PALETTE- Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Bayesian Basket Trial"

PALETTE is a perpetual adaptive platform to efficiently study sepsis interventions within 'treatable traits' in all-ages patients enabling prompt evaluation of pandemic treatments. Treatable traits, therapeutic targets identified by phenotypes or endotypes (defined by biological mechanism or by treatment response) through validated biomarkers (measurable characteristic reflecting normal or pathogenic processes, or treatment responses), may include multi-omics, cellular, immune, metabolic, endocrine features, or intelligent algorithms. PALETTE Bayesian adaptive design enables parallel investigations of multiple interventions for sepsis, and quick inclusion of pandemic pathogens. PALETTE's new conceptual model will respond to the challenges of standard approaches, i.e. series of sepsis trials, each investigating one or two interventions, expensive, time consuming, and inappropriate in pandemic context.

开始日期2026-04-01

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

NCT06923072

/ Recruiting临床2期IIT

A Phase IIa Trial of Baricitinib in the Treatment of Kohlmeier-Degos Disease Patients With Neurological Involvement

Background:
Kohlmeier-Degos (KD) is a rare disease that causes inflammation and blood clots, leading to blockages in small blood vessels. These blockages can result in K-D lesions throughout the body, affecting the skin, lungs, heart, spinal cord, and brain. KD can be fatal. No treatment exists for this disease.
Objective:
To test a study drug (baricitinib) in people with brain and spine lesions caused by KD disease. Baricitinib is FDA approved to treat other disorders but has not yet been tried in people with KD.
Eligibility:
People aged 18 years or older with KD-related lesions in the brain and spine.
Design:
Participants will be screened; they will have a physical exam with blood tests. They will also have a baseline visit that may include multiple tests, such as imaging scans of the brain and spine; a lumbar puncture to collect fluid from the spinal canal; and a meeting with a neurologist. They will fill out a questionnaire about their health. They will continue to take their normal medications throughout the study.
Baricitinib is a tablet taken by mouth. Participants will remain on their normal medications for 12 weeks after their baseline visit. Then they will also take the study drug once a day at home for 24 weeks.
Participants will have clinic visits every few weeks for up to 40 weeks. Some visits may take 1 to 4 days. Baseline tests will be repeated 3 more times during study visits. Other visits will require only blood tests; these may be done by local labs that will send the samples to NIH; 2 visits may be done via telehealth....

开始日期2025-06-16

申办/合作机构

National Heart, Lung & Blood Institute

NCT07003997

/ Not yet recruiting临床2期IIT

JAK Signaling in Depression

This study will test the hypothesis that Janus kinase (JAK) signaling is involved in major depression (MD) with high inflammation by determining whether its inhibition with baricitinib can improve functional connectivity in reward and motor circuits in association with improved motivation and motor function in MD patients enriched for high C-reactive protein (CRP) and anhedonia.

开始日期2025-06-01

申办/合作机构

Emory University

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100 项与巴瑞替尼相关的临床结果

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100 项与巴瑞替尼相关的转化医学

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100 项与巴瑞替尼相关的专利（医药）

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3,645

项与巴瑞替尼相关的文献（医药）

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Risk of serious infection with JAK inhibitors in immune-mediated inflammatory skin diseases: a meta-analysis of randomized clinical trials

Review

作者: Lv, Xiaoqing ; Ji, Chao ; Mao, Jing ; Qin, Kun ; Ou, Yushan ; Ruan, Shifan ; Su, Xinhong

BACKGROUND:

Emerging research suggests that Janus kinase-signal transducer and activator of transcription (JAK-STAT) inhibitors may be associated with a higher risk of serious infection for patients with rheumatoid arthritis. However, there is no consensus on whether JAK inhibitors increase the risk of serious infection in patients with Immune-mediated inflammatory skin diseases (IMISDs).

OBJECTIVES:

To ascertain the correlation between JAK inhibitor use and the risk of serious infection in patients with IMISDs.

METHODS:

PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and registered Clinical Trials were searched up to June 1, 2024, using specific search terms related to JAK inhibitors and IMISDs. Randomized clinical trials (RCTs) comparing JAK inhibitors with a control group in patients with IMISDs were included. Studies focusing on cohort studies, case reports, case series, review articles, pooled analysis studies, post hoc analyses and topical JAK inhibitors were excluded. Data were extracted independently by two authors, focusing on serious infections defined according to each study's criteria. Crude numbers for serious infections were pooled and underwent meta-analysis. We assessed the primary outcome regarding the occurrence of severe infections for each study.

RESULTS:

Thirty-two randomized clinical trials involving 11,917 patients were included. Serious infections were reported in 0.62% of patients receiving JAK inhibitors and 0.51% of controls. Meta-analysis found no significant increase in risk of serious infection (I²=0.00%, RR, 0.68; 95% CI, 0.43-1.07). Subgroup analyses revealed no significant heterogeneity based on condition (p = .56) or medication (p = .69).

CONCLUSIONS:

This meta-analysis demonstrates that JAK inhibitors do not significantly increase the risk of serious infections in IMISD patients compared to control treatments. These findings support the safety of JAK inhibitors in this population. Future research should focus on real-world evidence to further assess their risk-benefit profile in dermatological practice.

2025-12-01·JOURNAL OF CLINICAL IMMUNOLOGY

Baricitinib-Induced Remission of Alopecia Universalis in a Child with NFKB2-Associated Immune Dysregulation

Letter

作者: Flinn, A M ; Browne, F ; Blokhuis, C ; Irvine, A D ; Leahy, T R

2025-12-01·Current Hematologic Malignancy Reports

Emerging Therapeutic Approaches for Anemia in Myelofibrosis

Review

作者: Harrington, Patrick ; Palumbo, Giuseppe A ; Chifotides, Helen T ; Duminuco, Andrea ; Bose, Prithviraj ; Torre, Elena ; Vetro, Calogero

PURPOSE OF REVIEW:

In this review, we highlight conventional agents and novel emerging therapeutic strategies to treat anemia in MF.

RECENT FINDINGS:

Anemia is a common and challenging feature of myelofibrosis (MF). The pathobiology of anemia is multifactorial, including progressive bone marrow fibrosis, decreased erythropoiesis due to high hepcidin levels leading to iron sequestration in the reticuloendothelial system, hypersplenism, erythropoiesis inhibition by myelosuppressive JAK inhibitors (ruxolitinib, fedratinib), and others. MF-associated anemia has a negative impact on survival. Conventional agents to manage anemia include erythropoiesis-stimulating agents, danazol, corticosteroids, and immunomodulatory agents, but responses are infrequent and lack durability. Notable advancements have emerged in developing novel treatments for anemia in MF, including the regulatory approval of momelotinib (ACVR1/JAK1/2 inhibitor) in 2023 and development of novel promising agents targeting hemojuvelin and activins. Momelotinib and pacritinib (ACVR1/JAK2 inhibitor) are the preferred JAK inhibitors for patients with cytopenias (anemia, thrombocytopenia). Luspatercept and elritercept are activin receptor ligand traps, promoting erythroid maturation and late-stage erythropoiesis. Currently, luspatercept is being evaluated in a phase 3 trial (INDEPENDENCE™) for anemia in MF patients who are on a JAK2 inhibitor and require transfusions, and in a phase 2 trial (ODYSSEY) in combination with momelotinib in MF patients who are transfusion dependent, whether or not on a JAK inhibitor. Interim results of the RESTORE trial demonstrated that elritercept significantly decreased transfusions in MF patients. DISC-0974 is a first-in-class anti-hemojuvelin (positive hepcidin regulator) monoclonal antibody that decreased hepcidin expression, increased serum iron, and enhanced erythropoiesis in anemic patients with MF in a phase 1b/2 study. Burgeoning studies of novel anemia-targeted agents and combinations are significantly improving the quality of life and outcomes of patients with MF. The recent approval of momelotinib to treat MF with anemia and the emerging novel anemia-directed strategies in early and advanced clinical development have ushered in a new era in the treatment of MF-related anemia.

981

项与巴瑞替尼相关的新闻（医药）

2025-06-10

·PRNewswire

DeepCure Announces DC-15442 as Development Candidate, an Oral STAT6 Inhibitor with 100% in vivo inhibition of pSTAT6 and comparable efficacy to dupilumab across disease models

DC-15442 is a potent small molecule STAT6 inhibitor, which is not a degrader or prodrug, being advanced as a safe dupilumab-in-a-pill alternative for patients BOSTON, June 10, 2025 /PRNewswire/ -- DeepCure, an immunology therapeutics company leveraging artificial intelligence (AI) to rapidly advance novel small molecule drugs, today announced the nomination of DC-15442 as its second development candidate. DC-15442 is a potent, selective, oral STAT6 inhibitor designed to replicate the safety as well as the efficacy of dupilumab, without requiring regular subcutaneous injections. Dupilumab is FDA-approved for multiple indications driven by Type 2 inflammation, including atopic dermatitis, asthma, chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, eosinophilic esophagitis, and prurigo nodularis. DeepCure designed DC-15442 to meet the demand for an oral alternative that is not only equally effective as dupilumab, but also has excellent safety, given that many patients are children and reproductive-aged adults with chronic, non-life-threatening conditions. DC-15442 inhibits the same IL-4/IL-13 signaling pathway as dupilumab by blocking the interaction between unphosphorylated STAT6 (uSTAT6) and the IL-4Ra receptor, and by preventing nuclear translocation and dimerization of phosphorylated STAT6 (pSTAT6). Importantly, like dupilumab, DC-15442 does not degrade STAT6 proteins or impair uSTAT6 non-inflammatory functions. Therefore, DC-15442 does not have the on-target safety concerns of potential therapies based on STAT6 degradation. In preclinical evaluations, DC-15442 achieved nearly 100% inhibition of pSTAT6 in the acute ovalbumin (OVA) allergy models, which outperforms IL-4Ra antibodies and other STAT6 inhibitors. In direct comparisons using the MC903 atopic dermatitis model, DC-15442 matched dupilumab's effectiveness, significantly reducing serum IgE levels to those seen in healthy controls. Additionally, DC-15442 has a dramatic effect on lung function in asthma models, restoring lung function to almost the same levels as healthy controls, with an effect superior to a leading JAK inhibitor (upadacitinib) and dexamethasone. The development candidate also exhibits outstanding selectivity, showing no off-target activity across extensive screening panels - including 102 SH2 domain proteins, 468 kinases, and 78 assays targeting clinical adverse drug reaction-associated proteins. Preliminary in vivo safety assessments confirmed outstanding tolerability, with no observed adverse effects, underscoring its suitability for chronic use. In addition, DC-15442 is not a degrader, and therefore it does not have the potential toxicity concerns of PROTACs. "We are extremely pleased that, in addition to excellent efficacy, DC-15442 demonstrates a very clean safety profile," said Kfir Schreiber, CEO & Co-Founder, DeepCure. "Many of the patients who will consider an oral STAT6 inhibitor will need to have chronic treatment for non-life-threatening conditions, so safety is paramount. As a selective, oral inhibitor that replicates dupilumab's proven mechanism without the target and modality risks associated with protein degradation, DC-15442 may expand the treated population and transform patient quality of life." About DeepCure DeepCure was founded by researchers at MIT to accelerate breakthrough therapies using artificial intelligence (AI) and advanced physics simulations to innovate small molecule discovery. The company is based in Boston, MA, and its engineers, chemists, and biologists collaborate on hard problems to find solutions that will have an enormous impact on patient health. For more information, visit . Contact [email protected] SOURCE DeepCure WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准临床结果

2025-06-02

·信狐药迅

四个国产1类新药提交上市申请：伊托法替布、洛布替尼、STSP-0601和单抗MIL62|新受理（5.26-6.1）

本周药品注册受理数据，分门别类呈现，一目了然。(5.26-6.1）新药上市申请药品名称企业注册分类受理号伊托法替布软膏明慧医药(杭州)有限公司1CXHS2500058洛布替尼片广州麓鹏制药有限公司1CXHS2500057洛布替尼片广州麓鹏制药有限公司1CXHS2500056ACYW???群脑膜炎球菌多糖结合疫苗北京智飞绿竹生物制药有限公司3.2CXSS2500056注射用STSP-0601江苏贝捷泰生物科技有限公司1CXSS2500057重组人源化单抗MIL62注射液北京天广实生物技术股份有限公司1CXSS2500054新药临床申请药品名称企业注册分类受理号BGB-16673片百济神州(苏州)生物科技有限公司1CXHL2500526BGB-16673片百济神州(苏州)生物科技有限公司1CXHL2500525HSK47388片海思科医药集团股份有限公司1CXHL2500521SZ2001片苏中药业集团股份有限公司1CXHL2500524SZ2001片苏中药业集团股份有限公司1CXHL2500523HSK47388片海思科医药集团股份有限公司1CXHL2500522RO7840734罗氏(中国)投资有限公司1CXHL2500519RO7840734罗氏(中国)投资有限公司1CXHL2500518SYN818片杭州圣域生物医药科技有限公司1CXHL2500511SYN818片杭州圣域生物医药科技有限公司1CXHL2500510富马酸奥比特嗪肠溶微丸胶囊深圳市真兴医药技术有限公司1CXHL2500512HEC20002胶囊广东东阳光药业股份有限公司2.2CXHL2500527CZ006注射液浙江萃泽医药科技有限公司2.2CXHL2500520硫酸阿托品滴眼液湖南迈欧医疗科技有限公司2.2CXHL2500516KEM2417缓释干混悬剂深圳珐玛易药品科技有限公司2.2CXHL2500515KEM2417缓释干混悬剂深圳珐玛易药品科技有限公司2.2CXHL2500514硫酸阿托品滴眼液湖南迈欧医疗科技有限公司2.2CXHL2500517MZ-01吸入溶液成都米子生物医药科技有限公司2.2;2.4CXHL2500513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1.1CXSL2500430重组呼吸道合胞病毒疫苗(CHO细胞)(佐剂)江苏中慧元通生物科技股份有限公司1.2CXSL2500429三价流感病毒裂解疫苗(MDCK细胞)兰州百灵生物技术有限公司2.2CXSL2500428注射用YL201苏州宜联生物医药有限公司1CXSL2500441注射用BAT8008百奥泰生物制药股份有限公司1CXSL2500440BAT1308注射液百奥泰生物制药股份有限公司1CXSL2500438SM2275注射液珠海烁星生物医药科技有限公司1CXSL2500443注射用YL202苏州宜联生物医药有限公司1CXSL2500437注射用HB0043上海华奥泰生物药业股份有限公司1CXSL2500431注射用YL201苏州宜联生物医药有限公司1CXSL2500436IBI363信达生物制药(苏州)有限公司1CXSL2500435IBI363信达生物制药(苏州)有限公司1CXSL2500434注射用MHB088C明慧医药(杭州)有限公司1CXSL2500433注射用MHB039A明慧医药(杭州)有限公司1CXSL2500432HEC-301注射液东莞市东阳光生物药研发有限公司1CXSL2500426注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500424重组人PD-L1/CD3 双抗溶瘤II型单纯疱疹病毒注射液(Vero细胞)武汉滨会生物科技股份有限公司1CXSL2500425注射用RMMV疫苗长春康悦生物科技有限公司1CXSL2500423注射用IMD303亲合力(成都)药业有限公司1CXSL2500422BAT4706注射液百奥泰生物制药股份有限公司2.4CXSL2500439注射用重组A型肉毒毒素乐普健糖药业(重庆)有限公司2.4CXSL2500427仿制药申请药品名称企业注册分类受理号利伐沙班颗粒广州大光制药有限公司3CYHS2501949利伐沙班颗粒广州大光制药有限公司3CYHS2501948硫酸沙丁胺醇注射液亚邦医药股份有限公司3CYHS2501947氟比洛芬贴剂湖南九典制药股份有限公司3CYHS2501944硫酸妥布霉素注射液湖北华鸿医药有限公司3CYHS2501943辅酶Q10片海南元盈医药科技有限公司3CYHS2501942维生素B6注射液上海禾丰制药有限公司3CYHS2501936复方氨基酸注射液(20AA-Ⅱ)内蒙古白医制药股份有限公司3CYHS2501930复方氨基酸注射液(20AA-Ⅱ)内蒙古白医制药股份有限公司3CYHS2501929维生素B6注射液南京海鲸药业股份有限公司3CYHS2501927盐酸氨溴索滴剂浙江赛默制药有限公司3CYHS2501926盐酸氨溴索滴剂浙江赛默制药有限公司3CYHS2501925富马酸酮替芬口服溶液安徽茂康药业有限公司3CYHS2501921中性腹膜透析液(碳酸氢盐-G4.25%)石家庄四药有限公司3CYHS2501913注射用盐酸头孢替安/氯化钠注射液湖南科伦制药有限公司3CYHS2501904盐酸昂丹司琼片南京海鲸药业股份有限公司3CYHS2501901盐酸昂丹司琼片南京海鲸药业股份有限公司3CYHS2501900盐酸普萘洛尔注射液安徽美来药业股份有限公司3CYHS2501895氨磺必利口服溶液福安药业集团湖北人民制药有限公司3CYHS2501908利伐沙班口腔崩解片山东新时代药业有限公司3CYHS2501884利伐沙班口腔崩解片山东新时代药业有限公司3CYHS2501883奥美拉唑碳酸氢钠干混悬剂(II)裕松源药业有限公司3CYHS2501882复方聚乙二醇电解质散(II)湖南润兴药业有限公司3CYHS2501876腺苷钴胺胶囊济南中渔润医药科技有限公司3CYHS2501874乙酰半胱氨酸注射液长春澜江医药科技有限公司4CYHS2501957洛索洛芬钠贴剂津药达仁堂集团股份有限公司新新制药厂4CYHS2501956洛索洛芬钠贴剂津药达仁堂集团股份有限公司新新制药厂4CYHS2501955巴瑞替尼片广州大光制药有限公司4CYHS2501954脂肪乳氨基酸(17)葡萄糖(19)注射液瑞阳制药股份有限公司4CYHS2501953盐酸尼卡地平注射液赤峰源生药业有限公司4CYHS2501952盐酸尼卡地平注射液赤峰源生药业有限公司4CYHS2501951乙酰半胱氨酸注射液湖北津药药业股份有限公司4CYHS2501950氟伐他汀钠缓释片浙江百代医药科技有限公司4CYHS2501946乙酰半胱氨酸注射液合肥启旸生物医药科技有限公司4CYHS2501945聚乙烯醇滴眼液湖南华纳大药厂股份有限公司4CYHS2501941环索奈德吸入气雾剂上海上药信谊药厂有限公司4CYHS2501937硫酸特布他林雾化吸入用溶液上海旭东海普药业有限公司4CYHS2501938注射用伏立康唑湖北午时医药研究院有限公司4CYHS2501935瑞巴派特片浙江浙北药业有限公司4CYHS2501934磷酸西格列汀片云鹏医药集团有限公司4CYHS2501933西格列汀二甲双胍片(II)江西施美药业股份有限公司4CYHS2501932达可替尼片北京康立生医药技术开发有限公司4CYHS2501931依达拉奉右莰醇注射用浓溶液陕西丽彩药业有限公司4CYHS2501928恩他卡朋双多巴片(II)复星万邦(江苏)医药集团有限公司4CYHS2501940盐酸乙哌立松片西洲医药科技(浙江)有限公司4CYHS2501939玻璃酸钠滴眼液润尔眼科药物(广州)有限公司4CYHS2501918蒙脱石散成都恒瑞制药有限公司4CYHS2501916比拉斯汀片新乡市常乐制药有限责任公司4CYHS2501914乌帕替尼缓释片广东华润顺峰药业有限公司4CYHS2501912非诺贝特酸胆碱缓释胶囊苏州特瑞药业股份有限公司4CYHS2501911氟比洛芬钠滴眼液广州大光制药有限公司4CYHS2501910布瑞哌唑片杭州和康药业有限公司4CYHS2501924布瑞哌唑片杭州和康药业有限公司4CYHS2501923布瑞哌唑片杭州和康药业有限公司4CYHS2501922乙酰半胱氨酸注射液浙江赛默制药有限公司4CYHS2501920乙酰半胱氨酸注射液四川科伦药业股份有限公司4CYHS2501919乙酰半胱氨酸注射液广州大光制药有限公司4CYHS2501917乙酰半胱氨酸注射液广州君博医药科技有限公司4CYHS2501915克林霉素磷酸酯过氧苯甲酰凝胶江苏知原药业股份有限公司4CYHS2501905依折麦布阿托伐他汀钙片(II)山东创新药物研发有限公司4CYHS2501903依折麦布阿托伐他汀钙片(I)山东创新药物研发有限公司4CYHS2501902艾普拉唑肠溶片江苏和晨药业有限公司4CYHS2501899结构脂肪乳注射液(C6-24)成都国为生物医药有限公司4CYHS2501898盐酸左布比卡因注射液河南普瑞药业有限公司4CYHS2501897盐酸左布比卡因注射液河南普瑞药业有限公司4CYHS2501896硫酸氨基葡萄糖胶囊福州闽海药业有限公司4CYHS2501894左甲状腺素钠片江苏德源药业股份有限公司4CYHS2501893左甲状腺素钠片江苏德源药业股份有限公司4CYHS2501892氧云县长隆工业气体有限公司4CYHS2501891达格列净片陕西君可力医药科技有限公司4CYHS2501890达格列净片陕西君可力医药科技有限公司4CYHS2501889硫酸氨基葡萄糖胶囊唐山利康药业有限责任公司4CYHS2501888盐酸阿罗洛尔片长春海悦药业股份有限公司4CYHS2501907克立硼罗软膏山东达冠医药科技有限公司4CYHS2501906盐酸尼卡地平注射液湖南赛隆药业(长沙)有限公司4CYHS2501909地夸磷索钠滴眼液海南斯达制药有限公司4CYHS2501887阿达帕林过氧苯甲酰凝胶江苏知原药业股份有限公司4CYHS2501886阿达帕林过氧苯甲酰凝胶江苏知原药业股份有限公司4CYHS2501885氯吡格雷阿司匹林片湖南尚众合生物医药有限公司4CYHS2501881苹果酸奈诺沙星氯化钠注射液广州大光制药有限公司4CYHS2501880阿达帕林凝胶乐泰药业(兰西)有限公司4CYHS2501879酒石酸美托洛尔片山东普瑞曼药业有限公司4CYHS2501878酒石酸美托洛尔片山东普瑞曼药业有限公司4CYHS2501877阿司匹林肠溶片赤峰万泽药业股份有限公司4CYHS2501875雷珠单抗注射液杭州中美华东制药有限公司3.3CXSS2500055硫酸特布他林注射液广东万泰科创药业有限公司3CYHL2500102氨苯砜凝胶深圳珐玛易药品科技有限公司3CYHL2500101去氧胆酸注射液江苏润恒制药有限公司3CYHL2500099卡麦角林片长春金赛药业有限责任公司3CYHL2500098倍氯米松福莫特罗吸入气雾剂鲁南贝特制药有限公司4CYHL2500100冻干b型流感嗜血杆菌结合疫苗艾美坚持生物制药有限公司3.3CXSL2500442进口申请药品名称企业注册分类受理号甲苯磺酸纳地美定片Shionogi & Co., Ltd.5.1JXHS2500060伊奈利珠单抗注射液Horizon Therapeutics Ireland DAC2.2JXSS2500070注射用维泊妥珠单抗Roche Pharma (Schweiz) AG2.2JXSS2500069注射用维泊妥珠单抗Roche Pharma (Schweiz) AG2.2JXSS2500068比奇珠单抗注射液UCB Pharma S.A.3.1JXSS2500067比奇珠单抗注射液UCB Pharma S.A.3.1JXSS2500066比奇珠单抗注射液UCB Pharma S.A.3.1JXSS2500065比奇珠单抗注射液UCB Pharma S.A.3.1JXSS2500064恩他卡朋片Aurobindo Pharma Limited5.2JYHS2500024GIREDESTRANTGenentech, Inc.1JXHL2500122PF-08046047Pfizer Inc.1JXSL2500085Mosunetuzumab Injection (Subcutaneous Injection)F. Hoffmann-La Roche Ltd.2.1JXSL2500084Mosunetuzumab Injection (Subcutaneous Injection)F. Hoffmann-La Roche Ltd.2.1JXSL2500083中药相关申请药品名称企业注册分类受理号桃红四物汤颗粒瑞阳制药股份有限公司3.1CXZS2500023健脾疏肝固本颗粒江苏康缘药业股份有限公司1.1CXZL2500032JMZ-2102胶囊江西济民可信药业有限公司1.2CXZL2500034JMZ-2102江西济民可信药业有限公司1.2CXZL2500033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。

疫苗申请上市

2025-05-26

·ETPharma

Trump's MFN pricing plan may hobble Sun Pharma's specialty ride in US, say analysts

New Delhi: What distinguishes India’s largest drug manufacturer, Sun Pharma , among its domestic peers might work against the company's future growth ambitions, on account of a new pricing model announced by the US President earlier this month. Speaking at a webinar hosted by ET Pharma over the new Most-Favoured Nation (MFN) pricing model, a market analyst voiced that while the Indian Pharma industry stands immune with generics, Sun Pharma, which has made specialty novel drugs as its key focus, might encounter some bumps on its future ambition track. “The proposed model is meant to play on the price differentiation of drugs and if it gets implemented it is going to be disruptive for the innovator pharma industry and cutting down prices by up to 50-60 per cent might push innovators into losses," said Vishal Mabchanda, a pharma analyst at Systematix Group. “Among the Indian companies, Sun Pharma that have an innovative portfolio, stands to get impacted," he added. According to an price differential analysis undertaken by the US department of Health and Human Services, using 2022 data, “US prices were closer to those in other countries—at 173 and 213 percent of international prices—when applying the overall and retail-dispensed, and for only brand-name drugs, US prices stands 308 per cent of prices in other countries.” However, at Sun Pharma's last earnings call for Q4 FY25, the company Chairman and MD, Dilip Shanghvi said that, “currently the order is at a voluntarily level and we have wait for greater clarity on this.” At the webinar, Nishith Sanghvi, Director, Corporates at India Ratings, also underlined that, the channels which procure drugs in US plays a major role in deciding the prices and notably, while announcing the order US President Donald Trump specifically voiced that the administration wants to remove the middle-men from the distribution chains. “The Secretary of Health and Human Services will establish a mechanism through which American patients can buy their drugs directly from manufacturers who sell to Americans at a “Most-Favored-Nation” price, bypassing middlemen,” the Factsheet on the order issued from the Whitehouse suggests. “When the order was announced, the market reaction reflected that the proposed order is highly unlikely to be implemented in its initial proposed format and it will likely be in a more diluted form,” Manchanda noted. Besides this, the chance of a legal challenge is always there on the horizon as seen in the past during Trump's first term-though the order was restricted to the government-funded Medicare program. Following the Ranbaxy fiasco, what is often described as Sun Pharma’s 'second stint' saw the Indian drugmaker shift its focus from the traditional generics ANDA pathway to novel innovations in specialty therapeutic segments. Over the last few years, driven by in-licensing agreements and in-house capabilities, the company has established a solid foundation in this segment. In the latest concluded quarter ended March this year, while the company reported a 19 per cent year-on-year (YoY) decline in its net profit , the global specialty sales went up by 8.6 per cent to $295 million (around ₹2,500 crore)--accounting for 19.9 per cent of the total quarterly sales. Moreover, for the full fiscal period, the specialty portfolio accounted for 19.7 per cent of the total global sales and generated $1,216 million (around ₹10,330 crore), up by 17.1 per cent against the previous fiscal. Expanding its specialty portfolio, the drugmaker is looking to launch two of its approved pipeline candidates--Leqselvi and Unloxcyt---in the near future. Leqselvi , a JAK 1/2 inhibitor was approved by the FDA in July 2024 for treatment of adults with severe alopecia areata (a type of hair loss). The company's plans were mired by a court ruling which blocked the drug launch in November 2024, but in April this year the US Court of Appeals for the Federal Circuit lifted the preliminary injunction and cleared its market entry. According to experts, “Sun Pharma’s Leqselvi higher dose of 8 mg twice daily, positions it in a stronger position as the higher dose will have a slightly better efficacy in comparison to Eli Lilly’s Olumiant which is taken at 2mg or 4mg per day for severe alopecia areata treatment.” A market assessment report published by GlobalData expects that, “total sales of Leqselvi is expected to reach $698.3 million (around ₹5,930 crore) in the US by 2033, accounting for approximately 35 per cent of the anticipated $2 billion (₹1,7000 crore) market for alopecia areata therapies in the country. Besides this, in March this year, the Indian drugmaker acquired a US-based immunotherapy and targeted oncology company, Checkpoint Therapeutics , with an upfront payment of up to $355 million (around ₹3000 crore). Unloxcyt (cosibelimab-ipdl) has received approval from the USFDA for the treatment of adults with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. Industry experts suggest that in the US, Onco-derma drugs have the highest profit margin among all therapeutic segments. Announcing, the company's Q4 FY25 results, Dilip Shanghvi said that, "The near-term pipeline in Global Specialty is promising, with products such as Leqselvi and Unloxcyt—the latter through our recently announced Checkpoint acquisition—offering significant improvements in patient care and we look forward to specialty drugs becoming an increasingly important part of our business." For FY25, the company's total revenue of ₹52,578 crore and the R&D spent (largely aligned for specialty projects) stands at ₹3,248 crore–accounting for nearly 6.2 per cent of total sales. While the administration is yet to convey the price targets, the recent developments reflect that with a majority in both houses and the commendation on the executive machinery, there is no holding back on the part of US. For the Indian drugmaker, identified with the unpredictable strategy of turning niche gaps into million-dollar bets, the road ahead may soon be shaped by equally unconventional policies and mounting unpredictability. By Abhijeet Singh ,

上市批准并购免疫疗法引进/卖出生物类似药

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KEGG	Wiki	ATC	Drug Bank
D10308	巴瑞替尼	L04AA37	DB11817

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适应症	国家/地区	公司	日期
附着点炎相关关节炎	欧盟	Eli Lilly Nederland BV	2023-09-21
附着点炎相关关节炎	冰岛	Eli Lilly Nederland BV	2023-09-21
附着点炎相关关节炎	列支敦士登	Eli Lilly Nederland BV	2023-09-21
附着点炎相关关节炎	挪威	Eli Lilly Nederland BV	2023-09-21
幼年特发性关节炎	欧盟	Eli Lilly Nederland BV	2023-09-21
幼年特发性关节炎	冰岛	Eli Lilly Nederland BV	2023-09-21
幼年特发性关节炎	列支敦士登	Eli Lilly Nederland BV	2023-09-21
幼年特发性关节炎	挪威	Eli Lilly Nederland BV	2023-09-21
少关节关节炎	欧盟	Eli Lilly Nederland BV	2023-09-21
少关节关节炎	冰岛	Eli Lilly Nederland BV	2023-09-21
少关节关节炎	列支敦士登	Eli Lilly Nederland BV	2023-09-21
少关节关节炎	挪威	Eli Lilly Nederland BV	2023-09-21
多关节型幼年特发性关节炎	欧盟	Eli Lilly Nederland BV	2023-09-21
多关节型幼年特发性关节炎	冰岛	Eli Lilly Nederland BV	2023-09-21
多关节型幼年特发性关节炎	列支敦士登	Eli Lilly Nederland BV	2023-09-21
多关节型幼年特发性关节炎	挪威	Eli Lilly Nederland BV	2023-09-21
新型冠状病毒感染	瑞士	Eli Lilly & Co.	2017-06-19
斑秃	欧盟	Eli Lilly Nederland BV	2017-02-13
斑秃	冰岛	Eli Lilly Nederland BV	2017-02-13
斑秃	列支敦士登	Eli Lilly Nederland BV	2017-02-13

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适应症	最高研发状态	国家/地区	公司	日期
Aicardi-Goutieres综合征	临床3期	日本	Eli Lilly & Co.	2020-10-27
慢性非典型中性粒细胞性皮肤病伴脂肪营养不良和体温升高	临床3期	日本	Eli Lilly & Co.	2020-10-27
肢骨纹状肥大	临床3期	日本	Eli Lilly & Co.	2020-10-27
Nakajo综合征	临床3期	日本	Eli Lilly & Co.	2020-10-27
婴儿期发病的STING相关血管病变	临床3期	日本	Eli Lilly & Co.	2020-10-27
全身型幼年特发性关节炎	临床3期	日本	Eli Lilly & Co.	2020-02-12
全身型幼年特发性关节炎	临床3期	阿根廷	Eli Lilly & Co.	2020-02-12
全身型幼年特发性关节炎	临床3期	奥地利	Eli Lilly & Co.	2020-02-12
全身型幼年特发性关节炎	临床3期	比利时	Eli Lilly & Co.	2020-02-12
全身型幼年特发性关节炎	临床3期	巴西	Eli Lilly & Co.	2020-02-12

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06662721 (Pubmed \| Rheumatology (Oxford))	临床2期	大动脉炎 TNF-α inhibitors	10	Baricitinib 4 mg daily	壓鏇憲憲遞壓鬱衊窪襯(願艱鑰簾遞選鹽選憲憲) = 襯廠襯齋鹽窪衊夢鑰構膚製窪鬱鹹鑰願範築鹹 (獵餘蓋製鏇窪衊壓夢醖 ) 更多	积极	2025-05-24
SLE-BRAVE-I and SLE-BRAVE-II (Pubmed \| PLoS One)	临床3期	系统性红斑狼疮	1,535	Baricitinib 4 mg	網憲淵淵窪範獵製醖簾(獵廠獵範選餘鹹選淵願) = 襯膚醖鬱鹽艱觸製夢糧遞觸願觸觸範築淵餘淵 (範鏇製醖淵積築簾構製 )	不佳	2025-04-30
				Baricitinib 2 mg	網憲淵淵窪範獵製醖簾(獵廠獵範選餘鹹選淵願) = 遞願襯製築衊窪顧淵選遞觸願觸觸範築淵餘淵 (範鏇製醖淵積築簾構製 )
BRAVE-AA1 and BRAVE-AA2 (Pubmed \| Am J Clin Dermatol)	临床3期	斑秃	1,303	Baricitinib 2 mg	獵顧憲艱築醖淵蓋製糧(襯窪鹹艱憲願膚廠構餘) = 窪鏇壓廠網糧顧鹽範齋廠顧廠遞糧齋襯膚遞觸 (構艱積鏇糧蓋觸醖醖製 ) 更多	积极	2025-04-11
				Baricitinib 4 mg	獵顧憲艱築醖淵蓋製糧(襯窪鹹艱憲願膚廠構餘) = 衊齋齋鹽鏇構醖網艱構廠顧廠遞糧齋襯膚遞觸 (構艱積鏇糧蓋觸醖醖製 ) 更多
BRAVE-AA1; BRAVE-AA2 (Pubmed \| Br J Dermatol)	N/A	斑秃	-	Baricitinib 2 mg	構衊築淵壓鹹繭鑰淵範(淵憲簾鹽鬱淵鹹選選遞) = 鹹製顧夢遞觸簾醖憲淵築遞鏇顧繭鹹簾製網膚 (網積顧憲齋築製積築夢 )	积极	2025-04-03
				Baricitinib 4 mg	構衊築淵壓鹹繭鑰淵範(淵憲簾鹽鬱淵鹹選選遞) = 築蓋鬱醖衊繭夢糧範製築遞鏇顧繭鹹簾製網膚 (網積顧憲齋築製積築夢 )
NCT05723198 (BRAVE-AA-PEDS, Company_Website) 人工标引	临床3期	斑秃	257	Baricitinib 4 mg	獵壓鹽艱窪壓廠鹽選衊(窪憲構觸築鑰築襯糧蓋) = 觸願糧醖範艱獵糧遞醖糧遞範選鑰淵衊鹹廠繭 (製鹹遞艱壓鹽窪齋淵積 ) 更多	积极	2025-03-08
				Baricitinib 2 mg	獵壓鹽艱窪壓廠鹽選衊(窪憲構觸築鑰築襯糧蓋) = 壓鬱顧顧網範齋築鬱鏇糧遞範選鑰淵衊鹹廠繭 (製鹹遞艱壓鹽窪齋淵積 ) 更多
NCT05188521 (Pubmed \| J Clin Invest)	临床2期	扁平苔藓 IFN-γ \| CD8+ \| CXCL13+	-	Baricitinib 2 mg	壓積窪範願襯網鹹廠衊(顧選鑰鬱鏇鏇壓顧願襯) = 膚憲餘襯願鬱遞膚夢鹽蓋範壓襯淵襯壓憲簾衊 (醖鑰觸簾蓋壓蓋遞憲鬱 )	积极	2025-01-16
NCT03952559 (BREEZE-AD-PEDS, Pubmed \| J Dermatolog Treat)	临床3期	中度特应性皮炎 \| 重度特应性皮炎	467	Baricitinib 4-mg equivalent	壓醖繭艱鹹鏇選構壓壓(鬱壓製蓋顧齋膚範積構) = 積蓋窪遞淵夢製製觸衊鹽鬱觸衊鬱選遞網餘夢 (鏇襯壓網繭醖糧醖築廠 )	积极	2024-12-31
NCT01885078 (RA-BEYOND, Pubmed \| Rheumatology (Oxford)) 人工标引	临床3期	类风湿关节炎	-	Baricitinib 4 mg	繭蓋鏇積膚顧簾膚鬱觸(膚範鑰顧廠蓋範艱淵鏇) = 壓觸糧鹹鬱範觸蓋鏇憲淵廠獵憲簾範鑰製齋餘 (獵鹹觸觸鹹觸糧壓餘憲 ) 更多	积极	2024-10-01
				Baricitinib 2 mg	繭蓋鏇積膚顧簾膚鬱觸(膚範鑰顧廠蓋範艱淵鏇) = 廠壓淵觸鏇築淵艱積鹽淵廠獵憲簾範鑰製齋餘 (獵鹹觸觸鹹觸糧壓餘憲 ) 更多
NCT04088409 (CTgov)	临床3期	前葡萄膜炎 \| 葡萄膜炎 \| 幼年特发性关节炎	30	Baricitinib (Baricitinib)	獵製觸醖鬱築鹽衊窪顧 = 觸鹹餘遞襯鬱製獵鹹艱夢壓構衊網艱鹽簾製鹹 (齋構壓顧窪鹹餘繭願鑰, 餘齋憲夢壓鹽壓繭艱鏇 ~ 觸夢築夢憲糧憲觸構窪) 更多	-	2024-08-13
				Adalimumab (Adalimumab)	醖簾鏇蓋簾糧築選蓋觸(壓顧衊廠鏇廠鏇鹹鬱膚) = 願網廠壓憲製糧糧積齋積糧獵鏇遞範蓋淵壓襯 (衊鹽膚鹽積築廠築顧鬱, 醖蓋鹹壓醖鬱獵繭壓構 ~ 積糧選遞築醖遞鏇範淵) 更多
NCT03570749 \| NCT03899259 (BRAVE-AA1; BRAVE-AA2, Pubmed)	临床3期	斑秃	131	Baricitinib 4 mg	鑰糧醖憲糧選糧獵夢鹹(獵鬱選鏇鏇夢製積願願) = progressive improvements 網膚簾壓積廠獵鑰簾鹹 (襯築繭壓艱鏇鏇壓願顧 ) 更多	积极	2024-06-21
				Baricitinib 2 mg