Bevacizumab

WILMINGTON, Del.--(BUSINESS WIRE)--Positive high-level results from the CLARITY-Gastric01 global Phase III trial showed that sonesitatug vedotin (Sone-Ve) demonstrated a statistically significant and highly clinically meaningful improvement in overall survival (OS) in 2nd and later-line Claudin 18.2-positive advanced gastric cancers versus investigator’s choice of therapy. The trial included patients with locally advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma (EAC) with Claudin 18.2 (CLDN18.2) expression on at least 25% of tumor cells at any staining intensity. The trial had dual primary endpoints of OS in 3rd and later-line treatment and progression-free survival (PFS) in the overall trial population. The trial met the dual primary endpoint of OS in 3rd and later-line treatment, and a key secondary endpoint of OS in the overall trial population of patients treated in the 2nd and later-line setting, demonstrating a statistically significant and highly clinically meaningful improvement. For the other dual primary endpoint of PFS as assessed by blinded independent central review (BICR), results showed a trend toward improved PFS in patients treated in the 2nd and later-line setting but did not reach statistical significance. The majority of patients with gastric/GEJ cancers are diagnosed at an advanced or metastatic stage, where the prognosis is especially poor and treatment options are limited, with less than 20% surviving more than one year.1,2 CLDN18.2 has emerged as an important therapeutic target for these patients, with an estimated 60% of gastric/GEJ cancers expressing CLDN18.2 in 25% or more of tumor cells.3 Each year, there are roughly 183,500 patients in the US, EU, China and Japan treated in the 2nd and later-line setting for advanced or metastatic CLDN18.2-positive, non-HER2-positive gastric/GEJ cancers.4 Rui-Hua Xu, M.D., Ph.D., Professor in the Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China, and principal investigator of the trial said: “Metastatic gastric cancer is an aggressive disease with very limited options once patients progress after first-line treatment. Sone-Ve is the first CLDN18.2-targeted antibody drug conjugate to demonstrate an overall survival benefit in this setting and has the potential to establish a new precision treatment for a broader population of patients with CLDN18.2 expression.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, said: “Sone-Ve has the potential to reshape the treatment of gastric cancer by replacing classic chemotherapy with this novel targeted antibody drug conjugate to improve outcomes for patients. These transformative results from the first Phase III readout for Sone-Ve, together with our broad development program, highlight the potential for Sone-Ve to become an important new medicine in CLDN18.2-positive cancers.” Sone-Ve was well tolerated, and its profile was consistent with the known safety profile of Sone-Ve with no new safety signals identified. Sone-Ve is a potential global first-in-class CLDN18.2-targeting antibody drug conjugate (ADC) with a monomethyl auristatin E (MMAE) payload. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. Sone-Ve has received Orphan Drug Designation from the US Food and Drug Administration and the European Commission for the treatment of gastric and GEJ cancers. It has also received Breakthrough Designation in China for the 2nd-line treatment of gastric cancer. Notes Gastric and GEJ cancers Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth-leading cause of cancer-related death.5 Nearly one million new patients were diagnosed with gastric cancer in 2024, with approximately 650,000 deaths reported globally. In many regions, its incidence has been increasing in patients younger than 50 years old, along with other gastrointestinal (GI) malignancies.5 GEJ cancer is a type of gastric cancer that arises from and spans the area where the esophagus connects to the stomach.6 Most advanced gastric cancer patients will eventually experience disease progression after standard 1st-line therapies, and subsequent lines yield poor outcomes, with median survival of 5-9 months for patients receiving 2nd and later-line systemic treatments.7-9 CLARITY-Gastric01 CLARITY-Gastric01 is a randomized, open-label, sponsor-blinded, multicenter, global Phase III trial evaluating Sone-Ve as a 2nd and later-line therapy for patients with advanced or metastatic gastric cancer, GEJ cancer, or EAC with CLDN18.2 expression in 25% or more of tumor cells, with IHC+ of any intensity. In the trial, patients were randomized 1:1:1 in Stage 1 (dose selection) to Sone-Ve monotherapy 2.2 mg/kg or 1.8 mg/kg every three weeks, or investigator’s choice of therapy, the comparator arm. In Stage 2, the trial continued with Sone-Ve 2.2 mg/kg as the recommended Phase III dose. The efficacy analyses from this study will also provide the basis to evaluate the clinical performance of the Ventana SP455 assay for the identification of patients with advanced or metastatic gastric, GEJ or EAC cancers expressing CLDN18.2 who may benefit from Sone-Ve. The trial is being conducted in 175 centers across 19 countries, including in North America, Europe, South America and Asia. Its dual primary endpoints are PFS as assessed by BICR in the 2nd and later-line setting and OS in the 3rd and later-line setting. A key secondary endpoint is OS in the 2nd and later-line setting. Sonesitatug Vedotin (Sone-Ve) Sone-Ve is a novel ADC targeting CLDN18.2, a protein found in the stomach lining and a validated therapeutic target in oncology, particularly for GI cancers. Sone-Ve consists of an anti-CLDN18.2 monoclonal antibody, a protease-degradable linker and a cytotoxic small molecule MMAE payload. AstraZeneca entered into a global exclusive license agreement with KYM Biosciences to develop and commercialize Sone-Ve in March 2023. In addition to CLARITY-Gastric01, Sone-Ve is being evaluated in the CLARITY-Gastric02 Phase III trial in combination with capecitabine, with or without rilvegostomig, as a 1st-line treatment for advanced or metastatic gastric cancer, GEJ cancer and EAC. In Phase II development, Sone-Ve is being evaluated in patients with advanced solid tumors in multiple combinations across settings, including in CLDN18.2-positive pancreatic and biliary tract cancers (BTC). AstraZeneca in GI cancers AstraZeneca has a broad development program for the treatment of GI cancers across several medicines and a variety of tumor types and stages of disease. In 2024, GI cancers collectively represented approximately 5 million new cancer cases leading to approximately 3.3 million deaths.10 Within this program, the Company is committed to improving outcomes in gastric, liver, biliary tract, esophageal, pancreatic and colorectal cancers. Durvalumab, an anti-PDL1 antibody, is approved in the US, China, EU, Japan and other countries in combination with chemotherapy in locally advanced or metastatic BTC, in combination with tremelimumab-actl in unresectable hepatocellular carcinoma (HCC) and in combination with FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) in early-stage and locally advanced gastric and GEJ cancers. Durvalumab is also approved as a monotherapy in unresectable HCC in Japan, China and the EU. Fam-trastuzumab deruxtecan-nxki, a HER2-directed ADC is approved in the US, China, EU, Japan and several other countries for HER2-positive advanced gastric cancer. Fam-trastuzumab deruxtecan-nxki is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. Olaparib, a first-in-class PARP inhibitor, is approved in the US and several other countries for the treatment of BRCA-mutated metastatic pancreatic cancer. Olaparib is developed and commercialized in collaboration with Merck & Co., Inc., known as MSD outside the US and Canada. Savolitinib, an oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI), has received conditional approval in China for the treatment of patients with locally advanced or metastatic gastric cancer or GEJ adenocarcinoma harboring MET amplification who have progressed on at least two prior lines of systemic therapy. Savolitinib is being jointly developed and commercialized by AstraZeneca and HUTCHMED. The Company is also assessing rilvegostomig, a PD-1/TIGIT bispecific antibody, in combination with chemotherapy as an adjuvant therapy in BTC, and in combination with fam-trastuzumab deruxtecan-nxki in previously untreated, HER2-expressing, locally advanced or metastatic BTC. Rilvegostomig is also being evaluated in combination with bevacizumab with or without tremelimumab-actl as a 1st-line treatment in patients with advanced HCC, and as a 1st-line combination treatment in patients with HER2-positive, or CLDN18.2-positive and HER2-negative, locally advanced unresectable or metastatic gastric and GEJ cancers. In addition to Sone-Ve, AstraZeneca is also advancing AZD5863, a novel CLDN18.2/CD3 T-cell engager bispecific antibody licensed from Harbour Biomed in Phase I development. In early development, AstraZeneca is developing AZD7003, a Glypican 3 armored CAR T, in HCC. The Company is also advancing a pan-KRAS inhibitor program licensed from Jacobio Pharma, which is being evaluated in Phase I trials in advanced solid tumors with KRAS alterations, including in pancreatic ductal adenocarcinoma. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca. References Davis JA, et al. Treatment heterogeneity and overall survival in patients with advanced/metastatic gastric or gastroesophageal junction adenocarcinoma in the United States. J Gastrointest Oncol . 2022 Jun;13(3):949-957. Cancer Research UK. Survival for stomach cancer. https://www.cancerresearchuk.org/about-cancer/stomach-cancer/survival . Accessed July 2026. Poniewierska-Baran A, et al. Claudin18.2 as a Promising Therapeutic Target in Gastric Cancer. Cells. 2025;14(16):1285. AstraZeneca PLC. Investor Relations Epidemiology Spreadsheet. Top 8 Countries. Available at: https://www.astrazeneca.com/investor-relations.html . Accessed July 2026. World Health Organization. International Agency for Research on Cancer. Stomach Fact Sheet. Available at: https://gco.iarc.who.int/today/en/fact-sheets-cancers/7/stomach . Accessed July 2026. National Cancer Institute. Gastroesophageal junction. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/gastroesophageal-junction . Accessed July 2026. Abderhalden LA, et al. Clinical Outcomes for Previously Treated Patients with Advanced Gastric or Gastroesophageal Junction Cancer: A Systematic Literature Review and Meta-Analysis. J Gastrointest Cancer. 2023;54(4):1031-1045. Ford HE, et al. Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): an open-label, phase 3 randomised controlled trial. ⁠ The Lancet Oncology , 2014;15(1), 78-86. Wilke H, et al. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a randomised, multicentre, double-blind, phase 3 trial. ⁠ The Lancet Oncology , 2014;15(11), 1224-1235. World Health Organization. World Cancer Fact Sheet. Available at https://gco.iarc.who.int/today/en/fact-sheets-populations/900/world . Accessed July 2026. US- 114581 Last Updated 7/26

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石药集团巨石生物制药有限公司 1 CXSL2600524 SCTB35注射液 神州细胞工程有限公司 1 CXSL2600521 SCTB35注射液 神州细胞工程有限公司 1 CXSL2600520 SCTB35注射液 神州细胞工程有限公司 1 CXSL2600519 SCTB41注射液 神州细胞工程有限公司 1 CXSL2600518 注射用SKB500 四川科伦博泰生物医药股份有限公司 1 CXSL2600525 IM-101注射液 正大天晴药业集团南京顺欣制药有限公司 1 CXSL2600507 SPY002-091, 200 mg/mL IV 辟埃赛医药科技(上海)有限公司 1 CXSL2600506 SPY002-091, 200 mg/mL SC 辟埃赛医药科技(上海)有限公司 1 CXSL2600505 OTOV-102预混注射液 星奥拓维(南京)生物技术有限公司 1 CXSL2600479 KHN921注射液 成都弘基生物科技有限公司 1 CXSL2600466 贝伐珠单抗注射液 苏州盛迪亚生物医药有限公司 2.2 CXSL2600537 阿得贝利单抗注射液 上海盛迪医药有限公司 2.2 CXSL2600544 SHR-8068注射液 苏州盛迪亚生物医药有限公司 2.2 CXSL2600543 QL2107注射液 齐鲁制药有限公司 2.2 CXSL2600528 阿得贝利单抗注射液 上海盛迪医药有限公司 2.2 CXSL2600514 酪酸梭菌活菌滴剂(胶囊型) 杭州远大生物制药有限公司 2.2 CXSL2600500 SPY003-207, 180 mg/mL SC 辟埃赛医药科技(上海)有限公司 2.4 CXSL2600504 SPY001-001, 150mg/mL IV 辟埃赛医药科技(上海)有限公司 2.4 CXSL2600501 SPY003-207, 150 mg/mL IV 辟埃赛医药科技(上海)有限公司 2.4 CXSL2600503 SPY001-001, 180 mg/mL SC 辟埃赛医药科技(上海)有限公司 2.4 CXSL2600502 仿制药申请 药品名称 企业 注册分类 受理号 乳酸钠林格冲洗液 上海长征富民金山制药有限公司 3 CYHS2501332 盐酸美金刚口崩片 合肥恩瑞特药业有限公司 3 CYHS2500954 盐酸美金刚口崩片 合肥恩瑞特药业有限公司 3 CYHS2500953 地奈德软膏 湖南明瑞制药股份有限公司 3 CYHS2500829 盐酸异丙肾上腺素注射液 成都瑞尔医药科技有限公司 3 CYHS2500819 盐酸异丙肾上腺素注射液 成都瑞尔医药科技有限公司 3 CYHS2500818 复方电解质醋酸钠注射液 回音必集团江西东亚制药有限公司 3 CYHS2500795 复方电解质醋酸钠注射液 回音必集团江西东亚制药有限公司 3 CYHS2500794 酒石酸美托洛尔注射液 白云山东泰商丘药业有限公司 3 CYHS2500749 布美他尼注射液 山东方明药业集团股份有限公司 3 CYHS2500562 乙酰半胱氨酸片 广东泰来润至医药科技有限公司 3 CYHS2500502 盐酸溴己新注射液 福安药业集团宁波天衡制药有限公司 3 CYHS2500493 铝镁匹林片(II) 福建省闽东力捷迅药业股份有限公司 3 CYHS2500461 依帕司他片 沈阳永大制药股份有限公司 3 CYHS2500372 吡拉西坦注射液 石药银湖制药有限公司 3 CYHS2500336 苯溴马隆片 广州一品红制药有限公司 3 CYHS2500326 腺苷钴胺胶囊 合肥康惠医药技术有限公司 3 CYHS2500313 盐酸非索非那定干混悬剂 桂林华信制药有限公司 3 CYHS2500300 盐酸非索非那定干混悬剂 桂林华信制药有限公司 3 CYHS2500298 左甲状腺素钠口服溶液 泊诺(天津)创新医药研究有限公司 3 CYHS2500173 舒必利片 万邦德制药集团有限公司 3 CYHS2500105 酮咯酸氨丁三醇注射液 四川美大康华康药业有限公司 3 CYHS2500081 地氯雷他定口服溶液 浙江华润三九众益制药有限公司 3 CYHS2404549 氨磺必利口服溶液 浙江浙北药业有限公司 3 CYHS2404541 普瑞巴林口服溶液 岳阳新华达制药有限公司 3 CYHS2404462 重酒石酸去甲肾上腺素注射液 浙江尚科生物医药有限公司 3 CYHS2404416 复合磷酸氢钾注射液 石家庄荣雾迪医药科技有限公司 3 CYHS2404290 盐酸氯胺酮注射液 国药集团工业有限公司廊坊分公司 3 CYHS2404278 注射用硫酸多黏菌素B 合肥华威药业有限公司 3 CYHS2404191 铝碳酸镁混悬液 合肥远志医药科技开发有限公司 3 CYHS2404126 氨溴特罗口服溶液 山东龙洋生物医药科技有限公司 3 CYHS2403801 氨溴特罗口服溶液 山东龙洋生物医药科技有限公司 3 CYHS2403800 黄体酮注射液 重庆万霖生物医药科技有限公司 3 CYHS2403721 盐酸氢吗啡酮注射液 青海制药有限公司 3 CYHS2403606 吲哚布芬片 石家庄龙泽制药股份有限公司 3 CYHS2403553 维生素B6注射液 江苏润恒制药有限公司 3 CYHS2403488 氯化钾注射液 黑龙江省知润药业有限公司 3 CYHS2403391 卡马西平缓释片(II) 宜昌人福药业有限责任公司 3 CYHS2403175 卡马西平缓释片(II) 宜昌人福药业有限责任公司 3 CYHS2403174 卡马西平缓释片(II) 宜昌人福药业有限责任公司 3 CYHS2403173 对乙酰氨基酚维生素C泡腾片 郑州泰丰制药有限公司 3 CYHS2403104 维生素B6注射液 河北桥洲医药科技有限公司 3 CYHS2403047 硫酸镁注射液 石家庄杏泽医药科技有限公司 3 CYHS2402809 琥珀酸亚铁片 浙江华海药业股份有限公司 3 CYHS2402039 阿替卡因肾上腺素注射液 扬州中宝药业股份有限公司 3 CYHS2401623 碳酸氢钠血滤置换液 上海峰林生物科技有限公司 3 CYHS2401218 氧(液态) 扬州盈德气体有限公司 4 CYHS2503496 盐酸达利雷生片 海南先声药业有限公司 4 CYHS2503110 盐酸达利雷生片 海南先声药业有限公司 4 CYHS2503109 硫酸氨基葡萄糖胶囊 江西迪赛诺医药集团有限公司 4 CYHS2502668 注射用阿糖胞苷 广东星昊药业有限公司 4 CYHS2501719 注射用阿糖胞苷 广东星昊药业有限公司 4 CYHS2501718 盐酸乙哌立松片 山东京卫制药有限公司 4 CYHS2501684 硝酸异山梨酯注射液 珠海润都制药股份有限公司 4 CYHS2501462 达格列净二甲双胍缓释片(III) 江苏德源药业股份有限公司 4 CYHS2501438 棕榈酸帕利哌酮注射液 石药集团中诺药业(石家庄)有限公司 4 CYHS2501206 棕榈酸帕利哌酮注射液 石药集团中诺药业(石家庄)有限公司 4 CYHS2501205 棕榈酸帕利哌酮注射液 石药集团中诺药业(石家庄)有限公司 4 CYHS2501204 富马酸伏诺拉生片 山西宝泰药业有限责任公司 4 CYHS2501109 富马酸伏诺拉生片 山西宝泰药业有限责任公司 4 CYHS2501108 乳果糖口服溶液 福建省融恒医药有限公司 4 CYHS2501069 布瑞哌唑片 浙江诺得药业有限公司 4 CYHS2501004 布瑞哌唑片 浙江诺得药业有限公司 4 CYHS2501003 盐酸贝尼地平片 石家庄四药有限公司 4 CYHS2500984 注射用紫杉醇(白蛋白结合型) 浙江圣兆药物科技股份有限公司 4 CYHS2500978 聚多卡醇注射液 哈尔滨誉衡制药有限公司 4 CYHS2500919 聚多卡醇注射液 哈尔滨誉衡制药有限公司 4 CYHS2500918 聚多卡醇注射液 哈尔滨誉衡制药有限公司 4 CYHS2500917 乙酰半胱氨酸颗粒 海南海神同洲制药有限公司 4 CYHS2500912 乙酰半胱氨酸颗粒 海南海神同洲制药有限公司 4 CYHS2500911 多种微量元素注射液(III) 合肥市未来药物开发有限公司 4 CYHS2500882 盐酸帕罗西汀片 深圳市新阳唯康科技有限公司 4 CYHS2500828 利丙双卡因乳膏 南京瑞捷医药科技有限公司 4 CYHS2500825 帕拉米韦氯化钠注射液 博智安健(河北)药业有限公司 4 CYHS2500809 聚乙烯醇滴眼液 石家庄四药有限公司 4 CYHS2500771 枸橼酸钠血滤置换液 石家庄四药有限公司 4 CYHS2500761 枸橼酸西地那非口腔崩解片 河南君善生物技术有限公司 4 CYHS2500746 盐酸艾司洛尔注射液 广东南国药业有限公司 4 CYHS2500698 瑞舒伐他汀依折麦布片(I) 齐鲁制药(海南)有限公司 4 CYHS2500652 乌帕替尼缓释片 华益泰康药业股份有限公司 4 CYHS2500617 奥氮平片 山东普瑞曼药业有限公司 4 CYHS2500575 甲苯磺酸艾多沙班片 江苏华阳制药有限公司 4 CYHS2500540 甲苯磺酸艾多沙班片 江苏华阳制药有限公司 4 CYHS2500539 达芦那韦片 江苏艾迪药业集团股份有限公司 4 CYHS2500397 硫酸特布他林雾化吸入用溶液 复星医药(徐州)有限公司 4 CYHS2500351 注射用磷酸特地唑胺 浙江尖峰药业有限公司 4 CYHS2500344 脂肪乳氨基酸(17)葡萄糖(19)注射液 石家庄四药有限公司 4 CYHS2500227 脂肪乳氨基酸(17)葡萄糖(19)注射液 石家庄四药有限公司 4 CYHS2500226 左卡尼汀口服溶液 浙江普洛康裕制药有限公司 4 CYHS2500128 左卡尼汀口服溶液 浙江普洛康裕制药有限公司 4 CYHS2500127 洛索洛芬钠凝胶膏 浙江昂利康制药股份有限公司 4 CYHS2500120 复方氨基酸注射液(18AA-IX) 四川太平洋药业有限责任公司 4 CYHS2500140 奥卡西平片 杭州和康药业有限公司 4 CYHS2500064 奥卡西平片 杭州和康药业有限公司 4 CYHS2500063 丁酸氢化可的松乳膏 江苏知原药业股份有限公司 4 CYHS2500053 瑞舒伐他汀依折麦布片(I) 常州制药厂有限公司 4 CYHS2500048 他达拉非片 浙江百代医药科技有限公司 4 CYHS2500021 他达拉非片 浙江百代医药科技有限公司 4 CYHS2500020 他达拉非片 浙江百代医药科技有限公司 4 CYHS2500019 噻托溴铵奥达特罗吸入喷雾剂 艾特美(苏州)医药科技有限公司 4 CYHS2404540 米拉贝隆缓释片 浙江普利药业有限公司 4 CYHS2404323 二甲双胍恩格列净片(I) 河北龙海药业股份有限公司 4 CYHS2404299 二甲双胍恩格列净片(V) 河北龙海药业股份有限公司 4 CYHS2404298 二甲双胍恩格列净片(VI) 河北龙海药业股份有限公司 4 CYHS2404297 莫匹罗星软膏 苏州天马医药集团天吉生物制药有限公司 4 CYHS2404251 达格列净片 上海现代制药股份有限公司 4 CYHS2404178 达格列净片 上海现代制药股份有限公司 4 CYHS2404177 富马酸伏诺拉生片 郑州韩都药业集团有限公司 4 CYHS2404143 富马酸伏诺拉生片 郑州韩都药业集团有限公司 4 CYHS2404141 卡左双多巴缓释片 海南慧通生物医药科技有限公司 4 CYHS2404120 利丙双卡因乳膏 唐山红星药业有限责任公司 4 CYHS2404019 沙格列汀二甲双胍缓释片 江苏永安制药有限公司 4 CYHS2403931 注射用两性霉素B脂质体 齐鲁制药(海南)有限公司 4 CYHS2403828 盐酸莫西沙星氯化钠注射液 重庆药谷制药有限公司 4 CYHS2403767 酒石酸长春瑞滨软胶囊 人福普克药业(武汉)有限公司 4 CYHS2403627 硝酸异山梨酯注射液 山东力诺制药有限公司 4 CYHS2403591 硝酸异山梨酯注射液 山东力诺制药有限公司 4 CYHS2403590 米库氯铵注射液 成都诺和晟鸿生物制药有限公司 4 CYHS2403580 米库氯铵注射液 成都诺和晟鸿生物制药有限公司 4 CYHS2403579 ω-3脂肪酸乙酯90软胶囊 瑞阳制药股份有限公司 4 CYHS2403545 小儿法罗培南钠颗粒 珠海前列药业有限公司 4 CYHS2403532 阿卡波糖片 上海现代制药股份有限公司 4 CYHS2403513 阿卡波糖片 上海现代制药股份有限公司 4 CYHS2403512 盐酸艾司洛尔注射液 山东力诺制药有限公司 4 CYHS2403395 布瑞哌唑片 江苏飞马药业有限公司 4 CYHS2403247 布瑞哌唑片 江苏飞马药业有限公司 4 CYHS2403246 布瑞哌唑片 江苏飞马药业有限公司 4 CYHS2403245 布瑞哌唑片 浙江普利药业有限公司 4 CYHS2403142 布瑞哌唑片 浙江普利药业有限公司 4 CYHS2403141 布瑞哌唑片 浙江普利药业有限公司 4 CYHS2403140 布瑞哌唑片 安徽泰恩康制药有限公司 4 CYHS2403075 布瑞哌唑片 安徽泰恩康制药有限公司 4 CYHS2403074 布瑞哌唑片 安徽泰恩康制药有限公司 4 CYHS2403073 注射用盐酸美法仑 吉斯美(武汉)制药有限公司 4 CYHS2402970 盐酸特比萘芬涂膜剂 江苏知原药业股份有限公司 4 CYHS2402788 注射用丁二磺酸腺苷蛋氨酸 北京金城泰尔制药有限公司 4 CYHS2402611 小儿法罗培南钠颗粒 河北智恒医药科技股份有限公司 4 CYHS2402441 噻托溴铵奥达特罗吸入喷雾剂 南昌谷森生物制药有限公司 4 CYHS2402337 注射用卡非佐米 昆山龙灯瑞迪制药有限公司 4 CYHS2301630 玛巴洛沙韦 东北制药集团股份有限公司 CYHS2560195 碳酸镧 珠海润都制药股份有限公司 CYHS2461139 苯磺酸氨氯地平 珠海润都制药股份有限公司 CYHS2461015 注射用甲钴胺 石药集团欧意药业有限公司 3 CYHL2600062 马沙骨化醇注射液 南京泽恒医药技术开发有限公司 3 CYHL2600061 奥美沙坦酯氨氯地平氢氯噻嗪片 安徽佳和药业有限公司 3 CYHL2600057 进口申请 药品名称 企业 注册分类 受理号 奥博雷通片 Takeda Pharmaceuticals U.S.A., Inc. 1 JXHS2600017 奥博雷通片 Takeda Pharmaceuticals U.S.A., Inc. 1 JXHS2600016 奥博雷通片 Takeda Pharmaceuticals U.S.A., Inc. 1 JXHS2600015 BMS-986458片 Bristol-Myers Squibb Company 1 JXHL2600180 BMS-986458片 Bristol-Myers Squibb Company 1 JXHL2600179 Enpatoran Merck Healthcare KGaA 1 JXHL2600178 ASP2138注射液 Astellas Pharma Global Development, Inc. 1 JXSL2600143 VAY736注射液 Novartis Pharma AG 1 JXSL2600115 中药相关申请 药品名称 企业 注册分类 受理号 归柴止痛颗粒 深圳市双百康医药科技有限公司 1.1 CXZL2600047 柴芪固溺丸 上海守正中医药研究有限公司 1.1 CXZL2600043 参芪温阳阴道膨胀栓 哈尔滨田美药业股份有限公司 2.3 CXZL2600044 麝香通心滴丸 内蒙古康恩贝药业有限公司 2.3 CXZL2600042 半夏白术天麻颗粒 四川光大制药有限公司 3.1 CXZS2500047 五味消毒饮颗粒 瑞阳制药股份有限公司 3.1 CXZS2400022 注：橙色字体部分结论为不批准或收到通知件；