A Randomized, Double-blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®

The objective of the current study is to assess the immunogenicity and safety of transitioning subjects with RA to DRL_RI from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab.
The primary objective of this study is to assess the immunogenicity of transitioning subjects with RA to DRL_RI (biosimilar rituximab) from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab
To assess the safety of transitioning subjects with RA to DRL_RI from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab.

开始日期2020-04-08

申办/合作机构

Dr. Reddy's Laboratories Ltd.

EUCTR2018-004223-36-BG

/ Not yet recruiting临床3期IIT

A Randomised, Double-blind, Parallel-group, Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) with MabThera® in Subjects with Previously Untreated, Stage II-IV, Cluster of Differentiation (CD)20-Positive, Low Tumour Burden Follicular Lymphoma

开始日期2019-10-11

申办/合作机构-

NCT03976102

/ Completed临床3期

A Double-blind, Parallel-group, Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in Subjects With Previously Untreated (CD)20-Positive LTB Follicular Lymphoma

The primary objective of the current study is to demonstrate the equivalent efficacy of rituximab (DRL_RI) and MabThera® in subjects with Low Tumor Burden Follicular Lymphoma (LTB-FL).
Also evaluated by Pharmacokinetic, safety, and immunogenicity assessment between a proposed biosimilar (DRL_RI) and the RMP, as an component of clinical study program, and collectively providing the evidence of biosimilarity.
The study will compare the safety and efficacy of DRL_RI vs MabThera in patients with Low Tumor Burden Follicular Lymphoma (LTB-FL). The primary objective is to establish comparative efficacy as measured by ORR up to week 28

开始日期2019-05-15

申办/合作机构

Dr. Reddy's Laboratories Ltd.

100 项与利妥昔单抗生物类似药(Dr. Reddy’s Laboratories) 相关的临床结果

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100 项与利妥昔单抗生物类似药(Dr. Reddy’s Laboratories) 相关的专利（医药）

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项与利妥昔单抗生物类似药(Dr. Reddy’s Laboratories) 相关的文献（医药）

2025-05-01·Therapeutic Advances in Medical Oncology

Efficacy and safety of rituximab biosimilar (DRL_RI) versus MabThera ^® in low-tumor-burden follicular lymphoma: the FLINTER study

Article

作者: Ramos, Ana Oliveira ; Kim, Jin Seok ; Reddy, Pramod ; Maharaj, Narendra ; Belada, David ; Eswaraiah, Anand ; Uppada, Dharma Rao ; Kakkattu, Ranjith ; Kalenik, Volha A. ; Baranau, Yauheni V.

Background and objectives::

This phase III study (RI-01-006; FLINTER) was conducted to demonstrate equivalent efficacy of DRL_RI to EU-approved rituximab (MabThera ® ) in patients with previously untreated Stage II–IV, CD20-positive, low-tumor-burden follicular lymphoma (LTB-FL). This study also evaluated safety, immunogenicity, rituximab concentrations, and pharmacodynamics (PD) of DRL_RI compared with MabThera.

Design and methods::

Previously untreated, stage II–IV, CD20-positive LTB-FL patients ( N = 317) were randomized (1:1) to receive DRL_RI ( n = 162) or MabThera ( n = 155) as intravenous infusions of 375 mg/m² weekly for 4 weeks (induction period), and thereafter every 8 weeks from Week 12 to Week 36 (maintenance treatment), and followed up till Week 52. The primary end point was best overall response rate (BORR) up to Week 28 based on blinded independent central review. Efficacy equivalence was demonstrated if the two-sided 90% confidence interval (CI) for BORR difference was within the prespecified equivalence margin (±17%). Secondary end points included objective and complete responses, duration of response, progression-free survival, overall survival, safety, immunogenicity, mean serum concentrations, and PD.

Results::

The BORR up to Week 28 was 80.2% versus 79.4% for DRL_RI versus MabThera group; with a difference of 0.89% (90% CI: −6.67 to 8.48; 95% CI: −8.05 to 9.93 within the prespecified margin). Both treatment groups were comparable for all secondary efficacy end points. Treatment-emergent adverse events were reported in 68.6% of patients; safety, immunogenicity, and mean serum concentrations were similar between groups. Peripheral B-cell counts declined below quantifiable limits in most patients, with a median time to B-cell depletion of 6.9 versus 7.0 days for DRL_RI versus MabThera.

Conclusion::

The study demonstrated efficacy equivalence of DRL_RI to MabThera; with comparable safety, immunogenicity, serum concentrations, and PD between groups.

Trial registration::

This trial was registered at ClinicalTrials.gov identifier: NCT03976102 and EudraCT (2018-004223-36).

2023-02-01·CPT: pharmacometrics & systems pharmacology

Rituximab pharmacokinetic and pharmacokinetic–pharmacodynamic evaluation based on a study in diffuse large B‐cell lymphoma: Influence of tumor size on pharmacokinetic and assessment of pharmacokinetic similarity

Article

作者: López‐Lázaro, Luis ; Ooi, Qing Xi ; Svensson, Robin J. ; Maharaj, Narendra ; Friberg, Lena E. ; Hansson, Emma ; Reddy, Pramod Kumar

Abstract:

Dr. Reddy's Laboratories rituximab (DRL_RI; Dr. Reddy's Laboratories SA, Basel, Switzerland) is under development as a rituximab biosimilar. Study RI‐01‐002 (Clinical Trials Registry ‐ India/2012/11/003129), comparing DRL_RI to the reference medicinal product (RMP) MabThera® (Roche, Grenzach‐Wyhlen, Germany), demonstrated pharmacokinetic (PK) equivalence and showed comparable pharmacodynamic, efficacy, safety, and immunogenicity profiles. We used data from the same study to perform population PK and PK–pharmacodynamic analyses: first exploring possible factors influencing the PK similarity assessment between products and then performing simulations to investigate the impact of tumor size on rituximab PK. Nonlinear mixed‐effects models for PK, tumor size, tumor size–PK, and tumor response were developed independently. The final PK model included drug product as a dose‐scaling parameter and predicted a 6.75% higher dose reaching the system in RMP‐treated patients. However, when tumor size was included in the tumor size–PK model, the drug product effect was no longer observed. The model rather indicated that patients with larger tumor size have higher clearance. Further simulations confirmed that higher baseline tumor size is associated to slightly lower rituximab exposure. Tumor response, described by a continuous‐time Markov model, did not differ between drug products. Both had higher effects during the first 20 weeks of treatment. Also, the model described a subpopulation of nonresponders to treatment (42%) with faster transitions to a worse state. The different rituximab exposure initially detected between drug products (6.75%) was shown using PK/PK–pharmacodynamic analysis to be attributed to a tumor size imbalance between treatment groups. PK/PK–pharmacodynamic analyses may contribute to PK similarity assessments.

2020-12-01·Pharmaceutical research3区 · 医学

Sedimentation Velocity Analytical Ultracentrifugation Analysis of Marketed Rituximab Drug Product Size Distribution

3区 · 医学

Article

作者: Patil, Sharadrao M ; Keire, David A ; Nguyen, John ; Chen, Kang

PURPOSE:

Analytical methods suitable for intact drug products are often necessary to evaluate the equivalence in physicochemical properties between two drug products (DP) containing the same drug substance (DS), e.g., an innovator biologic drug and its proposed biosimilar. Analytical Ultracentrifugation (AUC) is a biophysics technique applied to the analysis of size and shape of biomolecules. However, the application of AUC to formulated monoclonal antibody (mAb) DP at high concentration has not been reported.

METHODS:

A sedimentation velocity (SV) AUC procedure with a short-pathlength centerpiece was applied to two marketed rituximab DPs, Rituxan® (US) and Reditux® (India), without any buffer exchange or dilution. Detailed precision analysis was performed.

RESULTS:

Highly reproducible sedimentation coefficient values (S) and peak areas were obtained for the dominant (> 84%) monomeric rituximab peak. The minor mAb fragment peaks had large variation in both S values and peak areas (3-12%). The identification of oligomer peaks was only reproducible once the abundance was higher than 2%.

CONCLUSIONS:

SV-AUC provides an orthogonal characterization tool for protein size distribution, composition and assay, which could be informative for biosimilar drug developers who mostly only have access to formulated mAb. However, AUC needs thorough validation on its accuracy, precision and sensitivity.

项与利妥昔单抗生物类似药(Dr. Reddy’s Laboratories) 相关的新闻（医药）

2024-12-07

·瑞迪博士

瑞迪博士特瑞普利单抗在印度获批上市

2024年11月28日-瑞迪博士实验室有限公司（BSE: 500124, NSE: DRREDDY），宣布特瑞普利单抗在印度上市，这是首个也是唯一一个获批用于治疗鼻咽癌的免疫肿瘤药物。 ➤ 特瑞普利单抗是唯一获得美国食品药品监督管理局（USFDA）、印度中央药品标准控制组织（DCGI）、欧洲药品管理局（EMA）、英国药品和健康产品管理局（MHRA）、中国国家药品监督管理局（NMPA）等主要监管机构批准用于治疗成人复发或转移性鼻咽癌（RM-NPC）的免疫肿瘤药物 ➤ 特瑞普利单抗与标准化疗的联合使用显示病程进展或死亡风险降低了48% ➤ 特瑞普利单抗在印度上市和在美国推出是同一年，使印度成为世界上第三个获得这种新生物实体（NBE）的国家 ➤ 特瑞普利单抗是首个从中国引进并在印度获批的NBE产品特瑞普利单抗是一种新型生物实体（NBE）。它是唯一获得美国食品药品监督管理局（USFDA）、欧洲药品管理局（EMA）、英国药品和保健品管理局（MHRA）等全球主要监管机构批准用于治疗成人复发性或转移性鼻咽癌（RM-NPC）的免疫肿瘤药物。2023年，瑞迪博士与上海君实生物科技有限公司就特瑞普利单抗签订了许可和商业化协议。根据该协议，瑞迪博士获得了在印度、南非、巴西和拉丁美洲等21个国家开发和商业化特瑞普利单抗的独家权利。此外，该协议允许瑞迪博士将许可范围扩大到澳大利亚、新西兰和其他9个国家。随着瑞迪博士上市该产品，印度成为继中国和美国之后世界上第三个获得这种PD-1抑制剂1的国家。瑞迪博士将在印度以Zytorvi®的品牌名进行市场推广。在使用特瑞普利单抗之前，印度RM-NPC的标准治疗是化疗（吉西他滨和顺铂）。特瑞普利单抗适用于成人转移性或复发局部晚期鼻咽癌（NPC）的一线治疗，与吉西他滨和顺铂联合使用，这种联合疗法显示了病程进展或死亡风险2降低了48%。此外，特瑞普利单抗已被批准作为单药疗法，用于治疗患有复发性不可切除或转移性鼻咽癌（NPC），且在接受含铂化疗期间或之后出现疾病进展的成人患者。首席执行官 M. V. Ramana先生瑞迪博士品牌市场（印度和新兴市场）首席执行官M. V. Ramana先生说到：“特瑞普利单抗的上市对于印度鼻咽癌患者来说是一个重要的里程碑。鼻咽癌是一种罕见的头颈部癌症，但晚期患者预后较差，印度是世界上疾病负担最重的五个国家之一3。作为PD-1抑制剂，特瑞普利单抗在治疗复发性不可切除或转移性鼻咽癌（RM-NPC）方面，相较于标准治疗显示出了更优越的疗效，从而满足了印度鼻咽癌患者群体中一个重要的未被满足的医疗需求。此次产品上市也是我们公司的一个重要里程碑。肿瘤学一直是我们最关注的治疗领域。我们的目标是构建一个端到端的护理生态系统——在全球多个国家提供当前标准的癌症药物，在制剂上创新，在印度和其他新兴市场针对创新分子开展战略合作，以及提供超越药物的支持，如营养建议和数字工具。我们在印度和其他新兴市场的针对癌症标准治疗的小分子和生物类似药产品组合包括Reditux™、Versavo®、Lenangio™和Hervycta™。此外，根据我们的创新计划，通过合作获得新型分子是业务关键支柱之一。因为在新兴市场，获得有意义的创新和最新标准的治疗仍然是患者面临的挑战。在我们跨职能团队不懈努力下，特瑞普利单抗与美国同年在印度上市。我们将继续努力为我们的患者和利益相关者提供服务，致力于成为他们的首选合作伙伴，并朝着到2030年服务超过15亿患者的目标迈进”。瑞迪博士与君实生物签署特瑞普利单抗许可与商业化协议鼻咽癌（NPC）是一种起源于鼻咽上皮的恶性肿瘤。根据2022年全球癌症统计（GLOBOCAN 2022）的数据，全年全球新诊断的鼻咽癌病例超过12万例。在印度，2022年新诊断的鼻咽癌病例为6,519例4。印度东北部各邦的鼻咽癌年龄调整发病率最高，其中那加兰邦的科希马（Kohima）发病率为每10万人口19.4例5。特瑞普利单抗是一种抗PD-1单克隆抗体，因其能够阻断PD-1与其配体PD-L1和PD-L2的相互作用，并增强受体内化（内吞功能）。阻断PD-1与PD-L1和PD-L2的相互作用，可提高免疫系统攻击和杀伤肿瘤细胞的能力6。参考文献： 1．Ravindranathan S,王X等人，特瑞普利单抗的特性：一种下一代抗PD-1抗体，具有强大的T细胞激活能力和在不考虑PD-L1状态的情况下增强的临床疗效。《J Immunother Cancer》2023;11(Suppl 1):A1–A1731。 2．Mai, HQ.、Chen, QY.、Chen, D.等人，特瑞普利单抗或安慰剂联合化疗作为晚期鼻咽癌的一线治疗方案：一项多中心随机3期试验。《自然医学》杂志27卷，1536-1543页（2021年）。 3. 陈玉萍、陈志明、乐秋婷、布兰查德、孙阳、马静。鼻咽癌。《柳叶刀》杂志。2019年7月6日；394(10192):64-80。 4. Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2024). 全球癌症观察：今日癌症。法国里昂：国际癌症研究机构。可从以下网址获取：https://gco-iarc-who-int.libproxy1.nus.edu.sg/today. 5. Mailankody, Sharada 等人。“印度和南亚国家罕见癌症的流行病学——记住被遗忘的。”《柳叶刀区域健康-东南亚》12期（2023年）。 6. 陈玉萍、陈志明、乐秋婷、布兰查德、孙阳、马静。《鼻咽癌》。《柳叶刀》杂志。2019年7月6日；394(10192):64-80。前瞻性声明：本新闻稿可能包括基于管理层发表的当前观点、假设的未来预期声明及其他前瞻性声明，这些声明涉及已知或未知的风险与不确定性，可能导致实际结果、业绩或事件与该声明明示或暗示的结果、业绩或事件存在重大差异。除因上下文而具有前瞻性的声明外，“可能”、“将会”、“应该”、“预期”、“计划”、“意图”、“预计”、“相信”、“估计”、“预测”、“潜在”或“继续”等用词以及类似表述均指前瞻性声明。实际结果、业绩或事件可能与该声明中表述的结果、业绩、事件存在重大差异，原因包括但不限于：（i）一般经济状况，如金融市场表现、信用违约、货币汇率、利率、持续性水平及保险损失事件的发生频率/严重程度；（ii）死亡率与发病率的发展水平及趋势；（iii）竞争水平与一般竞争因素的变化；（iv）法律法规与中央银行和/或政府政策的变化；（v）收购或重组的影响，包括相关的整合问题；（vi）我公司业务、市场、客户、产品及服务对自然灾害、流行病、流行病或其他广泛流行疾病（包括冠状病毒（或新冠肺炎）所造成经济衰退的易感性；（vii）在我公司提交给证券交易委员会公开文件中所确定的其他风险与不确定性，包括截至2023年3月31日年度报告表20-F“风险因素”和“前瞻性声明”中列出的内容。公司没有义务更新在此包含的任何信息。 1. 本文翻译自瑞迪博士全球新闻稿，原文链接为： Dr. Reddy's press release - launch of Toripalimab in India.pdf 2. 本文旨在传递医药前沿信息，不构成对任何药物或诊疗方案的推荐或推广。 3. 如您想了解更多疾病知识或药品、诊疗相关信息，请咨询医疗卫生专业人士。关于瑞迪博士瑞迪博士实验室有限公司是一家全球性制药公司，并于纽约证券交易所（股份代号：RDY）、印度国家证券交易所（股份代号：DRREDDY）及孟买证券交易所（股份代号：500124）上市。瑞迪博士成立于1984年，其产品和服务涵盖广泛的治疗领域，涉及制药服务与活性成分(PSAI)、全球仿制药、专利产品和生物类似药。我们本着加快获得经济实惠的创新药品的承诺，不断寻求进入新的治疗领域以满足世界各地患者未被满足的用药需求，因为“健康不能等待”！

上市批准申请上市临床3期

2024-08-01

·ETPharma

Dr Reddy’s drug gets EMA CHMP approval

Hyderabad: Pharma biggie Dr Reddy’s Laboratories Ltd on Monday said the European Medicines Agency ’s (EMA) committee for medicinal products for human use (CHMP) has recommended its proposed Rituximab biosimilar candidate — Ituxredi — for the European markets . The EMA CHMP has adopted a positive opinion recommending the launch of its proposed Rituximab biosimilar Ituxredi in European markets, the Hyderabad-based company said in a regulatory filing. Dr Reddy’s Ituxredi is a generic version of Roche’s MabThera that is used for the treatment of non-Hodgkin’s lymphoma , chronic lymphocytic leukaemia , rheumatoid arthritis , Wegener’s granulomatosis, among others. The CHMP positive opinion will now be reviewed by the European Commission (EC)as part of the established approval process, and a decision on granting the marketing authorisation in EU member countries and European Economic Area (EEA) member states such as Norway, Iceland, and Liechtenstein would be taken after this, it said. Dr Reddy’s said a marketing authorisation application submission will be made separately to the UK Medicines and Healthcare products Regulatory Agency (MHRA).

上市批准

2024-07-29

·ETPharma

Dr Reddy’s receives EMA's positive CHMP opinion for its proposed Rituximab biosimilar

Hyderabad: Dr Reddy’s Laboratories Ltd announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the launch of its proposed biosimilar Rituximab candidate DRL_RI (ITUXREDI) in European markets. The company had previously received the EU GMP certificate for its Rituximab drug substance and drug product manufacturing facility located in Hyderabad, India. As part of the established approval process , the CHMP positive opinion will now be reviewed by the European Commission (EC), following which a decision will be made on the grant of marketing authorisation in the European Union (EU) member countries, and the European Economic Area (EEA) member states of Norway, Iceland, and Liechtenstein. A Marketing Authorisation Application (MAA) for submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA) will be made separately in keeping with the reliance route under the International Recognition Procedure (IRP). DRL_RI is being developed as a biosimilar of MabThera (Rituximab), a cluster of differentiation 20 (CD20) directed cytolytic antibody. ITUXREDI / DRL_RI (rituximab) is a proposed biosimilar to reference medicinal product MabThera and the intended indications are the same as those currently approved for MabThera: Non–Hodgkin’s Lymphoma (NHL); Chronic Lymphocytic Leukaemia (CLL); Rheumatoid Arthritis (RA); Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA); Pemphigus Vulgaris (PV). EMA reference product, MabThera, is a registered trademark of Roche. By Online Bureau ,

上市批准

100 项与利妥昔单抗生物类似药(Dr. Reddy’s Laboratories) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC02	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
慢性淋巴细胞白血病	欧盟	Reddy Holding GmbH	2024-09-19
慢性淋巴细胞白血病	冰岛	Reddy Holding GmbH	2024-09-19
慢性淋巴细胞白血病	列支敦士登	Reddy Holding GmbH	2024-09-19
慢性淋巴细胞白血病	挪威	Reddy Holding GmbH	2024-09-19
非霍奇金淋巴瘤	印度	Dr. Reddy's Laboratories Ltd.	2007-01-01
类风湿关节炎	印度	Dr. Reddy's Laboratories Ltd.	2007-01-01

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
急性淋巴细胞白血病	申请上市	欧盟	Reddy Holding GmbH	2024-07-25
伯基特淋巴瘤	申请上市	欧盟	Reddy Holding GmbH	2024-07-25
CD20阳性弥漫性大B细胞淋巴瘤	申请上市	欧盟	Reddy Holding GmbH	2024-07-25
难治性慢性淋巴细胞白血病	申请上市	欧盟	Reddy Holding GmbH	2024-07-25
滤泡性淋巴瘤	申请上市	欧盟	Reddy Holding GmbH	2024-07-25
肉芽肿伴多血管炎	申请上市	欧盟	Reddy Holding GmbH	2024-07-25
显微镜下多血管炎	申请上市	欧盟	Reddy Holding GmbH	2024-07-25
天疱疮	申请上市	欧盟	Reddy Holding GmbH	2024-07-25
复发性慢性淋巴细胞白血病	申请上市	欧盟	Reddy Holding GmbH	2024-07-25

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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


NCT03976102 (RI-01-006; FLINTER, Pubmed \| Ther Adv Med Oncol)	临床3期	滤泡性淋巴瘤 CD20-positive	317	DRL_RI	鹽顧鏇餘鹹艱構餘鹽構(築構築顧範蓋築糧艱築) = 築襯鹹糧積觸範膚簾廠糧願網齋壓鑰鹽餘繭糧 (衊獵壓鹽積淵夢選製願, -6.67 ~ 8.48)	积极	2025-05-01
				MabThera	鹽顧鏇餘鹹艱構餘鹽構(築構築顧範蓋築糧艱築) = 獵積壓夢憲襯夢憲觸獵糧願網齋壓鑰鹽餘繭糧 (衊獵壓鹽積淵夢選製願 )
NCT03976102 (RI-01-006; FLINTER \| FLINTER, CTgov)	临床3期	滤泡性淋巴瘤	317	DRL_RI (Proposed rituximab biosimilar) (Arm A: DRL_RI)	簾憲膚夢遞積鹽顧淵膚 = 襯願網膚鬱繭獵遞壓積鏇齋鑰築積製襯製膚醖 (襯餘齋繭憲鏇網醖鹽醖, 襯廠選鹽廠網蓋積簾憲 ~ 艱襯願積選簾窪積蓋膚) 更多	-	2024-01-22
				MabThera® (Arm B: MabThera®)	簾憲膚夢遞積鹽顧淵膚 = 顧選獵遞願淵鹹製夢積鏇齋鑰築積製襯製膚醖 (襯餘齋繭憲鏇網醖鹽醖, 鬱獵壓顧齋遞憲顧網衊 ~ 蓋範襯願襯範製膚製顧) 更多
NCT04268771 (RI-01-007, CTgov)	临床3期	类风湿关节炎	140	Experimental: Arm A: DRL_RI (Arm A: DRL_RI)	顧齋餘願選餘繭夢蓋獵 = 繭襯鹽網觸積夢憲構廠積繭鏇積築鹽選築廠鹽 (齋蓋襯齋選觸壓窪膚選, 憲願衊艱鑰觸簾憲鏇壓 ~ 繭艱顧醖選淵糧構醖選) 更多	-	2023-11-18
				Mabthera+Rituxan (Arm B: US-Rituximab or EU-Rituximab)	顧齋餘願選餘繭夢蓋獵 = 構鏇醖膚夢襯簾襯遞齋積繭鏇積築鹽選築廠鹽 (齋蓋襯齋選觸壓窪膚選, 醖膚鬱襯廠觸築鑰獵繭 ~ 遞蓋鏇糧鹽鹹簾鹽夢範) 更多
NCT02296775 (CTgov)	临床1/2期	类风湿关节炎	276	Rituximab (DRL- Rituximab-DRL_RI)	觸齋糧窪鹹積願繭膚膚(衊夢鑰艱構構襯憲蓋淵) = 構獵遞襯範糧繭構獵醖鑰鬱網鏇夢齋網窪觸鏇 (築夢廠願簾鏇鬱範衊遞, 27.1) 更多	-	2020-01-13
				Rituxan (Rituxan® (US Licensed Reference Product): RP)	觸齋糧窪鹹積願繭膚膚(衊夢鑰艱構構襯憲蓋淵) = 鹽網鹹鬱鑰膚艱鹹壓鬱鑰鬱網鏇夢齋網窪觸鏇 (築夢廠願簾鏇鬱範衊遞, 25.4) 更多