A Phase II, Multi-Centre, Double Blind, Randomized, Comparative Study to Evaluate Efficacy and Safety of Etanercept in Patients with Moderate COVID-19 (COVETA) - COVETA

开始日期2021-04-12

申办/合作机构

Lupin Ltd

CTRI/2019/01/016851

/ Recruiting临床3期

Randomized, Controlled Open Label Clinical Study to Compare the Impact of Single Transition from EnbrelÂ® Auto-Injector (AI) to YLB113 AI on Safety, PK and Compare Usability of Both AIs in Patients with Active Rheumatoid Arthritis (RA).

开始日期2019-01-04

申办/合作机构-

CTRI/2016/05/006899

/ Completed临床3期

A Comparative Study to Assess the Efficacy, Safety and Immunogenicityof YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

开始日期2016-05-16

申办/合作机构

YL Biologics Ltd.

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项与依那西普生物类似药(鲁宾有限公司) 相关的文献（医药）

2024-05-01·Journal of Orthopaedic Surgery

Efficacy of switching from originator etanercept to biosimilar YLB113 in real-world patients with rheumatoid arthritis: A retrospective 12 months follow-up study

Article

作者: Okamura, Koichi ; Suto, Takahito ; Sakane, Hideo ; Mitomi, Hirofumi ; Inoue, Makoto ; Chikuda, Hirotaka ; Tsuchida, Kosei ; Kaneko, Tetsuya ; Tamura, Yasuyuki ; Yonemoto, Yukio

Purpose: To investigate the disease activity in real-world patients with rheumatoid arthritis (RA) who switched from originator etanercept (ETN) to biosimilar YLB113. Methods: Forty one RA patients who switched from ETN to YLB113 were divided into 2 groups based on the Disease Activity Score based on the 28-joint count (DAS28) 12 months after switching (R group: DAS28 < 2.6, N group: DAS28 ≥ 2.6), and the baseline characteristics were statistically examined. A receiver operating characteristics (ROC) analysis was performed to estimate the cut-off value of DAS28 at baseline to achieve remission 12 months after switching. Results: There was no significant difference in the DAS28 at baseline and 12 months after switching ( p = .83). Sixteen out of the 20 patients in remission at baseline achieved remission after switching. A univariate analysis revealed the rheumatoid factor ( p = .04) and DAS28 ( p < .001) at baseline were significantly lower in the R group than in the N group. Furthermore, logistic regression analysis revealed DAS28 was an independent factor ( p = .004) for achieving remission 12 months after switching. An ROC curve analysis showed the optimal cut-off value for DAS28 at baseline to achieve remission at 12 months after switching was 2.5. Conclusions: RA patients who achieved remission using originator ETN, were able to maintain remission even if they switched to YLB113.

2023-01-01·International journal of rheumatic diseases

Lower injection‐site reactions and long‐term safety, immunogenicity, and efficacy of etanercept biosimilar YLB113: Results from a post‐hoc analysis of a double‐blind, randomized, phase III comparative study and its open‐label extension in patients with rheumatoid arthritis

Article

作者: Bakhle, Dhananjay ; Shah, Chirag ; Yamanaka, Hisashi ; Hibino, Toshihiko ; Stefanidis, Dimitris ; Tanaka, Yoshiya ; Unmesh, Gopalakrishnan

Abstract:

Aim:

YLB113 biosimilar was evaluated in an open‐label extension single‐arm study to assess long‐term safety, efficacy, and immunogenicity in patients with rheumatoid arthritis (RA). We also report post‐hoc results on the incidence of injection‐site reactions (ISRs) and injection‐site erythema (ISE) from a phase III study.

Method:

Participants from the phase III, double‐blind, randomized, 96 week equivalence study who completed the final visit received 50 mg YLB113 subcutaneously every 2 weeks. Key safety end points were assessed through adverse events (AEs), ISRs, ISE, and anti‐drug antibody (ADA) incidence. The efficacy end point was change from baseline in Disease Activity Score 28‐joint count (DAS28) over time.

Results:

Of 201 participants, 184 (91.5%) completed the study. Treatment‐emergent AEs were experienced by 93.5% and severe AEs by 10.0% of participants. The discontinuation rate due to AEs was 2.0%. Overall, 20.0% of participants reported an incidence of ISRs throughout the open‐label extension study. Two participants developed ADAs, and none developed neutralizing ADAs at any time after study drug administration. The overall DAS28 (mean ± SD) change was 2.22 ± 0.95 at the study transition, 2.10 ± 0.91 at week 72, and 2.06 ± 0.89 at the end of the study. In the post‐hoc analysis, YLB113 showed a statistically significant lower incidence of ISRs (10 [3.8%], P < 0.0001) and ISE (5 [1.9%], P < 0.0001) compared with the reference product Enbrel®.

Conclusion:

YLB113 demonstrated long‐term safety and sustained efficacy for up to 96 weeks. Patients on YLB113 experienced significantly lower ISRs and ISE in a post‐hoc analysis of the phase III study when compared with reference product.

2020-08-01·European journal of drug metabolism and pharmacokinetics4区 · 医学

An Open-Label, Randomized, Single-Dose, Crossover, Comparative Pharmacokinetics Study of YLB113 and the Etanercept Reference Product in Healthy Adult Male Subjects

4区 · 医学

Article

作者: Kshirasagar, Santhosh ; Vittala, Praveen ; Al-Ghazawi, Ahmad ; Al-Jaouni, Rana ; Kasibhatta, Ravi Sekhar ; Bakhle, Dhananjay ; Shennak, Mustafa ; Godse, Neelima

BACKGROUND AND OBJECTIVES:

YLB113 is being developed as a biosimilar of the antitumor necrosis factor-alpha antagonist etanercept, which is approved for the treatment of moderate-to-severe rheumatoid arthritis (RA) and other chronic immune-mediated inflammatory diseases. An open-label, crossover, pharmacokinetic study was conducted to compare the relative bioavailability and safety of YLB113 and the etanercept reference product (RP) Enbrel^®.

METHODS:

Healthy male subjects aged 18-50 years were randomized to receive a single subcutaneous dose of YLB113 in one period and the etanercept RP in another period. A washout period of 28 days separated the two treatment periods. Blood samples were collected for pharmacokinetic analysis predose and until 480 h postdose during both periods.

RESULTS:

Overall, 52 subjects were enrolled, including 51 subjects who completed the first period and 43 subjects who completed the second period. The 90% confidence intervals for the least squares means derived from an analysis of the log-transformed pharmacokinetic parameters maximum serum concentration (C_max), area under the serum concentration-time curve (AUC) from 0 to the last measurable concentration (AUC_(0-t)) and AUC from 0 to infinity (AUC_(0-∞)) for etanercept were between the limits of 80 and 125%. Thus, YLB113 met the bioequivalence criterion. YLB113 and the etanercept RP were well tolerated, with 24 subjects reporting 53 adverse events, including 42 mild and 11 moderate events. Treatment-emergent adverse events were reported by 14 and 16 subjects following the administration of YLB113 and the etanercept RP, respectively.

CONCLUSIONS:

A single dose of YLB113 exhibited pharmacokinetic and safety profiles comparable with those of the etanercept RP in healthy adult male subjects. Therefore, YLB113 and the etanercept RP can be considered bioequivalent. These findings support the continued development of YLB113 for use in patients with RA.

JORDAN FOOD & DRUG ADMINISTRATION UNIQUE TRIAL NUMBER:

31/Clinical/2018.

项与依那西普生物类似药(鲁宾有限公司) 相关的新闻（医药）

2024-08-06

·PipelineReview

Lupin Launches Rymti® Biosimilar Etanercept in Canada

MUMBAI, India | BOUCHERVILLE, Canada I May 03, 2024 I Global pharma major Lupin Limited (Lupin) today announced the launch of Rymti®, Lupin’s first biosimilar in Canada, through its partner Sandoz Canada (Sandoz). Rymti® is indicated for the treatment of moderate to severe active rheumatoid arthritis, juvenile idiopathic arthritis, active and progressive psoriatic arthritis, severe axial spondyloarthritis, moderate to severe plaque psoriasis and chronic severe plaque psoriasis in children and adolescents. Rymti® is approved for all therapeutic indications of the reference product Enbrel®. Etanercept as an established therapy option Lupin’s Etanercept was first approved for the treatment of rheumatoid arthritis by PMDA in 2019, EMA in 2020, Health Canada in 2022, and since then has offered an effective treatment option for several chronic inflammatory diseases. Patient friendly application by means of pre-filled pen Rymti® is available as a solution for injection in a pre-filled pen and pre-filled syringe. Data show a high patient acceptance of the easy-to-handle pre-filled pen. Patients favored this latex-free device for self-injection, which can lead to improvement in compliance. Cost-effective treatment with Rymti® Rymti®, with an equivalent efficacy and safety to reference product Enbrel®, is an attractive cost-effective treatment alternative that can contribute to sustainable healthcare and treatment options. The etanercept biosimilar Rymti, produced by Lupin, received approval from Canada’s drug regulator, Health Canada (HC), in August 2022, for all indications of the reference product Enbrel. “We are delighted to announce the launch of Rymti®, Lupin’s first biosimilar in Canada through our partner Sandoz,” said Vinita Gupta, Chief Executive Officer, Lupin . “With this important milestone, we continue to advance healthcare accessibility and affordability for patients in Canada.” “Etanercept is used globally in the fight against a range of severe autoimmune disorders. We are happy to bring etanercept to the patients in Canada. We have diligently worked to build our portfolio to include etanercept ensuring patients have access to effective and affordable equivalent. This launch demonstrates our commitment to fostering healthcare solutions that truly make a difference,” said Dr. Cyrus Karkaria, President Biotechnology, Lupin. Michel Robidoux, President and General Manager, Sandoz Canada said, “The launch of Rymti® is a key milestone for Sandoz Canada. Thanks to our exclusive partnership with Lupin, we’re adding another etanercept option on the Canadian market, increasing access for patients.” About Etanercept Etanercept is an injectable biologic medicine that inhibits the biological activity of Tumor Necrosis Factor (TNF). TNF is a key cytokine involved in the pro-inflammatory cascade in many chronic, immune-mediated inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis. Etanercept as a soluble TNF receptor fusion protein specifically binds to TNF and blocks its activity, thereby reducing inflammation and disease symptoms. About Lupin Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastrointestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centres, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector. Please visit www.lupin.com for more information. SOURCE: Lupin

上市批准生物类似药

2021-04-13

·药融圈

印度巨头Lupin：2020年依然正增长;位列全球TOP 10仿制药企

注：本文不构成任何投资意见和建议，以上市公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）。鲁宾制药（Lupin Pharma）是一家跨国制药公司，总部位于印度孟买。由Dr. Desh Bandhu Gupta于1968年成立。研发主体坐落在浦那-马哈拉施特拉邦。Lupin制药提供多种产品，涵盖品牌药物和仿制药、生物药、原料药中间体以及特种化学产品。药物所涉及的疾病领域有：妇科、心血管、糖尿病、哮喘、儿科、中枢神经系统（CNS）、胃肠道（GI）、抗感染（AI）和非甾体抗炎药（NSAIDs）等。公司部分产品在抗结核和头孢菌素领域处于全球领导地位，业务遍及全球100多个国家。目前印度制药巨头Lupin2020年依然正增长;位列全球TOP 10仿制药企。来源：公司财报；药融圈；由于各国财年不同，仅供参考注：（因Viatris刚重组而成，营收根据21年全年指引）据公司预计披露，尽管面临着COVID-19疫情的压力，Lupin于2020-2021年（2020/03-2021/03）在全球所有地区依然实现了正增长，尤其是印度的品牌药产品业务，这主要得益于Lupin新产品的推出和品牌建设。更多信息，等待最新一季年报，以下以上一财年年报撰文。 2019-2020年（2019/03-2020/03），Lupin的全球业务在结核病和抗艾滋病毒药物方面取得了里程碑的进展。在仿制药领域，美国市场的价格经历了几年波动之后，现在正走向稳定。在欧洲方面，依那西普生物类似药（Biosimilar）已获得欧洲批准。此外，Lupin的左旋甲状腺素钠占了整体市场比较不错的份额。在战略投资方面，Lupin撤资日本kyowa，资本结构进一步得到了完善。从总体来说，Lupin的主要市场：印度市场和美国市场的业务增长强劲，业绩占其全球收入的72%。Lupin在美国的仿制药市场上有174种产品，其中有63种在细分市场排名第一，123个产品排名前三，产品平均市场占有率达30%。按处方量计算，公司拥有美国市场第3大仿制药处方。Lupin计划将其营收的10.3%用于药物研发管线和平台的建设，目前有43种产品首次申请上市，其中14个是市场首个申请上市的产品（FTF，First-to-Files），预计在未来将为公司带来丰厚的营收。美国市场占有率和仿制药市场TRx当时排名来源：2019-2020年Lupin年报 1主要市场美国市场 Lupin制药的美国总部位于马里兰州巴尔的摩市，其美国营销部门Lupin 制药公司（LPI）致力于提供该地区医疗保健专业人员和患者信任的特药（Specialty）和仿制药。在过去五年中，公司在美国研发基础设施和制造生产工厂设施方面进行了战略投资。位于佛罗里达州珊瑚泉的吸入制剂药物研究与发展中心成立于2013年，并于2014年初开始全面运作。2016年收购GAVIS这使得公司能够扩大其在处方管控药物、皮肤科、妇女健康和其他利基市场治疗领域的渠道。 2017年10月，Lupin收购了美国新药公司Symbiomix Therapeutics及其FDA批准的新药Solosec（secnidazole，塞克硝唑颗粒剂）。这是一款治疗细菌性阴道炎的单剂口服疗法（single-dose oral therapy），也是10多年来治疗这一疾病的第一款口服新药。细菌性阴道炎是美国最普遍的女性妇科感染，每年影响2100万年龄在21岁至49岁之间的妇女。对Solosec（secnidazole，塞克硝唑）专营权的收购显著扩展了公司妇女健康专业业务。 2019-2020年在美国的净销售额比去年增长了近3%，贡献了全球销售额的38%，共计8亿美元，主要得益于左旋甲状腺素钠的增长。该产品在美国仿制药市场上依然保持第三的地位，占美国仿制药处方量的6.3%，公司计划来年增加左旋甲状腺素的份额。此外吸入性产品沙丁胺醇正等待美国FDA的审批。来源：2019-2020年Lupin年报美国仿制药市场TRx此前排名，供参考，第一位TEVA 来源：2019-2020年Lupin年报印度市场印度业务仍然是Lupin的第二大业务部分，营收占其全球收入的34%。2019-2020年印度市场，Lupin品牌仿制药销售额增长了13.6%。目前在印度制药市场（IPM）中排名第六，突破了5亿卢比的里程碑。复合年增长率一直超过IPM，四年复合年均增长率为11.7%，而IPM为9.4%。重要的是，在过去四年中，Lupin品牌仿制药市场份额从2016年的3.46%提高到2020的3.61%。 Lupin的前十产品在前300个品牌名单中 IPM的市场份额从3.46%提高到了3.61% 来源：2019-2020Lupin年报 2020年心脏病领域、抗糖尿病、呼吸/抗感染、胃肠道用药贡献了公司超过74%的销售额。Lupin继续在抗结核病领域处于印度市场领先地位，在呼吸系统用药保持第二位，在抗糖尿病和心脏病用药领域保持第三位。Lupin在抗糖尿病领域增长显著，为18.4%，而IPM 的增长率为11.8%，市场份额从2019年的7.9% 提高到2020年的8.4%。现在有10 个Lupin 品牌位于IPM 的Top300品牌中。2020年，Lupin成功启动了三个新的部门，专注于泌尿科、皮肤科和儿科呼吸治疗领域。 Lupin的Therapy-wise排名来源：2019-2020Lupin年报 2Lupin2019-2020年研发方面的主要情况 2020年，Lupin在复杂仿制药制剂的开发和新药研究方面取得了重大进展，2020年Lupin累计申请了430份ANDA文件，被批准的有272份，优先申请的有43份，独家申请的有14份。原料药API产品和制剂研究 Lupin的仿制药研发布局，主要致力于开发吸入、注射剂、眼科、口腔领域的高准入门槛产品，这些产品和原料药、给药系统、设备设计、临床试验要求有关，需要建设完善的技术平台。据悉，2021年，Lupin将继续投资复杂的仿制药技术平台。 Lupin申请递交了21份ANDA文件，包括口服，可注射，眼科，吸入和皮肤科剂型和2份NDA新药上市申请，已获得美国FDA批准的ANDA文件有14份，有18种产品已在美国上市。在除美国外的其他几个市场提交了11种非专利产品，包括EMEA（欧洲，南非和俄罗斯），亚太地区（日本和澳大利亚），拉美（墨西哥和巴西）和加拿大，获得批准的ANDA文件有10份。另外，为抗Anti-TB（抗结核）和Antiretroviral（抗逆转录病毒药物）机构的产品提交了2份市场许可批准（MAA）文件，其中，包括一份PEPFAR文件。 Biosimilar研究 2020年Lupin成果显著，在日本完成了与Yoshindo和Nichi-Iko的合作，推出了抗类风湿关节炎的生物类似药Etanercept。 2020年3月，欧洲人用药品委员会(CHMP)通过了一项积极的意见，该意见是基于生物相似性评估，包括临床前和临床研究，证明Enbrel®的生物等效性。此外，一项针对中重度活动性类风湿性关节炎患者的全球3期临床研究证Nepexto®与Enbrel®的等效性，在有效性、安全性和免疫原性方面具有等价性。 2020年6月，欧盟委员会（EC）授予了Etanercept（品牌为Nepexto®）的上市许可，适用于参考产品的（Enbrel®）的所有适应症。 *主要临床研究的进程 Pegfilgrastim：已获得美国FDA的临床研究批准，正积极展开试验 Ranibizumab：印度正在进行3期临床研究，已启动全球临床试验 Aflibercept: 根据印度政府生物技术部的国家生物制药计划，获得了美国650万美元的拨款新药研发目前，Lupin的新药研发团队在肿瘤学、免疫学和代谢障碍等重点治疗领域开发了高度分化和创新的新化学实体。在2019年10月，成功地与Boehringer Ingelheim 合作，推进了临床阶段的MEK抑制剂LNP3794来治疗难以治疗的癌症。（与勃林格殷格翰新兴KRAS抑制剂管线进行联合临床研发，以抗击KRAS突变引发的癌症，该交易鲁宾制药获得2000万美元预付款，并有望获得总额高达7亿美元的潜在阶段性付款以及基于产品销售额的版税） 3财务状况截止2020年3月31日，Lupin制药综合运营收入为20.64亿美元，同比增长4.8%。国际业务贡献了其收入的63%。 Lupin10年的财务数据总结来源：2019-2020Lupin年报 2019-2020年美国市场的收入占全球的收入38%，印度市场占全球收入的34%，拉丁美洲和亚太地区都占全球收入的4%，欧洲占比约8%。截至到2019年3月31日财年结束，Lupin的合并销售额和净利润分别为1636.94亿卢比（23.4亿美元）和94.66亿卢比（1.36亿美元）。 4发展历程从API到制剂再到新药；从合作/合资/到并购升级，制药企业出海之路。 1968 Lupin开始创立营业 1972 Lupin Laboratories Pvt. Ltd. 成立 1987 Mandideep的Cephalexin工厂和Ankleshwar的7家ADCA工厂正在投产 1988 Lupin人类福利和研究基金会（LHWRF）由Dr. Desh Bandhu Gupta创立 1991在Mandideep公司开始生产Injectable Cephalosporin (Bulk And Dosages)（注射用头孢菌素） 1992 在Maharashtra的Tarapur建立一个叫Lupin Chemicals Ltd.的无菌工厂，用于生产Injectable Cephalosporin 1993 Lupin Laboratories Ltd. 和Lupin Chemicals Ltd. 首次通过IPO筹集资金上市 2000 Mandideep的Cefotaxime Facility 获得了美国食品和药品管理局（FDA）的批准 2001在浦那设立了Lupin最先进的研发中心开始向其在美国的联盟伙伴供应Cephalosporin Bulk ActivesLupin Laboratories Ltd. 和Lupin ChemicalsLtd.合并，并更名为Lupin Ltd.成为唯一一家获得美国FDA批准的有Sterile Cephalosporin 设备的亚洲制药公司美国FDA批准的最先进的Cephalosporin Bulk Active 工厂已在Mandideep投入使用 2003Aurangabad的配方工厂获得世卫组织批准的最先进的称号成功在公司范围内实施SAPERP，以统一所有业务职能和流程在内联网中引入协作消息传递和工作流解决方案Mandideep的Oral Cephalosporin工厂获得美国FDA批准Lupin Pharmaceuticals Inc.USA成立，从事贸易、营销和发展活动 2011在Pithampur的新型口服固体剂量设施开始商业化生产在日本收购I'rom Pharmaceuticals与Medicis签订联合开发协议取得Goanna®品牌的全球版权 2014与日本Yoshindo Inc.签署战略合资协议收购墨西哥专业眼科公司Laboratorios Grin S.A. De C.V.并以此进入拉丁美洲市场收购NanomiB.V.，进入复杂的注射剂领域 2015Florida珊瑚泉吸入研究中心成立收购德国Temmler Pharma GmbH＆Co.的特殊产品组合在巴西收购Medquimica Industria Farmaceutica S.A.收购南非制药公司 2018收购新泽西州的Symbiomix Therapeutics，LLC推出Softovac®进入OTC领域在Sikkim开设新工厂 2019 从Kyowa Pharmaceutical Industry Co.撤资参考： NMPA/CDE；药融云数据 www.pharnexcloud.com； FDA/EMA；相关公司公开披露；鲁宾制药官网：https://www.lupin.com/； Lupin2019-2020年报； https://www.drugs.com/solosec.html； Lupin Presents Phase 3 Data for Solosec (secnidazole) Demonstrating Significant Response Rate in Female Patients with Trichomoniasis； https://www.prnasia.com/story/256885-1.shtml；等等。【关于药融圈】药融圈围绕我国生物医药产业链，针对生物医药大数据、技术和资本投资、药融园(产业园)等开展系列系统性工作，促进我国生物医药产业健康发展，完善产业链，共同面对全球合作和竞争。点分享点点赞点在看

仿制药并购合作免疫疗法生物类似药

2019-03-26

·BioSpace

Obtainment of Manufacturing and Sales Approval for Etanercept Biosimilar, Anti-rheumatoid Arthritis Agent

YL Biolologics Ltd., Yoshindo Inc. and Teijin Ltd. have announced that on March 26, 2019, YL Biologics obtained manufacturing and sales approval for Etanercept biosimilar, an agent for anti-rheumatoid arthritis and polyarticular-course juvenile idiopathic arthritis which YL Biologics has developed globally. YL Biolologics Ltd. (Head office: Chuo-ku, Tokyo, President and Representative Director: Toshihiko Hibino), Yoshindo Inc. (Head Office: Toyama City, Toyama, President and Representative Director: Hiroki Kitamura) and Teijin Ltd. (Head office: Kita-ku, Osaka, President and CEO: Jun Suzuki) have announced that on March 26, 2019, YL Biologics obtained manufacturing and sales approval for Etanercept biosimilar, an agent for anti-rheumatoid arthritis and polyarticular-course juvenile idiopathic arthritis (Development code: YLB113) which YL Biologics has developed globally. YL Biologics has led the global phase III study enrolled over 500 Rheumatoid Arthritis patients and a half of them were recruited in Japan. Based on the results of phase III study, YL Biologics submitted NDA to MHLW in March, 2018. Although YL Biologics obtains active pharmaceutical ingredients of YLB113 from Lupin Ltd., an India based global pharmaceutical company, YL Biologics subcontracts manufacturing of it to AY Pharma Co. Ltd., a wholly owned subsidiary of Yoshindo. Yoshindo entered into the sales collaboration agreement with Teijin Pharma Ltd. (Head Office: Chiyoda-ku, Tokyo, President and Representative Director: Akihisa Nabeshima) in July, 2018, which is playing central role of health care business in Teijin group. Based on the agreement, Yoshindo and Teijin Pharma will jointly distribute and market YLB113 in Japan. YL Biologics is committed to take the biosimilar products with high medical needs as the targets for the pipeline and effectively develop them by making good use of the company’s rich know-how. YL biologics will contribute to the society and people by cutting medical spending and reducing financial burden of patients through stably providing its products to the medical field around the world. Yoshindo manufactures generic drugs with high quality and reasonable prices through its systems with research and development, manufacturing and sales and marketing. Furthermore, Yoshindo is accelerating manufacturing and sales activities for essential drugs such as infusion and dialysis fluid, and advancing research and development into biopharmaceuticals. Yoshindo is building new technologies and know-how, with the aim of remaining an irreplaceable pharmaceutical company for Japan moving into the future. Teijin Pharma intends to contribute the healthier lives of rheumatoid arthritis patients and improve their quality of life through putting YLB113 on their product line-up and accordingly further strengthening “Bone and Joint Field” as Teijin Pharma’s expertise area. For further information, please contact: YL Biologics Ltd. Liaison & Business Development Department Tel: +81-3-6667-5900 Yoshindo Inc. Corporate Planning Department Tel: +81-76-465-7736 Teijin Ltd. Corporate Communications Department Tel: +81-3-3506-4055

临床3期上市批准临床结果引进/卖出申请上市

100 项与依那西普生物类似药(鲁宾有限公司) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	依那西普生物类似药(鲁宾有限公司)	L04AB01	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
非放射性轴性脊柱关节炎	澳大利亚	Lupin Australia Pty Ltd.	2020-10-01
强直性脊柱炎	欧盟	Biocon Biologics Ireland Ltd.	2020-05-20
强直性脊柱炎	冰岛	Biocon Biologics Ireland Ltd.	2020-05-20
强直性脊柱炎	列支敦士登	Biocon Biologics Ireland Ltd.	2020-05-20
强直性脊柱炎	挪威	Biocon Biologics Ireland Ltd.	2020-05-20
银屑病关节炎	欧盟	Biocon Biologics Ireland Ltd.	2020-05-20
银屑病关节炎	冰岛	Biocon Biologics Ireland Ltd.	2020-05-20
银屑病关节炎	列支敦士登	Biocon Biologics Ireland Ltd.	2020-05-20
银屑病关节炎	挪威	Biocon Biologics Ireland Ltd.	2020-05-20
中轴性脊柱关节炎	欧盟	Biocon Biologics Ireland Ltd.	2020-05-20
中轴性脊柱关节炎	冰岛	Biocon Biologics Ireland Ltd.	2020-05-20
中轴性脊柱关节炎	列支敦士登	Biocon Biologics Ireland Ltd.	2020-05-20
中轴性脊柱关节炎	挪威	Biocon Biologics Ireland Ltd.	2020-05-20
附着点炎相关关节炎	欧盟	Biocon Biologics Ireland Ltd.	2020-05-20
附着点炎相关关节炎	冰岛	Biocon Biologics Ireland Ltd.	2020-05-20
附着点炎相关关节炎	列支敦士登	Biocon Biologics Ireland Ltd.	2020-05-20
附着点炎相关关节炎	挪威	Biocon Biologics Ireland Ltd.	2020-05-20
斑块状银屑病	欧盟	Biocon Biologics Ireland Ltd.	2020-05-20
斑块状银屑病	冰岛	Biocon Biologics Ireland Ltd.	2020-05-20
斑块状银屑病	列支敦士登	Biocon Biologics Ireland Ltd.	2020-05-20

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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


YLB113-003 (EULAR2021)	N/A	-	201	YLB113	衊壓觸簾艱繭簾願糧餘(膚繭壓糧憲鹹鹽繭願鏇) = 顧憲鹽獵繭鬱窪壓壓醖獵鬱範襯願鑰醖鹹簾壓 (遞鏇築構窪廠觸鹽獵網 ) 更多	-	2021-06-02
YLB113-002 (EULAR2021)	临床3期	注射部位反应 \| 红斑	-	YLB113	構壓遞醖築範製鹽鬱憲(膚鹹鏇鬱鬱膚廠夢範糧) = 艱醖製簾艱糧夢繭選製廠築鬱淵顧糧簾築糧蓋 (鏇範選築製繭鹹膚窪壓 ) 更多	积极	2021-06-02
YLB113-002 (EULAR2021)	临床3期	注射部位反应 \| 红斑	-	Reference Product (RP)	構壓遞醖築範製鹽鬱憲(膚鹹鏇鬱鬱膚廠夢範糧) = 選衊襯糧鹹構鏇艱鹽鹽廠築鬱淵顧糧簾築糧蓋 (鏇範選築製繭鹹膚窪壓 ) 更多	积极	2021-06-02
EULAR2019	临床3期	类风湿关节炎	528	YLB113	夢鹽觸簾淵製壓顧淵襯(鑰淵夢齋蓋顧鹹廠鑰觸) = 窪糧顧壓廠範淵製鹽構網窪醖製顧憲網鹹遞醖 (窪鏇淵製夢憲壓壓鬱夢 )	积极	2019-06-12