Jiangsu Xiansheng Biopharmaceutical Co., Ltd.

Reported two positive readouts for rademikibart, the Company’s lead asset, from the Global Phase 2b trial in moderate-to-severe persistent asthma and from the China pivotal trial in moderate-to-severe atopic dermatitis (AD) Type C meeting in AD and End-of-Phase 2 (EoP2) meeting in asthma have been scheduled with the U.S. Food and Drug Administration (FDA) in Q2 2024 to discuss trial results and proposed registrational programs Granted Simcere the exclusive rights to develop, manufacture, and commercialize rademikibart for all indications in Greater China. Simcere is actively engaged with China’s Center for Drug Evaluation (CDE) regarding the potential NDA filing for marketing approval in China for treatment with rademikibart in patients with AD Cash, cash equivalents and short-term investments of $118.7 million expected to support planned operations into at least 2026 SAN DIEGO, CA and TAICANG, China, April 16, 2024 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma,” “Connect” or the “Company”), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today reported financial results for the year ended December 31, 2023, and provided a business update. “2023 marked an achievement-filled year for Connect highlighted by two positive readouts with our lead asset rademikibart from the global Phase 2b trial in asthma and the pivotal trial in China in AD. The clinical data we shared from these two trials demonstrated the potential for fast onset of relief, impressive maintenance effect and strong durable efficacy, even with every 4 weeks dosing, and no significant safety concerns. Taken together, the results further underscore rademikibart’s best-in-biologics potential,” said Zheng Wei, Ph.D., Co-Founder and Chief Executive Officer of Connect Biopharma. “Connect is well positioned for another important year in 2024, as we look forward to the scheduled meetings with the FDA to discuss rademikibart registrational programs in AD and asthma in the second quarter of 2024.” Full Year 2023 and Recent Highlights Clinical Programs Highlights Rademikibart Program Reported positive topline data in the Global Phase 2b trial in adult patients with moderate-to-severe asthma in December 2023. The trial met its primary endpoint showing both doses of rademikibart treatment significantly improved lung function at Week 12. Moreover, the improvement in lung function was seen as early as Week 1 and was sustained through Week 24 with both doses. Significant improvements were also observed in asthma control symptoms early and were sustained through Week 24. Rademikibart was generally well tolerated with no unexpected safety signals. Announced positive long-term data from the China pivotal trial in patients with moderate-to-severe AD in November 2023. Clinical response (IGA0/1 and EASI-75) achieved at Week 16 (Stage 1) with rademikibart treatment was maintained through Week 52 (Stage 2) with both every two weeks (Q2W) and every four weeks (Q4W) dosing regimens, with about 90% of the patients on Q4W dose maintaining both IGA0/1 and EASI-75 through Week 52. Additionally, the percentage of patients achieving IGA 0/1 and EASI-75 continued to increase over the 36 weeks of Stage 2 of the study. Rademikibart continued to be well tolerated over 52 weeks of treatment. Icanbelimod Program Reported positive long-term data from the maintenance period through Week 48 of CN002 phase 2 icanbelimod trial in patients with moderate-to-severe ulcerative colitis (UC) in June 2023. Icanbelimod demonstrated sustained clinical remission through Week 48 in 80% of patients who achieved clinical remission at Week 12 of the induction period. There were no new safety signals in the maintenance period and icanbelimod continued to be well-tolerated, consistent with the observed safety data in the induction period. Publications Silverberg JI, et al. Efficacy and safety of rademikibart (CBP-201), a next-generation mAb targeting IL-4Rα, in adults with moderate to severe atopic dermatitis: A phase 2 randomized trial (CBP-201-WW001). J Allergy Clin Immunol. 2024 Apr;153(4):1040-1049.e12. Wang J, et al. Rademikibart (CBP-201), a next-generation monoclonal antibody targeting human IL-4Rα: Two phase I randomized trials, in healthy individuals and patients with atopic dermatitis. Clin Transl Sci. 2023 Dec;16(12):2614-2627. Silverberg JI, et al. A Mini Review of the Impact of Baseline Disease Severity on Clinical Outcomes: Should We Compare Atopic Dermatitis Clinical Trials?Dermatol Ther (Heidelb). 2023 Dec;13(12):3019-3029. Zhang L, et al. Preclinical immunological characterization of rademikibart (CBP-201), a next-generation human monoclonal antibody targeting IL-4Rα, for the treatment of Th2 inflammatory diseases. Sci Rep. 2023 Jul 31;13(1):12411. Presentations Poster presentation at the 2023 Advances in Inflammatory Bowel Diseases Meeting in December 2023 on the Phase 2 trial of icanbelimod showing that patients with UC would likely derive greater clinical benefit with higher doses than icanbelimod 0.2 mg QD, the maximum administered in this Phase 2 dose-ranging trial, which will thus be investigated in the Phase 3 trial program. Four posters at the 2023 World Congress of Dermatology in July 2023 on data from the initial 16-week treatment period with rademikibart of the pivotal trial in China in patients with moderate-to-severe AD. The posters provided detailed and new information on the achievement of primary and secondary endpoints, and highlighted that consistent improvements were observed in both investigator-rated outcomes and patient reported outcomes. Poster presentation at the 2023 Revolutionizing Atopic Dermatitis (RAD) Annual Meeting in April 2023 on the meaningful improvements observed in patients with either moderate or severe AD with 16 weeks of rademikibart treatment at either two- or four-week dosing from the global Phase 2 trial in AD. Late breaking oral presentation and an e-poster with an oral presentation on rademikibart clinical development program in patients with moderate-to-severe AD at the American Academy of Dermatology (AAD) Annual Meeting in March 2023. Data presented showed that patients treated with rademikibart were observed to demonstrate rapid and sustained improvements at Week 16 in the primary population from the China pivotal trial and show rapid and sustained improvement across all body regions in a post-hoc analyses from the Global Phase 2b trial. Given the highly compelling therapeutic potential observed with rademikibart in multiple therapeutic areas, the Company announced the strategic prioritization of rademikibart development program to further support near-term and long-term value drivers. To maximize resources and extend its cash runway, the Company has decided to terminate, effective May 2024, the in-license agreement for CBP-174 with Pfizer (originally licensed from Arena Pharmaceuticals) and postpone the advancement of all pre-clinical and discovery programs. The Company’s overall partnership strategy remains unchanged and the Company will continue to actively seek a development and commercialization partner for rademikibart and development partner for icanbelimod at a global or a regional level. Corporate Development Highlights Signed an exclusive licensing and collaboration agreement with Simcere in November 2023. The agreement granted Simcere the exclusive rights to develop, manufacture, and commercialize rademikibart for all indications in Greater China, while Connect retains all the rights to develop and commercialize rademikibart in all other markets. As part of the agreement, the Company received a ¥150 million ($21 million) upfront payment and will receive up to ¥875 million ($120 million) upon achieving certain development and commercial milestones, in addition to royalties up to low double-digit percentages of net sales. Appointed James Zuie-chin Huang, M.B.A., a successful entrepreneur, investor, and key opinion leader in the healthcare sector, in February 2024 to the Company’s Board of Directors. Anticipated Upcoming Milestones The Company has scheduled two meetings with the FDA in Q2 2024, including a Type C meeting to discuss the potential U.S. registrational path for rademikibart in AD, followed by an EoP2 meeting to discuss a U.S. registrational program for rademikibart in asthma. Simcere, Connect’s partner in Greater China who holds responsibility for future development, including for additional indications and NDA submission, is progressing its regulatory discussion with China’s CDE ahead of a planned NDA filing for rademikibart for patients with AD. Connect expects to receive an update from Simcere as early as Q2 2024 on these next steps. 2023 Financial Results Cash, cash equivalents and short-term investments were $118.7 million as of December 31, 2023, compared with $161.9 million on December 31, 2022. The $43.2 million decrease was mainly due to cash used to advance the Company’s clinical programs and fund its operations, offset by the upfront partnership payment received from Simcere. Based on its current operating plans, management believes the Company has sufficient cash and investments to support planned operations into at least 2026. R&D expenses for the year ended December 31, 2023, totaled $51.9 million, compared with $96.6 million for the year ended December 31, 2022, a decrease of $44.7 million primarily due to fewer clinical trials, less drug product manufacturing activity, and lower personnel costs due to fewer research and development headcount compared to prior year. Administrative expenses totaled $14.5 million for the year ended December 31, 2023, compared with $20.8 million for the year ended December 31, 2022. The decrease in administrative expenses was primarily due to lower professional fees, including accounting, insurance, legal, and other consulting costs, and lower share-based compensation expense compared to the prior year. Net loss totaled $59.5 million for the year ended December 31, 2023, compared with a net loss of $118.1 million for the year ended December 31, 2022. Connect Biopharma Holdings Ltd. Condensed Consolidated Statements of Loss For the Year Ended December 31, (in USD thousands) 2022 2023 Research and development expenses $ (96,630) $ (51,913) Administrative expenses (20,806) (14,515) Net impairment losses (4,698) - Other income 929 1,580 Other (losses)/gains - net 1,889 2,774 Operating loss (119,316) (62,074) Finance income 1,544 2,714 Finance cost (21) (23) Finance income – net 1,523 2,691 Net loss before income tax (117,793) (59,383) Income tax expense (298) (120) Net loss $ (118,091) $ (59,503) Net loss attributable to： Owners of the Company $ (118,091) $ (59,503) Net loss per share Basic and diluted $ (2.15) $ (1.08) Connect Biopharma Holdings Ltd. Selected Consolidated Balance Sheet Data December 31, (in USD thousands) 2022 2023 Cash, cash equivalents, short-term and long-term investments $ 161,857 $ 118,653 Total assets 174,013 125,892 Total liabilities 16,521 24,849 Accumulated losses (479,844) (539,347) Total shareholders' equity 157,492 101,043 About Connect Biopharma Holdings Limited Connect Biopharma is a global, clinical-stage biopharmaceutical company applying its expertise in T cell biology and deep knowledge of the drug discovery industry to develop innovative therapies to treat chronic inflammatory diseases with the goal of improving the lives of millions of those affected around the world. The Company is building a rich pipeline of proprietary small molecules and antibodies, using functional T cell assays, to screen and discover potent product candidates against validated immune targets. The Company’s lead product candidate, rademikibart (formerly known as CBP-201), is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα) in development for the treatment of atopic dermatitis (AD) and asthma. The Company’s second product candidate, icanbelimod (formerly known as CBP-307), is a modulator of S1P1 T cell receptors and is in development for the treatment of ulcerative colitis (UC). For more information, please visit: Forward-Looking Statements Connect Biopharma cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may”, “could”, “will”, “would”, “should”, “expect”, “plan”, “anticipate”, “believe”, “estimate”, “intend”, “predict”, “seek”, “contemplate”, “look forward”, “potential”, “continue” or “project” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include the Company’s plans to advance the development of its product candidates, the timing of achieving any development, regulatory or commercial milestones or reporting data or whether such milestones or data will be achieved or generated, including whether any new drug application will be submitted or accepted and the timing thereof, and the potential of such product candidates, including to achieve any benefit, improvement, differentiation, trend or pro any product approval or be effective, the Company’s ability to identify and enter into any strategic partnership, whether the Company’s Greater China partnership will meet expectations, and the sufficiency of the Company’s cash and investments to support planned operations. The inclusion of forward-looking statements should not be regarded as a representation by Connect Biopharma that any of its plans will be achieved. Actual data may differ materially from those set forth in this release due to the risks and uncertainties inherent in the Company’s business and other risks described in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on April 11, 2023, and its other reports. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Connect Biopharma undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included in Connect Biopharma’s filings with the SEC which are available from the SEC’s website ( ) and on Connect Biopharma’s website ( ) under the heading “Investors.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. INVESTOR CONTACT: Tim McCarthy LifeSci Advisors tim@lifesciadvisors.com

摘要abstract2024年3月7个1类新药、5个改良型新药申请上市；167个品种按新分类仿制申请申报，其中33个品种暂无国内仿制获批，石家庄四药申报品种数最多；32个存量品种有企业申报一致性评价，其中2个品种为首次申报。3款1类新药获批上市，4个品种获批新适应症；15个品种首家过评，其中5个为首仿。创新药品种申报情况2024年3月，97个创新药品种（药品注册分类为“1”的品种）获CDE承办。7个品种申请上市：己二酸他雷替尼胶囊(葆元生物医药(杭州))、盐酸来罗西利片(玉溪嘉和生物)、盐酸去甲乌药碱注射液(珠海润都制药)、注射用Datopotamab Deruxtecan(第一三共)、注射用苏维西塔单抗(江苏先声生物)、通络健脑片(广州悦康生物制药)、紫花温肺止嗽颗粒(广州悦康生物制药)。2024年3月创新药上市申请承办情况2024年3月创新药临床申请承办情况改良型新药品种申报情况2024年3月，19个改良型新药品种获CDE承办，5个品种申请上市，呋喹替尼胶囊(和记黄埔医药(上海))、古塞奇尤单抗注射液(强生)、聚乙二醇干扰素α-2b注射液(厦门特宝生物)、赛沃替尼片(和记黄埔医药(上海))为新适应症上市申请。2024年3月改良型新药上市申请承办情况2024年3月改良型新药临床申请承办情况新分类仿制药品种申报情况2024年3月，167个品种仿制申请获CDE承办，33个品种目前暂无国内仿制药获批。石家庄四药共有10个品种获CDE承办：比拉斯汀片、二羟丙茶碱注射液、复方醋酸钠林格注射液、富马酸福莫特罗吸入溶液、精氨酸培哚普利片、氯化钙注射液、吗啉硝唑氯化钠注射液、葡萄糖酸钙注射液、盐酸尼卡地平氯化钠注射液、盐酸左沙丁胺醇雾化吸入溶液。2024年3月新分类仿制药品种申报情况存量品种一致性评价申报情况2024年3月，32个品种的一致性评价补充申请获CDE承办。法罗培南钠片和复合磷酸氢钾注射液为首次申报。2024年3月存量品种一致性评价申报情况获批情况2024年3月有3款1类新药获批上市：秦威颗粒(成都华西天然药物)、妥拉美替尼胶囊(上海科州药物研发)、泽沃基奥仑赛注射液(恺兴生命科技(上海))。4个品种获批新适应症：佩索利单抗注射液(皮下注射)(勃林格殷格翰)、舒格利单抗注射液(辉瑞)、阿布昔替尼片(辉瑞)、阿那白滞素注射液(苏庇医药)。103个品种按新分类仿制申请获批，44个品种按存量品种一致性评价补充申请过评。15个品种首家过评，其中ω-3甘油三酯(2%)中/长链脂肪乳/氨基酸(16)/葡萄糖(16%)注射液(四川科伦药业)、醋酸钙口服溶液(山东朗诺制药)、盐酸阿那格雷胶囊(黑龙江天宏药业)、依折麦布辛伐他汀片(北京福元医药)、注射用塞替派(江苏恒瑞医药)等5个品种为国内首仿。2024年3月主要注册类型品种获批情况数据来源：米内网中国申报进度数据库（MED）、CDE、NMPA；相关统计字段按药品名称统计，时间截至2024年3月31日；获批品种按NMPA发布时间统计；药物作用靶点以及适应症整理自公开资料。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

本周药品注册受理数据，分门别类呈现，一目了然。(3.11-3.17）新药上市申请药品名称企业注册分类受理号盐酸来罗西利片Genor Biopharma(USA), Inc.1JXHS2400020注射用Datopotamab DeruxtecanDaiichi Sankyo Europe GmbH1JXSS2400026注射用苏维西塔单抗江苏先声生物制药有限公司1CXSS2400022聚乙二醇干扰素α-2b注射液厦门特宝生物工程股份有限公司2.2CXSS2400026聚乙二醇干扰素α-2b注射液厦门特宝生物工程股份有限公司2.2CXSS2400025聚乙二醇干扰素α-2b注射液厦门特宝生物工程股份有限公司2.2CXSS2400024聚乙二醇干扰素α-2b注射液厦门特宝生物工程股份有限公司2.2CXSS2400023Belzutifan片MERCK SHARP & DOHME (UK) LIMITED5.1JXHS2400021环索奈德吸入气雾剂Covis Pharma GmbH5.1JXHS2400019环索奈德吸入气雾剂Covis Pharma GmbH5.1JXHS2400018新药临床申请药品名称企业注册分类受理号BAT6005注射液百奥泰生物制药股份有限公司1CXSL2400189BAT1308注射液百奥泰生物制药股份有限公司1CXSL2400188ABBV-400注射用粉末AbbVie Inc.1JXSL2400060ABP1618片上海爱博医药科技有限公司1CXHL2400285ABP1618片上海爱博医药科技有限公司1CXHL2400284FC084CSA片中山医诺维申新药研发有限公司1CXHL2400283FC084CSA片中山医诺维申新药研发有限公司1CXHL2400282Balcinrenone达格列净胶囊AstraZeneca AB1JXHL2400064Balcinrenone达格列净胶囊AstraZeneca AB1JXHL2400063SHR-4849注射液苏州盛迪亚生物医药有限公司1CXSL2400186注射用YL205苏州宜联生物医药有限公司1CXSL2400185注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2400183F230片北京康蒂尼药业股份有限公司1CXHL2400281F230片北京康蒂尼药业股份有限公司1CXHL2400280F230片北京康蒂尼药业股份有限公司1CXHL2400279替古索司他片信达生物制药(苏州)有限公司1CXHL2400278替古索司他片信达生物制药(苏州)有限公司1CXHL2400277替古索司他片信达生物制药(苏州)有限公司1CXHL2400276CU-10101软膏科笛生物医药(无锡)有限公司1CXHL2400275CU-10101软膏科笛生物医药(无锡)有限公司1CXHL2400274CU-10101软膏科笛生物医药(无锡)有限公司1CXHL2400273CU-10101软膏科笛生物医药(无锡)有限公司1CXHL2400272BI 1839100 片Boehringer Ingelheim International GmbH1JXHL2400062SSGJ-707注射液沈阳三生制药有限责任公司1CXSL2400184SI-B001双特异性抗体注射液四川百利药业有限责任公司1CXSL2400182金纳单抗注射液长春金赛药业有限责任公司1CXSL2400179ER2001注射液艾码生物科技(南京)有限公司1CXSL2400181INNA1605软膏武汉亿诺药业有限公司1CXHL2400271INNA1605软膏武汉亿诺药业有限公司1CXHL2400270MK-1084片默沙东研发(中国)有限公司1CXHL2400267MK-1084片默沙东研发(中国)有限公司1CXHL2400266ABP2111Na片上海爱博医药科技有限公司1CXHL2400265ABP2111Na片上海爱博医药科技有限公司1CXHL2400264BPYT-01胶囊百极优棠(广东)医药科技有限公司1CXHL2400269BPYT-01胶囊百极优棠(广东)医药科技有限公司1CXHL2400268SHR-9539注射液苏州盛迪亚生物医药有限公司1CXSL2400178SHR-9539注射液苏州盛迪亚生物医药有限公司1CXSL2400177温肺定喘颗粒山东康众宏医药科技开发有限公司1.1CXZL2400015鼻喷重组呼吸道合胞病毒疫苗(5型副流感病毒载体)广州思安信生物技术有限公司1.1CXSL2400180FTZ浓缩丸深圳前海吉奥健康科技有限公司1.1CXZL2400014呼吸道合胞病毒IN006二价mRNA疫苗深圳深信生物科技有限公司1.2CXSL2400187TAR-210Janssen Research & Development, LLC2.2JXHL2400065帕博利珠单抗注射液Merck Sharp & Dohme LLC2.2JXSL2400059重组人绒促性素注射液苏州晟济药业有限公司3.3CXSL2400176仿制药申请药品名称企业注册分类受理号西咪替丁注射液苏州朗科生物技术股份有限公司3CYHS2400845复方聚乙二醇电解质散(儿童型)四川科伦药业股份有限公司3CYHS2400838硫酸阿托品注射液江苏开元药业有限公司3CYHS2400853普仑司特干糖浆济川药业集团有限公司3CYHS2400849溴吡斯的明缓释片上海上药中西制药有限公司3CYHS2400832小儿复方氨基酸注射液(19AA-I)湖北民康药业集团有限公司3CYHS2400830小儿复方氨基酸注射液(19AA-I)湖北民康药业集团有限公司3CYHS2400829盐酸左沙丁胺醇雾化吸入溶液石家庄四药有限公司3CYHS2400827盐酸麻黄碱注射液成都苑东生物制药股份有限公司3CYHS2400825倍他米松磷酸钠注射液吉林省辉南长龙生化药业股份有限公司3CYHS2400824拉米地坦片江苏恩华药业股份有限公司3CYHL2400059拉米地坦片江苏恩华药业股份有限公司3CYHL2400058钠钾镁钙注射用浓溶液辰欣药业股份有限公司3CYHS2400820法莫替丁注射液湖南柏齐鹤药物研发有限公司3CYHS2400817洛索洛芬钠口服溶液江西施美药业股份有限公司3CYHS2400809腺苷钴胺胶囊华益药业科技(安徽)有限公司3CYHS2400811复方托吡卡胺滴眼液山东辰欣佛都药业股份有限公司4CYHS2400860枸橼酸西地那非口腔崩解片济南高华制药有限公司4CYHS2400859盐酸尼卡地平注射液北京新美泰克医药科技有限公司4CYHS2400858吡仑帕奈片锦州奥鸿药业有限责任公司4CYHS2400857吡仑帕奈片锦州奥鸿药业有限责任公司4CYHS2400856孟鲁司特钠咀嚼片牡丹江恒远药业股份有限公司4CYHS2400855孟鲁司特钠咀嚼片牡丹江恒远药业股份有限公司4CYHS2400854枸橼酸氢钾钠颗粒浙江沣华医药科技有限公司4CYHS2400848二十碳五烯酸乙酯软胶囊人福普克药业(武汉)有限公司4CYHS2400847二十碳五烯酸乙酯软胶囊人福普克药业(武汉)有限公司4CYHS2400846玻璃酸钠滴眼液辅必成(上海)医药科技有限公司4CYHS2400844左氧氟沙星氯化钠注射液辽宁民康制药有限公司4CYHS2400843卡左双多巴缓释片精华制药集团股份有限公司4CYHS2400842卡左双多巴缓释片精华制药集团股份有限公司4CYHS2400841苯磺酸氨氯地平片华益药业科技(安徽)有限公司4CYHS2400840苯磺酸氨氯地平片华益药业科技(安徽)有限公司4CYHS2400839乳果糖口服溶液安徽四环科宝制药有限公司4CYHS2400836他达拉非片湘北威尔曼制药股份有限公司4CYHS2400852他达拉非片湘北威尔曼制药股份有限公司4CYHS2400851他达拉非片湘北威尔曼制药股份有限公司4CYHS2400850富马酸福莫特罗吸入溶液石家庄四药有限公司4CYHS2400837莫匹罗星软膏浙江众延医药科技有限公司4CYHS2400831盐酸氨溴索口服溶液黑龙江澳利达奈德制药有限公司4CYHS2400828富马酸伏诺拉生片重庆圣华曦药业股份有限公司4CYHS2400826瑞戈非尼片仁合熙德隆药业有限公司4CYHS2400835头孢托仑匹酯颗粒福安药业集团庆余堂制药有限公司4CYHS2400834头孢托仑匹酯颗粒福安药业集团庆余堂制药有限公司4CYHS2400833甲氨蝶呤注射液胜思(广州)制药科技有限公司4CYHS2400816甲氨蝶呤注射液江苏奥赛康药业有限公司4CYHS2400815甲氨蝶呤注射液江苏奥赛康药业有限公司4CYHS2400814吉非替尼片山东鲁抗医药股份有限公司4CYHS2400813孟鲁司特钠颗粒广州博济生物医药科技园有限公司4CYHS2400823苯磺酸氨氯地平片湖南状元制药有限公司4CYHS2400822苯磺酸氨氯地平片湖南状元制药有限公司4CYHS2400821盐酸伊立替康注射液吉斯美(武汉)制药有限公司4CYHS2400819盐酸伊立替康注射液吉斯美(武汉)制药有限公司4CYHS2400818醋酸加尼瑞克注射液广东粤和泽药物研究有限公司4CYHS2400808艾考糊精腹膜透析液山东齐都药业有限公司4CYHS2400807左氧氟沙星滴眼液河北合渡药业有限公司4CYHS2400806屈螺酮炔雌醇片武汉九珑人福药业有限责任公司4CYHS2400812注射用氟氧头孢钠浙江惠迪森药业有限公司4CYHS2400810进口申请药品名称企业注册分类受理号盐酸来罗西利片Genor Biopharma(USA), Inc.1JXHS2400020注射用Datopotamab DeruxtecanDaiichi Sankyo Europe GmbH1JXSS2400026ABBV-400注射用粉末AbbVie Inc.1JXSL2400060Balcinrenone达格列净胶囊AstraZeneca AB1JXHL2400064Balcinrenone达格列净胶囊AstraZeneca AB1JXHL2400063BI 1839100 片Boehringer Ingelheim International GmbH1JXHL2400062TAR-210Janssen Research & Development, LLC2.2JXHL2400065帕博利珠单抗注射液Merck Sharp & Dohme LLC2.2JXSL2400059Belzutifan片MERCK SHARP & DOHME (UK) LIMITED5.1JXHS2400021环索奈德吸入气雾剂Covis Pharma GmbH5.1JXHS2400019环索奈德吸入气雾剂Covis Pharma GmbH5.1JXHS2400018他达拉非片Sawai Pharmaceutical Co., Ltd.5.2JYHS2400012中药相关申请药品名称企业注册分类受理号温肺定喘颗粒山东康众宏医药科技开发有限公司1.1CXZL2400015FTZ浓缩丸深圳前海吉奥健康科技有限公司1.1CXZL2400014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。