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.

CTRI/2019/05/019044

/ Completed临床3期

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 - FLINTER

开始日期2019-05-20

申办/合作机构

Dr. Reddy's Laboratories SA

[+1]

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.

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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）

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.

2020-04-01·BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy

Pharmacokinetic Similarity and Comparative Pharmacodynamics, Safety, Efficacy, and Immunogenicity of DRL_RI Versus Reference Rituximab in Biologics-Naïve Patients with Moderate-to-Severe Rheumatoid Arthritis: A Double-Blind, Randomized, Three-Arm Study

Article

作者: Kankanwadi, Suresh ; Kharkar, Sandeep ; Katta, Rahul ; Lopez-Lazaro, Luis ; Haridas, Vikram Muralidhar ; Nalawade, Ajit ; Garmish, Olena ; Zhdan, Vyacheslav ; Batra, Sonica Sachdeva

OBJECTIVES:

The aims were to demonstrate pharmacokinetic (PK) similarity between DRL_RI, a proposed rituximab biosimilar, and two reference innovator products (Rituxan^® [RTX-US] and MabThera^® [RTX-EU]) and compare their pharmacodynamics (PD), efficacy, safety, and immunogenicity in rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX)-based therapy and no prior biologic administration.

METHODS:

In this randomized, double-blind, parallel-group study, 276 patients with moderate-to-severe active RA were randomized to receive DRL_RI, RTX-US, or RTX-EU on days 1 and 15. The primary PK end points included area under the concentration-time curve from time 0 to 336 h after first infusion (AUC_{0-14 days, first infusion}), AUC from day 1 through week 16 (AUC_{0-∞, entire course}), and AUC from time 0 to time of last quantifiable concentration after the second dose (AUC_{0-t, second infusion}). Secondary end points included other PK parameters, such as maximum concentration (C_max), time to C_max after each infusion, terminal half-life, systemic clearance, and volume of distribution after the second infusion; PD parameters and efficacy until week 24; safety and immunogenicity at week 24 and 52; and B cell recovery until week 52. AUC from time 0 to time of last quantifiable concentration after the first dose and over the entire course from day 1 through week 16 (AUC_{0-t, entire course}) was analyzed as an exploratory end point.

RESULTS:

The 91% confidence intervals (CIs) of the geometric mean ratios (GMRs) for the primary end point of AUC_{0-∞, entire course} were within the bioequivalence limits of 80-125% for all comparisons: DRL_RI versus RTX-US 100.37% (92.30-109.14), DRL_RI versus RTX-EU 93.58% (85.98-101.85), and RTX-US versus RTX-EU 93.24% (85.62-101.54). PD outcomes (peripheral blood B-cell depletion and mean change in Disease Activity Score [28 joints]-C-reactive protein), efficacy, safety, and immunogenicity were also comparable between DRL_RI and the reference products.

CONCLUSION:

DRL_RI, a proposed biosimilar, demonstrated three-way PK similarity with RTX-EU and RTX-US, the reference innovator products, with comparable efficacy, PD, safety, and immunogenicity.

CLINICAL TRIALS REGISTRATION NUMBER:

ClinicalTrials.gov identifier: NCT02296775.

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/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

2024-11-28

·Business Wire

Dr. Reddy's launches Toripalimab in India, the first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma

HYDERABAD, India--( BUSINESS WIRE )--Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s”), announced the launch of Toripalimab in India. Toripalimab is a New Biological Entity (NBE). It is the only immuno-oncology drug approved by various regulatory authorities around the world such as the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), and others for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). In 2023, Dr. Reddy’s entered into a license and commercialisation agreement with Shanghai Junshi Biosciences Co. Ltd for Toripalimab. Under this agreement, Dr. Reddy’s obtained exclusive rights to develop and commercialise Toripalimab in 21 countries including India, South Africa, Brazil and various countries in Latin America. Additionally, the agreement allows Dr. Reddy’s to expand the scope of the license to cover Australia, New Zealand and nine other countries. With this launch by Dr. Reddy’s, India becomes the third country in the world after China and the United States to receive access to this next generation PD-1 inhibitor 1 . Dr. Reddy’s will market it under the brand name Zytorvi® in India. The standard of care for RM-NPC in India before Toripalimab was chemotherapy (gemcitabine and cisplatin). Toripalimab is indicated as first-line treatment of adults with metastatic or recurrent locally advanced NPC in combination with gemcitabine and cisplatin. This combination has shown a 48% reduction in risk of progression or death 2 . Additionally, Toripalimab has also been approved as monotherapy for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after platinum-containing chemotherapy. M.V. Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy’s, said: “ The launch of Toripalimab is a significant milestone for patients diagnosed with nasopharyngeal carcinoma (NPC) in India. NPC is a rare form of head and neck cancer. However, the prognosis of the disease for patients in advanced stages is poor, and India is among the top five countries in the world in terms of disease burden 3 . As the next generation PD-1 inhibitor, Toripalimab has demonstrated superior outcomes for RM-NPC versus standard of care, thereby meeting a significant unmet need for patients with NPC in India. This launch is also a major milestone for us as a company. Oncology has been a top focus therapy area for us. Our offerings aim to build an end-to-end ecosystem of care – access to current standard of care cancer medicines across multiple countries globally, innovation in formulations, strategic collaborations for novel innovative molecules particularly in India and other emerging markets, beyond-the-pill support such as nutrition and digital tools. Our portfolio of standard of care small molecules and biosimilars across cancer types in India and other emerging markets has included Reditux™, Versavo®, Lenangio™, and Hervycta™. Additionally, under our innovation agenda, access to novel molecules through collaborations is a key pillar, since access to meaningful innovation and the latest standard of care remains a challenge for patients in emerging markets. Thanks to the relentless efforts of our cross-functional teams, we have been able to launch Toripalimab in India in the same year as its launch in the U.S. We will continue to work hard to serve our patients and stakeholders to remain their partner of choice, and progress towards our goal of serving over 1.5 billion patients by 2030.” NPC is a malignant tumour that arises from the epithelium of the nasopharynx. According to GLOBOCAN 2022 statistics, the number of newly diagnosed NPC cases in 2022 exceeded 120,000 worldwide. In India, there were 6,519 newly diagnosed cases of NPC in 2022 4 . The highest age-adjusted rates for NPC were found in the north-eastern states in India, with Kohima in Nagaland having an incidence of 19.4/100,000 population 5 . Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalisation (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumour cells 6 . About Dr. Reddy’s : Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com . Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2024. The company assumes no obligation to update any information contained herein. 1 Ravindranathan S, Wang X, et al. Characteristics of toripalimab: a next generation anti-PD-1 antibody with potent T cell activation and enhanced clinical efficacy irrespective of PD-L-1 status. J Immunother Cancer 2023;11(Suppl 1):A1–A1731 2 Mai, HQ., Chen, QY., Chen, D. et al. Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial. Nat Med 27, 1536–1543 (2021). 3 Chen YP, Chan AT, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. The Lancet. 2019 Jul 6;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). Global Cancer Observatory: Cancer Today. Lyon, France:International Agency for Research on Cancer. Available from: https://gco.iarc.who.int/today . 5 Mailankody, Sharada, et al. "Epidemiology of rare cancers in India and South Asian countries–remembering the forgotten." The Lancet Regional Health-Southeast Asia 12 (2023). 6 Chen YP, Chan AT, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. The Lancet. 2019 Jul 6;394(10192):64-80.

上市批准引进/卖出临床3期

2024-08-15

·米内网

【重磅】山东新时代发威，抢$40亿大品种国内首仿

精彩内容近日，山东新时代药业提交了磷酸芦可替尼片的4类仿制上市申请。该产品是一款重磅JAK抑制剂，2023年全球销售额超过40亿美元，仅有诺华的原研产品在国内销售。今年以来，山东新时代药业已有7个新品获批，目前还有1个生物类似药和44个高端仿制药报产在审。图1：山东新时代药业最新申报的产品来源：CDE官网磷酸芦可替尼片是Incyte开发的一款JAK1/JAK2抑制剂，Incyte负责该产品在美国的开发和商业化，诺华负责该产品在美国以外地区商业化，2023年该药物的全球销售额合计超过43亿美元。原研的磷酸芦可替尼片于2017年获批进入中国市场，用于中危或高危的原发性骨髓纤维化（亦称为慢性特发性骨髓纤维化）、真性红细胞增多症继发的骨髓纤维化或原发性血小板增多症继发的骨髓纤维化的成年患者，治疗疾病相关脾肿大或疾病相关症状，2023年获批用于治疗对糖皮质激素或其他系统治疗应答不充分的12岁及以上急性移植物抗宿主病患者，2024年6月批准新适应症用于治疗对糖皮质激素或其他系统治疗应答不充分的12岁及以上慢性移植物抗宿主病患者。图2：磷酸芦可替尼片在国内的销售情况（单位：万元）来源：米内网格局数据库磷酸芦可替尼片在2019年进入国家医保谈判目录后在公立医院终端（城市公立医院+县级公立医院）的销售额快速攀升，2020年突破1亿元，2023年涨至5.3亿元；而在零售药店终端（城市实体药店+网上药店），磷酸芦可替尼片也是亿级产品，2022-2023年销售额保持在2亿元以上，2024年Q1增长了15.06%。南京正大天晴制药于2022年7月首家提交了磷酸芦可替尼片的4类仿制上市申请，目前还有成都苑东生物制药、重庆华森制药、昆山龙灯瑞迪制药、江西科睿药业、南京正科医药以及山东新时代药业参与该产品的国内首仿争夺。表1：今年以来山东新时代药业获批的新品来源：米内网中国申报进度（MED）数据库米内网数据显示，今年以来山东新时代药业已有7个新品获批，涉及抗肿瘤和免疫调节剂、肌肉-骨骼系统、心脑血管系统药物、全身用抗感染药物、杂类五个大类。其中罗库溴铵注射液是公司首款获批的肌肉松弛药，钆喷酸葡胺注射液是公司首款获批的造影剂，具有积极意义。目前山东新时代药业有1个生物类似药利妥昔单抗注射液、44个高端仿制药报产在审。除了磷酸芦可替尼片，比拉斯汀口崩片、比拉斯汀片、盐酸纳呋拉啡口崩片也暂无国产仿制药获批，公司将参与国内首仿争夺，我们拭目以待。资料来源：CDE官网、米内网数据库等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至8月15日，如有疏漏，欢迎指正。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 ●温馨提示● 因为微信公众号修改了推送规则，最近很多读者反映没有及时看到推文。把米内网设为“星标”，就能每天与我们不见不散啦，具体操作如下：【分享、点赞、在看】点一点不失联哦

生物类似药上市批准

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
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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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03976102 (FLINTER, CTgov)	临床3期	滤泡性淋巴瘤	317	DRL_RI (Proposed rituximab biosimilar) (Arm A: DRL_RI)	餘構築艱築艱壓顧鏇鹽(襯糧鏇範顧憲簾網衊壓) = 範襯範艱鹹顧網襯鹽壓醖餘鹽製積壓獵餘鏇繭 (願蓋膚艱構艱積蓋齋簾, 顧網襯淵壓襯鑰遞遞衊 ~ 膚襯齋襯觸簾醖繭簾網) 更多	-	2024-01-22
				MabThera® (Arm B: MabThera®)	餘構築艱築艱壓顧鏇鹽(襯糧鏇範顧憲簾網衊壓) = 築範繭積網顧繭簾鹽餘醖餘鹽製積壓獵餘鏇繭 (願蓋膚艱構艱積蓋齋簾, 遞繭壓夢鑰艱衊願鹹製 ~ 齋獵廠遞憲鹽積鹹構憲) 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)	鹽廠醖構鏇壓襯鏇壓鑰(鏇獵願網簾獵鏇繭醖遞) = 觸淵築衊壓鹹簾膚醖獵鑰膚簾艱齋繭淵選積襯 (選襯範糧廠簾餘構齋壓, 鑰糧選簾繭觸鏇鹹鏇窪 ~ 艱鏇淵觸醖觸醖齋獵鬱) 更多	-	2023-11-18
				Arm B: Rituxan®/Mabthera® (Arm B: US-Rituximab or EU-Rituximab)	鹽廠醖構鏇壓襯鏇壓鑰(鏇獵願網簾獵鏇繭醖遞) = 鏇蓋鹹窪壓鏇窪蓋壓鹹鑰膚簾艱齋繭淵選積襯 (選襯範糧廠簾餘構齋壓, 鹽憲範膚構膚鑰遞膚觸 ~ 糧鬱觸鬱遞糧願願膚製) 更多
NCT02296775 (CTgov)	临床1/2期	类风湿关节炎	276	Rituximab (DRL- Rituximab-DRL_RI)	糧選選糧鑰鹽網淵窪鬱(艱醖獵鏇鹽廠遞鹽齋築) = 觸蓋艱遞選壓繭衊網網網鏇顧窪獵夢膚繭淵願 (鑰鹽遞獵遞簾醖網窪艱, 夢艱襯積繭構鏇範遞艱 ~ 積積艱衊遞淵製餘糧糧) 更多	-	2020-01-13
				Rituxan (Rituxan® (US Licensed Reference Product): RP)	糧選選糧鑰鹽網淵窪鬱(艱醖獵鏇鹽廠遞鹽齋築) = 簾壓淵醖襯齋衊襯蓋鹽網鏇顧窪獵夢膚繭淵願 (鑰鹽遞獵遞簾醖網窪艱, 醖膚壓齋構製鹽遞窪襯 ~ 鏇齋壓艱艱糧鹽鹹鏇築) 更多