Phase I Clinical Study to Evaluate the Pharmacokinetics, Pharmacokinetics, and Safety of Intravenous Administration of Methoxyethyl Etomidate Hydrochloride for Injection in Subjects With Mild, Moderate, and Normal Hepatic Dysfunction.

A Phase I clinical study to compare the pharmacokinetics, pharmacokinetics, and safety of intravenous administration of methoxyetomidate hydrochloride for injection in subjects with mild hepatic insufficiency (Child-pugh A), moderate hepatic insufficiency (Child-Pugh B), and normal hepatic function.Main OBJECTIVE: To evaluate the pharmacokinetic characteristics of metoetomidate hydrochloride for injection in subjects with mild liver dysfunction (Child-Pugh A), moderate liver dysfunction (Child-Pugh B) and normal liver function, and to provide evidence for the clinical application of metoetomidate hydrochloride in patients with liver dysfunction.Secondary objective: To evaluate the safety and pharmacokinetics of metoetomidate hydrochloride for injection in subjects with mild hepatic insufficiency (Child-Pugh A), moderate hepatic insufficiency (Child-Pugh B), and normal hepatic dysfunction.Exploratory objective: To investigate and analyze the relationship between the pharmacokinetic index (MOAA/S, BIS) and the pharmacokinetic parameters of metoetomidate hydrochloride in subjects with different liver function states in this study.The CYP2C19 genotype of the subjects in the study was analyzed, and the influence of gene polymorphism on pharmacokinetic parameters of metoetomidate hydrochloride was explored according to the data of CYP2C19 genotype.The relationship between in vivo exposure to methoxyetomidate hydrochloride and liver injury was analyzed.

开始日期2023-12-06

申办/合作机构

锦州奥鸿药业有限责任公司

CTR20232988 / CompletedN/A

双氯芬酸钠缓释片（0.1 g）随机、开放、四周期、两序列、完全重复交叉单次空腹/餐后状态下在健康受试者中的生物等效性研究

主要目的：空腹/餐后条件下考察受试制剂和参比制剂在健康男性与女性受试者中的生物等效性。次要目的：观察受试制剂与参比制剂在健康受试者中的安全性。

开始日期2023-10-18

申办/合作机构

锦州奥鸿药业有限责任公司

100 项与锦州奥鸿药业有限责任公司相关的临床结果

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0 项与锦州奥鸿药业有限责任公司相关的专利（医药）

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项与锦州奥鸿药业有限责任公司相关的文献（医药）

2023-03-01·Cancer Research

Abstract P4-01-21: Phase 2 Study of the CDK4/6 Inhibitor FCN-437c in Combination With Fulvestrant or Letrozole and Goserelin in Patients With HR+, HER2– Advanced Breast Cancer

作者: Zhang, Yongjiao ; Song, Yanqiu ; Liu, Yunjiang ; Huang, Tao ; Yin, Yongmei ; Shi, JiaJie ; Li, Wei ; Diao, Lei ; Liang, Yan ; Wang, Ying ; Gui, Xiujuan ; Tian, Ling ; Shi, Yehui ; Lv, Zheng ; Wang, Shui ; Yang, Yuchen ; Wu, Zhuli ; Ming, Jie ; Luo, Simin ; Zang, Aimin ; Yang, Yaping ; Tan, Jie ; Zeng, Xiaohua ; Kang, Lihua ; Hui, Ai-Min ; Zhang, Wenjing ; Wu, Jing ; Yang, Hua ; Tong, Zhongsheng

AbstractBackground: FCN-437c is a second-generation CDK4/6 inhibitor. Phase 1b clinical results indicated improved antitumor activity in patients (pts) with HR+, HER2– advanced breast cancer (ABC), treated with FCN-437c + letrozole.Methods: This Phase 2, multicenter, open-label clinical study evaluated the antitumor activity, pharmacokinetics (PK), and safety of FCN-437c + fulvestrant in post-menopausal pts (Cohort 1, treatment-naïve or 2L), FCN-437c + letrozole + goserelin in pre-menopausal pts (Cohort 2, treatment-naïve). Pts received FCN-437c (200 mg QD) in a 21-day-on and 7-day-off schedule either in combination with fulvestrant (500 mg D1) or letrozole (2.5 mg QD) + goserelin (3.6 mg once per cycle) in 28-day cycles. The primary endpoint was overall response rate (ORR) and secondary endpoints were progression-free survival (PFS), overall survival (OS), PK, and safety.Results: At study cutoff (Feb 7, 2022), 36 pts were enrolled in Cohort 1 and 31 pts were in Cohort 2; 42 (62.7%) pts had visceral metastases and 9 (13.4%) pts had bone-only metastases. In Cohort 1, 18 pts were treatment-naïve, 15 pts had received 1L treatment, and 3 pts had received ≥2L treatment. In Cohort 2, 25 pts were treatment-naïve and 6 pts had received 1L treatment. Overall, 27 pts in the per-protocol set achieved partial response (PR), resulting in an ORR of 40.9% (95% CI, 29.0-53.7). Median follow-up was 12.8 months, and median PFS (mPFS), OS, and DOR were not reached. However, at 12 months, the PFS rate was 67.7% (95% CI, 53.2-78.6) and the OS rate was 95.9% (95% CI, 84.5-99.0); the 6-month DOR rate was 96.0% (95% CI, 74.8-99.4). In Cohort 1 (n=35), 11 pts achieved PR: the ORR was 31.4% (16.9-49.3%) and mPFS was 12.9 months (95% CI, 9.2-NR); the 6-month DOR rate was 100%. In Cohort 2 (n=31), 16 pts achieved PR: the ORR was 51.6% (95% CI, 33.1-69.9%). mPFS, OS, and DOR were not reached; the 6-month DOR rate was 92.9% (95% CI, 59.08-98.96) (Table). Treatment-emergent adverse events (TEAEs) were observed in all pts. Majority of AE were G1 or 2 except for hematological TEAE. 58 (86.6%) pts reported grade ≥3 TEAEs, mainly neutropenia (74.6%), leukopenia (49.3%), hypertriglyceridemia (6.0%), lymphocyte count decrease (4.5%), and γ-glutamyltransferase increase (3.0%): most were reversed through dose interruption and symptomatic therapy. Steady-state PK parameters were analyzed after 15-21 days of QD administration: Cohort 1: median Tmax was 3 h, geomean T1/2 was 44.6 h, geomean Cmax was 1650.7 ng/mL, and geomean AUC0-24h was 29,148.08 h*ng/mL; the geomean accumulation ratios of AUC0-24h and RCmax were 2.18 and 1.74, respectively, compared with first dose. Cohort 2: median Tmax was 4 h, geomean T1/2 was 35.7 h, geomean Cmax was 1314.34 ng/mL, and geomean AUC0-24h was 22,889.96 h*ng/mL; the geomean accumulation ratios of AUC0-24h and RCmax were 1.95 and 1.63, respectively, compared with first dose.Conclusion: FCN-437c in combination with fulvestrant or letrozole + goserelin demonstrates antitumor activity and safety and is well tolerated in pts with HR+, HER2– ABC. This combination therapy will be further investigated in 2 ongoing Phase 3 trials (NCT05438810 and NCT05439499).Clinical trial number: NCT05004142. Research Sponsor: Avanc Pharmaceutical Co., LtdTable. Clinical outcomes for patients in the per-protocol set.Citation Format: JiaJie Shi, Wei Li, Zhongsheng Tong, Aimin Zang, Xiaohua Zeng, Shui Wang, Tao Huang, Ying Wang, Yanqiu Song, Lihua Kang, Zheng Lv, Yehui Shi, Hua Yang, Jing Wu, Yongmei Yin, Yan Liang, Jie Tan, Jie Ming, Yaping Yang, Simin Luo, Xiujuan Gui, Ai-Min Hui, Zhuli Wu, Ling Tian, Yuchen Yang, Lei Diao, Wenjing Zhang, Yongjiao Zhang, Yunjiang Liu. Phase 2 Study of the CDK4/6 Inhibitor FCN-437c in Combination With Fulvestrant or Letrozole and Goserelin in Patients With HR+, HER2– Advanced Breast Cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-01-21.

2022-06-01·Journal of Clinical Oncology

The CDK4/6 inhibitor FCN-437c plus letrozole for the treatment of HR+/HER2– advanced breast cancer: Updated results from a phase 1b study.

作者: Hu, Xichun ; Hui, Ai-Min ; Wu, Zhuli ; Li, Wei ; Zhang, Yushun ; Zhao, Han ; Wang, Ying ; Zhang, Jian ; Tian, Ling ; Huang, Tao ; Wang, Xian ; Zhang, Wenjing ; Yang, Yuchen ; Wang, Xiaojia ; Cheng, Ying

e13025 Background: FCN-437c is an oral potent and highly selective CDK4/6 inhibitor without the inhibition of CDK1, CDK2, or CDK5. In the phase 1a dose-escalation part of this study (NCT04488107), the safety profile of FCN-437c was acceptable in patients with ABC, and the maximum tolerated dose was determined to be 300 mg QD when used as monotherapy (presented at AACR 2021). Phase 1b aimed to explore the RP2D and to evaluate the tolerability and antitumor activity of FCN-437c combined with letrozole in patients with previously untreated HR+/HER2– ABC. Methods: Adult, post-menopausal female patients diagnosed with treatment-naive ER+/HER2– ABC were eligible for this expansion stage. Patients received FCN-437c once daily at 200 mg or 300 mg on a 21-day-on and 7-day-off schedule in combination with letrozole 2.5 mg once daily in 28-day cycles. The primary endpoints were safety and RP2D. Results: As of November 26, 2021, 29 patients were enrolled and had a median follow-up of 10.4 months. Of these patients, 25 (86.2%) were endocrine-sensitive and 4 (13.8%) were endocrine-resistant. Visceral disease was present in 21 patients (72.4%), and 1 (3.4%) patient had bone-only disease. DLTs of grade 4 neutropenia occurred in 2 patients (40.0%) in 300 mg dose group; they were considered intolerable. One out of the first 6 patients experienced DLTs in 200 mg dose group (grade 4 neutropenia, leukopenia, and thrombocytopenia); these were also considered to be FCN-437c-related SAEs. FCN-437c-related grade ≥3 TEAEs were observed in 26 (89.7%) patients, with neutropenia (n=24, 82.8%) and leukopenia (n=14, 48.3%) being most common. Among the 28 measurable patients, 16 patients had a PR, the ORR was 57.1% (95% CI 37.2–75.5); the CBR was 82.1% (95% CI 63.1–93.9) (Table). Median PFS, DOR, and OS were not reached. At 6 and 12 months, PFS rates were 92.3% and 83.5%, and DOR rates were 100% and 90%, respectively. A RP2D of 200 mg was suggested per safety considerations and preliminary antitumor activity. Conclusions: FCN-437c plus letrozole was well tolerated and demonstrated antitumor activity in patients with previously untreated HR+/HER2– ABC. FCN-437c in combination with NSAI as the first-line treatment for HR+/HER2– ABC will be further investigated in a phase 3 trial. Clinical trial information: NCT04488107. [Table: see text]

2022-04-01·Lung Cancer

A phase I study of FCN-411, a pan-HER inhibitor, in EGFR-mutated advanced NSCLC after progression on EGFR tyrosine kinase inhibitors

Article

作者: Pan, Hongming ; Wu, Zhuli ; Shan, Guoyong ; Ren, Xiubao ; Sun, Jiangtao ; Lin, Lin ; Luo, Xiaoyong ; Hu, Xingsheng ; Li, Xingya ; Zhao, Chengling ; Liu, Huilong ; Zhang, Yiping ; Hui, Ai-Min ; Wang, Mengzhao ; Shi, Yuankai ; Tian, Ling

BACKGROUNDThere are no approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) for EGFR-mutated non-small cell lung cancer (NSCLC) without EGFR T790M mutation after progression on first- or second-generation EGFR-TKIs.METHODSWe conducted this phase I, open-label, multicenter, dose-escalation/dose-expansion study to evaluate the safety, tolerability, antitumor activity, and pharmacokinetics of FCN-411, a TKI targeting EGFR, HER2, and HER4, in patients with EGFR-mutated advanced NSCLC whose disease had progressed during treatment of EGFR-TKIs. Adult patients with stage IIIB-IV NSCLC harboring EGFR mutations (exon 18/19/20/21) who had progressed on prior EGFR-TKIs were enrolled. In the dose-escalation phase, patients received 4 mg, 8 mg, 12 mg, and 16 mg FCN-411 once daily until the maximum tolerated dose (MTD). In the dose-expansion phase, patients received FCN-411 at the recommended phase II dose (RP2D) continuously in 21-day cycles. The primary endpoints were safety, tolerability, MTD, and RP2D.RESULTSFrom July 23, 2018 to September 29, 2020, 77 patients were enrolled, including 30 with EGFR T790M mutation in tumor tissues. The cut-off date was February 1, 2021. No dose-limiting toxicities were observed. The most common grade ≥ 3 treatment-emergent adverse events among all patients were diarrhea (8; 10.4%) and dermatitis acneiform (7; 9.1%). Ten of 67 evaluable patients achieved confirmed partial response, with an objective response rate (ORR) of 14.9% (95% confidence interval [CI], 8.3-24.0); the ORR was 33.3%, 14.0%, 0, and 25.0% at 4 mg, 8 mg, 12 mg, and 16 mg, respectively. Besides, the ORR in patients without and with EGFR T790M mutation was 20.5% and 7.4%, respectively. Moreover, 39 patients achieved stable disease across all doses, and the disease control rate was 73.1% (95% CI, 60.9-83.2). Median progression-free survival was 4.1 (95% CI, 2.9-5.3) months. Median duration of response and overall survival have not been reached.CONCLUSIONSFCN-411 was well tolerated and demonstrated preliminary antitumor activity in patients with EGFR-mutated NSCLC after progression on EGFR-TKIs, especially in those without EGFR T790M mutation. The RP2D was defined as 8 mg once daily. Future studies are warranted.TRIAL REGISTRATIONClinicalTrials.gov, NCT03420079.

项与锦州奥鸿药业有限责任公司相关的新闻（医药）

2024-10-27

·蒲公英Ouryao

“石家庄首届生物医药新质生产力交流会暨蒲公英第十四届（石家庄）年会”圆满落幕

2024年10月26-27日，“石家庄首届生物医药新质生产力交流会暨蒲公英第十四届（石家庄）年会”在石家庄富力洲际酒店举行。汇聚了来自全国各地的350家药企，618位制药行业精英、专家学者和制药同仁，20位院士、专家、制药高层分享，共同探讨制药行业的政策、技术及发展趋势。主论坛：领导致辞，振奋人心开幕致辞：李为军石家庄市人民政府副市长开幕致辞：臧克承国家药监局特药检查中心副主任主论坛：走进石家庄高新技术产业开发区报告嘉宾：丁飞燕石家庄高新区党工委委员管委会副主任丁飞燕副主任现场详细介绍了石家庄高新技术产业开发区的发展情况、招商政策、营商环境、未来发展等。主论坛：大咖分享，干货满满主论坛嘉宾围绕：2024中国制药现状、前沿技术、生物医药发展趋势、MAH制度热门话题展开分享。张金巍先生蒲公英创始人马大为院士中国科学院上海有机化学研究所、南方科技大学教授毕军先生深圳市市场监管局许可审查中心首席专家谭宏宇先生原 CFDI 骨干检查员吴军先生资深GMP专家左右滑动查看更多主论坛：辩论赛，激烈交锋 10月26日下午的“东富龙杯”辩论赛再次成为的年会亮点，辩论赛现场，氛围紧张而热烈。北京阳光诺和药物研究股份有限公司、石家庄以岭药业股份有限公司代表队就“仿制药和创新药，谁是中国制药的未来？”展开辩论。华北制药集团有限责任公司、石药控股集团有限公司代表队就“MAH制度的实施，促进还是限制了行业发展？”展开辩论。正大天晴药业集团南京顺欣制药有限公司、上海臻格生物技术有限公司代表队，就“带量采购，对行业发展利大于弊还是弊大于利？”展开辩论。六个代表队就三个辩题展开了智慧与口才的激烈交锋，辩论场上火花四溅，导师和评委的点评更是金句连连。现场观众也积极为心仪的赛队及辩手进行投票及举牌支持，将年会气氛推向了新的高潮。辩论赛不仅激发了参会者的思考，也为行业的发展提供了新的思路和方向。三大平行论坛：精彩分呈创新中药论坛带来了数智中药发展中药工业新质生产力实践与思考、智造转型构建中药行业新质生产力、中医医疗机构制剂向新药转化的政策-路径-经验分享、FDA植物药与创新中药发展、中药降本增效实施新策略等前沿热点技术话题。左右滑动查看更多前沿化学药论坛重点讨论了化学药精益生产管理在数字化时代的探索和实践、化学药降本增效实施新策略、PIC/S无菌药品附录的一些思考、化学制药,连续制造的前景展望、药品研发现状与研发质量管理体系构建。左右滑动查看更多生物药论坛重点关注热点新法规趋势下生物制品无菌保证策略与思考、基于风险的抗体药物现场检查、新冠变异株mRNA疫苗研发、监管环境趋严背景下的生物制药质量管理新视角、生物药从研发到商业化生产技术转移策略与常见问题。左右滑动查看更多 15位专家为我们奉上了专业知识和实践经验，收获满满。直击现场：走进园区现场花絮左右滑动查看更多欢迎晚宴彭华伟局长致辞石家庄高新区投资服务局杨奇峰先生致辞蒲公英联合创始人左右滑动查看更多石家庄首届生物医药新质生产力交流会暨蒲公英第十四届（石家庄）年会”圆满落幕！！！本次年会特别鸣谢：石家庄高新技术产业开发区管理委员会河北省医药行业协会锦州奥鸿药业有限责任公司安徽国正药业股份有限公司北京泰德制药股份有限公司河北博柯莱智能科技有限公司东莞中工通明光电科技有限公司倚世节能科技（上海）有限公司安徽省万生中药饮片有限公司中科圣杰（深圳）科技集团有限公司蒲公英生物医药孵化器无锡市灏源净化设备有限公司制药智能制造产业联盟口服固体制剂产业联盟生物制药国产化推进联合会上海申梵商务信息咨询有限公司本次年度盛会图片直播二维码：

高管变更带量采购

2024-07-31

·米内网

【市场】超10亿大品种，国药集团再下一城

精彩内容 7月31日，国药现代发布公告，其控股子公司国药一心制药收到国家药监局核准签发的《药品补充申请批准通知书》，批准醋酸奥曲肽注射液在已有品规1ml:0.1mg的基础上新增规格1ml:0.3mg并视同过评。同日，其全资子公司国药工业的硝苯地平缓释片（I）一致性评价补充申请获批过评。醋酸奥曲肽由诺华研发，临床主要用于控制手术治疗或放射治疗不能充分控制病情的肢端肥大症患者的症状、缓解与功能性胃肠胰腺（GEP）内分泌肿瘤有关的症状、预防胰腺手术后并发症、肝硬化患者胃-食管静脉曲张所致出血的紧急治疗等。 2023年中国公立医疗机构终端全身用激素类制剂（不含性激素和胰岛素)TOP5产品来源：米内网中国公立医疗机构药品终端竞争格局醋酸奥曲肽注射液在2023年中国城市公立医院、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）终端销售规模超过10亿元，是全身用激素类制剂（不含性激素和胰岛素)TOP4产品，诺华、国药一心制药、广东鼎信医药的市场份额位居前三。米内网数据显示，醋酸奥曲肽注射液有23家企业拥有生产批文，国药一心制药、成都圣诺生物制药、广东星昊药业等17家过评，锦州奥鸿药业的一致性评价补充申请在审。国药现代表示，国药一心的醋酸奥曲肽注射液新增药品规格并视同通过一致性评价，将有利于该产品未来的市场拓展和销售。 7月以来，国药现代捷报频传。公司发布2024年半年度业绩预告，预计净利润6.88亿~7.48亿元，同比增长99.42%~116.81%，创下新高；控股子公司国药一心制药的氟尿嘧啶注射液以仿制3类报产获批上市；控股孙公司汕头金石粉针剂成为注射用头孢他啶阿维巴坦钠（2.5g）上市许可持有人；公司的盐酸米那普仑片增加50mg规格；全资子公司国药集团威奇达药业的阿莫西林克拉维酸钾片过评；控股子公司上海现代哈森（商丘）药业的硫辛酸注射液获批增加24ml：0.6g规格并过评；控股子公司国药一心制药的醋酸奥曲肽注射液新增规格1ml:0.3mg并视同过评；全资子公司国药工业的硝苯地平缓释片（I）过评。据了解，国药现代定位为国药集团旗下统一的化学制药工业平台，聚焦“抗感染、心血管、麻醉及精神、代谢及内分泌、抗肿瘤及免疫调节、大健康”六大领域，以多轮驱动实现健康、稳定和高质量发展，致力于成为创新驱动型、中国领先、国际一流的制药企业，做有活力、有实力、有影响力的行业引领者。资料来源：米内网数据库、公司公告等注：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。如有疏漏，欢迎指正。本文为原创稿件，转载请注明来源和作者，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

一致性评价上市批准

2024-06-03

·信狐药迅

仿制药申请6个品规发通知件；临床申请品种均默示许可| 新获批（5.27-6.2）

每周药品注册获批数据，分门别类呈现，一目了然。(5.27-6.2）小编收到有些用户反应，不想收到咱们每周文章的推送提醒，而有些用户又特别需要这个提醒，在小编强烈要求下，我们给力的程序员终于实现了可以关闭提醒的功能，这个绝对全网独一家喔，不想收到提醒的，只要在信狐药迅对话框内回复关键词“拒收文章提醒”，那么就可以不受推送的打扰啦!新药上市申请药品名称企业注册分类受理号依沃西单抗注射液康方赛诺医药有限公司1CXSS2300061地舒单抗注射液山东博安生物技术股份有限公司3.3CXSS2300014精蛋白锌赖脯胰岛素混合注射液(50R)江苏万邦生化医药集团有限责任公司3.3CXSS2200071国;CXSS2200071人凝血酶原复合物深圳市卫光生物制品股份有限公司3.4CXSS2200091国;CXSS2200091新药临床申请药品名称企业注册分类受理号盐酸杰克替尼片苏州泽璟生物制药股份有限公司1CXHL2400298盐酸杰克替尼片苏州泽璟生物制药股份有限公司1CXHL2400297盐酸希美替尼片中国科学院上海药物研究所1CXHL2400288D-1553片益方生物科技(上海)股份有限公司1CXHL2400287ABP1618片上海爱博医药科技有限公司1CXHL2400285ABP1618片上海爱博医药科技有限公司1CXHL2400284FC084CSA片中山医诺维申新药研发有限公司1CXHL2400283FC084CSA片中山医诺维申新药研发有限公司1CXHL2400282替古索司他片信达生物制药(苏州)有限公司1CXHL2400278替古索司他片信达生物制药(苏州)有限公司1CXHL2400277替古索司他片信达生物制药(苏州)有限公司1CXHL2400276盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHL2400295盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHL2400294盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHL2400293吸入用盐酸溴己新溶液江苏正大清江制药有限公司3CYHL2400062吸入用盐酸溴己新溶液江苏正大清江制药有限公司3CYHL2400061酒石酸匹莫范色林胶囊江苏艾立康医药科技有限公司3CYHL2400060拉米地坦片江苏恩华药业股份有限公司3CYHL2400059拉米地坦片江苏恩华药业股份有限公司3CYHL2400058氟比洛芬凝胶贴膏浙江百代医药科技有限公司4CYHL2400057注射用重组酰化胰高血糖素样肽2类似物重庆派金生物科技有限公司1CXSL2400204注射用DB-1305映恩生物制药(苏州)有限公司1CXSL2400196DP303c注射液石药集团巨石生物制药有限公司1CXSL2400195DP303c注射液石药集团巨石生物制药有限公司1CXSL2400194贝伐珠单抗注射液百奥泰生物制药股份有限公司2.2CXSL2400202贝伐珠单抗注射液百奥泰生物制药股份有限公司2.2CXSL2400201仿制药申请药品名称企业注册分类受理号阿瑞匹坦注射液江苏康禾生物制药有限公司3CYHS2302273盐酸丙美卡因滴眼液合肥立方制药股份有限公司3CYHS2301650注射用拉氧头孢钠江苏江丰医药科技有限公司3CYHS2300871左氧氟沙星注射液河北天成药业股份有限公司3CYHS2300402左氧氟沙星注射液河北天成药业股份有限公司3CYHS2300401注射用青霉素钠成都天之翼尚品医药科技有限公司3CYHS2300019国;CYHS2300019注射用青霉素钠成都天之翼尚品医药科技有限公司3CYHS2300018国;CYHS2300018注射用青霉素钠成都天之翼尚品医药科技有限公司3CYHS2300017国;CYHS2300017左氧氟沙星注射液国仁健康制药(北京)有限公司3CYHS2202080国;CYHS2202080醋酸维持液南京恩泰医药科技有限公司3CYHS2201921国;CYHS2201921醋酸维持液南京恩泰医药科技有限公司3CYHS2201920国;CYHS2201920地氯雷他定口服溶液锦州奥鸿药业有限责任公司3CYHS2201876盐酸氨溴索滴剂北京民康百草医药科技有限公司3CYHS2201643国;CYHS2201643阿立哌唑口服溶液沈阳天邦药业有限公司3CYHS2201311国;CYHS2201311铝碳酸镁混悬液浙江寰领医药科技有限公司3CYHS2201322国;CYHS2201322奥硝唑片福安药业集团烟台只楚药业有限公司3CYHS2201100国;CYHS2201100多种微量元素注射液(I)洋浦京泰药业有限公司3CYHS2200906国;CYHS2200906阿立哌唑口腔崩解片瑞阳制药股份有限公司3CYHS2200439国;CYHS2200439吸入用布地奈德混悬液艾特美(苏州)医药科技有限公司4CYHS2302443氧武汉润桦辉氧气气瓶检验有限责任公司4CYHS2301933普拉洛芬滴眼液广东华南药业集团有限公司4CYHS2300908多索茶碱注射液山东鲁抗医药集团赛特有限责任公司4CYHS2300616硝酸异山梨酯注射液山东新时代药业有限公司4CYHS2300442马昔腾坦片上海上药睿尔药品有限公司4CYHS2300472乙酰半胱氨酸颗粒河北龙海药业有限公司4CYHS2300348骨化三醇软胶囊四川科伦药业股份有限公司4CYHS2300302乙酰半胱氨酸颗粒四川海梦智森生物制药有限公司4CYHS2300251乙酰半胱氨酸颗粒四川海梦智森生物制药有限公司4CYHS2300250拉考沙胺注射液舒美奇成都生物科技有限公司4CYHS2300206拉考沙胺注射液舒美奇成都生物科技有限公司4CYHS2300205盐酸多柔比星脂质体注射液齐鲁制药(海南)有限公司4CYHS2300202盐酸多柔比星脂质体注射液齐鲁制药(海南)有限公司4CYHS2300201他达拉非片江西施美药业股份有限公司4CYHS2300217他达拉非片江西施美药业股份有限公司4CYHS2300216他达拉非片江西施美药业股份有限公司4CYHS2300215他克莫司颗粒杭州中美华东制药有限公司4CYHS2300146他达拉非片浙江康恩贝制药股份有限公司4CYHS2300061依折麦布片山东丹红制药有限公司4CYHS2300031国;CYHS2300031吡仑帕奈片江苏康缘药业股份有限公司4CYHS2202172国;CYHS2202172吡仑帕奈片江苏康缘药业股份有限公司4CYHS2202171国;CYHS2202171硫酸羟氯喹片苏州长征-欣凯制药有限公司4CYHS2202067国;CYHS2202067恩他卡朋片福建省宝诺医药研发有限公司4CYHS2202051国;CYHS2202051磷酸特地唑胺片齐鲁制药(海南)有限公司4CYHS2202036国;CYHS2202036间苯三酚注射液亚宝药业集团股份有限公司4CYHS2202024国;CYHS2202024他达拉非片好医生药业集团有限公司4CYHS2202010国;CYHS2202010卡贝缩宫素注射液海南中和药业股份有限公司4CYHS2201993国;CYHS2201993非布司他片涿州东乐制药有限公司4CYHS2201938国;CYHS2201938孟鲁司特钠颗粒山东华铂凯盛生物科技有限公司4CYHS2201928国;CYHS2201928甲磺酸雷沙吉兰片浙江华海药业股份有限公司4CYHS2201914国;CYHS2201914马来酸茚达特罗吸入粉雾剂健康元药业集团股份有限公司4CYHS2201835国;CYHS2201835注射用唑来膦酸浓溶液山东新时代药业有限公司4CYHS2201794国;CYHS2201794盐酸昂丹司琼注射液石家庄四药有限公司4CYHS2201678国;CYHS2201678盐酸昂丹司琼注射液石家庄四药有限公司4CYHS2201677国;CYHS2201677盐酸奥洛他定滴眼液艾尔健康眼药(辽宁)有限公司4CYHS2201628国;CYHS2201628醋酸加尼瑞克注射液深圳翰宇药业股份有限公司4CYHS2201612国;CYHS2201612酒石酸溴莫尼定滴眼液艾尔健康眼药(辽宁)有限公司4CYHS2201598国;CYHS2201598甲钴胺片浙江京新药业股份有限公司4CYHS2201586国;CYHS2201586西格列汀二甲双胍片(II)惠升生物制药股份有限公司4CYHS2201496国;CYHS2201496西格列汀二甲双胍片(I)惠升生物制药股份有限公司4CYHS2201495国;CYHS2201495注射用氯诺昔康知和(山东)大药厂有限公司4CYHS2201438国;CYHS2201438枸橼酸坦度螺酮片江苏百奥信康医药科技有限公司4CYHS2201415国;CYHS2201415熊去氧胆酸胶囊绍兴来多科技有限公司4CYHS2201412国;CYHS2201412盐酸莫西沙星滴眼液广州仁恒医药科技股份有限公司4CYHS2201299国;CYHS2201299注射用哌拉西林钠他唑巴坦钠福安药业集团庆余堂制药有限公司4CYHS2201229国;CYHS2201229注射用哌拉西林钠他唑巴坦钠福安药业集团庆余堂制药有限公司4CYHS2201228国;CYHS2201228注射用哌拉西林钠他唑巴坦钠福安药业集团庆余堂制药有限公司4CYHS2201226国;CYHS2201226头孢地尼胶囊海南日中天制药有限公司4CYHS2201279国;CYHS2201279酒石酸美托洛尔片翎耀生物科技(上海)有限公司4CYHS2201191国;CYHS2201191酒石酸美托洛尔片翎耀生物科技(上海)有限公司4CYHS2201190国;CYHS2201190碳酸镧咀嚼片仁合益康集团有限公司4CYHS2201134国;CYHS2201134碳酸镧咀嚼片仁合益康集团有限公司4CYHS2201133国;CYHS2201133盐酸达泊西汀片瑞阳制药股份有限公司4CYHS2201132国;CYHS2201132盐酸达泊西汀片瑞阳制药股份有限公司4CYHS2201131国;CYHS2201131吡仑帕奈片西安远大科创医药科技有限公司4CYHS2201092吡仑帕奈片西安远大科创医药科技有限公司4CYHS2201091头孢克洛干混悬剂苏州第三制药厂有限责任公司4CYHS2200891国;CYHS2200891缬沙坦氨氯地平片(Ⅰ)宁波科尔康美诺华药业有限公司4CYHS2200835国;CYHS2200835钆贝葡胺注射液上海司太立制药有限公司4CYHS2200367国;CYHS2200367丙酸氟替卡松雾化吸入用混悬液上海方予健康医药科技有限公司4CYHS2200372国;CYHS2200372甲钴胺片北京春风药业有限公司4CYHS2102249国;CYHS2102249进口申请药品名称企业注册分类受理号盐酸替洛利生片Bioprojet Pharma5.1JXHS2300058盐酸替洛利生片Bioprojet Pharma5.1JXHS2300057醋酸氟氢可的松片ASPEN PHARMA TRADING LIMITED5.1JXHS2300033依西美坦片Cipla Ltd.5.2JYHS2200048国;JYHS2200048达格列净片M/s Cipla Ltd.5.2JYHS2101019国;JYHS2101019Balcinrenone达格列净胶囊AstraZeneca AB1JXHL2400064Balcinrenone达格列净胶囊AstraZeneca AB1JXHL2400063TAR-210Janssen Research & Development, LLC2.2;2.4JXHL2400065呼吸道合胞病毒减毒活疫苗Sanofi Pasteur Inc.1.1JXSL2400058MK-7240注射用浓溶液Merck Sharp & Dohme LLC1JXSL2400063MK-7240注射液Merck Sharp & Dohme LLC1JXSL2400062BudigalimabAbbVie Inc.1JXSL2400061中药相关申请药品名称企业注册分类受理号柴桂解感颗粒山东中医药大学1.1CXZL2400016温肺定喘颗粒山东康众宏医药科技开发有限公司1.1CXZL2400015注：橙色字体部分结论为不批准或收到通知件；

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