching placebo; ENHERTU in combination with pertuzumab; or THP. Randomization was stratified by prior treatment ( de novo metastatic disease versus progression from early-stage disease), hormone receptor (HR) status and PIK3CA mutation status. The primary endpoint of DESTINY-Breast09 is PFS as assessed by blinded independent central review in both the ENHERTU monotherapy and ENHERTU combination arms. Secondary endpoints include investigator-assessed PFS, OS, objective response rate, duration of response, pharmacokinetics and safety. DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America, and South America. For more information about the trial, visit ClinicalTrials.gov . About HER2 Positive Metastatic Breast Cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. 8 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally. 8 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or progress to metastatic disease are expected to live five years following diagnosis. 9 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer. 10 HER2 protein overexpression may occur as a result of HER2 gene amplification. 2 Approximately one in five cases of breast cancer are considered HER2 positive. 11 HER2 positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer. 1 While HER2 targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade. 2,3,4,5 Further, approximately one in three patients never go on to receive treatment following first-line therapy due to disease progression or death. 6,7 About ENHERTU ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. ENHERTU (5.4 mg/kg) is approved in more than 75 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial. ENHERTU (5.4 mg/kg) is approved in more than 75 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. ENHERTU (5.4 mg/kg) is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial. ENHERTU (5.4 mg/kg) is approved in more than 50 countries worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 ( ERBB2 ) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ENHERTU (6.4 mg/kg) is approved in more than 65 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 , DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ENHERTU (5.4 mg/kg) is approved in Brazil, Israel, Russia, Taiwan, U.K. and the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02 , DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. About the ENHERTU Clinical Development Program A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU monotherapy across multiple HER2 targetable cancers. Trials in combination with other anticancer treatments, such as immunotherapy, also are underway. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and DATROWAY ® in July 2020 , except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. Please see accompanying full Prescribing Information , including Boxed WARNINGS, and Medication Guide . About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com . SOURCE: Daiichi Sankyo