作者: Gonçalves, Elaine C D ; Rodrigues, Mariana ; Marcolino, Alexandre M ; Dutra, Rafael C ; Barbosa, Rafael I ; Santos, Adair R S ; Neves, Lais M S ; Kuriki, Heloyse U

BACKGROUND:

The present study investigated the effects of pulsed and continuous ultrasound (USP and USC) in edema and hyperalgesia after chronic inflammatory process induced by Complete Freund's Adjuvant-CFA and analyzing the relationship of the application frequency of ultrasound, in pro- and anti-inflammatory cytokine production.

METHODS:

Forty-five animals were divided into 9 groups; all animals from groups 2 to 9 were subjected to a persistent inflammation model induced by CFA in mice. We report the effects and the underlying action mechanisms of USP and USC in the animals which were irradiated two, three or five times a week on the left hind paw. The analyses performed in this study were: evaluation of hind paw edema through the plethysmometer, evaluation of thermal hyperalgesia through withdrawal test using a water container at 44.5°C (± 0.5°C), and the plantar region of the left paw which was removed for analysis of cytokines.

RESULTS:

Our results showed that USP and USC consistently reduced paw edema, and pulsed ultrasound showed a higher significant effect than the continuous mode. Moreover, groups with irradiation frequency of five times a week presented an inhibition of the edema, and groups with frequency of three or two times a week reduced mainly hyperalgesia, in comparison with the control group. The beneficial effects of the US then seem to be associated with upregulation of anti- and pro-inflammatory mediators, such as IL-10 and IL-6, respectively.

CONCLUSION:

This study provided evidence that ultrasound constitutes an important non-pharmacological intervention for the management of inflammatory and pain states.

2023-08-22·Veterinary sciences

Equine Placentitis in Mares Induces the Secretion of Pro-Inflammatory Cytokine eIL-1β and the Active Extracellular Matrix Metalloproteinase (MMP)-9.

Article

作者: Acuña-González, Ricardo Josué ; Meza-Serrano, Europa ; Morales-Vázquez, María Margarita ; Alonso-Morales, Rogelio ; López-Canales, Jorge Skiold ; Hayen-Valles, Sergio ; Lara-Pereyra, Irlando ; Zarco, Luis ; Boeta, Ana Myriam ; Flores-Herrera, Héctor ; Lozano-Cuenca, Jair

Equine placentitis is characterized by infection and inflammation of the placenta. Different biomarkers associated with this inflammatory response have been evaluated in experimentally induced equine placentitis, but not in pregnant mares with spontaneous placentitis. The aim of the current study was to determine the concentration of eIL-1β and the activity of proMMP-2 and proMMP-9 in the serum of healthy mares and mares with placentitis on days 240 and 320 of gestation to explore whether these biomarkers are associated with equine maternal placentitis and/or with the birth of an infected or inviable foals. Serum samples were collected from sixteen pregnant English Thoroughbred mares, retrospectively classified as follows: (1) healthy mares with full-term gestation; and (2) mares with ultrasonographic signs of placentitis. The health of each foal was examined at birth, and it was decided to classify the cases into four groups: (1) healthy mares delivering a healthy foals (HM-HF, n = 6); (2) mares with USP delivering a healthy foal (USP-HF, n = 3); (3) mares with USP delivering a live septic foal (USP-LSeF, n = 4); and (4) mares with USP delivering a dead foal (USP-DF, n = 3). eIL-1β was quantified by ELISA, and proMMP-2 and proMMP-9 activity by gelatin zymography electrophoresis. In healthy mares, the serum concentrations of eIL-1β underwent a significant 16.5-fold increase from day 240 to day 320 of gestation. Although similar results were found in the mares with ultrasonographic signs of placentitis that delivered a healthy foal, those delivering a live septic or nonviable foal exhibited much higher concentrations of eIL-1β. proMMP-2 and proMMP-9 activity was not associated with maternal placentitis, foal infection, or death. Hence, the presence of placentitis severe enough to affect the health of the foal can be confirmed or discarded by determining the eIL-1β concentration in mares that have shown ultrasonographic signs of placentitis.

2023-08-15·International journal of biological macromolecules

Pectin from sunflower by-products obtained by ultrasound: Chemical characterization and in vivo evaluation of properties in inflammatory bowel disease.

Article

作者: Sánchez-Milla, María ; Molina-Tijeras, Jose Alberto ; Villamiel, Mar ; Montilla, Antonia ; Vezza, Teresa ; Muñoz-Almagro, Nerea ; Rico-Rodríguez, Fabián

Inflammatory bowel disease (IBD) is a public health challenge and the use of pectin for symptom amelioration is a promising option. In this work, sunflower pectin has been extracted without (CHP) and with assistance of ultrasound (USP) using sodium citrate as a food-grade extracting agent. At optimal conditions (64 °C, 23 min) the highest yield was obtained with ultrasound application (15.5 vs. 8.1 %). Both pectins were structurally characterized by ¹H NMR, HPSEC-ELSD, FT-IR and GC-FID. Unlike CHP, USP showed a lower molecular weight, higher galacturonic acid, lower degree of methyl-esterification and, overall, higher viscosity. These characteristics could affect the anti-inflammatory activity of pectins, evaluated using DSS-induced IBD model mice. So, USP promoted the defence (ICAM-1) and repair of the gastrointestinal mucosa (TFF3, ZO-1) more effectively than CHP. These results demonstrate the potential amelioration of acute colitis in IBD mice through USP supplementation. Taking into account the biomarkers analysed, these results demonstrate, for the first time, the positive impact of sunflower pectin extracted by ultrasound under very soft conditions on inflammatory bowel disease that might open up new possibilities in the treatment of this serious pathology.

项与磷酸二氢钾/磷酸氢二钾相关的新闻（医药）

2024-07-29

·Business Wire

Amneal Receives U.S. FDA Approval for Potassium Phosphates Injection IV Bags

BRIDGEWATER, N.J.--( BUSINESS WIRE )--Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has received New Drug Application (“NDA”) approval from the U.S. Food and Drug Administration (FDA) for its new presentation of potassium phosphates in 0.9% sodium chloride injection intravenous (IV) ready-to-use (RTU) bags. This sterile presentation reduces the compounding steps for clinicians typically required with administering the product. Potassium Phosphates in Sodium Chloride Injection is a phosphorus replacement product indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient or contraindicated. The product is available as a single-dose infusion bag and is formulated without preservatives. It is natural rubber latex-free and can be stored at room temperature. In 2024, Amneal has already launched PEMRYDI RTU ® , a ready-to-use formulation of pemetrexed, and FOCINVEZ ® , a ready-to-use version of fosaprepitant. Both products offer hospitals and oncology clinics new, value-added presentations that should improve pharmacy efficiency by eliminating preparation steps. The expected third quarter launch of potassium phosphates injection IV bag represents the Company’s third 505(b)(2) launch this year. “We are pleased to offer this new differentiated injectable product to hospitals,” said Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics. “This new IV parenteral infusion bag is preservative-free and can be stored at room temperature. With the addition of new 505(b)(2) injectables, we are meaningfully expanding our injectables portfolio.” "Our third 505(b)(2) injectable product approval this year reflects our deep capabilities in developing new and impactful complex products. We look forward to bringing more innovative 505(b)(2) injectable products to market over the coming years," said Dr. Srinivas Kone, Senior Vice President, Chief Scientific Officer – Generics. Adverse effects reported for the potassium phosphates injection IV bags include hyperkalemia, hyperphosphatemia, hypocalcemia and hypomagnesemia. For full prescribing information, see package insert located here . About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com . Cautionary Statement on Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company. Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the impact of a prolonged business interruption within our supply chain; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents; our ability to attract, hire and retain highly skilled personnel; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of claims brought against us by third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties, including recent events affecting the financial services industry; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our class A common stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

上市批准

2024-07-22

·信狐药迅

正大天晴乳腺癌1类新药库莫西利和重庆精准生物CD19 CAR-T疗法普基仑赛提交上市申请 |新受理（7.15-7.21）

本周药品注册受理数据，分门别类呈现，一目了然。(7.15-7.21）新药上市申请药品名称企业注册分类受理号库莫西利胶囊正大天晴药业集团股份有限公司1CXHS2400056库莫西利胶囊正大天晴药业集团股份有限公司1CXHS2400055布瑞哌唑口溶膜齐鲁制药有限公司2.2CXHS2400059布瑞哌唑口溶膜齐鲁制药有限公司2.2CXHS2400058布瑞哌唑口溶膜齐鲁制药有限公司2.2CXHS2400057甲磺酸阿美替尼片江苏豪森药业集团有限公司2.4CXHS2400060氟维司群注射液正大天晴药业集团股份有限公司2.4CXHS2400054普基仑赛注射液重庆精准生物技术有限公司1CXSS2400076普基仑赛注射液重庆精准生物技术有限公司1CXSS2400075特瑞普利单抗注射液上海君实生物医药科技股份有限公司2.2CXSS2400069特瑞普利单抗注射液上海君实生物医药科技股份有限公司2.2CXSS2400070注射用重组人透明质酸酶上海宝济药业股份有限公司2.4CXSS2400067 新药临床申请药品名称企业注册分类受理号GD-N1801外用溶液四川好医生攀西药业有限责任公司1CXHL2400740GD-N1801外用溶液四川好医生攀西药业有限责任公司1CXHL2400739BGB-26808片百济神州(苏州)生物科技有限公司1CXHL2400738BGB-26808片百济神州(苏州)生物科技有限公司1CXHL2400737BGB-26808片百济神州(苏州)生物科技有限公司1CXHL2400736富马酸奥比特嗪肠溶微丸胶囊深圳市真兴医药技术有限公司1CXHL2400735HY-1608注射液北京君科华元医药科技有限公司1CXHL2400734XS-04片江苏星盛新辉医药有限公司1CXHL2400727XS-04片江苏星盛新辉医药有限公司1CXHL2400726XS-04片江苏星盛新辉医药有限公司1CXHL2400725SY-009胶囊苏州亚宝药物研发有限公司1CXHL2400733RNK08954片珃诺生物医药科技(杭州)有限公司1CXHL2400724RNK08954片珃诺生物医药科技(杭州)有限公司1CXHL2400723注射用CG009301上海睿跃生物科技有限公司1CXHL2400722RX108-A片苏州润新生物科技有限公司1CXHL2400721注射用QD202上海魁特迪生物科技有限公司1CXHL2400720H021片江苏柯菲平医药股份有限公司1CXHL2400718AST2303片上海艾力斯医药科技股份有限公司1CXHL2400715AST2303片上海艾力斯医药科技股份有限公司1CXHL2400714GD-19乳状注射液天津谷堆生物医药科技有限公司1CXHL2400711JC242片北京佳诚生物医药科技开发有限公司2.1CXHL2400719盐酸氨溴索口溶膜合肥华方医药科技有限公司2.2CXHL2400717盐酸氨溴索口溶膜合肥华方医药科技有限公司2.2CXHL2400716司美格鲁肽注射液江苏诺泰澳赛诺生物制药股份有限公司2.2CXHL2400713司美格鲁肽注射液江苏诺泰澳赛诺生物制药股份有限公司2.2CXHL2400712GEN-725片河南真实生物科技有限公司2.4CXHL2400732GEN-725片河南真实生物科技有限公司2.4CXHL2400731阿奇霉素滴眼液浙江莎普爱思药业股份有限公司3CYHL2400151枸橼酸苯海拉明布洛芬片合肥恩瑞特药业有限公司3CYHL2400152盐酸卡利拉嗪胶囊浙江华海药业股份有限公司3CYHL2400150盐酸卡利拉嗪胶囊浙江华海药业股份有限公司3CYHL2400149盐酸卡利拉嗪胶囊浙江华海药业股份有限公司3CYHL2400148IDT-003凝胶南京毓浠医药技术有限公司2.2;2.3;2.4CXHL2400730IDT-003凝胶南京毓浠医药技术有限公司2.2;2.3;2.4CXHL2400729IDT-003凝胶南京毓浠医药技术有限公司2.2;2.3;2.4CXHL2400728重组带状疱疹疫苗(CHO细胞)广州派诺生物技术有限公司1.2CXSL2400467重组带状疱疹疫苗(CHO细胞)广州派诺生物技术有限公司1.2CXSL2400466四价流感病毒裂解疫苗(MDCK细胞)深圳康泰生物制品股份有限公司2.2CXSL2400449QL1706注射液齐鲁制药有限公司1CXSL2400472注射用XTL6001上海西泰利生物医药科技有限公司1CXSL2400471RGB-5088胰岛细胞注射液杭州瑞普晨创科技有限公司1CXSL2400465靶向HPV16-E6/E7抗原自体免疫T细胞注射液武汉华大吉诺因生物科技有限公司1CXSL2400469NGGT007注射液苏州诺洁贝生物技术有限公司1CXSL2400468IM96嵌合抗原受体T细胞注射液(IM96 CAR-T细胞注射液)北京艺妙医疗科技有限公司1CXSL2400463TQB2252注射液正大天晴(广州)医药有限公司1CXSL2400462IVB103注射液北京诺惟生物医药科技有限公司1CXSL2400464注射用BGB-C354广州百济神州生物制药有限公司1CXSL2400461RGL-193注射液上海瑞宏迪医药有限公司1CXSL2400459RM-101注射液广州瑞风生物科技有限公司1CXSL2400458MBS314 注射液(SC)康源博创生物科技(北京)有限公司1CXSL2400457注射用LBL-024南京维立志博生物科技有限公司1CXSL2400456GNC-077多特异性抗体注射液成都百利多特生物药业有限责任公司1CXSL2400460YT001注射液上海原天生物科技有限公司1CXSL2400453AK137注射液中山康方生物医药有限公司1CXSL2400452注射用HY07121四川汇宇海玥医药科技有限公司1CXSL2400451泽贝妥单抗注射液浙江博锐生物制药有限公司2.2CXSL2400455泽贝妥单抗注射液浙江博锐生物制药有限公司2.2CXSL2400454纳基奥仑赛注射液广东合源生物医药有限公司2.2CXSL2400450人抗凝血酶III四川远大蜀阳药业有限责任公司3.2CXSL2400470 仿制药申请药品名称企业注册分类受理号硝酸甘油注射液成都瑞尔医药科技有限公司3CYHS2402294硝酸甘油注射液成都瑞尔医药科技有限公司3CYHS2402293醋酸钙口服溶液沈阳欣瑞制药有限公司3CYHS2402291对乙酰氨基酚片江苏贝佳制药有限公司3CYHS2402290丁酸氯维地平注射用乳剂上海上药第一生化药业有限公司3CYHS2402285丁酸氯维地平注射用乳剂上海上药第一生化药业有限公司3CYHS2402284氨磺必利口服溶液江苏长泰药业股份有限公司3CYHS2402279硫酸镁注射液焦作市民康药业有限公司3CYHS2402265恩那度司他片深圳信立泰药业股份有限公司3CYHS2402262恩那度司他片深圳信立泰药业股份有限公司3CYHS2402261恩那度司他片深圳信立泰药业股份有限公司3CYHS2402260盐酸布比卡因注射液广州合和医药有限公司3CYHS2402267盐酸布比卡因注射液广州合和医药有限公司3CYHS2402266复合磷酸氢钾注射液广东健信制药股份有限公司3CYHS2402263氨氯地平贝那普利胶囊江西施美药业股份有限公司3CYHS2402277氨溴特罗口服溶液翎耀生物科技(上海)有限公司3CYHS2402269盐酸普萘洛尔注射液苏州朗科生物技术股份有限公司3CYHS2402217二羟丙茶碱注射液苏州朗科生物技术股份有限公司3CYHS2402216盐酸纳洛酮注射液浙江华海药业股份有限公司3CYHS2402214注射用哌拉西林钠武汉恒泰医药科技有限公司3CYHS2402242注射用哌拉西林钠武汉恒泰医药科技有限公司3CYHS2402241布瑞哌唑口腔崩解片齐鲁制药有限公司3CYHS2402236布瑞哌唑口腔崩解片齐鲁制药有限公司3CYHS2402235布瑞哌唑口腔崩解片齐鲁制药有限公司3CYHS2402234布美他尼注射液广东健信制药股份有限公司3CYHS2402233布美他尼注射液苏州朗科生物技术股份有限公司3CYHS2402232布美他尼注射液苏州朗科生物技术股份有限公司3CYHS2402231注射用硫酸多黏菌素B合肥亿帆生物制药有限公司3CYHS2402222钠钾镁钙注射用浓溶液江苏正大丰海制药有限公司3CYHS2402252卡络磺钠注射液海南卓科制药有限公司3CYHS2402251卡络磺钠注射液海南卓科制药有限公司3CYHS2402250盐酸异丙嗪注射液汇禹远和(海南)药业有限公司3CYHS2402247盐酸异丙嗪注射液汇禹远和(海南)药业有限公司3CYHS2402246氨磺必利注射液南京恩泰医药科技有限公司3CYHS2402245氨磺必利注射液南京恩泰医药科技有限公司3CYHS2402244维生素B12注射液海南爱科制药有限公司3CYHS2402212硫酸沙丁胺醇注射液广州大光制药有限公司3CYHS2402211布美他尼注射液苏州特瑞药业股份有限公司3CYHS2402210布美他尼注射液苏州特瑞药业股份有限公司3CYHS2402209地高辛注射液湖北午时医药研究院有限公司3CYHS2402187熊去氧胆酸片南京海纳制药有限公司3CYHS2402186阿仑膦酸钠口服溶液长春澜江医药科技有限公司3CYHS2402178氯化钾颗粒湖北唯森制药有限公司3CYHS2402200复方醋酸钠林格注射液西安京西双鹤药业有限公司3CYHS2402197复方醋酸钠林格注射液西安京西双鹤药业有限公司3CYHS2402196法莫替丁注射液江西和盈药业有限公司3CYHS2402194氯甲西泮注射液江苏华泰晨光药业有限公司3CYHS2402193叶酸片南京泽恒医药技术开发有限公司3CYHS2402192门冬氨酸钾注射液海韬新药研发(江苏)有限公司3CYHS2402191妥布霉素滴眼液扬州中宝药业股份有限公司4CYHS2402292盐酸尼卡地平注射液西藏诺泽生物医药有限公司4CYHS2402289氧(液态)侨源气体(眉山)有限公司4CYHS2402288美阿沙坦钾片华益药业科技(安徽)有限公司4CYHS2402287美阿沙坦钾片华益药业科技(安徽)有限公司4CYHS2402286盐酸尼卡地平注射液成都瑞尔医药科技有限公司4CYHS2402283西甲硅油乳剂青岛格恩制药有限公司4CYHS2402282他达拉非片广东彼迪药业有限公司4CYHS2402281他达拉非片广东彼迪药业有限公司4CYHS2402280注射用醋酸西曲瑞克南京海融制药有限公司4CYHS2402278酒石酸西尼必利片浙江远力健药业有限责任公司4CYHS2402264非那雄胺片山东鲁抗医药集团赛特有限责任公司4CYHS2402276非那雄胺片山东鲁抗医药集团赛特有限责任公司4CYHS2402275熊去氧胆酸胶囊山西同达药业有限公司4CYHS2402274注射用阿扎胞苷贵州益佰制药股份有限公司4CYHS2402273布瑞哌唑片南京正科医药股份有限公司4CYHS2402272布瑞哌唑片南京正科医药股份有限公司4CYHS2402271布瑞哌唑片南京正科医药股份有限公司4CYHS2402270吸入用布地奈德混悬液立生医药(苏州)有限公司4CYHS2402268二甲硅油乳剂浙江众延医药科技有限公司4CYHS2402219头孢地尼胶囊浙江普洛康裕制药有限公司4CYHS2402218洛索洛芬钠凝胶贴膏海南赛立克药业有限公司4CYHS2402215盐酸尼卡地平注射液济南良福精合医药科技有限公司4CYHS2402213甲氨蝶呤注射液成都瑞尔医药科技有限公司4CYHS2402243沙库巴曲缬沙坦钠片江西泰吉立生物医药科技有限公司4CYHS2402240盐酸左西替利嗪片四川依科制药有限公司4CYHS2402227磷/碳酸氢钠血滤置换液上海峰林生物科技有限公司4CYHS2402226双氯芬酸二乙胺乳胶剂浙江普利药业有限公司4CYHS2402225双氯芬酸二乙胺乳胶剂浙江普利药业有限公司4CYHS2402224间苯三酚口服冻干片南京艾德凯腾生物医药有限责任公司4CYHS2402223二甲硅油乳剂浙江众延医药科技有限公司4CYHS2402221缬沙坦氨氯地平片(I)合肥国高药业有限公司4CYHS2402220盐酸莫西沙星滴眼液浙江和泽医药科技股份有限公司4CYHS2402258盐酸莫西沙星滴眼液浙江和泽医药科技股份有限公司4CYHS2402256注射用利福平北京品尚品医药科技有限公司4CYHS2402253注射用盐酸伊达比星吉斯美(武汉)制药有限公司4CYHS2402249艾曲泊帕乙醇胺片浙江三生蔓迪药业有限公司4CYHS2402248布瑞哌唑片齐鲁制药有限公司4CYHS2402239布瑞哌唑片齐鲁制药有限公司4CYHS2402238布瑞哌唑片齐鲁制药有限公司4CYHS2402237布瑞哌唑片成都苑东生物制药股份有限公司4CYHS2402230布瑞哌唑片成都苑东生物制药股份有限公司4CYHS2402229布瑞哌唑片成都苑东生物制药股份有限公司4CYHS2402228布瑞哌唑片哈尔滨三联药业股份有限公司4CYHS2402259布瑞哌唑片哈尔滨三联药业股份有限公司4CYHS2402257非布司他片宁波美诺华天康药业有限公司4CYHS2402255非布司他片宁波美诺华天康药业有限公司4CYHS2402254盐酸艾司洛尔注射液浙江创新生物有限公司4CYHS2402208恩格列净片湖南千金湘江药业股份有限公司4CYHS2402207恩格列净片湖南千金湘江药业股份有限公司4CYHS2402206匹维溴铵片上海雅培制药有限公司4CYHS2402205盐酸达泊西汀片湖南及正医药科技有限公司4CYHS2402204盐酸达泊西汀片湖南及正医药科技有限公司4CYHS2402203甲硝唑凝胶湖南状元制药有限公司4CYHS2402202利那洛肽胶囊四川国为制药有限公司4CYHS2402190多巴丝肼片呋欧医药科技(湖州)有限公司4CYHS2402189氟伐他汀钠缓释片南通联亚药业股份有限公司4CYHS2402188多巴丝肼片安徽万邦医药科技股份有限公司4CYHS2402185厄贝沙坦氢氯噻嗪片宁波美诺华天康药业有限公司4CYHS2402184注射用尼可地尔西安力邦联盟医疗科技有限公司4CYHS2402183注射用尼可地尔西安力邦联盟医疗科技有限公司4CYHS2402182注射用尼可地尔西安力邦联盟医疗科技有限公司4CYHS2402181非布司他片温岭市创新生物医药科技股份有限公司4CYHS2402180非布司他片温岭市创新生物医药科技股份有限公司4CYHS2402179亚叶酸钙注射液成都新恒创药业有限公司4CYHS2402177乳果糖口服溶液广州琥瑞医药科技发展有限公司4CYHS2402176氧福建融航气体有限公司4CYHS2402201非布司他片陕西西岳制药有限公司4CYHS2402199非布司他片陕西西岳制药有限公司4CYHS2402198间苯三酚注射液山东新华制药股份有限公司4CYHS2402195重组人促卵泡激素-CTP融合蛋白注射液长春金赛药业有限责任公司3.2CXSS2400074重组人促卵泡激素-CTP融合蛋白注射液长春金赛药业有限责任公司3.2CXSS2400073注射用A型肉毒毒素兰州生物技术开发有限公司3.2CXSS2400072注射用A型肉毒毒素兰州生物技术开发有限公司3.2CXSS2400071阿柏西普眼内注射溶液山东博安生物技术股份有限公司3.3CXSS2400068 进口申请药品名称企业注册分类受理号雷芬那辛吸入溶液Mylan Ireland Limited5.1JXHS2400048盐酸达利雷生片Idorsia Pharmaceuticals Deutschland GmbH5.1JXHS2400050盐酸达利雷生片Idorsia Pharmaceuticals Deutschland GmbH5.1JXHS2400049巴托利单抗注射液DRAGON MERIT HOLDINGS LIMITED1JXSS2400060纳武利尤单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400062纳武利尤单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400061纳武利尤单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400059纳武利尤单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400058罗莫佐单抗注射液UCB Pharma S.A.3.1JXSS2400057氨甲环酸注射液Maxmind Pharmaceutical S.L5.2JYHS2400038氨甲环酸注射液Maxmind Pharmaceutical S.L5.2JYHS2400037注射用BRII-693Brii Biosciences Limited1JXHL2400182罗氟司特乳膏Arcutis Biotherapeutics INC5.1JXHL2400181重组呼吸道合胞病毒(RSV)疫苗GlaxoSmithKline Biologicals SA2.6JXSL2400126RO7790121注射液F. Hoffmann-La Roche Ltd.1JXSL2400125RO7790121注射液F. Hoffmann-La Roche Ltd.1JXSL2400124 中药相关申请药品名称企业注册分类受理号升陷颗粒神威药业集团有限公司3.1CXZS2400027 注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

细胞疗法免疫疗法申请上市临床申请ASH会议

2024-07-15

·信狐药迅

正大天晴 JAK/ROCK抑制剂罗伐昔替尼；5个潜在3类、4类首仿品种提交上市申请，看看谁家品种？|新受理（7.8-7.14）

本周药品注册受理数据，分门别类呈现，一目了然。(7.8-7.14）新药上市申请药品名称企业注册分类受理号TQ05105片正大天晴药业集团股份有限公司1CXHS2400053苯胺洛芬注射液石家庄以岭药业股份有限公司1CXHS2400052布瑞哌唑口溶膜四川科伦药业股份有限公司2.2CXHS2400051布瑞哌唑口溶膜四川科伦药业股份有限公司2.2CXHS2400050重组红细胞生成刺激蛋白注射液(CHO细胞)沈阳三生制药有限责任公司1CXSS2400064塞多明基注射液北京诺思兰德生物技术股份有限公司1CXSS2400066索卡佐利单抗注射液兆科(广州)肿瘤药物有限公司2.2CXSS2400065 新药临床申请药品名称企业注册分类受理号注射用亚胺培南西司他丁钠福诺巴坦苏州信诺维医药科技股份有限公司1CXHL2400709RZ-629片宁康瑞珠生物制药(珠海)有限公司1CXHL2400708RZ-629片宁康瑞珠生物制药(珠海)有限公司1CXHL2400707H018软膏江苏柯菲平医药股份有限公司1CXHL2400705H018软膏江苏柯菲平医药股份有限公司1CXHL2400704H018软膏江苏柯菲平医药股份有限公司1CXHL2400703HSK21542注射液辽宁海思科制药有限公司1CXHL2400710SIGX1094R片希格生科(深圳)有限公司1CXHL2400697SIGX1094R片希格生科(深圳)有限公司1CXHL2400696注射用Pt(0506)101北京硕佰医药科技有限责任公司1CXHL2400695VSA003注射液维亚臻生物技术(苏州)有限公司1CXHL2400694SIR9900片维泰瑞隆(北京)生物科技有限公司1CXHL2400700SIR9900片维泰瑞隆(北京)生物科技有限公司1CXHL2400699SIR9900片维泰瑞隆(北京)生物科技有限公司1CXHL2400698SPH4336片上海医药集团股份有限公司1CXHL240069118F-LNC1007注射液烟台蓝纳成生物技术有限公司1CXHL2400682ICP-248片北京诺诚健华医药科技有限公司1CXHL2400693ICP-248片北京诺诚健华医药科技有限公司1CXHL2400692JAB-23E73片北京加科思新药研发有限公司1CXHL2400689JAB-23E73片北京加科思新药研发有限公司1CXHL2400688JAB-23E73片北京加科思新药研发有限公司1CXHL2400687WJ47156片上海君实生物医药科技股份有限公司1CXHL2400680WJ47156片上海君实生物医药科技股份有限公司1CXHL2400678CFT8919胶囊贝达药业股份有限公司1CXHL2400677CFT8919胶囊贝达药业股份有限公司1CXHL2400676ENC0653软膏轶诺(浙江)药业有限公司1CXHL2400664ENC0653软膏轶诺(浙江)药业有限公司1CXHL2400674ENC0653软膏轶诺(浙江)药业有限公司1CXHL2400673ENC0653软膏轶诺(浙江)药业有限公司1CXHL2400672ENC0653软膏轶诺(浙江)药业有限公司1CXHL2400671ENC0653软膏轶诺(浙江)药业有限公司1CXHL2400670ENC0653软膏轶诺(浙江)药业有限公司1CXHL2400669ENC0653软膏轶诺(浙江)药业有限公司1CXHL2400668ENC0653软膏轶诺(浙江)药业有限公司1CXHL2400667ENC0653软膏轶诺(浙江)药业有限公司1CXHL2400666HMPL-760胶囊和记黄埔医药(上海)有限公司1CXHL2400665TDI01混悬液北京泰德制药股份有限公司1CXHL2400663HBW-004285片成都海博为药业有限公司1CXHL2400662注射用NC527-X浙江海擘生物科技有限公司1CXHL2400661JC242片北京佳诚生物医药科技开发有限公司2.1CXHL2400706醋酸锌直服颗粒北京科信必成医药科技发展有限公司2.2CXHL2400702醋酸锌直服颗粒北京科信必成医药科技发展有限公司2.2CXHL2400701QLM2014齐鲁制药有限公司2.2CXHL2400679司美格鲁肽注射液江苏诺泰澳赛诺生物制药股份有限公司2.2CXHL2400686司美格鲁肽注射液江苏诺泰澳赛诺生物制药股份有限公司2.2CXHL2400685司美格鲁肽注射液江苏诺泰澳赛诺生物制药股份有限公司2.2CXHL2400684司美格鲁肽注射液江苏诺泰澳赛诺生物制药股份有限公司2.2CXHL2400683HKG-215合肥柏安医药科技有限公司2.3CXHL2400690缬沙坦马来酸左氨氯地平片石药集团中奇制药技术(石家庄)有限公司2.3CXHL2400675叶酸片北京斯利安药业有限公司2.4CXHL2400681IPM001注射液北京臻知医学科技有限责任公司1CXSL2400447IX001 TCR-T注射液上海镔铁生物科技有限责任公司1CXSL2400446IX001 TCR-T注射液上海镔铁生物科技有限责任公司1CXSL2400445注射用PRO1286普方生物制药(苏州)有限公司1CXSL2400443TQB2253注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2400448SHR-1905注射液广东恒瑞医药有限公司1CXSL2400442IBR900细胞注射液英百瑞(杭州)生物医药有限公司1CXSL2400441SK08活菌散广州知易生物科技有限公司1CXSL2400440CM380康诺亚生物医药科技(成都)有限公司1CXSL2400439TQH2722注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2400437注射用CMDE005浙江时迈药业有限公司1CXSL2400438SCTB35注射液神州细胞工程有限公司1CXSL2400435 仿制药申请药品名称企业注册分类受理号利多卡因丁卡因乳膏科笛生物医药(无锡)有限公司3CYHS2402174尼麦角林片海南斯达制药有限公司3CYHS2402142注射用氢化可的松琥珀酸钠江苏江丰医药科技有限公司3CYHS2402154维生素B12注射液江苏宝东医药科技有限公司3CYHS2402153硫代硫酸钠注射液山东齐都药业有限公司3CYHS2402152硫代硫酸钠注射液山东齐都药业有限公司3CYHS2402151卡络磺钠注射液广州一品红制药有限公司3CYHS2402150阿仑膦酸钠口服溶液苏州华健瑞达医药技术有限公司3CYHS2402149恩那度司他片深圳信立泰药业股份有限公司3CYHS2402145恩那度司他片深圳信立泰药业股份有限公司3CYHS2402144恩那度司他片深圳信立泰药业股份有限公司3CYHS2402143米诺地尔搽剂广州绿十字制药股份有限公司3CYHS2402141米诺地尔搽剂广州绿十字制药股份有限公司3CYHS2402140盐酸普罗帕酮注射液海南慧通生物医药科技有限公司3CYHS2402138盐酸普罗帕酮注射液海南慧通生物医药科技有限公司3CYHS2402137盐酸罗匹尼罗片江苏和晨药业有限公司3CYHS2402136地塞米松磷酸钠注射液安徽美来药业股份有限公司3CYHS2402133门冬氨酸钾镁注射液山东华鲁制药有限公司3CYHS2402129注射用比阿培南悦康药业集团股份有限公司3CYHS2402162西格列汀二甲双胍缓释片河南中杰药业有限公司3CYHS2402158西格列汀二甲双胍缓释片河南中杰药业有限公司3CYHS2402157己酮可可碱缓释片河北一品生物医药有限公司3CYHS2402127米诺地尔搽剂江西海尔思药业股份有限公司3CYHS2402125氟比洛芬酯注射液重庆药友制药有限责任公司3CYHS2402099依巴斯汀口服溶液浙江易泽达医药科技有限公司3CYHS2402101氯化钾注射液江苏华阳制药有限公司3CYHS2402100钠钾镁钙注射用浓溶液山东方明药业集团股份有限公司3CYHS2402098巴氯芬注射液南京海纳医药科技股份有限公司3CYHS2402094巴氯芬注射液南京海纳医药科技股份有限公司3CYHS2402093巴氯芬注射液南京海纳医药科技股份有限公司3CYHS2402092巴氯芬注射液南京海纳医药科技股份有限公司3CYHS2402091重酒石酸去甲肾上腺素注射液湖南华纳大药厂股份有限公司3CYHS2402087复方醋酸钠林格注射液安徽丰原药业股份有限公司3CYHS2402119复方醋酸钠林格注射液安徽丰原药业股份有限公司3CYHS2402118法莫替丁注射液海南慧通生物医药科技有限公司3CYHS2402117硫代硫酸钠注射液重庆凯林制药有限公司3CYHS2402108硫代硫酸钠注射液重庆凯林制药有限公司3CYHS2402107盐酸普罗帕酮注射液石家庄四药有限公司3CYHS2402115奥沙利铂注射液华夏生生药业(北京)有限公司3CYHS2402086奥沙利铂注射液华夏生生药业(北京)有限公司3CYHS2402085奥沙利铂注射液华夏生生药业(北京)有限公司3CYHS2402084硫代硫酸钠注射液华夏生生药业(北京)有限公司3CYHS2402069缩宫素注射液江西泰吉立生物医药科技有限公司3CYHS2402068注射用盐酸罗沙替丁醋酸酯沈阳新马药业有限公司3CYHS2402066硝普钠注射液重庆药友制药有限责任公司3CYHS2402082布瑞哌唑口腔崩解片湖南科伦制药有限公司3CYHS2402079布瑞哌唑口腔崩解片湖南科伦制药有限公司3CYHS2402078盐酸纳洛酮注射液海南普利制药股份有限公司3CYHS2402071盐酸纳洛酮注射液海南普利制药股份有限公司3CYHS2402070阿仑膦酸钠口服溶液湖南普道医药技术有限公司3CYHS2402058复合磷酸氢钾注射液石家庄迪斯凯威医药科技有限公司3CYHS2402065米诺地尔搽剂武汉华尔生物科技有限公司3CYHS2402064米诺地尔搽剂河北义海医药科技有限公司3CYHS2402063米诺地尔搽剂河北义海医药科技有限公司3CYHS2402062维生素B6注射液济川药业集团有限公司3CYHS2402061盐酸阿莫罗芬搽剂景时(杭州)药业有限公司4CYHS2402175达格列净二甲双胍缓释片南京汉欣医药科技有限公司4CYHS2402173阿卡波糖片福建省宝诺医药研发有限公司4CYHS2402172左氧氟沙星滴眼液珠海联邦制药股份有限公司中山分公司4CYHS2402171维生素B12滴眼液珠海同源药业有限公司4CYHS2402170乙酰半胱氨酸泡腾片浙江领创优品药业有限公司4CYHS2402169二甲双胍恩格列净片(I)广州仁恒医药科技股份有限公司4CYHS2402168二甲双胍恩格列净片(V)广州仁恒医药科技股份有限公司4CYHS2402167二甲双胍恩格列净片(VI)广州仁恒医药科技股份有限公司4CYHS2402166左卡尼汀注射液海南卓科制药有限公司4CYHS2402155氧(液态)浙江中龙气体科技有限公司4CYHS2402148丙酸氟替卡松鼻喷雾剂齐鲁制药有限公司4CYHS2402147双氯芬酸钠肠溶片浙江昂利康制药股份有限公司4CYHS2402146他达拉非片白云山东泰商丘药业有限公司4CYHS2402139左氧氟沙星滴眼液石家庄四药有限公司4CYHS2402135亚叶酸钙注射液泽田(山东)药业有限公司4CYHS2402134布瑞哌唑片西安远大科创医药科技有限公司4CYHS2402132布瑞哌唑片西安远大科创医药科技有限公司4CYHS2402131他达拉非片四川益生智同医药生物科技发展有限公司4CYHS2402130硫酸氨基葡萄糖胶囊北京华睿鼎信科技有限公司4CYHS2402165培哚普利氨氯地平片(III)远大医药(中国)有限公司4CYHS2402164双氯芬酸钠双释放肠溶胶囊北京福元医药股份有限公司4CYHS2402163二甲硅油乳剂山东齐都药业有限公司4CYHS2402161二甲硅油乳剂山东齐都药业有限公司4CYHS2402160二甲硅油乳剂山东齐都药业有限公司4CYHS2402159夫西地酸乳膏湖北科益药业股份有限公司4CYHS2402156恩格列净片康臣药业(内蒙古)有限责任公司4CYHS2402128碳酸镧咀嚼片浙江中同药业有限公司4CYHS2402126阿昔莫司胶囊浙江恒研医药科技有限公司4CYHS2402123沙格列汀二甲双胍缓释片北京康而福药业有限责任公司4CYHS2402122沙格列汀二甲双胍缓释片北京康而福药业有限责任公司4CYHS2402121熊去氧胆酸胶囊海南斯达制药有限公司4CYHS2402120硫酸氨基葡萄糖胶囊通化万通药业股份有限公司4CYHS2402124注射用头孢呋辛钠成都倍特药业股份有限公司4CYHS2402113注射用头孢呋辛钠成都倍特药业股份有限公司4CYHS2402112注射用阿糖胞苷山西铭羽生物科技有限公司4CYHS2402111依折麦布阿托伐他汀钙片(II)乐普制药科技有限公司4CYHS2402110注射用唑来膦酸浓溶液海南葫芦娃药业集团股份有限公司4CYHS2402109来特莫韦注射液山东诚创蓝海医药科技有限公司4CYHS2402106盐酸奥布卡因滴眼液浙江莎普爱思药业股份有限公司4CYHS2402105苯磺顺阿曲库铵注射液山东威智百科药业有限公司4CYHS2402104盐酸氨溴索注射液上海现代哈森(商丘)药业有限公司4CYHS2402090苯磺酸左氨氯地平片石家庄四药有限公司4CYHS2402089苯磺酸左氨氯地平片石家庄四药有限公司4CYHS2402088铝碳酸镁咀嚼片白云山汤阴东泰药业有限责任公司4CYHS2402116乳酸钠林格注射液成都医路康医学技术服务有限公司4CYHS2402114恩格列净片江苏康缘药业股份有限公司4CYHS2402096恩格列净片江苏康缘药业股份有限公司4CYHS2402095布瑞哌唑片湖南科伦制药有限公司4CYHS2402103布瑞哌唑片湖南科伦制药有限公司4CYHS2402102二甲硅油乳剂浙江恒研医药科技有限公司4CYHS2402097盐酸阿罗洛尔片成都苑东生物制药股份有限公司4CYHS2402067替米沙坦氨氯地平片苏州中化药品工业有限公司4CYHS2402083雌二醇片/雌二醇地屈孕酮片复合包装扬州奥锐特药业有限公司4CYHS2402081雌二醇片/雌二醇地屈孕酮片复合包装扬州奥锐特药业有限公司4CYHS2402080富马酸伏诺拉生片杭州煌森生物科技有限公司4CYHS2402077盐酸莫西沙星片哈尔滨珍宝制药有限公司4CYHS2402076富马酸伏诺拉生片湖南千金湘江药业股份有限公司4CYHS2402075富马酸伏诺拉生片湖南千金湘江药业股份有限公司4CYHS2402074非那雄胺片四川依科制药有限公司4CYHS2402073替勃龙片长春金赛药业有限责任公司4CYHS2402072碘克沙醇注射液重庆药友制药有限责任公司4CYHS2402060碘克沙醇注射液重庆药友制药有限责任公司4CYHS2402059注射用盐酸兰地洛尔海南合瑞制药股份有限公司3CYHL2400147甘露醇山梨醇注射液山东齐都药业有限公司3CYHL2400145氟[18F]美他酚注射液天津恒瑞医药有限公司3CYHL2400142阿齐沙坦片江西施美药业股份有限公司3CYHL2400144盐酸左米那普仑缓释胶囊浙江华海药业股份有限公司3CYHL2400141盐酸左米那普仑缓释胶囊浙江华海药业股份有限公司3CYHL2400140盐酸左米那普仑缓释胶囊浙江华海药业股份有限公司3CYHL2400139布洛肾素片山东新华制药股份有限公司3CYHL2400138酒石酸匹莫范色林胶囊武汉人福药业有限责任公司3CYHL2400137注射用伏立康唑天津力生制药股份有限公司4CYHL2400146噻托溴铵吸入粉雾剂南京力成药业有限公司4CYHL2400143盐酸伊立替康脂质体注射液西安力邦制药有限公司4CYHL2400136皮下注射人免疫球蛋白四川远大蜀阳药业有限责任公司3.2CXSL2400434SAL023注射液信立泰(成都)生物技术有限公司3.3CXSL2400444德谷胰岛素利拉鲁肽注射液正大天晴药业集团股份有限公司3.3CXSL2400436 进口申请药品名称企业注册分类受理号伊匹木单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400056伊匹木单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400055盐酸左西替利嗪口服溶液BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED5.2JYHS2400036Bomedemstat胶囊Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.1JXHL2400176Bomedemstat胶囊Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.1JXHL2400175Bomedemstat胶囊Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.1JXHL2400174Bomedemstat胶囊Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.1JXHL2400173BI 1839100 片Boehringer Ingelheim International GmbH1JXHL2400171TAK-861片Takeda Development Center Americas,Inc.1JXHL2400180TAK-861片Takeda Development Center Americas,Inc.1JXHL2400179TAK-861片Takeda Development Center Americas,Inc.1JXHL2400178TAK-861片Takeda Development Center Americas,Inc.1JXHL2400177BAY 2862789片Bayer AG1JXHL2400168BAY 2862789片Bayer AG1JXHL2400167PF-06821497片Pfizer Inc.1JXHL2400166PF-06821497片Pfizer Inc.1JXHL2400165罗氟司特乳膏Arcutis Biotherapeutics INC2.4JXHL2400172Elacestrant片Stemline Therapeutics, Inc.5.1JXHL2400170Elacestrant片Stemline Therapeutics, Inc.5.1JXHL2400169MK-3475A注射液Merck Sharp & Dohme LLC1JXSL2400121CSL300 (Clazakizumab)CSL Behring LLC1JXSL2400120艾加莫德α注射液argenx BV2.2JXSL2400122度普利尤单抗注射液Sanofi Winthrop Industrie3.1JXSL2400123 中药相关申请药品名称企业注册分类受理号温经汤颗粒上海医药集团青岛国风药业股份有限公司3.1CXZS2400026SY617嘉亨(珠海横琴)医药科技有限公司1.1CXZL2400038 注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

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