Perampanel

Reports Q3 2024 Total Revenues of $128.7 Million, Representing a 25.3% YoY Increase Record Revenues Driven by Continued Organic Growth in its Rare Disease Franchise Robust Financial Performance Highlights Operational Excellence and Strong Commercial Execution FIRDAPSE® Q3 2024 Net Product Revenues of $79.3 Million, Representing a 19.7% YoY Increase AGAMREE® Q3 2024 Net Product Revenues of $15.0 Million, Demonstrating Early U.S. Launch Success FYCOMPA® Q3 2024 Net Product Revenues of $32.1 Million Q3 2024 GAAP Net Income of $43.9 Million, $0.35 Per Share Diluted Q3 2024 Non-GAAP Net Income of $71.1 Million, $0.57 Per Share Diluted Updating 2024 Full Year Total Revenue Guidance to Between $475 Million and $485 Million Conference Call and Webcast to be Held on November 7, 2024, at 8:30 AM ET CORAL GABLES, Fla., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (“Catalyst” or “Company”) (Nasdaq: CPRX) today reported financial results for the third quarter of 2024 and provided a corporate update. "Our strong financial performance reflects our unwavering commitment to operational and commercial excellence, driving sustained momentum and long-term growth. The early success of our newest product, AGAMREE®, along with the continued robust organic growth of our flagship product, FIRDAPSE®, highlights the strength of our U.S. commercial strategy, with revenues exceeding expectations and significantly contributing to our overall success," stated Richard J. Daly, President and CEO of Catalyst. "Through our strategic partnerships, we are advancing initiatives to expand the geographic footprint of our rare disease portfolio in key territories outside the U.S. As we pursue opportunities aligned with our long-term growth objectives and forge new partnerships to broaden our global presence, our achievements to date underscore the strength of our strategic vision to address critical unmet medical needs, driven by the outstanding execution of our teams. With a resolute focus on sustained growth and value creation, we are optimistic about the path ahead and remain confident in meeting our full-year 2024 revenue guidance, laying a strong foundation for continued success." Financial Highlights For the Three Months Ended September 30, 2024 2023 % Change(In thousands, except per share data) Product Revenue, Net$126,424$102,617 23.2% FIRDAPSE Product Revenue, Net$79,303$66,224 19.7% FYCOMPA Product Revenue, Net$32,075$36,393 (11.9%) AGAMREE Product Revenue, Net$15,046 N/A N/A GAAP Net Income (Loss)$43,884($30,764) 242.6% Non-GAAP Net Income (Loss)**$71,080($25,643) 377.2% GAAP Net Income (Loss) Per Share – Basic$0.37($0.29) 227.6% Non-GAAP Net Income (Loss) Per Share – Basic**$0.60($0.24) 350.0% GAAP Net Income (Loss) Per Share – Diluted$0.35($0.29) 220.7% Non-GAAP Net Income (Loss) Per Share – Diluted**$0.57($0.24) 337.5% As of September 30, 2024, and December 31, 2023(In thousands)Cash and Cash Equivalents$442,331$137,636 221.4% **Statements made in this press release include non-GAAP financial measures. Such information is provided as additional information and not as an alternative to Catalyst's financial statements presented in accordance with U.S. generally accepted accounting principles (“GAAP”). These non-GAAP financial measures are intended to enhance an overall understanding of Catalyst's current financial performance. Catalyst believes that the non-GAAP financial measures presented in this press release provide investors and prospective investors with an alternative method for assessing Catalyst's operating results in a manner that Catalyst believes is focused on the performance of ongoing operations and provides a more consistent basis for comparison between periods. Non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP accounting. Further, non-GAAP measures of net income used by Catalyst may be different from and not directly comparable to similarly titled measures used by other companies. Beginning with the third quarter of 2024, Catalyst will no longer include acquisition in-process research and development ("IPR&D") in its non-GAAP financial measures. Previously reported non-GAAP net income for the third quarter of 2023 included $81.5 million in acquisition IPR&D relating to Catalyst's acquisition, during that period, of the North American license for AGAMREE, which had not yet been approved by the U.S. Food and Drug Administration (“FDA”) at the time of the acquisition. The commercialization was subsequently approved by the FDA during the fourth quarter of 2023. Prior period amounts have been revised to conform to the current period presentation. Catalyst is making this change to its presentation following discussions with the Staff of the Division of Corporation Finance of the U.S. Securities and Exchange Commission. Recent Business Highlights Achieved total revenues of $128.7 million, including net product revenues of $126.4 million for the third quarter (“Q3”) of 2024, reflecting a 23.2% increase over net product revenues for Q3 of 2023. Reported record quarterly FIRDAPSE net product revenues of $79.3 million for Q3 2024, reflecting a 19.7% increase over Q3 2023, driven by sustained organic growth. Achieved robust AGAMREE net product revenues of $15.0 million for Q3 2024, demonstrating continued momentum in its second full quarter of U.S. commercial availability. Reported FYCOMPA® net product revenues of $32.1 million for Q3 2024, an 11.9% decrease compared to Q3 2023 revenues of $36.4 million. Announced that DyDo Pharma, Inc. (Catalyst’s sub-licensee in Japan), received regulatory approval in Japan to commercialize FIRDAPSE 10 mg tablets for the treatment of Lambert-Eaton myasthenic syndrome in Japan, marking a key milestone in expanding the product’s commercial footprint. DyDo has advised Catalyst that it expects to launch in Japan by the end of Q4 2024. Announced an exclusive agreement with KYE Pharmaceuticals, Inc. for the Canadian commercial rights to AGAMREE for Duchenne muscular dystrophy and other potential indications, further expanding Catalyst’s North American footprint. This marks the licensing of Catalyst’s second rare disease product in Canada, and KYE has advised us that it expects to file a Health Canada application for AGAMREE by early 2025. Expect total revenues for the full year 2024 to be between $475 million and $485 million, which includes the $2.1 million milestone payment received from DyDo that is included in License and other revenue. Revising full-year 2024 net product revenue guidance for FIRDAPSE to be between $300 million and $310 million; reaffirming FYCOMPA net product revenue guidance to be between $130 million and $135 million; and increasing AGAMREE net product revenue guidance to be between $40 million and $45 million, respectively. Revising full year research and development (“R&D”) expense guidance to less than $15 million due to delays in the timing of certain R&D related initiatives. Third Quarter 2024 Financial Results Total revenues: Total revenues during the third quarter of 2024 were $128.7 million, compared to $102.7 million for the third quarter of 2023, representing an increase of approximately 25.3%. Product revenue, net: Product revenue, net for the third quarter of 2024 was $126.4 million, compared to $102.6 million for the third quarter of 2023, representing an increase of approximately 23.2%. License and other revenue: License and other revenue includes $2.1 million from the arrangement with DyDo for both the three and nine months ended September 30, 2024, which consisted of a milestone payment earned upon DyDo receiving regulatory approval to commercialize FIRDAPSE for the treatment of patients with LEMS in Japan. Research and development expenses: Research and development expenses for the third quarter of 2024 were $3.3 million, compared to $83.7 million for the third quarter of 2023, representing a decrease of approximately 96.1%. Research and development expenses for the third quarter of 2023 included acquisition IPR&D of $81.5 million. Selling, general and administrative expenses: Selling, general and administrative expenses for the third quarter of 2024 were $45.9 million, compared to $33.6 million for the third quarter of 2023, representing an increase of approximately 36.7%. Amortization of intangible assets: Amortization of intangible assets was $9.3 million in the third quarter of 2024, compared to $8.5 million in the third quarter of 2023, representing an increase of approximately 10.1%. Operating income (loss): Operating income (loss) for the third quarter of 2024 was $50.9 million, compared to ($37.2) million for the third quarter of 2023, representing an increase of approximately 236.9%. GAAP net income (loss): GAAP net income (loss) for the third quarter of 2024 was $43.9 million ($0.37 per basic and $0.35 per diluted share), compared to GAAP net income (loss) of ($30.8) million (($0.29) per basic and diluted share) for the third quarter of 2023. Non-GAAP net income (loss): Non-GAAP net income (loss) for the third quarter of 2024 was $71.1 million ($0.60 per basic and $0.57 per diluted share), compared to non-GAAP net income (loss) of ($25.6) million (($0.24) per basic and diluted share) for the third quarter of 2023. Cash and cash equivalents: Cash and cash equivalents were $442.3 million as of September 30, 2024. Catalyst’s Form 10-Q for the third quarter of 2024, filed with the U.S. Securities and Exchange Commission on November 6, 2024, provides more detailed financial information and analysis of Catalyst’s financial condition and results of operations. Conference Call & Webcast DetailsThe Company will host a conference call and webcast on Thursday, November 7, 2024, at 8:30 AM ET to discuss the financial results and provide a business update. US/Canada Dial-in Number:800-715-9871International Dial-in Number:646-307-1963 A webcast will be accessible under the investor section on the Company's website at www.catalystpharma.com. A webcast replay will be available on the Catalyst website for 30 days after the event. About Catalyst Pharmaceuticals Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) is a biopharmaceutical company committed to improving the lives of patients with rare diseases. With a proven track record of bringing life-changing treatments to the market, Catalyst’s focus is on in-licensing, commercializing, and developing innovative therapies. Guided by its deep commitment to patient care, Catalyst prioritizes accessibility, ensuring patients receive the care they need through a comprehensive suite of support services designed to provide seamless access and ongoing assistance. Catalyst maintains a well-established U.S. presence while actively seeking to expand its global commercial footprint through strategic partnerships. Catalyst is headquartered in Coral Gables, FL., and was recognized on the Forbes 2024 list as one of America's most successful small-cap companies. For more information, please visit Catalyst's website at www.catalystpharma.com. Forward-Looking StatementsThis press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether the launch of AGAMREE® will continue to surpass initial expectations and exceed 2024 full-year revenue forecasts for sales of the product that have been published by the Company, (ii) whether AGAMREE's commercialization will ultimately be profitable, cash flow positive, and accretive to Catalyst, (iii) Catalyst's ability to continue to successfully sell its current products and continue to be profitable and cash flow positive, (iv) whether Catalyst's total revenue forecast for 2024 that is included in this press release will prove to be accurate, (v) whether Catalyst will complete additional acquisitions of products, and the timing of any such acquisitions, (vi) the impact of pending Paragraph IV litigation relating to FIRDAPSE® if the results of these litigation matters are adverse, (vii) whether AGAMREE will be approved for commercialization in Canada, (viii) whether DyDo can successfully commercialize FIRDAPSE in Japan, and (ix) those factors described in Catalyst's Annual Report on Form 10-K for the 2023 fiscal year, Catalyst's Quarterly Report on Form 10-Q for the third quarter of 2024, and Catalyst's other filings with the SEC, could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC and may be found on Catalyst's website or obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date. CATALYST PHARMACEUTICALS, INC.CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)(in thousands, except share and per share data) For the Three MonthsEnded September 30, For the Nine MonthsEnded September 30, 2024 2023 2024 2023Product revenue, net$126,424 $102,617 $347,518 $287,398License and other revenue 2,271 71 2,396 238Total revenues 128,695 102,688 349,914 287,636 Operating costs and expenses: Cost of sales (a) 19,277 14,167 47,202 36,158Research and development 3,284 83,662 8,850 91,178Selling, general and administrative (a) 45,880 33,560 133,548 91,674Amortization of intangible assets 9,345 8,487 28,033 23,506Total operating costs and expenses 77,786 139,876 217,633 242,516Operating income (loss) 50,909 (37,188) 132,281 45,120Other income (expense), net 6,296 (833) 9,801 2,684Net income (loss) before income taxes 57,205 (38,021) 142,082 47,804Income tax provision (benefit) 13,321 (7,257) 34,129 11,238Net income (loss)$43,884 $(30,764) $107,953 $36,566 Net income (loss) per share: Basic$0.37 $(0.29) $0.92 $0.34Diluted$0.35 $(0.29) $0.87 $0.32 Weighted average shares outstanding: Basic 118,931,153 106,568,137 117,976,056 106,133,077Diluted 125,407,279 106,568,137 124,519,838 113,751,370 (a) exclusive of amortization of intangible assets CATALYST PHARMACEUTICALS, INC.RECONCILIATION OF NON-GAAP METRICS (unaudited)(in thousands, except share and per share data) For the Three MonthsEnded September 30, For the Nine MonthsEnded September 30, 2024 2023 2024 2023GAAP net income (loss)$43,884 $(30,764) $107,953 $36,566Non-GAAP adjustments: Stock-based compensation expense 4,424 3,810 17,080 10,000Depreciation 106 81 283 232Amortization of intangible assets 9,345 8,487 28,033 23,506Income tax provision (benefit) 13,321 (7,257) 34,129 11,238Non-GAAP net income (loss)$71,080 $(25,643) $187,478 $81,542 Non-GAAP net income (loss) per share: Basic$0.60 $(0.24) $1.59 $0.77 Diluted$0.57 $(0.24) $1.51 $0.72 Weighted average shares outstanding: Basic 118,931,153 106,568,137 117,976,056 106,133,077 Diluted 125,407,279 106,568,137 124,519,838 113,751,370 CATALYST PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands) September 30,2024(unaudited) December 31,2023Assets Current Assets: Cash and cash equivalents$442,331 $137,636Accounts receivable, net 58,266 53,514Inventory 20,017 15,644Prepaid expenses and other current assets 18,384 12,535Total current assets 538,998 219,329Operating lease right-of-use asset, net 2,301 2,508Property and equipment, net 1,380 1,195License and acquired intangibles, net 166,016 194,049Deferred tax assets, net 48,473 36,544Investment in equity securities 14,842 16,489Total assets$772,010 $470,114 Liabilities and Stockholders’ Equity Current Liabilities: Accounts payable$11,563 $14,795Accrued expenses and other liabilities 93,832 61,268Total current liabilities 105,395 76,063Operating lease liability, net of current portion 2,889 3,188Other non-current liabilities 2,785 2,982Total liabilities 111,069 82,233Total stockholders’ equity 660,941 387,881Total liabilities and stockholders’ equity$772,010 $470,114 Source: Catalyst Pharmaceuticals, Inc. Contact information: Investor ContactMary ColemanCatalyst Pharmaceuticals, Inc.(305) 420-3200mcoleman@catalystpharma.com Media ContactDavid SchullRusso Partners(858) 717-2310david.schull@russopartnersllc.com

本周药品注册受理数据，分门别类呈现，一目了然。(10.21-10.27） 新药上市申请药品名称企业注册分类受理号康太替尼颗粒首药控股(北京)股份有限公司1CXHS2400110康太替尼颗粒首药控股(北京)股份有限公司1CXHS2400109注射用泰它西普荣昌生物制药(烟台)股份有限公司2.2CXSS2400115 新药临床申请药品名称企业注册分类受理号MAX-10181片北京再极医药科技有限公司1CXHL2401133MAX-10181片北京再极医药科技有限公司1CXHL2401132MAX-10181片北京再极医药科技有限公司1CXHL2401131OB756片杭州邦顺制药有限公司1CXHL2401128GD-N2203灌肠液四川好医生攀西药业有限责任公司1CXHL2401130GD-N2203灌肠液四川好医生攀西药业有限责任公司1CXHL2401129WA01片诺未生物技术(无锡)有限公司1CXHL2401126VSA012注射液维亚臻生物技术(苏州)有限公司1CXHL2401125安脑三醇注射液广州市赛普特医药科技股份有限公司1CXHL2401119氟[18F]吡酰胺注射液原子高科股份有限公司1CXHL2401118CL01阴道胶囊鸿花(北京)科技有限公司1CXHL2401123CL01阴道胶囊鸿花(北京)科技有限公司1CXHL2401122CL01阴道胶囊鸿花(北京)科技有限公司1CXHL2401121SYH2059片上海翊石医药科技有限公司1CXHL2401117SYH2059片上海翊石医药科技有限公司1CXHL2401116JSS-221江西施美药业股份有限公司2.2CXHL2401127B0110广州帝奇医药技术有限公司2.2CXHL2401124KLA480注射液湖南科伦制药有限公司2.2CXHL2401120BW-201北京百邑无忧科技发展有限公司1.3CXSL2400721BW-201北京百邑无忧科技发展有限公司1.3CXSL2400720BW-201北京百邑无忧科技发展有限公司1.3CXSL2400719BW-201北京百邑无忧科技发展有限公司1.3CXSL2400718甲型肝炎灭活疫苗(人二倍体细胞)浙江普康生物技术股份有限公司2.2CXSL2400726甲型肝炎灭活疫苗(人二倍体细胞)浙江普康生物技术股份有限公司2.2CXSL2400725HB0028注射液上海华奥泰生物药业股份有限公司1CXSL2400732HB002.1T注射液浙江华海生物科技有限公司1CXSL2400731SHR-4375注射液苏州盛迪亚生物医药有限公司1CXSL2400730注射用SIM0505上海先祥医药科技有限公司1CXSL2400729注射用MHB009C明慧医药(杭州)有限公司1CXSL2400724注射用SLN12140领诺(上海)医药科技有限公司1CXSL2400723注射用YK012益科思特(北京)医药科技发展有限公司1CXSL2400727CM313(SC)注射液康诺亚生物医药科技(成都)有限公司1CXSL2400717BM230冻干制剂苏州博奥明赛生物制药有限公司1CXSL2400722SCG142自体T细胞注射液星源德生物医药(上海)有限公司1CXSL2400715IMS001注射液珠海横琴爱姆斯坦生物科技有限公司1CXSL2400716靶向CD19基因修饰的异体嵌合抗原受体T细胞注射液上海邦耀生物科技有限公司1CXSL2400714拓培非格司亭注射液厦门特宝生物工程股份有限公司2.2CXSL2400728 仿制药申请药品名称企业注册分类受理号布比卡因脂质体注射液浙江圣兆药物科技股份有限公司3CYHS2403649布比卡因脂质体注射液浙江圣兆药物科技股份有限公司3CYHS2403648咪达唑仑口服溶液成都苑东生物制药股份有限公司3CYHS2403647辅酶Q10片成都倍特药业股份有限公司3CYHS2403644氯化钙注射液绪必迪药业(沧州)有限公司3CYHS2403638盐酸甲氧氯普胺注射液江西科为制药有限公司3CYHS2403635维生素B6注射液西安安健药业有限公司3CYHS2403625黄体酮注射液成都倍特得诺药业有限公司3CYHS2403624羧甲司坦干糖浆康芝药业股份有限公司3CYHS2403623盐酸溴己新口服溶液温岭市创新生物医药科技股份有限公司3CYHS2403622法罗培南钠片湖南华纳大药厂股份有限公司3CYHS2403621法莫替丁注射液南京黄龙生物科技有限公司3CYHS2403617肾上腺素注射液成都诺和晟鸿生物制药有限公司3CYHS2403616硫糖铝口服混悬液黑龙江中桂制药有限公司3CYHS2403610硫糖铝口服混悬液黑龙江中桂制药有限公司3CYHS2403608维生素B6注射液西藏奥斯必秀医药有限公司3CYHS2403607盐酸氢吗啡酮注射液青海制药有限公司3CYHS2403606维生素B6注射液山东齐都药业有限公司3CYHS2403632维生素B6注射液山东济坤生物制药有限公司3CYHS2403631倍他米松磷酸钠注射液四川美大康华康药业有限公司3CYHS2403629富马酸氯马斯汀注射液成都诺和晟鸿生物制药有限公司3CYHS2403599托吡酯口服溶液仁合益康集团有限公司3CYHS2403596枸橼酸西地那非口溶膜上海欣峰制药有限公司3CYHS2403593枸橼酸西地那非口溶膜上海欣峰制药有限公司3CYHS2403592氯化钙注射液山东华鲁制药有限公司3CYHS2403588酮洛芬凝胶贴膏南京海纳制药有限公司3CYHS2403587注射用氢化可的松琥珀酸钠海南未见药业有限公司3CYHS2403585注射用氢化可的松琥珀酸钠海南未见药业有限公司3CYHS2403584美索巴莫注射液山东百诺医药股份有限公司3CYHS2403582盐酸左西替利嗪口服溶液温岭市创新生物医药科技股份有限公司3CYHS2403576左羟丙哌嗪糖浆南京恒道医药科技股份有限公司3CYHS2403575米诺地尔搽剂西施兰(南阳)药业股份有限公司3CYHS2403574米诺地尔搽剂西施兰(南阳)药业股份有限公司3CYHS2403573奥美沙坦酯口崩片北京福元医药股份有限公司3CYHS2403569奥美沙坦酯口崩片北京福元医药股份有限公司3CYHS2403568二羟丙茶碱注射液上海禾丰制药有限公司3CYHS2403563法莫替丁注射液石药银湖制药有限公司3CYHS2403583硝普钠注射液成都瑞尔医药科技有限公司3CYHS2403556地氯雷他定口服溶液温岭市创新生物医药科技股份有限公司3CYHS2403554吲哚布芬片石家庄龙泽制药股份有限公司3CYHS2403553比拉斯汀口服溶液安徽四环科宝制药有限公司3CYHS2403551氨磺必利注射液湖北多瑞药业有限公司3CYHS2403550布美他尼注射液酒泉大得利制药股份有限公司3CYHS2403549布美他尼注射液酒泉大得利制药股份有限公司3CYHS2403548二甲双胍格列吡嗪片江苏安必生制药有限公司3CYHS2403546利多卡因丁卡因乳膏北京诺博特生物科技有限公司3CYHS2403544克立硼罗软膏湖南九典制药股份有限公司4CYHS2403650富马酸伏诺拉生片成都秦润医药科技有限公司4CYHS2403646富马酸伏诺拉生片成都秦润医药科技有限公司4CYHS2403645盐酸阿莫罗芬搽剂浙江恒研医药科技有限公司4CYHS2403643氧麻栗坡县民华燃气有限公司4CYHS2403642地屈孕酮片浙江美迪深生物医药有限公司4CYHS2403641盐酸特比萘芬喷雾剂辽宁新高制药有限公司4CYHS2403640克立硼罗软膏呋欧医药科技(湖州)有限公司4CYHS2403639非布司他片湖南状元制药有限公司4CYHS2403637非布司他片湖南状元制药有限公司4CYHS2403636乳酸钠林格注射液南京黄龙生物科技有限公司4CYHS2403634乳酸钠林格注射液南京黄龙生物科技有限公司4CYHS2403633酒石酸长春瑞滨软胶囊人福普克药业(武汉)有限公司4CYHS2403627卡格列净片浙江诺得药业有限公司4CYHS2403626沙库巴曲缬沙坦钠片湖南威特制药股份有限公司4CYHS2403620沙库巴曲缬沙坦钠片湖南威特制药股份有限公司4CYHS2403619布瑞哌唑片浙江诺得药业有限公司4CYHS2403618甲氨蝶呤注射液哈尔滨誉衡制药有限公司4CYHS2403615甲氨蝶呤注射液哈尔滨誉衡制药有限公司4CYHS2403613甲氨蝶呤注射液哈尔滨誉衡制药有限公司4CYHS2403612甲氨蝶呤注射液哈尔滨誉衡制药有限公司4CYHS2403611甲氨蝶呤注射液哈尔滨誉衡制药有限公司4CYHS2403609格列齐特缓释片山东福瑞达医药集团有限公司4CYHS2403605平衡盐溶液(供灌注用)河北天成药业股份有限公司4CYHS2403604平衡盐溶液(供灌注用)河北天成药业股份有限公司4CYHS2403603富马酸伏诺拉生片山东齐都药业有限公司4CYHS2403602富马酸伏诺拉生片山东齐都药业有限公司4CYHS2403601吡美莫司乳膏湖北人福成田药业有限公司4CYHS2403630丁溴东莨菪碱注射液广州合和医药有限公司4CYHS2403628卡前列素氨丁三醇注射液天泽恩源(天津)制药有限公司4CYHS2403600艾拉莫德片北京福元医药股份有限公司4CYHS2403598氢溴酸替格列汀片苏州中化药品工业有限公司4CYHS2403597富马酸伏诺拉生片海南葫芦娃药业集团股份有限公司4CYHS2403595富马酸伏诺拉生片海南葫芦娃药业集团股份有限公司4CYHS2403594硝酸异山梨酯注射液山东力诺制药有限公司4CYHS2403591硝酸异山梨酯注射液山东力诺制药有限公司4CYHS2403590氯雷他定糖浆四川嘉创景态生物医药科技有限公司4CYHS2403589聚乙烯醇滴眼液国药控股鑫烨(湖北)医药有限公司4CYHS2403586盐酸帕罗西汀片福建省宝诺医药研发有限公司4CYHS2403581米库氯铵注射液成都诺和晟鸿生物制药有限公司4CYHS2403580米库氯铵注射液成都诺和晟鸿生物制药有限公司4CYHS2403579达格列净片湖南千金湘江药业股份有限公司4CYHS2403578达格列净片湖南千金湘江药业股份有限公司4CYHS2403577玻璃酸钠滴眼液瀚玛斯(山西)医药科技有限公司4CYHS2403572吡仑帕奈片山东朗诺制药有限公司4CYHS2403571吡仑帕奈片山东朗诺制药有限公司4CYHS2403570乳果糖口服溶液江西博泰药业有限公司4CYHS2403567乳果糖口服溶液江西博泰药业有限公司4CYHS2403566甲磺酸贝舒地尔片齐鲁制药(海南)有限公司4CYHS2403565吸入用乙酰半胱氨酸溶液四川美大康华康药业有限公司4CYHS2403564注射用盐酸万古霉素福安药业集团湖北人民制药有限公司4CYHS2403562左卡尼汀口服溶液黑龙江中桂制药有限公司4CYHS2403561左卡尼汀口服溶液黑龙江中桂制药有限公司4CYHS2403560莫匹罗星软膏苏州高迈药业有限公司4CYHS2403559瑞舒伐他汀依折麦布片(Ⅰ)重庆圣华曦药业股份有限公司4CYHS2403555苯磺酸阿曲库铵注射液华夏生生药业(北京)有限公司4CYHS2403552兰索拉唑肠溶胶囊成都欣捷高新技术开发股份有限公司4CYHS2403547ω-3脂肪酸乙酯90软胶囊瑞阳制药股份有限公司4CYHS2403545盐酸尼卡地平注射液漯河市汇创医药有限公司4CYHS2403558替米沙坦氨氯地平片沈阳达善医药科技有限公司4CYHS2403557替米沙坦片江苏长江药业有限公司4CYHS2403543流感病毒裂解疫苗安徽智飞龙科马生物制药有限公司3.3CXSS2400114注射用盐酸兰地洛尔合肥亿帆生物制药有限公司3CYHL2400210比拉斯汀口服溶液上海博志研新药物研究有限公司3CYHL2400209盐酸阿考替胺片南京海纳医药科技股份有限公司3CYHL2400208拉莫三嗪缓释片南京海鲸药业股份有限公司3CYHL2400207拉莫三嗪缓释片南京海鲸药业股份有限公司3CYHL2400206注射用盐酸兰地洛尔海南海灵化学制药有限公司3CYHL2400205 进口申请药品名称企业注册分类受理号羧基麦芽糖铁注射液Dr. Reddy’s Laboratories Ltd.5.2JYHS2400052羧基麦芽糖铁注射液Dr. Reddy’s Laboratories Ltd.5.2JYHS2400051羧基麦芽糖铁注射液Dr. Reddy’s Laboratories Ltd.5.2JYHS2400050SAR441566Sanofi-Aventis Recherche & Développement1JXHL2400256Rilzabrutinib片Sanofi-Aventis Recherche & Developpement1JXHL2400255甲磺酸奥希替尼片AstraZeneca AB2.4JXHL2400258甲磺酸奥希替尼片AstraZeneca AB2.4JXHL2400257Remternetug注射液Eli Lilly and Company1JXSL2400205S095029Institut de Recherches Internationales Servier1JXSL2400204SAR442970注射液Sanofi-Aventis Recherche & Developpement1JXSL2400203ADI-001Adicet Therapeutics, Inc.1JXSL2400202Itepekimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400200Frexalimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400199RO7790121注射液F. Hoffmann-La Roche Ltd.1JXSL2400198注射用Belantamab mafodotinGlaxoSmithKline Trading Services Limited2.2JXSL2400201 中药相关申请药品名称企业注册分类受理号膝痛颗粒仲颐(广州)科技创新研究有限公司1.1CXZL2400067苦丁茶总皂苷提取物华医神农(珠海)医药科技有限公司1.2CXZL2400069苦丁茶皂苷片华医神农(珠海)医药科技有限公司1.2CXZL2400068 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。