Fosaprepitant Dimeglumine

精彩内容 2024上半年，豪森药业研发进展不断：瑞戈非尼片国产第3家获批，9款1类新药获批临床......目前豪森药业有44款新药（41款1类新药）处于申报临床及以上阶段，5款处于NDA或III期临床阶段；48个品种过评（26个首家），9个品种备战第十批集采。 拿下35个品种！乙肝新药、首仿药销售额大涨 2024上半年，豪森药业的瑞戈非尼片获批生产并视同过评，为国产第3家获批。这是一款多靶点酪氨酸激酶抑制剂，原研产品2023年在中国三大终端六大市场（统计范围详见本文末）的销售额超过11亿元。 米内网数据显示，2019年至今，豪森药业有7款新药（5款1类新药、1款进口新药及1款改良型新药）、28个仿制药（11个首仿）在国内获批上市，涵盖6个治疗大类，其中抗肿瘤和免疫调节剂有13个，消化系统及代谢药有8个，神经系统药物有6个。 2019年以来豪森药业获批上市的新药及首仿来源：米内网中国上市药品（MID）数据库 7款新药中，甲磺酸阿美替尼片、甲磺酸氟马替尼片2款抗肿瘤药已成长为重磅品种，2023年在中国三大终端六大市场的销售额分别超过30亿元、10亿元；乙肝新药艾米替诺福韦片亦快速放量，2023年在中国三大终端六大市场的销售额超过6亿元，同比增长129%。 11个首仿（含剂型首仿）中，帕利哌酮缓释片、恩扎卢胺软胶囊2023年在中国三大终端六大市场的销售额分别超过4亿元、1亿元，增长率分别约达22%、178%；地拉罗司片放量明显，2024年第一季度在中国零售药店（城市实体药店+网上药店）的销售额增速达3976%。 目前豪森药业有4个品种以新注册分类报产在审，且在国内均暂无首仿获批，分别为注射用卡非佐米、司来帕格片、普拉曲沙注射液及右兰索拉唑肠溶胶囊。值得一提的是，这4个品种均由豪森药业首家/独家申报，拿下首仿的几率较大，其中，原研厂家的注射用卡非佐米、司来帕格片2023年在中国三大终端六大市场的销售额分别超过1亿元、2亿元。 豪森药业新分类报产且在审的品种来源：米内网中国申报进度（MED）数据库 41款1类新药亮眼！5款新药上市可期 2024上半年，豪森药业有9款1类新药在国内获得临床默示许可，其中HS-10501片（2型糖尿病、肥胖症）、HS-10398胶囊（免疫球蛋白A肾病、膜性肾病）、HS-10509片（精神分裂症）、HS-10504片（晚期非小细胞肺癌）为首次获批临床。 含引进的产品在内，目前豪森药业有44款创新药（41款1类新药）在国内处于申报临床及以上阶段（不含已上市新药申报新适应症），涵盖抗肿瘤、神经系统、抗感染、消化系统及代谢、心脑血管系统、自身免疫等治疗领域。 豪森药业国内在研新药来源：米内网综合数据库 抗肿瘤和免疫调节剂是豪森药业重点聚焦的治疗领域，阿美替尼、氟马替尼、伊奈利珠单抗等已获批上市，还有20余款新药处于临床试验阶段。米内网数据显示，近年来中国三大终端六大市场抗肿瘤和免疫调节剂市场规模逐年扩大，2023年超过2200亿元，在TOP20集团中，近年来豪森药业一直榜上有名。 在该治疗领域，豪森药业布局了c-Met、CDK4/6、IL-23、RET、PLK、PIK3、Bcr-Abl、TYK2、HIF-2α等多个靶点，涵盖肺癌、乳腺癌、肾细胞癌等细分病种。从研发进度看，HS-10241（c-Met抑制剂）、HS-20090（地舒单抗生物类似药）已步入III期临床，HS-10342（CDK4/6抑制剂）、QX004N（IL-23单抗）、HS-10365（RET-TKI）等均在开展II期临床。值得一提的是，在当下国内外药企扎堆的ADC赛道，豪森药业差异化地布局了B7-H3（HS-20093，II期）、B7-H4（HS-20089，II期）等潜力靶点，不管是研发速度上还是适应症布局都极具竞争优势；在双抗方面，HS-20117步入I期临床，目前国内暂无靶向EGFR/cMet的双抗获批上市。 神经系统亦是豪森药业的优势及聚焦领域，近年来该大类在中国三大终端六大市场的销售额均达千亿规模，公司跻身TOP20集团。在研新药中，用于治疗抑郁症的HS-10353（GABA受体正向调节剂）、用于治疗急性期精神分裂症的HS-10380均处于II期临床，用于治疗失眠障碍的HS-10506处于Ib/II期临床等。 26个品种首家过评，9大品种备战第十批集采 截至目前，豪森药业有48个品种通过/视同通过一致性评价，集中抗肿瘤和免疫调节剂（17个）、消化系统及代谢药（10个）、神经系统药物（9个）、全身用抗感染药物（6个）等治疗大类。其中，26个品种为国内首家过评，酒石酸长春瑞滨软胶囊、阿戈美拉汀片等品种为独家过评。 豪森药业已过评品种注：带*为首家/独家过评，加粗为国采中标来源：米内网一致性评价进度数据库 在已开展的八批九轮化药集采中，豪森药业累计有24个品种中标，其中多个品种以新注册分类获批上市，集采中标有助于产品快速放量。第十批集采如箭在弦，目前豪森药业有15个已过评品种暂未纳入国采，其中有9个已满足5家及以上的充分竞争条件。 豪森药业已过评但未纳入国采且已满足条件的品种注：低于1亿元用*代表来源：米内网综合数据库 从销售额看，9个品种2023年在中国城市公立医院、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）终端合计销售额超过70亿元，其中达格列净片超过39亿元，瑞戈非尼片、帕利哌酮缓释片、注射用福沙匹坦双葡甲胺均达8亿元以上。 值得一提的是，瑞戈非尼片、乙磺酸尼达尼布软胶囊、达格列净片、哌柏西利胶囊、氢溴酸伏硫西汀片为豪森药业2022年之后获批上市的新品，公司2023年在上述品种所占市场份额较低或为0。 资料来源：米内网数据库、公司公告等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至7月12日，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

FOCINVEZ (fosaprepitant) 150 mg/50 mL single dose vial is an anti-nausea agent for highly emetogenic and moderately emetogenic chemotherapy (HEC and MEC) Second injectable RTU product launched by Amneal in 2024 BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced the launch of FOCINVEZ™, a ready-to-use injectable. Unlike other versions of fosaprepitant, this single-dose vial product is free of Polysorbate 80 and does not require reconstitution or dilution and can be administered directly from the vial using the included vial hanger. FOCINVEZ for injection is indicated in adults and pediatric patients 6 months of age and older, in combination with other antiemetic agents, for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC), including high-dose cisplatin, and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). “We continue to launch differentiated complex products that are clinically impactful,” said Sean McGowan, Vice President, Biosimilars and Branded Oncology. “This is the second ready-to-use injectable we have launched this year that offers hospitals and oncology clinics a new presentation format that can improve pharmacy efficiency. These new 505(b)(2) injectables represent a new vector of growth for our expanding injectables portfolio.” FOCINVEZ has a unique J-Code from the Centers for Medicare & Medicaid Services (CMS) to facilitate reimbursement: J1434, Injection, fosaprepitant (focinvez), 1 mg, and is available in one vial size 150mg/50mL (3mg/mL). Adverse effects reported with FOCINVEZ include fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, and pain in extremity. For full prescribing information, see package insert located here. According to IQVIA®, U.S. annual sales for fosaprepitant for the 12 months ended April 2024 were approximately $36 million. 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 . 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.