Nimodipine

Projected Cash Runway Extends into Second Calendar Quarter 2026, Well Beyond Potential 1H 2025 Submission of GTX-104 New Drug Application (NDA)Patient Enrollment in Pivotal STRIVE-ON Phase 3 Trial Continues, On Track for NDA Submission TimelinePoster Highlighting the STRIVE-ON Trial Presented at 2024 International Stroke Conference PRINCETON, N.J., Feb. 12, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced financial results and business highlights for the quarter ended December 31, 2023. "During the third quarter we continued to execute our focused strategy around our biggest value driver program GTX-104 and its pivotal Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial–NCT05995405). Having dosed the first patient in October, we’ve continued to enroll more patients and sites since that time,” said Prashant Kohli, CEO of Acasti. “With our balance sheet enhanced by the $7.5 million private placement secured last quarter and prudent use of resources announced in our strategic realignment plan in May 2023, our cash runway is now expected to extend into the second calendar quarter of 2026, well beyond our potential submission of GTX-104 NDA in the first half of 2025.” Recent Corporate Highlights Announced dosing of first patient in STRIVE-ON trial, a prospective, open-label, randomized (1:1 ratio), parallel group trial of GTX-104 compared with oral nimodipine, in patients hospitalized for aSAH.STRIVE-ON trial on track for potential NDA submission with the FDA anticipated to occur in the first half of calendar 2025.Hosted a Key Opinion Leader Event GTX-104: A Potential New Treatment Standard for Rare and Life-Threatening aneurysmal Subarachnoid Hemorrhage (aSAH)Overview of STRIVE-ON trial presented as a poster at the 2024 International Stroke Conference. Third Quarter 2024 Financial Results On June 29, 2023, the Board of Directors of the Company approved a reverse stock split of the Company's Class A common shares, no par value per share, at a ratio of 1-for-6, which was effective on July 10, 2023. All references below to the number of common shares, price per share and weighted average number of shares outstanding have been adjusted to reflect such reverse stock split. The Company reported a net loss of $2.4 million, or $0.21 per share, for the three months ended December 31, 2023, a decrease of $1.5 million from the net loss of $3.9 million, or $0.52 per share, for the three months ended December 31, 2022. The Company’s net loss of $2.4 million for the three months ended December 31, 2023, included $3.0 million of operating expenses, that were offset in part by interest income of $0.3 million from our investments, $0.1 million gain on change in fair of derivative warrant liabilities and $0.2 million in income tax recovery. Research and development expenses for the three months ended December 31, 2023 totaled $1.4 million compared to $2.5 million for the three months ended December 31, 2022. The decrease from the prior year period was mainly attributable to the Company’s strategic realignment plan to align the organizational and management cost structure to prioritize resources to GTX-104, thereby reducing losses to improve cash flow and extend available cash resources.General and administrative expenses were $1.6 million for the three months ended December 31, 2023, unchanged from $1.6 million for the three months ended December 31, 2022. The Company’s cash, cash equivalents and short-term investments as of December 31, 2023, were $25.1 million. The Company believes its cash, cash equivalents and short-term investments are sufficient to fund its operations into the second calendar quarter of 2026. About aneurysmal Subarachnoid Hemorrhage (aSAH) aSAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain. A primary cause of such bleeding is the rupture of an aneurysm. Approximately 70% of aSAH patients experience death or dependence, and more than 30% die within one month of hemorrhage. Approximately 50,000 patients in the United States are affected by aSAH per year, based on market research. About GTX-104 GTX-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for intravenous infusion (IV) in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTX-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTX-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTX-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTX-104 has the potential to better manage hypotension in aSAH patients. GTX-104 has been administered in over 150 healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine. The addressable market in the United States for GTX-104 is estimated to be about $300 million, based on market research. Outside of the United States, annual cases of aSAH are estimated at approximately 60,000 in the European Union, and approximately 150,000 in China. About Acasti Acasti is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Acasti's novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Acasti's lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents. Acasti's lead clinical asset, GTX-104, is an intravenous infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull. For more information, please visit: https://www.acastipharma.com/en. Forward-Looking Statements Statements in this press release that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Such forward looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Acasti to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements containing the terms "believes," "belief," "expects," "intends," "anticipates," "estimates", "potential," "should," "may," "will," "plans," "continue", "targeted" or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The forward-looking statements in this press release, including statements regarding the Company's anticipated cash runway, the timing of the planned NDA submission with the FDA in connection with the Company's STRIVE-ON trial, GTX-104’s commercial prospects, and GTX-104's potential to bring enhanced treatment options to patients suffering from aSAH are based upon Acasti's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions of the Phase 3 safety trial for GTX-104; (ii) regulatory requirements or developments and the outcome and timing of the proposed NDA application for GTX-104; (iii) changes to clinical trial designs and regulatory pathways; (iv) legislative, regulatory, political and economic developments; and (v) actual costs associated with Acasti's clinical trials as compared to management's current expectations. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and are filed by Acasti from time to time with the Securities and Exchange Commission and Canadian securities regulators. All forward-looking statements contained in this press release speak only as of the date on which they were made. Acasti undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable securities laws. For more information, please contact: Acasti Contact: Prashant KohliChief Executive OfficerTel: 450-686-4555Email: info@acastipharma.comwww.acasti.com Investor Relations: LifeSci AdvisorsMike MoyerManaging DirectorPhone: 617-308-4306Email: mmoyer@lifesciadvisors.com ACASTI PHARMA INC.Condensed Consolidated Interim Balance Sheets(Unaudited) December 31,2023 March 31,2023 (Expressed in thousands except share data) $ $ Assets Current assets: Cash and cash equivalents 18,545 27,875 Short-term investments 6,569 15 Receivables 959 802 Prepaid expenses 811 598 Total current assets 26,884 29,290 Operating lease right of use asset 23 463 Equipment 12 104 Intangible assets 41,128 41,128 Goodwill 8,138 8,138 Total assets 76,185 79,123 Liabilities and Shareholders’ equity Current liabilities: Trade and other payables 1,746 3,336 Operating lease liability 24 75 Total current liabilities 1,770 3,411 Derivative warrant liabilities 3,332 — Operating lease liability — 410 Deferred tax liability 6,403 7,347 Total liabilities 11,505 11,168 Commitments and contingencies Shareholders’ equity: Class A common shares, no par value per share; unlimited shares authorized as of December 31, 2023 and March 31, 2023; 9,399,404 and 7,435,533 shares issued and outstanding as of December 31, 2023 and March 31, 2023, respectively 261,038 258,294 Class B, C, D and E common shares, no par value per share; unlimited shares authorized as of December 31, 2023 and March 31, 2023; none issued and outstanding — — Additional paid-in capital 17,633 13,965 Accumulated other comprehensive loss (6,038) (6,038)Accumulated deficit (207,953) (198,266)Total shareholders' equity 64,680 67,955 Total liabilities and shareholders’ equity 76,185 79,123 ACASTI PHARMA INC.Condensed Consolidated Interim Statements of Loss and Comprehensive Loss(Unaudited) Three months ended Nine months ended December 31,2023 December 31,2022 December 31,2023 December 31,2022 (Expressed in thousands, except share and per share data) $ $ $ $ Operating expenses Research and development expenses, net of government assistance (1,443) (2,450) (2,998) (8,332)General and administrative expenses (1,570) (1,589) (4,922) (5,187)Sales and marketing (30) (206) (184) (563)Restructuring cost — — (1,485) — Loss from operating activities (3,043) (4,245) (9,589) (14,082) Foreign exchange gain (loss) 3 15 (2) (75)Change in fair value of derivative warrant liabilities 125 — (1,701) 10 Interest income and other expense, net 316 67 662 134 Total other income (expense), net 444 82 (1,041) 69 Loss before income tax recovery (2,599) (4,163) (10,630) (14,013) Income tax recovery 208 274 943 671 Net loss and total comprehensive loss (2,391) (3,889) (9,687) (13,342) Basic and diluted loss per share (0.21) (0.52) (1.09) (1.80) Weighted-average number of shares outstanding 11,506,257 7,435,472 8,874,872 7,416,318

每周药品注册受理数据，分门别类呈现，一目了然。(1.29-2.4）新药上市申请无。新药临床申请药品名称企业名称分类受理号DZD6008片迪哲(江苏)医药股份有限公司1CXHL2400131DZD6008片迪哲(江苏)医药股份有限公司1CXHL2400132HPP737胶囊恒翼生物医药(上海)股份有限公司1CXHL2400123HRS-5965胶囊成都盛迪医药有限公司1CXHL2400127HRS-5965胶囊成都盛迪医药有限公司1CXHL2400128HRS-5965胶囊成都盛迪医药有限公司1CXHL2400129HRS-5965胶囊成都盛迪医药有限公司1CXHL2400130HSK16149胶囊海思科医药集团股份有限公司1CXHL2400122HSK31858片西藏海思科制药有限公司1CXHL2400125MH004软膏明慧医药(杭州)有限公司1CXHL2400126TQ-B3525片正大天晴药业集团南京顺欣制药有限公司1CXHL2400139WGI-0301浙江海昶生物医药技术有限公司1CXHL2400133乙醇注射液成都倍特药业股份有限公司2.2;2.4CXHL2400120司美格鲁肽注射液深圳翰宇药业股份有限公司2.2CXHL2400134司美格鲁肽注射液深圳翰宇药业股份有限公司2.2CXHL2400135司美格鲁肽注射液深圳翰宇药业股份有限公司2.2CXHL2400136司美格鲁肽注射液深圳翰宇药业股份有限公司2.2CXHL2400137司美格鲁肽注射液深圳翰宇药业股份有限公司2.2CXHL2400138度他雄胺坦索罗辛胶囊昆明积大制药股份有限公司2.3CXHL2400121注射用HYH2006078P1天地恒一制药股份有限公司1CXHL2400124ABO2011注射液艾博生物科技(上海)有限公司1CXSL2400083BAT4406F注射液百奥泰生物制药股份有限公司1CXSL2400071IAH0968盛禾(中国)生物制药有限公司1CXSL2400086IBI133信达生物制药(苏州)有限公司1CXSL2400085KH658眼用注射液成都弘基生物科技有限公司1CXSL2400088KH658眼用注射液成都弘基生物科技有限公司1CXSL2400089KH658眼用注射液成都弘基生物科技有限公司1CXSL2400090KSH01注射液科士华(深圳)生物技术有限公司1CXSL2400079KYS202003A注射液江苏康缘药业股份有限公司1CXSL2400073SCTB14注射液神州细胞工程有限公司1CXSL2400069SHR-3276注射液苏州盛迪亚生物医药有限公司1CXSL2400081SSGJ-707注射液沈阳三生制药有限责任公司1CXSL2400087TQB2928注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2400080γδ-T细胞注射液广东暨德康民生物科技有限责任公司1CXSL2400078人凝血因子IX成都蓉生药业有限责任公司3.4CXSL2400072人脐带间充质干细胞注射液深圳市北科生物科技有限公司1CXSL2400092德谷胰岛素利拉鲁肽注射液东莞市东阳光生物药研发有限公司3.3CXSL2400082注射用BAT4306F百奥泰生物制药股份有限公司2.4CXSL2400070注射用TRS005浙江特瑞思药业股份有限公司1CXSL2400084索卡佐利单抗注射液兆科(广州)肿瘤药物有限公司2.2CXSL2400091输注用SN-001浓缩冻干粉昆明赛诺制药股份有限公司1CXSL2400077靶向CD99嵌合抗原受体基因修饰的自体T细胞注射液武汉波睿达生物科技有限公司1CXSL2400068靶向GPC3装甲型嵌合抗原受体自体T细胞注射液C-CAR031上海赛比曼生物科技有限公司1CXSL2400076六价重组诺如病毒疫苗(汉逊酵母)远大赛威信生命科学(南京)有限公司1.1CXSL2400074六价重组诺如病毒疫苗(汉逊酵母)远大赛威信生命科学(南京)有限公司1.1CXSL2400075仿制药申请药品名称企业名称分类受理号丁溴东莨菪碱注射液中润药业有限公司4CYHS2400394丙戊酸钠口服溶液山东达因海洋生物制药股份有限公司4CYHS2400465乙磺酸尼达尼布软胶囊沈阳红旗制药有限公司4CYHS2400376乙磺酸尼达尼布软胶囊沈阳红旗制药有限公司4CYHS2400377他达拉非片山东汇泽生物制药有限公司4CYHS2400427伏立康唑干混悬剂南京易亨制药有限公司4CYHS2400447利丙双卡因乳膏湖南状元制药有限公司4CYHS2400432利丙双卡因乳膏山东新华制药股份有限公司4CYHS2400440利丙双卡因乳膏江苏盈科生物制药有限公司4CYHS2400402加替沙星滴眼液合肥源丰顺医药科技有限公司3CYHS2400420卡左双多巴缓释片重庆华邦制药有限公司4CYHS2400443右美沙芬安非他酮缓释片江苏恩华药业股份有限公司3CYHL2400033吡拉西坦注射液西安达莫制药有限公司3CYHS2400403吸入用乙酰半胱氨酸溶液北京世桥生物制药有限公司4CYHS2400426吸入用盐酸氨溴索溶液北京韩美药品有限公司3CYHS2400419哈西奈德溶液宣城市竞成医药有限公司3CYHS2400457噻托溴铵吸入粉雾剂浙江仙琚医药科技有限公司4CYHL2400032地夸磷索钠滴眼液郑州维先医药科技有限公司4CYHS2400396地夸磷索钠滴眼液郑州维先医药科技有限公司4CYHS2400397培哚普利氨氯地平片(III)深圳市朗博生物医药股份有限公司4CYHS2400407多巴丝肼片安徽贝克生物制药有限公司4CYHS2400418奥贝胆酸片正大天晴药业集团股份有限公司3CYHS2400424奥贝胆酸片正大天晴药业集团股份有限公司3CYHS2400425富马酸伏诺拉生片四川制药制剂有限公司4CYHS2400451富马酸伏诺拉生片四川制药制剂有限公司4CYHS2400452富马酸伏诺拉生片浙江赛默制药有限公司4CYHS2400390富马酸伏诺拉生片浙江赛默制药有限公司4CYHS2400391富马酸福莫特罗吸入溶液浙江赛默制药有限公司4CYHS2400393尼莫地平注射液四川美大康佳乐药业有限公司4CYHS2400415布洛芬混悬液青岛黄海制药有限责任公司4CYHS2400439布美他尼注射液山东致泰医药技术有限公司3CYHS2400453帕拉米韦注射液山东齐都药业有限公司3CYHS2400400帕拉米韦注射液河南润弘制药股份有限公司3CYHS2400380普拉洛芬滴眼液江苏广承药业有限公司4CYHS2400437替米沙坦氨氯地平片湖南慧泽生物医药科技有限公司4CYHS2400458替米沙坦氨氯地平片(II)湖南慧泽生物医药科技有限公司4CYHS2400459枸橼酸坦度螺酮片南京海纳制药有限公司4CYHS2400381枸橼酸坦度螺酮片南京海纳制药有限公司4CYHS2400382枸橼酸西地那非片安若维他药业泰州有限公司4CYHS2400388枸橼酸西地那非片安若维他药业泰州有限公司4CYHS2400389比拉斯汀片北京四环科宝制药股份有限公司4CYHS2400460氨氯地平阿托伐他汀钙片湖南威特制药股份有限公司4CYHS2400461氯化钙注射液森淼(山东)药业有限公司3CYHS2400449注射用盐酸表柔比星合肥亿帆生物制药有限公司4CYHS2400442注射用硫酸多黏菌素B深圳华药南方制药有限公司3CYHS2400398注射用硫酸艾沙康唑山西德元堂药业有限公司4CYHS2400392注射用醋酸西曲瑞克江苏诺泰澳赛诺生物制药股份有限公司4CYHS2400431洛索洛芬钠贴剂北京诚济制药股份有限公司4CYHL2400028洛索洛芬钠贴剂北京诚济制药股份有限公司4CYHL2400027熊去氧胆酸胶囊山东淄博新达制药有限公司4CYHS2400384盐酸丙卡特罗口服溶液合肥远志医药科技开发有限公司3CYHS2400455盐酸丙美卡因滴眼液兆科(广州)眼科药物有限公司3CYHS2400405盐酸乌拉地尔注射液安徽长江药业有限公司4CYHS2400470盐酸乌拉地尔注射液安徽长江药业有限公司4CYHS2400471盐酸决奈达隆片石家庄四药有限公司4CYHS2400464盐酸决奈达隆片江西科睿药业有限公司4CYHS2400430盐酸去氧肾上腺素注射液珠海前列药业有限公司3CYHS2400404盐酸去氧肾上腺素注射液珠海前列药业有限公司3CYHS2400406盐酸多奈哌齐片山东新时代药业有限公司4CYHS2400445盐酸多奈哌齐片山东新时代药业有限公司4CYHS2400446盐酸多巴酚丁胺注射液西藏邦臣药业集团有限公司3CYHS2400385盐酸奥洛他定滴眼液石家庄格瑞药业有限公司4CYHS2400399盐酸尼卡地平注射液浙江华海药业股份有限公司4CYHS2400383盐酸左沙丁胺醇雾化吸入溶液山东达因金控儿童制药有限公司3CYHS2400429盐酸左米那普仑缓释胶囊江苏恩华药业股份有限公司3CYHL2400029盐酸左米那普仑缓释胶囊江苏恩华药业股份有限公司3CYHL2400030盐酸左米那普仑缓释胶囊江苏恩华药业股份有限公司3CYHL2400031盐酸曲唑酮片河北龙海药业有限公司3CYHS2400436盐酸氨溴索滴剂广西维威制药有限公司3CYHS2400422盐酸氨溴索滴剂广西维威制药有限公司3CYHS2400423盐酸甲氧氯普胺注射液山东致泰医药技术有限公司3CYHS2400466盐酸甲氧氯普胺注射液北京远方通达医药技术有限公司3CYHS2400468盐酸缬更昔洛韦片浙江车头制药股份有限公司4CYHS2400441盐酸美金刚口腔崩解片万全万特制药江苏有限公司3CYHS2400428盐酸胍法辛缓释片四川百利药业有限责任公司3CYHS2400472盐酸胍法辛缓释片四川百利药业有限责任公司3CYHS2400473盐酸艾司洛尔氯化钠注射液海南爱科制药有限公司4CYHS2400409盐酸苯海拉明注射液山东致泰医药技术有限公司3CYHS2400469盐酸贝尼地平片浙江赛默制药有限公司4CYHS2400386盐酸贝尼地平片浙江赛默制药有限公司4CYHS2400387硝酸异山梨酯注射液湖北民康药业集团有限公司4CYHS2400401硫酸氢氯吡格雷片天方药业有限公司4CYHS2400378硫酸氨基葡萄糖胶囊广州汇元医药科技有限公司4CYHS2400433硫酸镁钠钾口服用浓溶液安徽环球药业股份有限公司4CYHS2400450硫酸镁钠钾口服用浓溶液沈阳天邦药业有限公司4CYHS2400395碘美普尔注射液四川科伦药业股份有限公司4CYHS2400463磷酸奥司他韦干混悬剂福建省闽东力捷迅药业股份有限公司3CYHS2400421米诺地尔搽剂乐福思健康产业股份公司3CYHS2400410米诺地尔搽剂乐福思健康产业股份公司3CYHS2400411米诺地尔搽剂乐福思健康产业股份公司3CYHS2400412米诺地尔搽剂乐福思健康产业股份公司3CYHS2400413米诺地尔搽剂乐福思健康产业股份公司3CYHS2400414美索巴莫注射液广州合和医药有限公司3CYHS2400448聚乙二醇钠钾散四川科伦药业股份有限公司4CYHS2400408聚乙烯醇滴眼液吉林敖东药业集团延吉股份有限公司4CYHS2400434聚乙烯醇滴眼液吉林敖东药业集团延吉股份有限公司4CYHS2400435脂肪乳注射液(C14-24)江苏盈科生物制药有限公司4CYHS2400379舒更葡糖钠注射液乳源东阳光药业有限公司4CYHS2400462色甘酸钠滴眼液中山万汉制药有限公司3CYHS2400416色甘酸钠滴眼液中山万汉制药有限公司3CYHS2400417西罗莫司片杭州中美华东制药有限公司4CYHS2400467酒石酸阿福特罗雾化吸入用溶液湖南华纳大药厂股份有限公司3CYHL2400034门冬氨酸帕瑞肽注射液远大医药(中国)有限公司4CYHS2400456阿仑膦酸钠片安徽艾立德制药有限公司4CYHS2400444非诺贝特酸胆碱缓释胶囊华润双鹤药业股份有限公司4CYHS2400438非那雄胺他达拉非胶囊山东华铂凯盛生物科技有限公司3CYHS2400454进口申请药品名称企业名称分类受理号BRII-835 (VIR-2218) 注射液Brii Biosciences Limited1JXHL2400027Ulixacaltamide缓释片Praxis Precision Medicines1JXHL2400024Ulixacaltamide缓释片Praxis Precision Medicines1JXHL2400025Ulixacaltamide缓释片Praxis Precision Medicines1JXHL2400026八氟丙烷脂质微球注射液LANTHEUS MI CANADA INC5.1JXHS2400011利多卡因凝胶贴膏Teh Seng Pharmaceutical Mfg. Co., Ltd. Third Factory5.2JYHS2400007碳酸司维拉姆片Apothecon Pharmaceuticals Pvt. Ltd.5.2JYHS2400008非那雄胺喷雾剂Polichem S.A.5.1JXHS2400010BRII-179注射液Brii Biosciences Limited1JXSL2400029Elranatamab注射液Pfizer Inc.3.1JXSS2400005Elranatamab注射液Pfizer Inc.3.1JXSS2400006Frexalimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400030Frexalimab注射液Sanofi-Aventis Recherche & Développement1JXSL2400031GSK1070806注射液GlaxoSmithKline Research & Development Limited1JXSL2400028Ravulizumab注射液Alexion Pharmaceuticals, Inc.2.2JXSL2400032Ravulizumab注射液Alexion Pharmaceuticals, Inc.2.2JXSL2400033重组带状疱疹疫苗(CHO细胞)GlaxoSmithKline Biologicals SA3.1JXSS2400007中药相关申请药品名称企业名称分类受理号七味脂肝颗粒江苏康缘药业股份有限公司1.1CXZL2400008喉喑清胶囊贵州瑞和制药有限公司1.1CXZS2400007青杏颗粒广州中医药大学(广州中医药研究院)1.1CXZL2400007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。