Clazakizumab

Initiated Phase 2b trial of VYN201 in nonsegmental vitiligo, with top-line results expected in mid-2025Phase 1a SAD/MAD trial of VYN202 progressing, with data from the SAD and MAD portions expected in Q3 and Q4 2024, respectivelyBalance sheet expected to fund key clinical milestones for VYN201 and VYN202 through the end of 2025 BRIDGEWATER, N.J., Aug. 14, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need, today announced financial results as of and for the three and six months ended June 30, 2024 and provided a business update. "We advanced our clinical programs in the second quarter of 2024, highlighted by the initiation of our Phase 2b trial of VYN201 and the Phase 1a trial of VYN202," said David Domzalski, President and Chief Executive Officer of VYNE. "We are pleased with the progress we are making with both clinical programs. We remain on track to report top-line data from our Phase 2b clinical trial for VYN201 in subjects with nonsegmental vitiligo in the middle of next year. We also expect to report top-line data from the single ascending dose portion of the Phase 1a trial of VYN202 this quarter, followed by results from the multiple ascending dose portion in the fourth quarter. Upon the successful completion of this Phase 1a trial, we plan to advance VYN202 into two Phase 1b proof-of-concept trials with top-line readouts in the second half of next year." Recent Pipeline Updates VYN201 VYN201 is a locally administered pan-bromodomain ("BD") BET inhibitor designed as a “soft” drug to address diseases involving multiple, diverse inflammatory cell signaling pathways while providing low systemic exposure. VYNE initiated a Phase 2b trial of VYN201 in nonsegmental vitiligo in June 2024. The Phase 2b trial is a randomized, double-blind, vehicle-controlled trial evaluating the efficacy, safety and pharmacokinetics of once-daily VYN201 gel in three dose cohorts (1%, 2% and 3% concentrations) compared to vehicle for 24 weeks. Subjects are being randomized at 1:1:1:1 ratio. Following the 24-week treatment period, subjects in the 1%, 2%, and 3% cohorts will continue treatment with their respective dose concentrations for an additional 28-week open label extension. Subjects in the vehicle group during the initial 24-week treatment period will be equally re-randomized to receive VYN201 1%, 2% or 3% gel for an additional 28 weeks. VYNE expects to enroll approximately 40 subjects in each arm and to report top-line results from the 24-week double-blind portion of the trial in mid-2025. VYN202 VYN202 is an oral small molecule BD2-selective BET inhibitor designed to achieve potential class-leading selectivity and potency (BD2 vs. BD1). A first-in-human Phase 1a single ascending dose/multiple ascending dose ("SAD/MAD") trial was initiated in June 2024. VYNE expects to report top-line results from the SAD and MAD portions of the trial in the third and fourth quarters of 2024, respectively. If the Phase 1a trial is successfully completed, VYNE plans to initiate Phase 1b trials in adult subjects with moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis, with top-line results anticipated in the second half of 2025. Recent Corporate Update In July, VYNE appointed Subhashis Banerjee, M.D., as Senior Vice President of Clinical Development. Dr. Banerjee is a trained immunologist and rheumatologist with over 25 years of drug development experience at large pharmaceutical companies, including the development of therapies for psoriasis and arthritic conditions. He most recently served as Vice President & Disease Area Head, Rheumatology and Dermatology at Bristol Myers Squibb. Dr. Banerjee played a key role in the development strategy of immunology assets across multiple platforms for several immune-mediated diseases, including SOTYKTU® (deucravacitinib), ORENCIA® (abatacept), clazakizumab (anti-IL-6 antibody), TALTZ® (ixekizumab, anti-IL-17 antibody) and XELJANZ® (tofacitinib). Upcoming Conference Participation H.C. Wainwright 26th Annual Global Investment Conference, September 9-11, 2024, New York, NYStifel Immunology and Inflammation Virtual Summit, September 17-18, 2024 Financial Results as of and for the Second Quarter Ended June 30, 2024 Cash position. As of June 30, 2024, VYNE had cash, cash equivalents, restricted cash and marketable securities of $78.1 million. VYNE believes its cash, cash equivalents, restricted cash and marketable securities as of June 30, 2024 will be sufficient to fund its operations through the end of 2025. Revenues. Revenues totaled $0.2 million and $0.1 million for each of the quarters ended June 30, 2024 and 2023, respectively, consisting of royalty revenue from the Company's royalty agreement with LEO Pharma, to whom VYNE previously licensed the rights to Finacea® foam. Research and development expenses. VYNE’s research and development expenses for the quarter ended June 30, 2024 were $7.3 million, representing an increase of $0.1 million, or 1.0%, compared to $7.2 million for the quarter ended June 30, 2023. The increase was primarily driven by expenses related to preparatory and clinical trial activities for a Phase 2b trial of VYN201 in subjects with nonsegmental vitiligo, which was initiated in June 2024, of $3.2 million, including a $1.0 million development milestone payment due to Tay Therapeutics Ltd. ("Tay") upon the initiation of the Phase 2b trial. In addition, employee-related expenses increased by $0.3 million following the hiring of additional research and development personnel. These increases were partially offset by a decrease in expenses associated with VYN202 of $3.5 million, primarily driven by lower amounts owed to Tay under the license agreement with respect to VYN202 (the "VYN202 License Agreement"). In April 2023, VYNE made a one-time cash payment of $3.75 million to Tay in connection with entering into the VYN202 License Agreement. In the second quarter of 2024, the Company incurred a $1.0 million development milestone payment due to Tay following the initiation of a Phase 1a SAD/MAD trial of VYN202. General and administrative expenses. VYNE’s general and administrative expenses for the quarter ended June 30, 2024 were $3.3 million, representing an increase of $0.1 million, or 2.1%, compared to $3.2 million for the quarter ended June 30, 2023. The increase was primarily driven by consulting and professional fees. Net loss. Net loss and net loss per share for the quarter ended June 30, 2024 were $9.4 million and $0.22, respectively, compared to a net loss and net loss per share of $10.1 million and $3.09, respectively for the comparable period in 2023. About VYNE Therapeutics Inc. VYNE is a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need. VYNE's unique and proprietary BET inhibitors, which comprise its InhiBET™ platform, are designed to overcome limitations of early generation BET inhibitors by leveraging alternative routes of administration and enhanced selectivity. For more information about VYNE Therapeutics Inc. or its product candidates, visit www.vynetherapeutics.com. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts. Investor Relations:John FrauncesLifeSci Advisors, LLC917-355-2395jfraunces@lifesciadvisors.com Tyler ZerondaVYNE Therapeutics Inc.908-458-9106Tyler.Zeronda@VYNEtx.com Media Relations: Mike BeyerSam Brown Inc.312-961-2502mikebeyer@sambrown.com Cautionary Statement Regarding Forward-Looking StatementsThis release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding VYNE's ability to successfully complete its Phase 1a trial of VYN202, future clinical trials of VYN202, the expected enrollment and timing for reporting top-line results from trials of VYN201 and VYN202, VYNE’s projected cash runway, and other statements regarding the future expectations, plans and prospects of VYNE. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: VYNE’s ability to successfully develop its product candidates; the timing of commencement of future preclinical studies and clinical trials; VYNE’s ability to complete and receive favorable results from clinical trials of its product candidates; VYNE’s ability to obtain additional funding, either through equity or debt financing transactions or collaboration arrangements; and VYNE’s ability to comply with various regulations applicable to its business. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in VYNE’s Annual Report on Form 10-K for the year ended December 31, 2023, and VYNE’s other filings from time to time with the U.S. Securities and Exchange Commission. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events. Third-party products and company names mentioned herein may be the trademarks of their respective owners. VYNE THERAPEUTICS INC.CONDENSED CONSOLIDATED BALANCE SHEETS(U.S. dollars in thousands, except share and per share data)(Unaudited) June 30, December 31, 2024 2023 Assets Current Assets: Cash and cash equivalents$29,609 $30,620 Restricted cash 46 54 Investment in marketable securities 48,492 62,633 Prepaid and other current assets 5,629 2,656 Total Current Assets 83,776 95,963 Non-current Assets: Operating lease right-of-use assets 151 207 Non-current prepaid expenses and other assets 2,721 1,515 Total Non-current Assets 2,872 1,722 Total Assets$86,648 $97,685 Liabilities and Stockholders’ Equity Current Liabilities: Trade payables$4,516 $1,659 Accrued expenses 5,069 4,119 Employee related obligations 736 1,645 Operating lease liabilities 120 115 Other current liabilities 1,313 — Total Current Liabilities 11,754 7,538 Long-term Liabilities: Non-current operating lease liabilities 25 99 Other liabilities — 1,313 Total Long-term Liabilities 25 1,412 Total Liabilities 11,779 8,950 Commitments and Contingencies Stockholders' Equity: Preferred stock: $0.0001 par value; 20,000,000 shares authorized at June 30, 2024 and December 31, 2023; no shares issued and outstanding at June 30, 2024 and December 31, 2023 — — Common stock: $0.0001 par value; 150,000,000 shares authorized at June 30, 2024 and December 31, 2023; 14,536,124 and 14,098,888 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively 1 1 Additional paid-in capital 781,917 780,044 Accumulated other comprehensive (loss) income (58) 26 Accumulated deficit (706,991) (691,336)Total Stockholders' Equity 74,869 88,735 Total Liabilities and Stockholders’ Equity$86,648 $97,685 VYNE THERAPEUTICS INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(U.S. dollars in thousands, except per share data)(Unaudited) Three Months EndedJune 30, Six Months EndedJune 30, 2024 2023 2024 2023 Revenues Royalty revenues$198 $135 $296 $234 Total Revenues 198 135 296 234 Operating Expenses: Research and development 7,306 7,233 11,014 9,967 General and administrative 3,288 3,220 7,058 6,460 Total Operating Expenses 10,594 10,453 18,072 16,427 Operating Loss (10,396) (10,318) (17,776) (16,193)Other income, net 1,001 280 2,140 543 Loss from continuing operations before income taxes (9,395) (10,038) (15,636) (15,650)Income tax expense — — — — Loss from continuing operations (9,395) $(10,038) (15,636) (15,650)Loss from discontinued operations, net of income taxes (11) (20) (19) (30)Net Loss$(9,406) $(10,058) $(15,655) $(15,680) Loss per share from continuing operations, basic and diluted$(0.22) $(3.08) $(0.37) $(4.81)Income (loss) per share from discontinued operations, basic and diluted$0.00 $(0.01) $0.00 $(0.01)Loss per share, basic and diluted$(0.22) $(3.09) $(0.37) $(4.82) Weighted average shares outstanding - basic and diluted 42,586 3,274 42,584 3,265

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。