Efficacy and safety of the anti-TNF multivalent NANOBODY compound ozoralizumab in RA patients with high titers of rheumatoid factor (OHZORA High study) - OHZORA High study

Start Date07 Jun 2024

Sponsor / Collaborator

Taisho Pharmaceutical Co., Ltd.

JPRN-UMIN000054609 / RecruitingIIT

A Biomarker Based Evaluation Study of the Immediate Response of Ozoralizumab, an Anti TNFa Antibody - EAGLE study

Start Date16 May 2024

Sponsor / Collaborator-

JPRN-jRCTs071230067 / RecruitingPhase 4IIT

Analysis of effectiveness of Ozoralizumab toward bone structure in rheumatoid arthritis - AOZORA study

Start Date24 Oct 2023

Sponsor / Collaborator

Taisho Pharmaceutical Co., Ltd.

100 Clinical Results associated with Ozoralizumab

100 Translational Medicine associated with Ozoralizumab

100 Patents (Medical) associated with Ozoralizumab

173

Literatures (Medical) associated with Ozoralizumab

31 Dec 2024·mAbs

A pivotal decade for bispecific antibodies?

Article

Author: Surowka, Marlena ; Klein, Christian

Bispecific antibodies (bsAbs) are a class of antibodies that can mediate novel mechanisms of action compared to monospecific monoclonal antibodies (mAbs). Since the discovery of mAbs and their adoption as therapeutic agents in the 1980s and 1990s, the development of bsAbs has held substantial appeal. Nevertheless, only three bsAbs (catumaxomab, blinatumomab, emicizumab) were approved through the end of 2020. However, since then, 11 bsAbs received regulatory agency approvals, of which nine (amivantamab, tebentafusp, mosunetuzumab, cadonilimab, teclistamab, glofitamab, epcoritamab, talquetamab, elranatamab) were approved for the treatment of cancer and two (faricimab, ozoralizumab) in non-oncology indications. Notably, of the 13 currently approved bsAbs, two, emicizumab and faricimab, have achieved blockbuster status, showing the promise of this novel class of therapeutics. In the 2020s, the approval of additional bsAbs can be expected in hematological malignancies, solid tumors and non-oncology indications, establishing bsAbs as essential part of the therapeutic armamentarium.

01 Nov 2024·BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS

Structural design of the anti-TNFα therapeutic NANOBODY® compound, ozoralizumab, to support its potent and sustained clinical efficacy

Article

Author: Hachiuma, Kenji ; Iwata, Katsuya ; Morimoto, Mai ; Nakano, Koichiro ; Iwaoka, Ryo ; Ogata, Hitoshi ; Sakata, Mayumi ; Iwamoto, Kunihiko ; Fujii, Yasuyuki ; Mishima-Tsumagari, Chiemi ; Kurokawa, Tomofumi ; Mima, Masashi

This study aims to structural design of the anti-TNFα therapeutic NANOBODY compound, ozoralizumab, to support its potent and sustained clin. efficacy.Hence, the current study was aimed at verifying the importance of the bivalency of the humanized anti-TNFα NANOBODY mols. and the addition of humanized anti-HSA NANOBODY mol. for the potent human TNFα-neutralizing activity of OZR and its long serum half life, resp.We performed co-crystal structure analyses of the TNF30-TNFα complex and the ALB8-HSA complex to clarify that OZR binds to these target mols. at the reasonable sites for demonstrating the potent TNFα-neutralizing activity and the long serum half-life.We also confirmed that OZR could form a 1:1:1 tertiary complex with TNFα trimer and HSA by in silico modeling using the results of the co-crystal structure analyses.In addition, we verified that OZR can neutralize human TNFα in the presence of an excess amount of HSA.

15 Oct 2024·Modern Rheumatology

Systematic review and meta-analysis for the 2024 update of the Japan College of Rheumatology clinical practice guidelines for the management of rheumatoid arthritis

Review

Author: Harigai, Masayoshi ; Watanabe, Ryu ; Ono, Kumiko ; Ikeuchi, Hiroko ; Hosokawa, Yohei ; Nishiwaki, Hiroki ; Sumitomo, Shuji ; Kaneko, Yuko ; Suzuki, Shotaro ; Nakanishi, Yuichiro ; Nagata, Wataru ; Nishioka, Norihiro ; Ueno, Masanobu ; Hirota, Tomoya ; Kawamori, Kazutaka ; Minegishi, Kaoru ; Motoyama, Ryo ; Doi, Goro ; Kawahito, Yutaka ; Yanai, Ryo ; Tabuchi, Yuya ; Minami, Runa ; Wada, Takuma Tsuzuki ; Maeshima, Keisuke ; Nakayama, Yoichi ; Nakamura, Shohei ; Nishimura, Kenichi ; Takeuchi, Yoichi ; Onishi, Akira ; Fukui, Sho ; Saito, Shuntaro ; Fujita, Yuya ; Kida, Takashi ; Tanaka, Eiichi ; Sofue, Hideaki ; Yajima, Nobuyuki

ABSTRACT:

Objectives:

The aim of this article is to update evidence on the efficacy and safety of disease-modifying antirheumatic drugs (DMARDs) and provide information to the taskforce for the 2024 update of the Japan College of Rheumatology clinical practice guidelines for the management of rheumatoid arthritis (RA).

Methods:

We searched various databases for randomised controlled trials on RA published until June 2022, with no language restriction. For each of the 15 clinical questions, two independent reviewers screened the articles, evaluated the core outcomes, and performed meta-analyses.

Results:

Subcutaneous injection of methotrexate (MTX) showed similar efficacy to oral MTX in MTX-naïve RA patients. Ozoralizumab combined with MTX improved drug efficacy compared to the placebo in RA patients with inadequate response (IR) to conventional synthetic DMARD (csDMARD). Rituximab with and without concomitant csDMARDs showed similar efficacy to other biological DMARDs (bDMARDs) in bDMARD-IR RA patients. Combined Janus kinase inhibitors and MTX achieved similar clinical responses and equal safety during a 4-year period compared to tumour necrosis factor inhibitors in MTX-IR RA patients. Biosimilars showed efficacy equivalent to that of the original bDMARDs in csDMARD-IR and bDMARD-IR RA patients.

Conclusions:

This systematic review provides latest evidence for the 2024 update of the Japan College of Rheumatology clinical practice guidelines for RA management.

News (Medical) associated with Ozoralizumab

09 Jan 2023

·www.prnewswire.com

Rheumatoid Arthritis Market is Expected to Showcase Significant Growth in the 7MM at a Minimal CAGR of 1.9% During the Study Period (2019-2032), Predicts DelveInsight

The dynamics of the rheumatoid arthritis market are anticipated to change in the coming years owing to the increasing awareness and expected increase in investment in the R&D activities. Companies like GlaxoSmithKline [Otilimab (MOR103/GSK3196165)], Taisho Pharmaceutical [Ozoralizumab (TS-152)], Aclaris Therapeutics [Zunsemetinib (ATI-450)], Abivax [ABX464], and others with their key candidates are in the late clinical and filing stage. LAS VEGAS, Jan. 9, 2023 /PRNewswire/ -- DelveInsight's Rheumatoid Arthritis Market Insights report includes a comprehensive understanding of current treatment practices, rheumatoid arthritis emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into the 7MM [the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Rheumatoid Arthritis Market Report As per DelveInsight analysis, the rheumatoid arthritis market size in the 7MM was approximately USD 27 billion in 2021. According to the assessment done by DelveInsight, the estimated total rheumatoid arthritis prevalent population in the 7MM was approximately 4. 7 million in 2021. Leading rheumatoid arthritis companies such as Taisho Pharmaceuticals, R-Pharm, GlaxoSmithKline, Aclaris Therapeutics, Pfizer, Abivax, Bristol Myers Squibb, Oscotec/Genosco, Mesoblast, Pfizer Akros Pharma/Japan Tobacco, Abbvie, Horizon Therapeutics, Eli Lilly and Company, Taiho Pharmaceutical, Gilead Sciences, Kiniksa Pharmaceuticals, Istesso, SynAct Pharma, Cyxone, and others are developing novel rheumatoid arthritis drugs that can be available in the rheumatoid arthritis market in the coming years. The promising rheumatoid arthritis therapies in the pipeline include Ozoralizumab (TS-152), Artlegia (Olokizumab), Otilimab (GSK3196165/MOR103), Zunsemetinib (ATI-450), Ritlecitinib (PF-06651600), ABX464, Branebrutinib, Cevidoplenib (SKI-O-703), MPC-300-IV, PF-06650833, JTE -051, ABBV-154, TAS5315, MBS2320, AMT-101, AP1189, Rabeximod (Rob 803), and others. In June 2022, Cyxone received a response from a Type B Pre-IND meeting with the US FDA. The response from the FDA facilitates Cyxone to continue planning the Phase IIb study with Rabeximod in RA. In December 2021, Taisho Pharmaceuticals presented the interim results from a 24-week administration in Phase II/III clinical trial (OHZORA study) of ozoralizumab in adult patients with RA at the annual meeting of the Japanese Society for Clinical Rheumatology and Related Research. Discover which therapies are expected to grab the major rheumatoid arthritis market share @ Rheumatoid Arthritis Market Report Rheumatoid Arthritis Overview Rheumatoid arthritis is a type of autoimmune disease. It happens when our immune system, which is supposed to defend us, malfunctions and starts attacking our own tissues. It causes inflammation in the joint lining (the synovium). As a result, joints may become red, warm, swollen, and painful, which are all symptoms of rheumatoid arthritis. The precise causes of rheumatoid arthritis are still unknown. Because the early signs and symptoms of rheumatoid arthritis are similar to those of many other diseases, it can be difficult to detect in its early stages. There is no single blood test or physical finding that can confirm the diagnosis of rheumatoid arthritis. There is no known cure for rheumatoid arthritis. However, clinical trials of rheumatoid arthritis show that remission of symptoms is more common when rheumatoid arthritis treatment with disease-modifying antirheumatic medicines begins early (DMARDs). Rheumatoid Arthritis Epidemiology Segmentation DelveInsight estimates that there were approximately 4.7 million prevalent cases of rheumatoid arthritis in the 7MM in 2021. Among the EU4 and the UK countries, Germany accounted for the highest number of rheumatoid arthritis cases, whereas France accounted for the lowest cases in 2021 The rheumatoid arthritis market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Prevalent Cases Total Diagnosed Prevalent Cases Gender-specific Prevalent Cases Age-specific Prevalent Cases Severity-specific Prevalent Cases Patients on Targeted Therapies Line-Wise Treated Cases Download the report to understand which factors are driving rheumatoid arthritis epidemiology trends @ Rheumatoid Arthritis Epidemiological Insights Rheumatoid Arthritis Treatment Market Over the last few years, there has been a dramatic improvement in rheumatoid arthritis outcomes as a direct result of paradigm shifts in rheumatoid arthritis treatment. At the moment, the main rheumatoid arthritis treatment options are Medicine (for long-term relief of symptoms and slowing the progression of the condition), Supportive treatments (including physiotherapy and occupational therapy, to help keep the patient mobile and manage any problems related to daily activities), and Surgery (to correct any joint problems that develop over a period of time). Nonsteroidal anti-inflammatory drugs (NSAIDs) are typically used only for symptomatic treatment until a rheumatoid arthritis diagnosis is established because they reduce pain and stiffness in patients but have no effect on disease progression. Moreover, disease-modifying antirheumatic drugs (DMARDs) are used to target inflammation and prevent further joint damage and disease progression. DMARDs are a class of drugs that have been shown to affect the underlying cause of rheumatoid arthritis by reducing immune system overactivity, thereby alleviating pain, swelling, and stiffness and preventing joint changes. DMARDs can be prescribed singly or in combination as an initial part of treatment. Methotrexate is the first-line DMARD agent for the majority of rheumatoid arthritis patients. It has a relatively quick onset of action at therapeutic doses (6-8 weeks), good efficacy, a low toxicity profile, is easy to administer, and is relatively inexpensive. To know more about rheumatoid arthritis guidelines, visit @ Rheumatoid Arthritis Management Rheumatoid Arthritis Pipeline Therapies and Key Companies Artlegia (Olokizumab): R-Pharm TS-152 (Ozoralizumab): Taisho Pharmaceuticals Otilimab (GSK3196165/MOR103): GlaxoSmithKline ATI-450 (Zunsemetinib/CDD-450): Aclaris Therapeutics Branebrutinib: Bristol Myers Squibb LY3462817: Eli Lilly and Company TAS5315: Taiho Pharmaceutical Rabeximod (Rob 803): Cyxone GS-5718: Gilead Sciences KPL-404: Kiniksa Pharmaceuticals MBS2320: Istesso AMT-101: Applied Molecular Transport Dazodalibep (HZN-4920): Horizon Therapeutics Cevidoplenib (SKI-O-703): Genosco/Oscotec HB-AdMSCs: Hope Biosciences ABX464: Abivax MPC-300-IV: Mesoblast PF-06650833: Pfizer JTE 051: Akros Pharma/Japan Tobacco Dekavil (F8IL10): Pfizer/Philogen ABBV-154: AbbVie PF-06651600 (Ritlecitinib): Pfizer AP1189: SynAct Pharma Learn more about the FDA-approved drugs for rheumatoid arthritis @ Drugs for Rheumatoid Arthritis Treatment Rheumatoid Arthritis Market Dynamics The dynamics of the rheumatoid arthritis market is anticipated to change in the future due to the increasing awareness and expected increase in investment in the R&D activities by the leading companies working in the rheumatoid arthritis market space. Moreover, current therapies, such as biological DMARDs, have shown promising results in treating rheumatoid arthritis patients, and market penetration is expected to increase in the future, driving rheumatoid arthritis market growth. Furthermore, there is still a high demand for therapies with a similar efficacy profile to current therapies but a better safety profile and a more patient-friendly RoA. Oral classes, such as JAKi and the upcoming BTKi, are expected to contribute to the rheumatoid arthritis market growth due to patient-friendly RoA. However, several factors are likely to hamper the rheumatoid arthritis market growth. The rheumatoid arthritis market is highly competitive, and new entrants are expected to face some resistance and low uptake because anti-TNFs currently dominate the rheumatoid arthritis market, and the entry of biosimilars will pose significant challenges to new and upcoming treatment options in the rheumatoid arthritis market. In addition, the entry of biosimilars has already begun in the US and EU (i.e., Remicade biosimilars), and as a result, sales value has started to decline. The impact will be more pronounced when biosimilars/ generics of some blockbuster drugs, such as Humira (i.e., 2023 in the US), Xeljanz (i.e., 2025 in the US), will enter the rheumatoid arthritis market, and this will significantly impact the growth of the rheumatoid arthritis market. Scope of the Rheumatoid Arthritis Market Report Therapeutic Assessment: Rheumatoid Arthritis current marketed and emerging therapies Rheumatoid Arthritis Market Dynamics: Rheumatoid Arthritis market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, Rheumatoid Arthritis Market Access and Reimbursement Discover more about rheumatoid arthritis drugs in development @ Rheumatoid Arthritis Clinical Trials Table of Contents Related Reports Rheumatoid Arthritis Epidemiology Forecast Rheumatoid Arthritis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted rheumatoid arthritis epidemiology in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Juvenile Rheumatoid Arthritis Pipeline Juvenile Rheumatoid Arthritis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products and the key juvenile rheumatoid arthritis companies, including Novartis, AbbVie, Eli Lilly and Company, Sanofi, among others. Juvenile Rheumatoid Arthritis Market Juvenile Rheumatoid Arthritis Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key juvenile rheumatoid arthritis companies, including Novartis, AbbVie, Eli Lilly and Company, Sanofi, among others. Psoriatic Arthritis Pipeline Psoriatic Arthritis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key psoriatic arthritis companies, including Mylan, Celltrion, Pfizer, Amgen, among others. Psoriatic Arthritis Market Psoriatic Arthritis Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key psoriatic arthritis companies, including Mylan, Celltrion, Pfizer, Amgen, among others. Other Trending Reports Tay-sachs Disease Or Gm2 Gangliosidosis Market | Onycholysis Market | Diagnostic Imaging Equipment Market | Chemotherapy-induced Peripheral Neuropathy Market | Global Electrophysiology Devices Market | Anaphylaxis Market | Atherectomy Devices Market | Helicobacter Pylori Infections Market | Ophthalmic Imaging Equipment Market | Androgenetic Alopecia Market | Allergic Rhinitis Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Chronic Inflammtory Demyelinating Polyneuropathy Market | Colorectal Cancer Crc Market | Opioid Induced Constipation Market | Vertigo Market | Bone Anchored Hearing Systems Market | Wound Closure Devices Market | Hip Replacement Devices Market | Hemodynamic Monitoring Systems Market | Egfr Non-small Cell Lung Cancer Market | Helicobacter Pylori Infection Market | Hyperkalemia Market | Polycythemia Market Neurostimulation Devices Market | Carpal Tunnel Syndrome Market | Ventilator Market | Cerebral Aneurysm Market | Alpha Antitrypsin Market | Binge Eating Disorder Market | Bunion Market | Concussions Market Size | Exocrine Pancreatic Insufficiency Market | Healthcare Due Diligence Services | Minimal Residual Disease Market Related Healthcare Blogs Rheumatoid Arthritis Emerging Drugs Knee Osteoarthritis Pipeline Rheumatoid Arthritis Market Scenario Juvenile Idiopathic Arthritis Therapy Market Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Clinical Result

19 Mar 2021

·www.globenewswire.com

Novel Rheumatoid Arthritis drugs succeed in the clinical trials: A status report by DelveInsight

Los Angeles, USA , March 18, 2021 (GLOBE NEWSWIRE) -- Novel Rheumatoid Arthritis drugs succeed in the clinical trials: A status report by DelveInsight The Rheumatoid Arthritis Pipeline is robust as various companies such as Ablynx, Cyxone, Oryn Therapeutics, Gilead Sciences, Sorrento Therapeutics, Genor Biopharma, Kang Stem Biotech, Celltex Therapeutics, Bristol-Myers Squibb, Arthrogen, Baylx, R-Pharm, Astellas Pharma, Sanofi, Amgen, I-MAB Biopharma, Taisho Pharmaceutical, Novartis, Kymera Therapeutics, UCB, and many others are developing therapies to influence treatment scenarios. DelveInsight’s “Rheumatoid Arthritis Pipeline Insight'' report provides comprehensive insights about 200+ companies and 250+ pipeline drugs in the Rheumatoid Arthritis pipeline landscapes. It comprises Rheumatoid Arthritis pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Rheumatoid Arthritis therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Rheumatoid Arthritis pipeline products. Some of the significant features of the Rheumatoid Arthritis Pipeline Report Get an overview of pipeline landscape @ Rheumatoid Arthritis Clinical Trial AnalysisRheumatoid Arthritis is an autoimmune disease, which causes pain, swelling, and stiffness in the joints and usually affects the hands, feet and wrists.Rheumatoid Arthritis diagnosis is difficult since many conditions cause joint stiffness and inflammation, and there is no definitive test for the condition. Rheumatoid Arthritis treatment can help lessen inflammation in the joints, relieve pain, prevent/ slow down joint damage, reduce disability. However, there is no cure for the condition. But there have been several clinical trials that have shown potential treatments. Rheumatoid Arthritis Emerging Drugs Ozoralizumab (ATN-103) is a humanised monoclonal antibody designed to treat inflammatory diseases and is developed by Ablynx. It is a trivalent, bispecific nanobody that potently neutralises Tumour Necrosis Factor (TNF) and binds to human serum albumin to increase its in vivo half-life. It consists of two anti-tumour necrosis factor-α (TNF-α) nanobodies (TR2) and one albumin-binding nanobody (ARI) with an MW~45 kDa which was successfully developed preclinically. In a phase I study, ATN-103 showed good tolerability and subsequently was licensed to Pfizer. Taisho Pharmaceutical is carrying out the Phase III trial.Research and DevelopmentPhase III NCT04077567: Taisho Pharmaceutical initiated an extension study of TS-152 in subjects with Rheumatoid Arthritis in October 2019. The purpose of this trial is to assess the long-term safety and efficacy of TS-152 in subjects with Rheumatoid Arthritis who have finished the previous study (TS152-3000-JA study or TS152-3001-JA study). The trial is currently active but not recruiting with an estimated enrollment of 401 participants and is anticipated to get completed by December 2022.Results Ablynx announced that its anti-TNFα Nanobody, ozoralizumab (ATN-103), for the treatment of the inflammatory diseases, displayed excellent safety and efficacy results in the 48-week open-label extension (OLE) study of the globally and Japanese Phase II trials in the treatment of patients with Rheumatoid Arthritis who have an insufficient response to methotrexate alone.For further product profiles, request @ Rheumatoid Arthritis Pipeline Therapeutics Scope of Rheumatoid Arthritis Pipeline Drug Insight Key Questions regarding Current Rheumatoid Arthritis Treatment Landscape and Emerging Therapies Answered in the Pipeline Report Table of Contents Get a customized pipeline report @ Rheumatoid Arthritis Drugs Pipeline Report Related Reports DelveInsight's Rheumatoid Arthritis (RA) - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and an in-depth understanding of the disease, historical, and forecasted epidemiology. DelveInsight's Rheumatoid Arthritis (RA) - Epidemiology Forecast 2030 report delivers an in-depth understanding of the disease, historical, and forecasted epidemiology of Rheumatoid Arthritis. DelveInsight's Temporomandibular Disorders- Market Insights, Epidemiology, and Market Forecast - 2030 report provides a detailed overview, historical and forecasted epidemiology. DelveInsight's Ocular Hypertension - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and an in-depth understanding of historical and forecasted epidemiology. DelveInsight's DDR Defective Tumors - Market Insights, Epidemiology, and Market Forecast - 2030 report provides a detailed overview, historical and forecasted epidemiology. DelveInsight's Anorexia - Market Insights, Epidemiology, and Market Forecast - 2030 report provides a detailed overview, historical and forecasted epidemiology. DelveInsight's Chronic Cough - Market Insights, Epidemiology, and Market Forecast - 2030 report provides a detailed overview, historical and forecasted epidemiology. DelveInsight's Hairy Cell Leukemia (HCL) - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and an in-depth understanding of historical and forecasted epidemiology. About DelveInsightDelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

Antibody

01 Sep 2014

·www.pharmatimes.com

Ablynx signs RA deal with China's Eddingpharm

Ablynx of Belgium has signed a deal to license one of its investigational rheumatoid arthritis drug ozoralizumab to China's Eddingpharm. Ozoralizumab is a next-generation TNF-alpha targeting ‘nanobody’, which succeeded in Phase II trials for RA before then-partner Pfizer returned the rights to Ablynx in November 2011. Eddingpharm is getting rights to the compound and will be responsible for the clinical development, registration and commercialisation in Greater China. Cashwise, Ablynx will receive an upfront fee of 2 million euros, plus development and commercial milestones plus tiered, double-digit royalties of up to 20%. This is the second deal the firms have signed after inking a bone treatment pact just under a year ago. Edwin Moses,Ablynx chief executive, noted that China is “a huge and developing market” and his new partner’s “deep knowledge of the local market, clinical development expertise and our nanobody's potential in the treatment of inflammatory diseases, including RA”, augurs well. His counterpart at Eddingpharm, Ni Xin, argued that the deal “demonstrates that Eddingpharm is the partner of choice in China for biotechnology companies around the world”.

Collaborate

100 Deals associated with Ozoralizumab

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KEGG	Wiki	ATC	Drug Bank
D09944	Ozoralizumab	-	DB12014

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Rheumatoid Arthritis	JP	Taisho Pharmaceutical Co., Ltd.	26 Sep 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ankylosing Spondylitis	Phase 1	US	Pfizer Inc.	-
Crohn Disease	Phase 1	US	Pfizer Inc.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


JPRN-JapicCTI-184031 (NATSUZORA, Pubmed) Manual	Phase 3	Rheumatoid Arthritis	140	ozoralizumab	nwrfqsozcx(nrgsphflcc) = luflucebyw efqcaagnil (eobtsooiqq ) View more	Positive	06 Oct 2022

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