Paclitaxel

Based on DESTINY-Breast05 Phase III trial results which showed ENHERTU reduced the risk of invasive disease recurrence or death by 53% compared with T-DM1 If approved, AstraZeneca and Daiichi Sankyo’s ENHERTU has the potential to become a new standard of care in this early breast cancer setting WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for ENHERTU ® (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the US for the treatment of adult patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment. The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for its regulatory decision, is anticipated during the third quarter of 2026. ENHERTU was recently granted Breakthrough Therapy Designation (BTD) by the FDA in this setting. BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need. The sBLA also is being reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. Around one in five breast cancers are considered HER2-positive, a subtype that is often associated with aggressive disease and poor prognosis. 1-3 Currently, approximately half of patients with HER2-positive early breast cancer have residual disease following neoadjuvant treatment (before surgery), putting them at an increased risk of disease recurrence. 4-9 Despite receiving additional treatment in the post-neoadjuvant setting with current standards of care, some patients still experience tumor progression to metastatic disease, where the five-year survival rate drops from nearly 90% to approximately 30%. 10,11 Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “While there has been significant progress in treating HER2-positive early breast cancer, managing patients at a higher risk of recurrence remains challenging. With this Priority Review, we move closer to bringing ENHERTU to the post-neoadjuvant setting, offering more patients the opportunity for sustained long-term outcomes and a potential path to cure.” Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: “For patients with residual invasive disease after neoadjuvant therapy, identifying additional treatments following surgery is critical to help further reduce the risk of recurrence and help prevent progression to metastatic disease. This Priority Review reinforces the potential of ENHERTU to become a new standard of care for HER2-positive early breast cancer based on the results of DESTINY-Breast05.” The sBLA is based on data from the DESTINY-Breast05 Phase III trial presented at the European Society for Medical Oncology (ESMO) 2025 Congress and subsequently published in The New England Journal of Medicine . 1 In the trial, ENHERTU significantly reduced the risk of invasive disease recurrence or death (invasive disease-free survival [IDFS]) by 53% compared with trastuzumab emtansine (T-DM1; based on a hazard ratio [HR] of 0.47; 95% confidence interval [CI] 0.34-0.66; p28 days from date of onset, reduce dose 1 level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate systemic corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks. HER2-Positive, HER2-Low, and HER2-Ultralow Metastatic Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg) ENHERTU as Monotherapy In patients treated with ENHERTU 5.4 mg/kg, ILD occurred in 12% of patients. Median time to first onset was 5.5 months (range: 0.9 to 31.5). Fatal outcomes due to ILD and/or pneumonitis occurred in 0.9% of patients treated with ENHERTU. ENHERTU in Combination with Pertuzumab In patients treated with ENHERTU 5.4 mg/kg in combination with pertuzumab (N=431), ILD occurred in 12% of patients. Median time to first onset was 8.0 months (range: 0.6 to 33.8). Fatal outcomes due to ILD and/or pneumonitis occurred in 0.5% of patients treated with ENHERTU in combination with pertuzumab. HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg) In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, ILD occurred in 10% of patients. Median time to first onset was 2.8 months (range: 1.2 to 21). Neutropenia Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU monotherapy or ENHERTU in combination with pertuzumab. Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] 38.3º C or a sustained temperature of ≥38º C for more than 1 hour), interrupt ENHERTU until resolved, then reduce dose by 1 level. HER2-Positive, HER2-Low, and HER2-Ultralow Metastatic Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg) ENHERTU as Monotherapy In patients treated with ENHERTU 5.4 mg/kg, a decrease in neutrophil count was reported in 65% of patients. Nineteen percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 22 days (range: 2 to 939). Febrile neutropenia was reported in 1.2% of patients. ENHERTU in Combination with Pertuzumab In patients treated with ENHERTU 5.4 mg/kg in combination with pertuzumab (N=431), decreased neutrophil count occurred in 79% of patients. Median time to first onset was 22 days (range: 5 to 994). Twenty-nine percent had Grade 3 or 4 decreased neutrophil count. Febrile neutropenia was reported in 2.6% of patients. HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg) In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, a decrease in neutrophil count was reported in 72% of patients. Fifty-one percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 16 days (range: 4 to 187). Febrile neutropenia was reported in 4.8% of patients. Left Ventricular Dysfunction Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including ENHERTU. Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. Manage LVEF decrease through treatment interruption. When LVEF is >45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is 20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of 20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF 6 months and 38% were exposed for >1 year. In this pooled safety population, the most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (73%), nausea (72%), decreased hemoglobin (67%), decreased neutrophil count (65%), decreased lymphocyte count (60%), fatigue (55%), decreased platelet count (48%), increased aspartate aminotransferase (46%), increased alanine aminotransferase (44%), increased blood alkaline phosphatase (39%), vomiting (38%), alopecia (37%), constipation (32%), decreased blood potassium (32%), decreased appetite (31%), diarrhea (30%), and musculoskeletal pain (24%). ENHERTU in Combination with Pertuzumab The pooled safety population reflects exposure to ENHERTU 5.4 mg/kg in combination with pertuzumab intravenously every 3 weeks in 431 patients in DESTINY-Breast07 (n=50), and DESTINY-Breast09 (n=381). Among these patients, 86% were exposed for >6 months and 73% were exposed for >1 year. In this pooled safety population, the most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (86%), decreased hemoglobin (80%), decreased neutrophil count (79%), nausea (74%), increased alanine aminotransferase (65%), diarrhea (64%), increased aspartate aminotransferase (63%), decreased lymphocyte count (61%), decreased platelet count (55%), increased blood alkaline phosphatase (54%), decreased blood potassium (54%), fatigue (53%), alopecia (48%), vomiting (46%), upper respiratory tract infection (32%), constipation (31%), decreased appetite (31%), decreased weight (28%), musculoskeletal pain (23%), abdominal pain (22%), and increased blood bilirubin (23%). HER2-Positive Metastatic Breast Cancer DESTINY-Breast09 The safety of ENHERTU 5.4 mg/kg in combination with pertuzumab was evaluated in DESTINY-Breast09, a randomized, three-arm, multicenter study including 763 patients with HER2-positive (IHC 3+ or ISH+) unresectable or metastatic breast cancer. Three hundred eighty-one patients received ENHERTU in combination with pertuzumab and 382 patients received THP (taxane [docetaxel or paclitaxel], trastuzumab, and pertuzumab). Among patients who received ENHERTU in combination with pertuzumab, the median duration of treatment was 22 months (range: 0.3 months to 44.5 months). Serious adverse reactions occurred in 27% of patients receiving ENHERTU in combination with pertuzumab. Serious adverse reactions in >1% of patients were diarrhea, pneumonia, febrile neutropenia, hypokalemia, vomiting, ILD, pulmonary embolism, and sepsis. Fatalities due to adverse reactions occurred in 3.4% of patients including pneumonia (n=3), ILD (n=2), sepsis (n=2), pulmonary embolism, septic shock, acute kidney injury, dyspnea, febrile neutropenia, and intestinal ischemia (one patient each). ENHERTU was discontinued for adverse reactions in 21% of patients. The most frequent adverse reaction (>2%) associated with permanent discontinuation was ILD/pneumonitis (6.6%). Dose interruptions due to adverse reactions occurred in 69% of patients. The most frequent adverse reactions (>2%) associated with dose interruption were COVID-19, neutropenia, upper respiratory tract infection, fatigue, anemia, hypokalemia, ILD/pneumonitis, thrombocytopenia, pneumonia, diarrhea, transaminase increased, leukopenia, cough, pyrexia, decreased appetite, and blood bilirubin increased. Dose reductions occurred in 46% of patients treated with ENHERTU in combination with pertuzumab. The most frequent adverse reactions (>2%) associated with dose reduction were fatigue, neutropenia, nausea, diarrhea, ILD/pneumonitis, thrombocytopenia, vomiting, transaminases increased, decreased weight, febrile neutropenia, and hypokalemia. The most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (87%), decreased hemoglobin (80%), decreased neutrophil count (78%), nausea (75%), increased alanine aminotransferase (66%), diarrhea (64%), increased aspartate aminotransferase (62%), decreased lymphocyte count (62%), decreased platelet count (56%), increased blood alkaline phosphatase (55%), decreased blood potassium (54%), fatigue (53%), alopecia (48%), vomiting (46%), upper respiratory tract infection (33%), constipation (33%), decreased appetite (32%), decreased weight (30%), COVID-19 (28%), musculoskeletal pain (24%), increased blood bilirubin (23%), and abdominal pain (23%). DESTINY-Breast03 The safety of ENHERTU was evaluated in 257 patients with unresectable or metastatic HER2-positive breast cancer who received at least 1 dose of ENHERTU 5.4 mg/kg intravenously once every 3 weeks in DESTINY-Breast03. The median duration of treatment was 14 months (range: 0.7 to 30) for patients who received ENHERTU. Serious adverse reactions occurred in 19% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were vomiting, ILD, pneumonia, pyrexia, and urinary tract infection. Fatalities due to adverse reactions occurred in 0.8% of patients including COVID-19 and sudden death (1 patient each). ENHERTU was permanently discontinued in 14% of patients, of which ILD/pneumonitis accounted for 8%. Dose interruptions due to adverse reactions occurred in 44% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, leukopenia, anemia, thrombocytopenia, pneumonia, nausea, fatigue, and ILD/pneumonitis. Dose reductions occurred in 21% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were nausea, neutropenia, and fatigue. The most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (76%), decreased white blood cell count (74%), decreased neutrophil count (70%), increased aspartate aminotransferase (67%), decreased hemoglobin (64%), decreased lymphocyte count (55%), increased alanine aminotransferase (53%), decreased platelet count (52%), fatigue (49%), vomiting (49%), increased blood alkaline phosphatase (49%), alopecia (37%), decreased blood potassium (35%), constipation (34%), musculoskeletal pain (31%), diarrhea (29%), decreased appetite (29%), headache (22%), respiratory infection (22%), abdominal pain (21%), increased blood bilirubin (20%), and stomatitis (20%). HER2-Low and HER2-Ultralow Metastatic Breast Cancer DESTINY-Breast06 The safety of ENHERTU was evaluated in 434 patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer who received ENHERTU 5.4 mg/kg intravenously once every 3 weeks in DESTINY-Breast06. Contacts Media Inquiries Fiona Cookson +1 212 814 3923 US Media Mailbox: usmediateam@astrazeneca.com Read full story here

近期，国家药品监督管理局官网一则公示引发关注——广西五和博澳药业的桑枝总生物碱片申请中药保护品种获受理。这款已在糖尿病治疗领域创下年销2亿成绩的“现象级”中药新药，再度成为市场焦点。 值得关注的是，2月27日，其母公司北京五和博澳药业股份有限公司正式向港交所递交招股书，拟在主板挂牌上市，估值已达40.38亿元。 从一味中药到原创降糖药的“破圈”之路 桑博恩®（桑枝总生物碱片）的故事始于一味传统中药——桑枝。桑枝是桑科植物桑的干燥嫩枝，在中医中常用于祛风湿、利关节。五和博澳与中国医学科学院药物研究所合作，从中分离出降糖活性成分“桑枝总生物碱”，开发出这款中药1.2类新药。值得一提的是，该产品并非五和博澳自研，而是从中国医学科学院药物研究所受让而来，形成了产学研深度绑定的创新转化模式。 桑博恩®于2020年3月获批上市，当年即通过国家医保谈判纳入医保乙类目录，自此开启“放量加速度”。2024年销售额达2.08亿元，2025年前三季度即追平去年全年，同比增长37.95%，在全国院内中成药-糖尿病药物市场中跻身TOP3。 近期，NMPA官网公示显示，桑枝总生物碱片申请中药保护品种已获受理，这将为其市场竞争筑起“护城河”，进一步巩固其独家品种的市场地位。 头对头挑战拜唐苹，胃肠道不良反应降低50% 在临床试验中，桑博恩®直接对标当时市场上的降糖药霸主——德国拜耳的拜唐苹（阿卡波糖）。通过“头对头”试验证明，桑博恩®与拜唐苹具有相当的疗效，同时胃肠道不良反应发生率降低了50%。 这一差异化优势直击阿卡波糖的临床痛点——肠道产气多、导致患者不断排气。桑博恩®服用后不胀气、排气少，解决了患者的“尴尬”问题，显著提升了治疗依从性。 上市四年后，桑博恩®进一步获得权威指南推荐，被纳入《中国糖尿病防治指南(2024年版)》及《国家基层糖尿病防治管理指南(2025年版)》。尽管拜唐苹早已进入集采，京东大药房售价不足桑博恩®的五分之一，但凭借独特的产品优势和患者体验，桑博恩®的销售额仍节节攀升。 此外，桑枝总生物碱片的IV期临床试验仍在进行中，未来还有望延伸至非酒精性脂肪肝等新适应症，实现“异病同治”的系统治疗价值。公司围绕桑枝总生物碱拓展适应症： 减重（WH006）：2025年8月启动II期临床，高剂量组减重14.1%，效果与司美格鲁肽相当，且兼具“减脂不减少肌肉、增加骨密度”的潜在优势。 多囊卵巢综合征（WH007）：计划2026年启动II期临床，瞄准全球尚无获批药物的3440万中国患者市场。 肿瘤领域（WH002）：紫杉醇靶向脂质乳剂用于乳腺癌新辅助治疗，预计2026年启动III期临床。 关于五和博澳 北京五和博澳药业股份有限公司成立于2010年，是一家聚焦代谢性疾病、恶性肿瘤等重大疾病治疗领域的生物医药公司。公司立足“天然药物”创新主线，同时开展药物递送系统研发，旨在突破体内药物递送的技术瓶颈。 本文来源：网络收集与整理。 如有侵权，请联系作者删除。 近 期 文 章 一周一次！诺和诺德全球首创胰岛素/GLP-1复方周制剂在华获批 替尔泊肽之后，国产双靶点来了！翰森制药奥莱泊肽III期成功，减重19.3% 一图速览丨国产瑞加诺生突破原研边界，拿下超声心动图全球独家适应症 全球首创cAMP偏向型GLP-1再下一城！先为达埃诺格鲁肽减重适应症获批 FARAPULSE在中国补齐最后一块拼图！波士顿科学PFA三维标测系统获批 一图读懂全球首款自供电植入式CGM：不用贴、不用充、不用换 推 荐 阅 读 行业动态 ✦新政新规｜✦企业IPO｜✦企业融资｜✦企业并购 创新企业 ✦美敦力｜✦爱德华｜✦雅培｜✦赛诺菲｜✦礼来 ｜✦诺和诺德｜✦波士顿科学｜✦核心医疗｜✦恒瑞医药｜✦石药集团｜✦ 默沙东｜✦ 诺华｜✦罗氏｜✦微创医疗｜✦健世科技｜✦ 歌礼制药 新品获批 ✦获批NMPA/CDE｜✦获批FDA｜✦获批CE/MDR  长按二维码 关注我们