Belimumab

No CRS, ICANS, infections or serious adverse events observed in either of the first two patients through data cut-off of May 28, 2024 CABA-201 exhibited anticipated pro CAR T cell expansion and contraction with complete B cell depletion observed in both patients by day 15 post-infusion Improvements in both patients’ specific disease measures, consistent with academic experience of a similar 4-1BB CD19-CAR T, suggest emerging clinical benefit with CABA-201 while discontinuing all disease-specific therapies other than a planned steroid taper in one patient Immature, naïve B cell repopulation in first IMNM patient observed at week 8 consistent with a potential immune system reset 18 sites open and recruiting across four Phase 1/2 RESET™ trials with 5 patients enrolled as of June 12, 2024; initial clinical and translational data support continued development of CABA-201 at the current dose Company to host live investor conference call and webcast today at 8:00 a.m. ET PHILADELPHIA, June 14, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today reported positive initial clinical data from each of the first two patients dosed with CABA-201 in the Phase 1/2 RESET-Myositis and RESET-SLE trials. These data will be presented today at 8:15 a.m. CEST (2:15 a.m. ET) at a EULAR European Congress of Rheumatology 2024 Industry Symposia session titled “Immune Reset: The Potential of CAR T Cell Therapy to Transform the Treatment of Patients with Autoimmune Disease” in Vienna, Austria. Slides from the presentation can be found on the company’s website here. “We are encouraged by the initial safety, clinical and translational data from the RESET-Myositis and RESET-SLE trials which we believe provide important early validation regarding the potential of the selected clinical dose of CABA-201 to enable an immune system reset for patients with autoimmune diseases. By demonstrating a potentially well-tolerated safety pro with initial clinical and translational data consistent with the academic experience of a similar 4-1BB CD19-CAR T construct, we believe CABA-201 may be uniquely positioned to fulfill unmet patient needs across a broad range of autoimmune diseases,” said David J. Chang, M.D., Chief Medical Officer of Cabaletta. “With the RESET-SSc™ and RESET-MG™ trials recently opening for enrollment, an additional cohort evaluating patients with juvenile myositis incorporated into the RESET-Myositis trial and the momentum provided by the promising early clinical data, we are looking forward to accelerating clinical trial enrollment in the RESET clinical program. We continue to expect to report initial clinical data from the Phase 1/2 RESET-SSc and RESET-MG trials as well as additional data from the RESET-Myositis and RESET-SLE trials in the second half of this year.” Cabaletta designed CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, to deeply and transiently deplete CD19-positive B cells following a one-time infusion that may enable a reset of the immune system with the potential for durable remission without chronic therapy in patients with autoimmune diseases. Cabaletta is advancing four Phase 1/2 RESET trials evaluating CABA-201 within a total of ten cohorts with six patients in each cohort. All cohorts are evaluating the same single, weight-based dose of 1 x 106 cells/kg, following a preconditioning regimen of fludarabine and cyclophosphamide consistent with the dosing regimen used in the academic experience, without a dose escalation requirement. As of May 28, 2024, the data cut-off date, one patient treated in the immune-mediated necrotizing myopathy (IMNM) cohort in the RESET-Myositis trial had completed three months of follow-up and one patient enrolled in the systemic lupus erythematosus (SLE) non-renal cohort in the RESET-SLE trial had completed one month of follow-up. The patient with IMNM is a 33-year-old male with a two-year history of disease, positive for anti-SRP antibody and who had prior disease-specific therapy that included IVIg, rituximab, methotrexate and glucocorticoids. The patient with SLE is a 26-year-old male with a six-year history of disease, positive for anti-dsDNA antibody and who had prior disease specific therapy that included cyclophosphamide, voclosporin, belimumab, tacrolimus, mycophenolate mofetil, hydroxychloroquine and glucocorticoids. Both patients were administered a one-time infusion of CABA-201 at 1 x 106 cells/kg, following a preconditioning regimen of fludarabine and cyclophosphamide. The primary endpoint of each trial is safety and tolerability within 28 days of infusion. Secondary endpoints include translational assessments and clinical outcomes. Initial Clinical Data Summary Safety and Tolerability CABA-201 was administered during a four-day hospital stay, as currently required by the protocol, and was generally well-tolerated with no serious adverse events reported for either patient through the follow-up period. No evidence of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade was observed for either patient through the follow-up period. Tocilizumab was not administered for either patient. No infections were observed for either patient through the follow-up period. All chronic maintenance therapy or concomitant medications were discontinued for both patients through the follow-up period, other than a planned prednisone taper for the SLE patient. Clinical and Translational Pro > Complete B cell depletion was observed within 15 days post-infusion with CABA-201 in both patients. Both patients had early, transient leukopenia, as expected with the preconditioning regimen. CAR T cell expansion associated with CABA-201 reached its peak magnitude at day 15 post-infusion in both patients and the magnitude of expansion was consistent with the academic experience with a similar 4-1BB CD19-CAR T construct. At week 12 of follow-up for the IMNM patient, the data show a decline in creatinine kinase from 617 at infusion to 308 and a total improvement score (TIS) of 30, which is consistent with the clinically meaningful improvement seen in the academic experience of a similar 4-1BB CD19-CAR T construct that also recently reported data from an IMNM patient. At week 4 of follow-up for the SLE patient, the data demonstrated an improvement in the SLEDAI-2K (systemic lupus erythematosus disease activity index) score from 26 at baseline to 10. B cell repopulation was observed in the IMNM patient at week 8 with immature, naïve B cell phenotypes as demonstrated by flow cytometry, suggesting potential immune system reset with confirmatory analyses ongoing. Investor Conference Call and Webcast Information Cabaletta will host a conference call and webcast today, June 14, 2024, at 8:00 a.m. ET to review the initial clinical data presented at the satellite symposium at the EULAR 2024 Congress and provide an update on the RESET clinical development program. A webcast of the live call can be accessed on the News and Events section of the Company’s website at . An archived replay will be available on the Company’s website. About the RESET-Myositis™ Trial The RESET-Myositis™ trial is a Phase 1/2 open-label study of CABA-201 in subjects with active idiopathic inflammatory myopathy (IIM, or myositis), including the subtypes of dermatomyositis (DM), anti-synthetase syndrome (ASyS), immune-mediated necrotizing myopathy (IMNM) and juvenile myositis (JM), each evaluated in individual cohorts. Subjects will receive a one-time infusion of CABA-201 at a dose of 1 x 106 cells/kg, following a preconditioning regimen of fludarabine and cyclophosphamide. Key inclusion criteria for the DM, ASyS and IMNM cohorts include patients between ages 18 to 75 (inclusive), evidence of active disease and disease activity despite prior or current treatment with standard of care treatments. Key exclusion criteria for the DM, ASyS and IMNM cohorts include cancer-associated myositis, significant lung or cardiac impairment, treatment with a B cell depleting agent within the prior approximately six months or treatment with a biologic agent within the prior approximately three months. About the RESET-SLE™ Trial The RESET-SLE™ trial is a Phase 1/2 open-label study of CABA-201 in subjects with systemic lupus erythematosus (SLE) and lupus nephritis (LN), each evaluated in individual cohorts. Subjects will receive a one-time infusion of CABA-201 at a dose of 1 x 106 cells/kg, following a preconditioning regimen of fludarabine and cyclophosphamide. Key inclusion criteria include patients between ages 18 to 65 (inclusive), evidence of active disease and disease activity despite prior or current treatment with standard of care treatments. Key exclusion criteria include treatment with a B cell depleting agent within the prior approximately six months or treatment with a biologic agent within the prior approximately three months. About CABA-201 CABA-201 is designed to deeply and transiently deplete CD19-positive cells following a one-time infusion, which may enable an “immune system reset” with the potential for durable remission without chronic therapy in patients with autoimmune diseases. Cabaletta is evaluating CABA-201 in multiple autoimmune conditions within five disease-specific company sponsored INDs including myositis (idiopathic inflammatory myopathy, or IIM), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), generalized myasthenia gravis (gMG) and pemphigus vulgaris (PV; a sub-study to evaluate CABA-201 without preconditioning). About Cabaletta Bio Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis and in the RESET-PV™ sub-study within the DesCAARTes™ clinical trial in pemphigus vulgaris, along with the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK-associated myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. Forward-Looking Statements This press release contains “forward-looking statements” of Cabaletta Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including without limitation, express or implied statements regarding: Cabaletta’s ability to grow its autoimmune pipeline; Cabaletta’s future plans and strategies for its CAAR T and CARTA technologies and the company’s business plans and objectives as a whole; Cabaletta’s expectations around the potential safety and therapeutic benefits of CABA-201, including its belief that CABA-201 may enable an “immune system reset” with the potential for durable remission without chronic therapy in patients with autoimmune diseases; the Company’s advancement of separate Phase 1/2 clinical trials of CABA-201 in patients with SLE, myositis, SSc and gMG and advancement of a RESET-PV sub-study within the ongoing DesCAARTes trial in PV, including the Company’s expectations for the efficiency of the trial designs and updates related to status, safety data, or otherwise and the expected timing of the related data read-outs; Cabaletta’s ability to accelerate its pipeline, develop meaningful therapies for patients and leverage its research and translational insights; the clinical significance of the initial clinical data read-out at the EULAR 2024 Congress in June 2024 for patients with myositis and SLE treated with CABA-201; Cabaletta’s additional planned initial clinical data read-outs for patients with SSc and gMG treated with CABA-201 or otherwise; Cabaletta’s advancement of the process to activate clinical trial sites and pursue patient enrollment; and Cabaletta’s planned assessment of its DesCAARTes™ and MusCAARTes™ trials. Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to regulatory filings and potential clearance; the risk that signs of biologic activity or persistence may not inform long-term results; Cabaletta’s ability to demonstrate sufficient evidence of safety, efficacy and tolerability in its preclinical studies and clinical trials of CABA-201; the risk that the results observed with the similarly-designed construct employed in academic publications, including due to the dosing regimen, are not indicative of the results we seek to achieve with CABA-201; risks related to clinical trial site activation, delays in enrollment generally or enrollment rates that are lower than expected; delays related to assessment of clinical trial results; risks related to unexpected safety or efficacy data observed during clinical studies; risks related to volatile market and economic conditions and public health crises; Cabaletta’s ability to retain and recognize the intended incentives conferred by Orphan Drug Designation and Fast Track Designation or other designations for its product candidates, as applicable; risks related to Cabaletta’s ability to protect and maintain its intellectual property position; risks related to fostering and maintaining successful relationships with Cabaletta’s collaboration and manufacturing partners, including in light of recent legislation; uncertainties related to the initiation and conduct of studies and other development requirements for its product candidates; the risk that any one or more of Cabaletta’s product candidates will not be successfully developed and/or commercialized; and the risk that the initial or interim results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Cabaletta’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Cabaletta’s most recent annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in Cabaletta’s other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Cabaletta undertakes no duty to update this information unless required by law. Contacts: Anup Marda Chief Financial Officer investors@cabalettabio.com William Gramig Precision AQ william.gramig@precisionaq.com

本周药品注册受理数据，分门别类呈现，一目了然。(5.27-6.2）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度拉糖肽注射液山东博安生物技术股份有限公司3.3CXSS2400054度拉糖肽注射液山东博安生物技术股份有限公司3.3CXSS2400053度拉糖肽注射液山东博安生物技术股份有限公司3.3CXSS2400052度拉糖肽注射液山东博安生物技术股份有限公司3.3CXSS2400051新药临床申请药品名称企业注册分类受理号CS060380片凯思凯迪(上海)医药科技有限公司1CXHL2400553CS060380片凯思凯迪(上海)医药科技有限公司1CXHL2400552CS060380片凯思凯迪(上海)医药科技有限公司1CXHL2400551ABP2111Na片上海爱博医药科技有限公司1CXHL2400547ABP2111Na片上海爱博医药科技有限公司1CXHL2400546BGB-45035片百济神州(苏州)生物科技有限公司1CXHL2400550BGB-45035片百济神州(苏州)生物科技有限公司1CXHL2400548177Lu-LNC1011注射液烟台蓝纳成生物技术有限公司1CXHL2400545BN104片烨辉医药科技(上海)有限公司1CXHL2400536BN104片烨辉医药科技(上海)有限公司1CXHL2400535HX301胶囊杭州翰思生物医药有限公司1CXHL2400534BGB-24714胶囊百济神州(苏州)生物科技有限公司1CXHL2400533BGB-24714胶囊百济神州(苏州)生物科技有限公司1CXHL2400532BGB-24714胶囊百济神州(苏州)生物科技有限公司1CXHL2400531TQB3702片正大天晴药业集团股份有限公司1CXHL2400530HSK44459片四川海思科制药有限公司1CXHL2400529HSK44459片四川海思科制药有限公司1CXHL2400528HRS-1167片江苏恒瑞医药股份有限公司1CXHL2400544HRS-1167片江苏恒瑞医药股份有限公司1CXHL2400543HRS-1167片江苏恒瑞医药股份有限公司1CXHL2400542SHR2554片江苏恒瑞医药股份有限公司1CXHL2400541SHR7280片江苏恒瑞医药股份有限公司1CXHL2400540SHR7280片江苏恒瑞医药股份有限公司1CXHL2400539HRS-5041片江苏恒瑞医药股份有限公司1CXHL2400538HRS-5041片江苏恒瑞医药股份有限公司1CXHL2400537BCM878口崩片上海云晟研新生物科技有限公司2.2CXHL2400549糠酸莫米松鼻喷雾剂四川普锐特药业有限公司4CYHL2400102重组带状疱疹疫苗(CHO细胞)江苏中慧元通生物科技股份有限公司1.2CXSL2400350SHR-2106注射液广东恒瑞医药有限公司1CXSL2400359注射用HS-20093上海翰森生物医药科技有限公司1CXSL2400358注射用HS-20093上海翰森生物医药科技有限公司1CXSL2400357HS-20117注射液上海翰森生物医药科技有限公司1CXSL2400356XMVA09注射液合肥星眸生物科技有限公司1CXSL2400355夫那奇珠单抗注射液苏州盛迪亚生物医药有限公司1CXSL2400363夫那奇珠单抗注射液苏州盛迪亚生物医药有限公司1CXSL2400362夫那奇珠单抗注射液苏州盛迪亚生物医药有限公司1CXSL2400361注射用LNF2007双特异性抗体山东新时代药业有限公司1CXSL2400360人脐带间充质干细胞注射液浙江泉生生物科技有限公司1CXSL2400353MG-K10人源化单抗注射液上海麦济生物技术有限公司1CXSL2400354SGC001注射液北京舜景生物医药技术有限公司1CXSL2400352注射用ZG005苏州泽璟生物制药股份有限公司1CXSL2400351仿制药申请药品名称企业注册分类受理号依帕司他片中美华世通生物医药科技(武汉)股份有限公司3CYHS2401651氯化钾颗粒山东普瑞曼药业有限公司3CYHS2401648维生素B6注射液北京远方通达医药技术有限公司3CYHS2401646布美他尼注射液北京民康百草医药科技有限公司3CYHS2401641布美他尼注射液北京民康百草医药科技有限公司3CYHS2401640氨磺必利口服溶液常州四药制药有限公司3CYHS2401638氯化钙注射液河北千康医药科技有限责任公司3CYHS2401634异烟肼注射液漯河市汇创医药有限公司3CYHS2401633维生素K1注射液合肥亿帆生物制药有限公司3CYHS2401632维生素K1注射液合肥亿帆生物制药有限公司3CYHS2401631硫辛酸片苏州富士莱医药股份有限公司3CYHS2401626硫辛酸片苏州富士莱医药股份有限公司3CYHS2401625阿替卡因肾上腺素注射液扬州中宝药业股份有限公司3CYHS2401623利伐沙班颗粒南京海纳制药有限公司3CYHS2401606马来酸氯苯那敏注射液宝利化(南京)制药有限公司3CYHS2401605盐酸曲唑酮片重庆圣华曦药业股份有限公司3CYHS2401603复方匹可硫酸钠口服溶液南京海纳制药有限公司3CYHS2401595布洛芬片珠海润都制药股份有限公司3CYHS2401594氯化钾注射液福州基石医药科技有限公司3CYHS2401593多索茶碱糖浆山东朗诺制药有限公司3CYHS2401592重酒石酸去甲肾上腺素注射液锦州奥鸿药业有限责任公司3CYHS2401584吡格列酮二甲双胍片成都倍特药业股份有限公司3CYHS2401579布立西坦口服溶液海南全星制药有限公司3CYHS2401578恩格列净片云鹏医药集团有限公司4CYHS2401650聚乙烯醇滴眼液浙江百代医药科技有限公司4CYHS2401649盐酸尼卡地平注射液河南群益医药科技开发有限公司4CYHS2401647二甲硅油乳剂浙江赛默制药有限公司4CYHS2401645二甲硅油乳剂浙江赛默制药有限公司4CYHS2401644二甲硅油乳剂浙江赛默制药有限公司4CYHS2401643吗啉硝唑氯化钠注射液浙江百代医药科技有限公司4CYHS2401642双氯芬酸二乙胺乳胶剂浙江百代医药科技有限公司4CYHS2401639硫酸氨基葡萄糖胶囊山西复盛公大药厂有限公司4CYHS2401637妥布霉素滴眼液广州仁恒医药科技股份有限公司4CYHS2401636地诺孕素片常州四药制药有限公司4CYHS2401635阿普米司特片天津市中央药业有限公司4CYHS2401630阿普米司特片天津市中央药业有限公司4CYHS2401629阿普米司特片天津市中央药业有限公司4CYHS2401628夫西地酸乳膏浙江百代医药科技有限公司4CYHS2401627恩扎卢胺软胶囊嘉亨(珠海横琴)医药科技有限公司4CYHS2401624塞来昔布胶囊大桐制药(中国)有限责任公司4CYHS2401622盐酸伊立替康脂质体注射液上海研诺医药科技有限公司4CYHS2401621乳果糖口服溶液江苏万高药业股份有限公司4CYHS2401620乳果糖口服溶液江苏万高药业股份有限公司4CYHS2401619美阿沙坦钾片江苏和晨药业有限公司4CYHS2401618美阿沙坦钾片江苏和晨药业有限公司4CYHS2401617碘佛醇注射液重庆药友制药有限责任公司4CYHS2401616碘佛醇注射液重庆药友制药有限责任公司4CYHS2401615乳果糖口服溶液重庆和平制药有限公司4CYHS2401614乳果糖口服溶液重庆和平制药有限公司4CYHS2401613乳果糖口服溶液重庆和平制药有限公司4CYHS2401612利丙双卡因乳膏华熙生物科技股份有限公司4CYHS2401611氟比洛芬凝胶贴膏湖南普道医药技术有限公司4CYHS2401610通滞苏润江片新疆维吾尔药业有限责任公司4CYZS2400001罗沙司他胶囊郑州德迈药业有限公司4CYHS2401609罗沙司他胶囊郑州德迈药业有限公司4CYHS2401608ω-3脂肪酸乙酯90软胶囊北京双鹭药业股份有限公司4CYHS2401607双氯芬酸钠肠溶片浙江京新药业股份有限公司4CYHS2401604盐酸美金刚片云鹏医药集团有限公司4CYHS2401602盐酸米诺环素胶囊珠海同源药业有限公司4CYHS2401601盐酸米诺环素胶囊珠海同源药业有限公司4CYHS2401600他克莫司软膏齐鲁制药(海南)有限公司4CYHS2401599克立硼罗软膏湖北恒安芙林药业股份有限公司4CYHS2401596吡仑帕奈口服混悬液山东朗诺制药有限公司4CYHS2401591盐酸伐昔洛韦片以岭万洲国际制药有限公司4CYHS2401590枸橼酸托法替布缓释片华润双鹤利民药业(济南)有限公司4CYHS2401589艾拉莫德片四川国为制药有限公司4CYHS2401588尼莫地平片哈尔滨三联药业股份有限公司4CYHS2401587西甲硅油乳剂成都诺和晟鸿生物制药有限公司4CYHS2401586盐酸贝尼地平片福建海西新药创制股份有限公司4CYHS2401585磷酸西格列汀片济南高华制药有限公司4CYHS2401583磷酸西格列汀片济南高华制药有限公司4CYHS2401582注射用阿糖胞苷石家庄迪斯凯威医药科技有限公司4CYHS2401581乳果糖口服溶液成都克莱蒙医药科技有限公司4CYHS2401598乳果糖口服溶液成都克莱蒙医药科技有限公司4CYHS2401597吸入用异丙托溴铵溶液广州大光制药有限公司4CYHS2401580拉坦前列素滴眼液广州仁恒医药科技股份有限公司4CYHS2401577盐酸艾司洛尔氯化钠注射液北京新美泰克医药科技有限公司4CYHS2401576盐酸艾司洛尔氯化钠注射液北京新美泰克医药科技有限公司4CYHS2401575进口申请药品名称企业注册分类受理号左甲状腺素钠片Aristo Pharma GmbH5.2JYHS2400033盐酸万古霉素胶囊Orient Pharma Co.,LTD5.2JYHS2400032盐酸万古霉素胶囊Orient Pharma Co.,LTD5.2JYHS2400031地诺孕素片Laboratoires Besins International5.2JYHS2400030Orforglipron胶囊Eli Lilly and Company1JXHL2400123Orforglipron胶囊Eli Lilly and Company1JXHL2400122Orforglipron胶囊Eli Lilly and Company1JXHL2400121Orforglipron胶囊Eli Lilly and Company1JXHL2400120Orforglipron胶囊Eli Lilly and Company1JXHL2400119Orforglipron胶囊Eli Lilly and Company1JXHL2400118克拉屈滨胶囊Merck Healthcare KGaA2.2JXHL2400125克拉屈滨胶囊Merck Healthcare KGaA2.2JXHL2400124盐酸非苏拉生片Daewoong Pharmaceutical Co., Ltd.2.4JXHL2400117呼吸道合胞病毒疫苗Pfizer Inc.3.1JXSL2400107VAY736注射液Novartis Pharma AG1JXSL2400105Dostarlimab注射液GlaxoSmithKline Research & Development Limited2.2JXSL2400106贝利尤单抗注射液GlaxoSmithKline (Ireland) Limited2.2JXSL2400104中药相关申请药品名称企业注册分类受理号参蒲盆安颗粒江苏康缘药业股份有限公司1.1CXZS2400017开心散山东润中药业有限公司3.1CXZS2400019玉女煎颗粒江苏康缘药业股份有限公司3.1CXZS2400018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。