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LIVTENCITY Is the First and Only Post-Transplant Anti-CMV Treatment Approved in Japan That Targets/Inhibits UL97 Protein Kinase1 CMV Is One of the Most Common and Serious Post-transplant Infections and Can Lead to Secondary Infections and Serious Consequences, Including Loss of Transplanted Organ and Failure of Graft2,3 OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (TSE:4502/NYSE:TAK) today announced that LIVTENCITY® (maribavir) has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for post-transplant cytomegalovirus (CMV) infection/disease that is refractory to existing anti-CMV therapies.4 LIVTENCITY is the first and only post-transplant anti-CMV treatment approved in Japan that targets and inhibits pUL97 kinase and its natural substrates.1 “We are pleased by the approval of LIVTENCITY in Japan, which will provide the transplant community with a new option for treatment of post-transplant CMV infection in patients refractory to other therapies,” said Yasushi Kajii, Head, R&D Japan Region at Takeda. “A diagnosis of CMV infection can be particularly challenging for patients, and serious complications such as increased organ rejection and hospitalization rates can occur, when not successfully treated. We believe LIVTENCITY has the potential to help address the challenges faced by people with post-transplant CMV and transform the treatment landscape for patients in Japan.” The approval is primarily based on the results of the Phase 3 SOLSTICE trial (NCT02931539), which evaluated the safety and efficacy of LIVTENCITY versus alternative antiviral treatments for patients with CMV infection/disease refractory* to prior therapies who underwent hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT), and the Japanese Phase 3 open-label study in patients with CMV infection, including those with refractory* CMV infection who underwent HSCT or SOT (NCT05137717). In the SOLSTICE trial (maribavir n=235, alternative treatments n=117), maribavir showed statistically significant improvement when compared to alternative antiviral treatments at the end of Week 8 for the primary endpoint of confirmed CMV viremia clearancea in post-transplant (HSCT or SOT) adults with refractory* CMV infection.5 Of the 234 patients included in the safety evaluation, adverse reactions (related cases) were observed in 141 patients (60.3%).5 An open-label, multicenter, single-arm study was conducted to evaluate the efficacy and safety in Japanese patients in post-transplant (HSCT or SOT) adultsc (41 randomized, including 3 subjects with CMV infection refractory* to the most recently administered anti-CMV agent). The primary endpoint of CMV viremia clearanceb at the end of Study Week 8 was achieved in 33.3% of patients with refractory* CMV infection.4 Of 41 subjects included in the safety evaluation, adverse reactions (related events) were observed in 36.6% (15 subjects). 4 About LIVTENCITY LIVTENCITY (maribavir), an orally administered (tablet) anti-CMV compound, is the first and only antiviral agent that targets and inhibits the CMV-specific UL97 protein kinase and thus its natural substrates.1 As of June 2024, LIVTENCITY is approved in more than 30 countries for post-transplant CMV refractory* to prior therapies, including such major markets as Japan, the United States, Canada, Australia, the European Union and China. LIVTENCITY Product Overview in Japan Product Name LIVTENCITY 200 mg tablets. Generic Name Maribavir Indications The post-transplant cytomegalovirus (CMV) infection/disease that is refractory to existing anti-CMV therapies. Precautions concerning indications This drug should be administered to post-transplant patients with CMV infection/disease who have responded inadequately to other therapies. Efficacy and safety have not been studied in patients with CMV infection of the central nervous system and CMV retinitis. Based on nonclinical studies, this drug is expected to cross the blood-brain barrier but has low potential to enter the central nervous system. Dosage and Administration Usually, the recommended dosage for adultsc is 400 mg of maribavir to be administered orally twice daily. About Takeda’s SOLSTICE Trial The TAK-620-303 (SOLSTICE) trial (NCT02931539, EudraCT 2015-004725-13) was a Phase 3 global, multicenter, randomized, open-label, active-controlled trial to assess the efficacy and safety of maribavir treatment compared to investigator-assigned treatment (alternative antiviral therapies) in 352 HSCT and SOT recipients with CMV infections that were refractory* or resistant to one or a combination of the alternative antiviral therapies: ganciclovir, valganciclovir, foscarnet, or cidofovir. Adult patients underwent a 2-week screening period, followed by randomization 2:1 to maribavir (n=235) (400 mg, twice daily) or alternative antiviral treatments (n=117) (as dosed by the investigator) for up to 8 weeks. After completion of the treatment period, subjects entered a 12-week follow-up phase.5 The trial’s primary efficacy endpoint was confirmed CMV viremia clearance a at the end of Week 8. The key secondary endpoint was confirmed CMV viremia clearance and CMV infection symptom control† at the end of Study Week 8 with maintenance of this treatment effect through Study Week 16.5 About Cytomegalovirus (CMV) CMV is a beta herpesvirus that commonly infects humans; serologic evidence of prior infection can be found in 40-100% of various adult populations.6 CMV typically resides latent and asymptomatic in the body but may reactivate during periods of immunosuppression. Serious disease may occur in individuals with compromised immune systems, which includes patients who receive immunosuppressants associated with various types of transplants including HSCT or SOT.5,7 Out of the estimated 200,000 adult transplants per year globally, CMV is one of the most common viral infections experienced by transplant recipients, with an estimated incidence rate between 16-56% in SOT recipients and 30-80% in HSCT recipients.7,8 In transplant recipients, reactivation of CMV infection can lead to secondary infections and serious consequences, including graft loss and, in extreme cases, can be fatal.2,3,5 About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit . LIVTENCITY Safety Information Contraindications Contraindications include Hypersensitivity to the active substance or to any of the excipients and co‑administration with ganciclovir or valganciclovir. Special warnings and precautions for use Some maribavir pUL97 resistance-associated substitutions confer cross-resistance to ganciclovir and valganciclovir. CMV DNA levels should be monitored, and resistance mutations should be investigated in patients who do not respond to treatment. Treatment should be discontinued if maribavir resistance mutations are detected. LIVTENCITY is not expected to be effective in treating CMV CNS infections (e.g. meningo‑encephalitis). LIVTENCITY has the potential to increase the concentrations of immunosuppressants that are cytochrome P450 (CYP)3A/P-gp substrates with narrow therapeutic margins (including tacrolimus, cyclosporine, sirolimus and everolimus). The plasma levels of these immunosuppressants must be frequently monitored throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY, and doses should be adjusted, as needed. The concomitant use of LIVTENCITY and certain medicinal products may result in known or potentially significant medicinal product interactions, some of which may lead to: possible clinically significant adverse reactions from greater exposure of concomitant medicinal products. reduced therapeutic effect of LIVTENCITY. Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium‑free’. Pregnancy & Breast-feeding: LIVTENCITY is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast‑feeding should be discontinued during treatment with LIVTENCITY. Interactions Effect of other medicinal products on maribavir: Co-administration of maribavir with strong cytochrome P450 3A (CYP3A) inducers rifampicin, rifabutin or St. John’s wort is not recommended. If co-administration of maribavir with other strong or moderate CYP3A inducers (e.g., carbamazepine, efavirenz, phenobarbital and phenytoin) cannot be avoided, the maribavir dose should be increased to 1 200 mg twice daily. No dose adjustment is needed when maribavir is co‑administered with CYP3A inhibitors. Effect of maribavir on other medicinal products: If dose adjustments of concomitant medicinal products are made due to treatment with maribavir, doses should be readjusted after treatment with maribavir is completed. Co-administration of maribavir with valganciclovir and ganciclovir is contraindicated. Concomitant administration of maribavir and medicinal products that are sensitive substrates of CYP1A2 with a narrow therapeutic window (e.g., tizanidine and theophylline) should be avoided due to the risk for lack of efficacy of CYP1A2 substrates. When the immunosuppressants tacrolimus, cyclosporine, everolimus or sirolimus are co-administered with maribavir, immunosuppressant levels should be frequently monitored throughout treatment with maribavir, especially following initiation and after discontinuation of maribavir and dose adjusted, when needed. Caution should be exercised when maribavir and sensitive P-gp substrates (e.g., digoxin, dabigatran) are co‑administered. Serum digoxin concentrations should be monitored, and dose of digoxin may need to be reduced, as needed (see Table 1). Co‑administration of maribavir with sensitive BCRP substrates such as rosuvastatin, is expected to increase their exposure and lead to undesirable effects. Adverse Reactions Very common (≥1/10) Taste disturbance, Diarrhoea, Nausea, Vomiting, Fatigue Common (≥1/100 to <1/10) Headache, Abdominal pain upper, Decreased appetite, Immunosuppressant drug level increased, Weight decreased The most commonly reported serious adverse reactions were diarrhoea (2%) and nausea, weight decreased, fatigue, immunosuppressant drug level increased, and vomiting (all occurring at < 1%). Please consult the LIVTENCITY (maribavir) approved label before prescribing, particularly in relation to dosing and treatment monitoring. For Japan, please consult the LIVTENCITY Japan Package Insert. For the European Union, please consult the Summary of Products Characteristics (SmPC). For China, please consult the LIVTENCITY China Package Leaflet. For full U.S. Prescribing Information, including the approved indication and important safety information, please visit: Important Notice For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. 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Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. * Including a subgroup with genotypic resistance to alternative antiviral treatments. a Defined as confirmed CMV DNA concentration below the lower limit of quantification (<LLOQ; i.e., <137 IU/mL) in two consecutive samples separated by at least five days. b Defined as confirmed CMV DNA concentration below the lower limit of quantification (<LLOQ; i.e., <34.5 IU/mL) in two consecutive samples separated by at least five days. c Defined as > 15 years old † CMV infection symptom control was defined as resolution or improvement of tissue-invasive disease or CMV syndrome for symptomatic patients at baseline, or no new symptoms for patients who were asymptomatic at baseline. References Avram S, et al. Novel drug targets in 2021. Nature Reviews Drug Discovery. 2022;21(5):328-328. Ramanan P, Razonable RR. Cytomegalovirus infections in solid organ transplantation: a review. Infection & Chemotherapy. 2013;45(3):260 Camargo JF, Komanduri KV. Emerging concepts in cytomegalovirus infection following hematopoietic stem cell transplantation. Hematol Oncol Stem Cell Ther. 2017;10(4):233-238. doi:10.1016/j.hemonc.2017.05.001 LIVTENCITY Package Insert in Japan. Avery R, Alain S, Alexander BD, et al. SOLSTICE Trial Investigators. Maribavir for refractory cytomegalovirus infections with or without resistance post-transplant: results from a phase 3 randomized clinical trial. Clin Infect Dis. 2022;75(4):690–701. doi:10.1093/cid/ciab988 de la Hoz RE, Stephanie G, Sherlock C. Diagnosis and treatment approaches to CMV infections in adult patients. J Clin Virol. 2002;25(Suppl 1):S1-S12. doi:10.1016/s1386-6532(02)00091-4 Azevedo LS, Pierrotti LC, Abdala E, et al. Cytomegalovirus infection in transplant recipients. Clinics (Sao Paolo). 2015;70(7):515-523. doi:10.6061/clinics/2015(07)09 Styczynski J. Who is the patient at risk of CMV recurrence: a review of the current scientific evidence with a focus on hematopoietic cell transplantation. Infect Dis Ther. 2018;(7):1-16. doi:10.1007/s40121-017-0180-z View source version on businesswire.com: Contacts International Media Rand Walton rand.walton@takeda.com Japan Media Shigeyuki Matsui shigeyuki.matsui@takeda.com Source: Takeda Pharmaceutical Company Limited View this news release online at:

本周药品注册受理数据，分门别类呈现，一目了然。(4.15-4.21）小编收到有些用户反应，不想收到咱们每周文章的推送提醒，而有些用户又特别需要这个提醒，在小编强烈要求下，我们给力的程序员终于实现了可以关闭提醒的功能，这个绝对全网独一家喔，不想收到提醒的，只要在信狐药迅对话框内回复关键词“拒收文章提醒”，那么就可以不受推送的打扰啦!新药上市申请药品名称企业注册分类受理号盐酸普萘洛尔滴剂四川奥邦古得药业有限公司2.2CXHS2400029注射用醋酸曲普瑞林微球长春金赛药业有限责任公司2.2CXHS2400028新药临床申请药品名称企业注册分类受理号WSD0922-FU片威尚(上海)生物医药有限公司1CXHL2400406WSD0922-FU片威尚(上海)生物医药有限公司1CXHL2400405WSD0922-FU片威尚(上海)生物医药有限公司1CXHL2400404FH-2001胶囊江苏星盛新辉医药有限公司1CXHL2400403HRS-1358片山东盛迪医药有限公司1CXHL2400401HRS-1358片山东盛迪医药有限公司1CXHL2400400HRS-9813片广东恒瑞医药有限公司1CXHL2400397HRS-9813片广东恒瑞医药有限公司1CXHL2400396STC008注射液成都诺和晟泰生物科技有限公司1CXHL2400395YD0293片上海壹典医药科技开发有限公司1CXHL2400399YD0293片上海壹典医药科技开发有限公司1CXHL2400398SYHA1813口服溶液中国科学院上海药物研究所1CXHL2400394SYHA1813口服溶液中国科学院上海药物研究所1CXHL2400393SYHA1813口服溶液中国科学院上海药物研究所1CXHL2400392HJ787片华津(重庆)药业有限公司1CXHL2400389HJ787片华津(重庆)药业有限公司1CXHL2400388HJ787片华津(重庆)药业有限公司1CXHL2400387HJ787片华津(重庆)药业有限公司1CXHL2400386HJ787片华津(重庆)药业有限公司1CXHL2400385HJ787片华津(重庆)药业有限公司1CXHL2400384VIC-1911片捷思英达医药技术(上海)有限公司1CXHL2400376GP681片江西青峰药业有限公司1CXHL2400375GP681片江西青峰药业有限公司1CXHL2400374艾司奥美拉唑镁碳酸氢钠干混悬剂(II)海南广升誉制药有限公司2.2CXHL2400381BR170720口服混悬液山东百诺医药股份有限公司2.2CXHL2400383BCM894胶囊上海云晟研新生物科技有限公司2.3CXHL2400382林普利塞片上海璎黎药业有限公司2.4CXHL2400402海曲泊帕乙醇胺片江苏恒瑞医药股份有限公司2.4CXHL2400391注射用多西他赛(白蛋白结合型)石药集团中奇制药技术(石家庄)有限公司2.4CXHL2400390阿瑞匹坦注射液石药集团中诺药业(石家庄)有限公司3CYHL2400077噻托溴铵吸入粉雾剂长风药业股份有限公司4CYHL2400078注射用LX22001山东罗欣药业集团股份有限公司2.1;2.2CXHL2400378注射用LX22001山东罗欣药业集团股份有限公司2.1;2.2CXHL2400377注射用LX22001山东罗欣药业集团股份有限公司2.1;2.2;2.4CXHL2400380注射用LX22001山东罗欣药业集团股份有限公司2.1;2.2;2.4CXHL2400379呼吸道合胞病毒mRNA疫苗石药集团巨石生物制药有限公司1.2CXSL2400244呼吸道合胞病毒mRNA疫苗合肥阿法纳生物科技有限公司1.2CXSL2400233流感病毒裂解疫苗武汉生物制品研究所有限责任公司3.3CXSL2400248流感病毒裂解疫苗武汉生物制品研究所有限责任公司3.3CXSL2400247EX101注射液广州爱思迈生物医药科技有限公司1CXSL2400252KY-0118注射剂科弈(浙江)药业科技有限公司1CXSL2400254注射用BGB-B2033广州百济神州生物制药有限公司1CXSL2400253重组人源抗破伤风毒素单克隆抗体注射液兰州生物制品研究所有限责任公司1CXSL2400249VPD/FC01008 注射液微能生命科技集团有限公司1CXSL2400250WST03制剂(胶囊)上海上药信谊药厂有限公司1CXSL2400246WST03制剂(胶囊)上海上药信谊药厂有限公司1CXSL2400245FL115注射液苏州复融生物技术有限公司1CXSL2400239TQB2928注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2400238抗CD30嵌合抗原受体自体T细胞注射液明慧(南京)基因生物技术有限公司1CXSL2400242注射用BL-M17D1成都百利多特生物药业有限责任公司1CXSL2400237重组抗PD-1全人源单抗注射液石药集团中奇制药技术(石家庄)有限公司1CXSL2400243重组抗HER3人源化单抗注射液上海生物制品研究所有限责任公司1CXSL2400232BR105注射液杭州博之锐生物制药有限公司1CXSL2400236VPD/FC01002 注射液微能生命科技集团有限公司1CXSL2400235信迪利单抗注射液信达生物制药(苏州)有限公司2.2CXSL2400251司美格鲁肽注射液正大天晴药业集团股份有限公司3.3CXSL2400241司美格鲁肽注射液正大天晴药业集团股份有限公司3.3CXSL2400240LPS-001注射液乐普药业股份有限公司3.3CXSL2400231静注人免疫球蛋白(pH4)四川远大蜀阳药业有限责任公司3.4CXSL2400234仿制药申请药品名称企业注册分类受理号倍他米松磷酸钠注射液漯河市汇创医药有限公司3CYHS2401190盐酸甲氧氯普胺注射液山东如至生物医药科技有限公司3CYHS2401171盐酸甲氧氯普胺注射液北京柏雅联合药物研究所有限公司3CYHS2401169依巴斯汀口服溶液南京海纳制药有限公司3CYHS2401178氯硝西泮注射液国药集团国瑞药业有限公司3CYHS2401176二羟丙茶碱注射液四川天杏汇医药科技有限公司3CYHS2401173阿立哌唑口服溶液昆明南疆制药有限公司3CYHS2401168阿立哌唑口服溶液昆明南疆制药有限公司3CYHS2401167阿立哌唑口服溶液昆明南疆制药有限公司3CYHS2401165溴吡斯的明口服溶液上海上药中西制药有限公司3CYHS2401164左氧氟沙星口服溶液江苏盈科生物制药有限公司3CYHS2401163盐酸美金刚口服溶液安徽康融药业有限公司3CYHS2401162注射用尼可地尔浙江华海药业股份有限公司3CYHS2401156帕米膦酸二钠注射液南京正大天晴制药有限公司3CYHS2401138帕米膦酸二钠注射液南京正大天晴制药有限公司3CYHS2401137帕米膦酸二钠注射液南京正大天晴制药有限公司3CYHS2401136盐酸纳洛酮注射液辰欣药业股份有限公司3CYHS2401135美索巴莫注射液福州基石医药科技有限公司3CYHS2401134丙酸氟替卡松吸入粉雾剂润生药业有限公司3CYHS2401133膦甲酸钠注射液桂林南药股份有限公司3CYHS2401132盐酸拉贝洛尔注射液石家庄四药有限公司3CYHS2401131依帕司他片成都康弘药业集团股份有限公司3CYHS2401145磷酸奥司他韦干混悬剂山东新华制药股份有限公司3CYHS2401142碳酸氢钠林格注射液浙江康吉尔药业有限公司3CYHS2401141羧甲司坦糖浆成都天之翼尚品医药科技有限公司3CYHS2401119比拉斯汀口服溶液山东朗诺制药有限公司3CYHS2401118盐酸溴己新口服溶液山东如至生物医药科技有限公司3CYHS2401117复方聚乙二醇电解质散(II)广东科伦药业有限公司3CYHS2401130复方聚乙二醇电解质散(II)广东科伦药业有限公司3CYHS2401129玻璃酸钠滴眼液南京海纳制药有限公司4CYHS2401180硫酸氨基葡萄糖胶囊四川杨天生物药业股份有限公司4CYHS2401189注射用头孢唑肟钠山东鲁抗医药股份有限公司4CYHS2401188注射用头孢唑肟钠山东鲁抗医药股份有限公司4CYHS2401187硫辛酸注射液北京双鹭药业股份有限公司4CYHS2401186富马酸伏诺拉生片北京双鹭药业股份有限公司4CYHS2401185硫酸氨基葡萄糖胶囊德全药品(江苏)股份有限公司4CYHS2401184普拉洛芬滴眼液苏州乐珠制药有限公司4CYHS2401183依巴斯汀片华益药业科技(安徽)有限公司4CYHS2401182枸橼酸托法替布缓释片合肥华方医药科技有限公司4CYHS2401181西甲硅油乳剂成都诺和晟鸿生物制药有限公司4CYHS2401170玻璃酸钠滴眼液南京海纳制药有限公司4CYHS2401179盐酸阿莫罗芬搽剂江苏知原药业股份有限公司4CYHS2401177硫酸羟氯喹片重庆博腾药业有限公司4CYHS2401175间苯三酚口服冻干片河南敬东羲健药业股份有限公司4CYHS2401174普拉洛芬滴眼液湖北远大天天明制药有限公司4CYHS2401172蒙脱石混悬液广西维威制药有限公司4CYHS2401166沙格列汀二甲双胍缓释片山西同达药业有限公司4CYHS2401161哌柏西利胶囊山东新时代药业有限公司4CYHS2401160哌柏西利胶囊山东新时代药业有限公司4CYHS2401159哌柏西利胶囊山东新时代药业有限公司4CYHS2401158替米沙坦氨氯地平片南京海纳制药有限公司4CYHS2401157孟鲁司特钠片浙江诺得药业有限公司4CYHS2401155克立硼罗软膏杭州朱养心药业有限公司4CYHS2401154阿仑膦酸钠片山东华铂凯盛生物科技有限公司4CYHS2401153非诺贝特酸胆碱缓释胶囊江苏万高药业股份有限公司4CYHS2401152非诺贝特酸胆碱缓释胶囊江苏万高药业股份有限公司4CYHS2401151二甲硅油乳剂陕西丽彩药业有限公司4CYHS2401150二甲硅油乳剂陕西丽彩药业有限公司4CYHS2401149沙库巴曲缬沙坦钠片迪沙药业集团有限公司4CYHS2401148二甲硅油乳剂陕西丽彩药业有限公司4CYHS2401147氨甲环酸片杭州康恩贝制药有限公司4CYHS2401139甲硝唑凝胶华润三九医药股份有限公司4CYHS2401146贝前列素钠片江苏和晨药业有限公司4CYHS2401140左氧氟沙星氯化钠注射液北京百美特生物制药有限公司4CYHS2401144舒更葡糖钠注射液兆科药业(合肥)有限公司4CYHS2401143蛋白琥珀酸铁口服溶液哈药集团中药二厂4CYHS2401128盐酸阿罗洛尔片湖南华纳大药厂股份有限公司4CYHS2401127卡贝缩宫素注射液湖北长联杜勒制药有限公司4CYHS2401126盐酸莫西沙星氯化钠注射液北京吉洛华制药有限公司4CYHS2401125洛索洛芬钠凝胶膏浙江赛默制药有限公司4CYHS2401124碘帕醇注射液浙江兄弟药业有限公司4CYHS2401122碘帕醇注射液浙江兄弟药业有限公司4CYHS2401121盐酸尼卡地平注射液山东如至生物医药科技有限公司4CYHS2401120注射用醋酸卡泊芬净山东新时代药业有限公司4CYHS2401116注射用醋酸卡泊芬净山东新时代药业有限公司4CYHS2401115富马酸福莫特罗吸入溶液重庆壹零柒陆医药科技有限公司4CYHS2401123硫酸镁钠钾口服用浓溶液广东大冢制药有限公司4CYHS2401114培哚普利氨氯地平片(I)南京济群医药科技股份有限公司4CYHS2401113培哚普利氨氯地平片(III)南京济群医药科技股份有限公司4CYHS2401112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 EEIG2.2JXSS2400040纳武利尤单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400039伊匹木单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400038纳武利尤单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400037Dabigatran etexilateDr. Reddy's Laboratories Limited5.2JYHS2400021Dabigatran etexilateDr. Reddy's Laboratories Limited5.2JYHS2400020DapagliflozinHetero Labs Limited5.2JYHS2400017DapagliflozinHetero Labs Limited5.2JYHS2400016Sodium NitroprussideDr. Reddy’s Laboratories Limited5.2JYHS2400019Sodium NitroprussideCaplin Steriles Limited5.2JYHS2400018盐酸BAY 3283142片Bayer AG1JXHL2400092盐酸BAY 3283142片Bayer AG1JXHL2400091盐酸BAY 3283142片Bayer AG1JXHL2400090EYP-1901玻璃体内植入剂EyePoint Pharmaceuticals, Inc.2.2JXHL2400094EYP-1901玻璃体内植入剂EyePoint Pharmaceuticals, Inc.2.2JXHL2400093Axatilimab注射液Incyte Corporation1JXSL2400077Amlitelimab注射液Scleroderma Research Foundation, Inc.1JXSL2400076Anifrolumab注射液AstraZeneca AB2.2JXSL2400078中药相关申请药品名称企业注册分类受理号珍珠滴丸贵州民族药业股份有限公司1.1CXZS2400012平纳蜜膏新奇康药业股份有限公司1.1CXZL2400020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。