[Translation] An open, multicenter, extension trial based on the Phase III clinical study of SM03 in the treatment of moderately to severely active rheumatoid arthritis (SM03-RA-Ⅲ) to evaluate the long-term safety of SM03

评价 SM03 在已完成 III 期临床试验的中重度活动性类风湿关节炎患者的长期安全性。

[Translation]

To evaluate the long-term safety of SM03 in patients with moderately to severely active rheumatoid arthritis who have completed Phase III clinical trials.

Start Date07 Jul 2022

Sponsor / Collaborator

Lonn Ryonn PHARMA Ltd.

CTR20170914 / Active, not recruitingPhase 3

随机、双盲、安慰剂平行对照多中心Ⅲ期临床评价SM03联合甲氨蝶呤治疗中重度活动性类风湿关节炎有效性和安全性

[Translation] A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial to evaluate the efficacy and safety of SM03 combined with methotrexate in the treatment of moderately to severely active rheumatoid arthritis

评价SM03单抗联合甲氨蝶呤(MTX)治疗中重度活动性类风湿关节炎(RA)有效性和安全性。

[Translation]

To evaluate the efficacy and safety of SM03 monoclonal antibody combined with methotrexate (MTX) in the treatment of moderately to severely active rheumatoid arthritis (RA).

Start Date28 Dec 2017

Sponsor / Collaborator

Lonn Ryonn PHARMA Ltd.

NCT04312815 / Unknown statusPhase 3

A Randomized,Placebo Controlled, Double-blind, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of SM03, Compared to Placebo, in Patients With Moderate-to-Severely Active Rheumatoid Arthritis Receiving Methotrexate

To demonstrate that SM03 added to methotrexate (MTX) reduce signs and symptoms of rheumatoid arthritis (RA) in Chinese RA participants with an inadequate response to MTX.
To assess the safety of SM03 added to MTX in Chinese RA participants with an inadequate response to MTX

Start Date28 Dec 2017

Sponsor / Collaborator

Sinomab Bioscience Ltd.

100 Clinical Results associated with Suciraslimab

100 Translational Medicine associated with Suciraslimab

100 Patents (Medical) associated with Suciraslimab

Literatures (Medical) associated with Suciraslimab

15 Jun 2022·Journal of immunology (Baltimore, Md. : 1950)

SM03, an Anti-CD22 Antibody, Converts Cis-to-Trans Ligand Binding of CD22 against α2,6-Linked Sialic Acid Glycans and Immunomodulates Systemic Autoimmune Diseases

Article

Author: Li, Zhengdong ; Wang, Dong ; Ma, Felix ; Chong, Chi H. ; Luk, Ka K. ; Wong, Kin L. ; Song, Nan ; Leung, Shui O.

Abstract:

SM03, an anti-CD22 recombinant IgG1 mAb, is currently in a phase III clinical trial for the treatment of rheumatoid arthritis (NCT04312815). SM03 showed good safety and efficacy in phase I systemic lupus erythematosus and phase II moderate to severe rheumatoid arthritis clinical trials. We propose the success of SM03 as a therapeutic to systemic autoimmune diseases is through the utilization of a novel mechanism of action unique to SM03. CD22, an inhibitory coreceptor of the BCR, is a potential immunotherapeutic target against autoimmune diseases. SM03 could disturb the CD22 homomultimeric configuration through disrupting cis binding to α2,6-linked sialic acids, induce rapid internalization of CD22 from the cell surface of human B cells, and facilitate trans binding between CD22 to human autologous cells. This in turn increased the activity of the downstream immunomodulatory molecule Src homology region 2 domain-containing phosphatase 1 (SHP-1) and decreased BCR-induced NF-κB activation in human B cells and B cell proliferation. This mechanism of action gives rationale to support the significant amelioration of disease and good safety profile in clinical trials, as by enabling the “self” recognition mechanism of CD22 via trans binding to α2,6 sialic acid ligands on autologous cells, SM03 specifically restores immune tolerance of B cells to host tissues without affecting the normal B cell immune response to pathogens.

05 May 2022·RHEUMATOLOGYQ2 · MEDICINE

SM03, an anti-human CD22 monoclonal antibody, for active rheumatoid arthritis: a phase II, randomized, double-blind, placebo-controlled study

Q2 · MEDICINE

Article

Author: Leung, Shui-on ; Li, Jing ; Zhou, Jiaxin ; Zhang, Fengchun ; Li, Mengtao ; Wu, Di

Abstract:

Objective:

SM03, a novel chimaeric mAb specific to B cell-restricted antigen CD22, has been developed to treat RA and other B-cell-related diseases. This 24-week phase II randomized, double-blind, multi-dose, placebo-controlled study aimed to evaluate the efficacy and safety of SM03 in moderately-to-severely active RA patients in China.

Methods:

One hundred and fifty-six patients on background MTX were randomized in a 1:1:1 ratio to receive a cumulative dose of 3600 mg (high dose, 600 mg × 6 infusions at weeks 0, 2, 4, 12, 14 and 16) or 2400 mg SM03 (low dose, 600 mg × 4 infusions at weeks 0, 2, 12 and 14) or the placebo. The primary outcome was the 24-week ACR 20% improvement criteria (ACR20) response rate. Safety was also assessed.

Results:

The 24-week ACR20 response rate was significantly higher with high- (65.3%, P = 0.002) and low-dose SM03 (56.9%, P = 0.024) than with placebo (34.0%), but comparable between the high- and low-dose group. The rate of adverse events was not statistically different among the high-dose group (35.3%), the low-dose group (51.9%) and the placebo group (34.6%). Thirteen (12.6%) patients receiving SM03 reported treatment-emergent infections, including 3.9% patients in the high-dose group. No patients reported severe treatment-emergent infections or malignancies.

Conclusions:

In active RA Chinese patients receiving background MTX, SM03 at a cumulative dose of both 2400 mg and 3600 mg is efficacious and well-tolerated throughout the 24 weeks of treatment. Moreover, SM03 has demonstrated a good safety profile.

Trial registration:

ClinicalTrials.gov, https://clinicaltrials.gov, NCT04192617.

01 Apr 2022·Journal of applied microbiologyQ3 · BIOLOGY

Hydroxy-selenomethionine supplementation promotes the in vitro rumen fermentation of dairy cows by altering the relative abundance of rumen microorganisms

Q3 · BIOLOGY

Article

Author: Yang, Zhantao ; Wang, Wei ; He, Tengfei ; Sun, Xiaoge ; Wang, Jidong ; Li, Shengli ; Zheng, Yuhui ; Xie, Tian

Abstract:

Aims:

This study aims to investigate the effect of hydroxy-selenomethionine supplementation on the in vitro rumen fermentation characteristics and microorganisms of Holstein cows.

Methods and Results:

Five fermentation substrates, including control (without selenium supplementation, CON), sodium selenite supplementation (0.3 mg kg−1 DM, SS03), and hydroxy-selenomethionine supplementation (0.3, 0.6 and 0.9 mg kg−1 DM, SM03, SM06 and SM09, respectively) were incubated with rumen fluid in vitro. The results showed that in vitro dry matter disappearance and gas production at 48 h was significantly higher in SM06 than SM03, SS03 and CON; propionate and total volatile fatty acid (VFA) production was higher in SM06 than CON. Moreover, higher species richness of rumen fluid was found in SM06 than others. Higher relative abundance of Prevotella and Prevotellaceae-UCG-003 and lower relative abundance of Ruminococcus-1 were detected in SM06 than CON. Besides, higher relative abundance of Ruminococcaceae_UCG-005 was found in CON than other treatments.

Conclusions:

It is observed that 0.6 mg kg−1 DM hydroxy-selenomethionine supplementation could increase cumulative gas production, propionate, and total VFAs production by altering the relative abundance of Prevotella, Prevotellaceae-UCG-003, Ruminococcaceae_UCG-005 and Ruminococcus-1, so that it can be used as a rumen fermentation regulator in Holstein cows.

Significance and Impact of the Study:

This study provides an optimal addition ratio of hydroxy-selenomethionine on rumen fermentation and bacterial composition via an in vitro test.

News (Medical) associated with Suciraslimab

19 Nov 2024

·www.prnewswire.com

Systemic Lupus Erythematosus Clinical Trial Pipeline Gains Momentum as 120+ Key Companies at the Forefront | DelveInsight

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease characterized by inflammation and tissue damage across multiple organ systems, such as the skin, joints, kidneys, heart, and brain. The incidence of autoimmune diseases, including SLE, has been increasing globally, with a significant impact on demand for targeted and effective therapies. LAS VEGAS, Nov. 19, 2024 /PRNewswire/ -- DelveInsight's ' Systemic Lupus Erythematosus Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline systemic lupus erythematosus therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the systemic lupus erythematosus pipeline domain. Key Takeaways from the Systemic Lupus Erythematosus Pipeline Report DelveInsight's systemic lupus erythematosus pipeline report depicts a robust space with 120+ active players working to develop 140+ pipeline therapies for systemic lupus erythematosus treatment. Key systemic lupus erythematosus companies such as Roche, ImmuPharma, UCB, Idorsia Pharmaceuticals, Biogen, AbbVie, Bristol-Myers Squibb, Vera Therapeutics, Beijing Mabworks Biotech Co., Ltd., BeiGene, Jiangsu Renocell Biotech Company, AstraZeneca, Pfizer, Red de Terapia Celular, Kira Pharmacenticals (US), LLC., Jemincare, Galapagos NV, Alumis, argenx, Gilead Sciences, Novartis, Zenas Biopharma, Horizon Therapeutics, Provention Bio, Janssen Research & Development, Eli Lilly and Company, Medsenic, Sanofi, Merck KGaA, Resolve Therapeutics, ILTOO, Janssen, Alpine Immune Sciences, Kezar Life Sciences, Neovacs, Kangpu Biopharmaceuticals, Cartesian Therapeutics, Apellis Pharmaceuticals, Inc., Alexion Pharmaceuticals, Inc., Q32 Bio Inc., Conduit Pharmaceuticals, Miltenyi Biomedicine GmbH, Kyverna Therapeutics, ImmPACT Bio, Genrix (Shanghai) Biopharmaceutical Co., Ltd., Gracell Biotechnologies (Shanghai) Co., Ltd., Cabaletta Bio, Tenet Medicines, Ascentage Pharma Group Inc., InnoCare, Eisai, Sorrento Therapeutics, Carna Bioscience, Yake Biotechnology, Equillium, Daiichi Sankyo Company, SinoMab Bioscience Ltd, Citryll BV, Sareum, Shanghai Junshi Biosciences, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Millennium Pharmaceuticals, Inc., Takeda, Synthekine, Hangzhou Sumgen Biotech Co., Ltd., Sana Biotechnology, Hoffmann-La Roche, Guangdong Ruishun Biotech Co., Ltd, Shanghai Ming Ju Biotechnology Co., Ltd., Autolus Limited, Nkarta, Inc., Luminary Therapeutics, Kyowa Kirin Co., Ltd., Shanghai Ming Ju Biotechnology, IGM Biosciences, Inc., GlaxoSmithKline, Fate Therapeutics, Cugene Inc., Century Therapeutics, Inc., Cullinan Therapeutics Inc., Juno Therapeutics, Inc., EdiGene Inc., Atara Biotherapeutics, Annexon, Inc., Adicet Therapeutics, Bioray Laboratories, PersonGen BioTherapeutics (Suzhou) Co., Ltd., Juventas Cell Therapy Ltd., Nanjing Bioheng Biotech Co., Ltd., Pregene ShenZhen Biotechnology, Artiva Bio, KeyMed Biosciences, IASO, JW Therapeutics, ROME Therapeutics, Ventus Therapeutics, Allosite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, LongBio Pharma, Amytrx Therapeutics, Corestem, Eliem Therapeutics, SinoMab Bioscience Ltd., and others are evaluating new systemic lupus erythematosus drugs to improve the treatment landscape. Promising systemic lupus erythematosus pipeline therapies such as Obinutuzumab, Lupuzor (IPP-201101), Dapirolizumab pegol, Cenerimod, BIIB059, Upadacitinib, Deucravacitinib, Atacicept, MIL62, Zanubrutinib, RY_SW01 cell injection|Basic treatment, Ravulizumab, Rapcabtagene autoleucel, PF-06823859, Mesenchymal stem cells (MSC), KP104, JMKX000189, Iptacopan, GLPG3667, ESK-001, Elsubrutinib, Efgartigimod alfa, Edecesertib, Ianalumab, Obexelimab (XmAb5871), Daxdilimab (VIB7734), PRV-3279, Nipocalimab, ABBV 599, NKTR-358 (LY3471851), Arscimed, SAR441344, Enpatoran, RSLV-132, Aldesleukin, Daratumumab, Branebrutinib, BMS-986256, ALPN-101, KZR-616, IFNα kinoid, KPG 818, Descartes-08, CFZ533, APL-2, ALXN2050, ADX-097, AZD1656, MB-CART19.1, KYV-101, IMPT-514, GR1603, GC012F Injection, CABA-201, Budoprutug, APG-2575, ICP-022, E6742, ALPN-303, AC0058, Mosunetuzumab, AS-0871, CD19/BCMA CAR T-cells, PF-06835375, EQ001 (Itolizumab), DS-7011a, SM03, CIT-013, SDC-1801, UBP1213, TQB3702, TAK-079, TAK-007, SYNCAR-001, SG301, SC291, RO7507062, RJMty19 (CD19-CAR-DNT cells), Relma-cel, PIT565, Obecabtagene autoleucel (obe-cel), NKX019, LMY-920, KK4277, JWCAR201, Imvotamab, GSK4527363, GSK4347859, FT819, CUG252, CNTY-101, CLN-978, CC-97540, Belantamab, ATHENA CAR-T ATA3219, ANX009, ADI-001, BRL-301, T-cell injection targeting CD19 chimeric antigen receptor, CNCT19, RD06-04, PRG-2311, PRG-1801, AlloNK, CM313, CT103A, JWCAR 029, Research program: endogenous reverse transcriptase inhibitors, VENT 03, ONT01, BCMA-CD19 cCAR T cells, CB-010, LP-005, AMTX 100, CE211AT15, TN-119, SN1011, QX002N, RSLV-145, Recombinant human plasma gelsolin, LN-008, TST 008, IBL 100s, and others are under different phases of systemic lupus erythematosus clinical trials. In October 2024, the FDA approved the investigational new drug (IND) application for Cullinan Therapeutics' CLN-978 to treat systemic lupus erythematosus (SLE). In September 2024, Cartesian Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM). In September 2024, Caribou Biosciences announced that the U.S. Food and Drug Administration (FDA) had granted fast-track designation to CAR T-cell therapy CB-010 for systemic lupus erythematosus (SLE). In September 2024, UCB and Biogen reported successful results from their Phase III clinical trial of the PHOENYCS GO study, which tested dapirolizumab pegol as a treatment for moderate-to-severe systemic lupus erythematosus. In August 2024, Conduit Pharmaceuticals announced they will be conducting a Phase IIa clinical trial to evaluate AZD1656 for the treatment of multiple autoimmune diseases, including systemic lupus erythematosus (SLE). In July 2024, the first individual received the therapy Descartes-08 to treat systemic lupus erythematosus. This therapy has been previously administered to patients with myasthenia gravis, a long-term autoimmune disorder characterized by muscle weakness. In February 2024, Idorsia Pharmaceuticals formed a major global research and development partnership with Viatris to advance and commercialize two Phase III assets, selatogrel and cenerimod, on a global scale. Request a sample and discover the recent advances in systemic lupus erythematosus treatment drugs @ Systemic Lupus Erythematosus Pipeline Report The systemic lupus erythematosus pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage systemic lupus erythematosus drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the systemic lupus erythematosus clinical trial landscape. Systemic Lupus Erythematosus Overview Systemic lupus erythematosus (SLE) is a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissues in various parts of the body. The exact cause of SLE is unknown, but it is believed to result from a combination of genetic, environmental, and hormonal factors. Common triggers include infections, sunlight exposure, and certain medications. Women, particularly of childbearing age, are more commonly affected. Symptoms of SLE vary widely and can affect many organ systems, leading to a wide range of clinical presentations. Common symptoms include fatigue, joint pain, skin rashes, photosensitivity, and fever. More severe cases can affect the kidneys, heart, lungs, and central nervous system, potentially leading to life-threatening complications. Diagnosis of SLE is based on a combination of clinical features and laboratory tests. The antinuclear antibody (ANA) test is a common initial screening tool, but additional tests like anti-double stranded DNA (anti-dsDNA) and anti-Smith antibodies, as well as assessments of kidney and liver function, are often necessary. Diagnosis can be challenging because SLE symptoms often mimic those of other diseases. Treatment for SLE focuses on managing symptoms and preventing flares. Mild cases may be treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and antimalarial drugs like hydroxychloroquine. More severe cases may require corticosteroids, immunosuppressive drugs such as azathioprine, methotrexate, or newer biologics like belimumab. Lifestyle modifications, such as avoiding excessive sun exposure and managing stress, are also essential in controlling the disease. Find out more about systemic lupus erythematosus treatment drugs @ Drugs for Systemic Lupus Erythematosus Treatment A snapshot of the Systemic Lupus Erythematosus Pipeline Drugs mentioned in the report: Learn more about the emerging systemic lupus erythematosus pipeline therapies @ Systemic Lupus Erythematosus Clinical Trials Systemic Lupus Erythematosus Therapeutics Assessment The systemic lupus erythematosus pipeline report proffers an integral view of the systemic lupus erythematosus emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Systemic Lupus Erythematosus Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Antibody-dependent cell cytotoxicity, Cell death inhibitors, Cell death stimulants, Immunomodulators, CD40 ligand inhibitors, Sphingosine 1 phosphate receptor modulators, Calcineurin inhibitors, Immunosuppressants, Janus kinase 1 inhibitors, TYK2 kinase inhibitors, B cell activating factor inhibitors, Tumour necrosis factor ligand superfamily member 13 inhibitors Key Systemic Lupus Erythematosus Companies: Roche, ImmuPharma, UCB, Idorsia Pharmaceuticals, Biogen, AbbVie, Bristol-Myers Squibb, Vera Therapeutics, Beijing Mabworks Biotech Co., Ltd., BeiGene, Jiangsu Renocell Biotech Company, AstraZeneca, Pfizer, Red de Terapia Celular, Kira Pharmacenticals (US), LLC., Jemincare, Galapagos NV, Alumis, argenx, Gilead Sciences, Novartis, Zenas Biopharma, Horizon Therapeutics, Provention Bio, Janssen Research & Development, Eli Lilly and Company, Medsenic, Sanofi, Merck KGaA, Resolve Therapeutics, ILTOO, Janssen, Alpine Immune Sciences, Kezar Life Sciences, Neovacs, Kangpu Biopharmaceuticals, Cartesian Therapeutics, Apellis Pharmaceuticals, Inc., Alexion Pharmaceuticals, Inc., Q32 Bio Inc., Conduit Pharmaceuticals, Miltenyi Biomedicine GmbH, Kyverna Therapeutics, ImmPACT Bio, Genrix (Shanghai) Biopharmaceutical Co., Ltd., Gracell Biotechnologies (Shanghai) Co., Ltd., Cabaletta Bio, Tenet Medicines, Ascentage Pharma Group Inc., InnoCare, Eisai, Sorrento Therapeutics, Carna Bioscience, Yake Biotechnology, Equillium, Daiichi Sankyo Company, SinoMab Bioscience Ltd, Citryll BV, Sareum, Shanghai Junshi Biosciences, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Millennium Pharmaceuticals, Inc., Takeda, Synthekine, Hangzhou Sumgen Biotech Co., Ltd., Sana Biotechnology, Hoffmann-La Roche, Guangdong Ruishun Biotech Co., Ltd, Shanghai Ming Ju Biotechnology Co., Ltd., Autolus Limited, Nkarta, Inc., Luminary Therapeutics, Kyowa Kirin Co., Ltd., Shanghai Ming Ju Biotechnology, IGM Biosciences, Inc., GlaxoSmithKline, Fate Therapeutics, Cugene Inc., Century Therapeutics, Inc., Cullinan Therapeutics Inc., Juno Therapeutics, Inc., EdiGene Inc., Atara Biotherapeutics, Annexon, Inc., Adicet Therapeutics, Bioray Laboratories, PersonGen BioTherapeutics (Suzhou) Co., Ltd., Juventas Cell Therapy Ltd., Nanjing Bioheng Biotech Co., Ltd., Pregene ShenZhen Biotechnology, Artiva Bio, KeyMed Biosciences, IASO, JW Therapeutics, ROME Therapeutics, Ventus Therapeutics, Allosite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, LongBio Pharma, Amytrx Therapeutics, Corestem, Eliem Therapeutics, SinoMab Bioscience Ltd., and others. Key Systemic Lupus Erythematosus Pipeline Therapies: Obinutuzumab, Lupuzor (IPP-201101), Dapirolizumab pegol, Cenerimod, BIIB059, Upadacitinib, Deucravacitinib, Atacicept, MIL62, Zanubrutinib, RY_SW01 cell injection|Basic treatment, Ravulizumab, Rapcabtagene autoleucel, PF-06823859, Mesenchymal stem cells (MSC), KP104, JMKX000189, Iptacopan, GLPG3667|Placebo, ESK-001, Elsubrutinib, Efgartigimod alfa, Edecesertib, Ianalumab, Obexelimab (XmAb5871), Daxdilimab (VIB7734), PRV-3279, Nipocalimab, ABBV 599, NKTR-358 (LY3471851), Arscimed, SAR441344, Enpatoran, RSLV-132, Aldesleukin, Daratumumab, Branebrutinib, BMS-986256, ALPN-101, KZR-616, IFNα kinoid, KPG 818, Descartes-08, CFZ533, APL-2, ALXN2050, ADX-097, AZD1656, MB-CART19.1, KYV-101, IMPT-514, GR1603, GC012F Injection, CABA-201, Budoprutug, APG-2575, ICP-022, E6742, ALPN-303, AC0058, Mosunetuzumab, AS-0871, CD19/BCMA CAR T-cells, PF-06835375, EQ001 (Itolizumab), DS-7011a, SM03, CIT-013, SDC-1801, UBP1213, TQB3702, TAK-079, TAK-007, SYNCAR-001, SG301, SC291, RO7507062, RJMty19 (CD19-CAR-DNT cells), Relma-cel, PIT565, Obecabtagene autoleucel (obe-cel), NKX019, LMY-920, KK4277, JWCAR201, Imvotamab, GSK4527363, GSK4347859, FT819, CUG252, CNTY-101, CLN-978, CC-97540, Belantamab, ATHENA CAR-T ATA3219, ANX009, ADI-001, BRL-301, T-cell injection targeting CD19 chimeric antigen receptor, CNCT19, RD06-04, PRG-2311, PRG-1801, AlloNK, CM313, CT103A, JWCAR 029, Research program: endogenous reverse transcriptase inhibitors, VENT 03, ONT01, BCMA-CD19 cCAR T cells, CB-010, LP-005, AMTX 100, CE211AT15, TN-119, SN1011, QX002N, RSLV-145, Recombinant human plasma gelsolin, LN-008, TST 008, IBL 100s, and others. Dive deep into rich insights for new drugs for systemic lupus erythematosus treatment, visit @ Systemic Lupus Erythematosus Drugs Table of Contents For further information on the systemic lupus erythematosus pipeline therapeutics, reach out @ Systemic Lupus Erythematosus Treatment Drugs Related Reports Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key SLE companies including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Epidemiology Systemic Lupus Erythematosus Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted SLE epidemiology in the 7MM. Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lupus nephritis companies, including NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, NOVARTIS, CABALETTA BIO, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Inflection Biosciences, Equillium, Roche, Horizon Therapeutics, BeiGene, Janssen Research & Development, ImmPACT Bio, among others. 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 . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Phase 2Fast TrackCell Therapy

26 Jul 2022

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New Therapeutics Options in Rheumatoid Arthritis Pipeline as 120+ Key Companies are Working on Drug Profiles | DelveInsight

Rise in prevalence of rheumatoid arthritis, increase in demand for rheumatoid arthritis drugs, the entry of biosimilar drugs, the surge in geriatric population are the key factors driving the development of potential treatment of Rheumatoid arthritis. Major key players include Taisho Pharmaceutical, Zhejiang Hisun Pharmaceutical, SinoMab, Jiangsu Hengrui Medicine, RemeGen, GlaxoSmithKline, Modern Biosciences, Jiangsu Alphamab Biopharmaceuticals, and others. LAS VEGAS, July 26, 2022 /PRNewswire/ -- DelveInsight's ' Rheumatoid Arthritis Pipeline Insight 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline rheumatoid arthritis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the rheumatoid arthritis pipeline domain. Key Takeaways from the Rheumatoid Arthritis Pipeline Report DelveInsight's rheumatoid arthritis pipeline report depicts a robust space with 120+ active players working to develop 120 + pipeline therapies for rheumatoid arthritis treatment. Key rheumatoid arthritis companies such as Taisho Pharmaceutical, Zhejiang Hisun Pharmaceutical, SinoMab, Jiangsu Hengrui Medicine, RemeGen, GlaxoSmithKline, Modern Biosciences, Jiangsu Alphamab Biopharmaceuticals, Akros Pharma, Hanlim Pharm, Galapagos NV, Chong Kun Dang Pharmaceutical, Bristol Myers Squibb, AstraZeneca, Aclaris Therapeutics, Abivax, AbbVie, Synact Pharma, Gilead sciences, Mesoblast, Rottapharm Biotech, Eli Lilly and Company, Kiniksa Pharmaceuticals, Abcentra, Cyxone, Yungjin Pharm. Co., Ltd. Taiho Pharmaceutical, Oscotec Inc., Pfizer, Janssen Research & Development, Cipher Pharmaceuticals Inc., KLUS Pharma Inc., Revolo Biotherapeutics, Lynk Pharmaceuticals, Beijing Baylx Biotech, Hope Biosciences, Kangstem Biotech, Celltex Therapeutics, I-Mab Biopharma Co. Ltd., Synermore Biologics Co., Ltd, Oryn Therapeutics, Arthrogen, Bayer, Amgen, Draconis Pharma, Biozeus, Landos Biopharma, Imcyse, Kymera Therapeutics, RedHill Biopharma, 4D Pharma, CV6 Therapeutics, VYNE Therapeutics, MyMD Pharmaceuticals, Brickell Biotech Inc, Worg Pharmaceuticals, Almirall, Standigm, Metrion Biosciences, Jnana Therapeutics, Silo Pharma, SFA Therapeutics, Neutrolis Therapeutics, Ahead Therapeutics, Fresenius Kabi, Kidswell Bio, BioXpress Therapeutics, CinnaGen, Alvotech, Hetero Biopharma, Shanghai Henlius Biotech, Cadila Pharmaceuticals, Innovent Biologics, Torrent Pharmaceuticals, Emcure Pharmaceuticals, mAbxience, Shanghai Junshi Biosciences, Enosi Therapeutics, and others are evaluating novel rheumatoid arthritis treatment drugs candidate to improve the treatment landscape. Promising rheumatoid arthritis pipeline therapies in various stages of development includes TS152, HS-016, SM03, SHR0302, RC18, Otilimab, NI-0101, MBS2320, KN019, JTE-051, Interleukin 2, HL237, GLPG3970, Elsubrutinib, CKD-506, Branebrutinib, AZD9567, ATI-450, ABX464, ABBV 3373, ABBV 154, AP1189, F8IL10, AMT-101, GS-9876, CR 6086, LY 3462817, KPL-404, Orticumab, Rabeximod, YRA 1909, VIB4920, Varicella Zoster Vaccine, TAS5315, SKI-O-703, SAN-300, PF-06650833, Nipocalimab, CF-101, A223, IRL 201805, LNK 01001, PRTX-100, hUC-MSC infusion, HB-adMSC, LABP-104, VAY736, TJ003234 , SYN060, GS-5718, PF-06835375, Nivolumab, MH004, ORTD-1, ART-I02, FB704A, Amilo 5MER, CKD-374 , CFZ-533, BAY 1830839, AMG 570, JNJ-4703, CT-P47, BZ068, Invossa, LABP-69, ICM-203-R, NX-5948, KT-474 , Clarithromycin/clofazimine/rifabutin (RHB-104), Research programme: small molecule TYK2 inhibitors, MRx0006, CV6 1271, VYN201, MYMD-1, BBI 02, Research Programme: Immune mediated diseases, Foralumab, SPU-21, SFA002, NTR-441, Research programme: autoimmune disease therapeutics, AT_1001, MSB11456, MabionCD20, DMB-3113, GB232, GBS 005, TX17, BX 2922, Cinnora, AVT02, MYL-1401A, and others. In July 2022, Enosi Therapeutics, announced a partnership with Danuo Science Group, based in Hong Kong, to further develop two products currently in Enosi's pipeline for Greater China. Enosi's Growth Factor Trap (EN-2000 Program) and TNFR1 Blocker (EN-1000 Program) were licensed as part of the partnership. Both programs have the potential to be used as cross-over drugs to treat cancer and autoimmune diseases. EN-2000 blocks inflammatory growth factors that drive cancer and rheumatoid arthritis while EN-1000 is a specific blocker of TNFR1, which Enosi believes may be useful in treating autoimmune disease. In February 2022, Biogen Inc. and Xbrane Biopharma AB announced that they have entered into a commercialization and license agreement to develop, manufacture, and commercialize Xcimzane™, a preclinical monoclonal antibody that is a proposed biosimilar referencing CIMZIA® (certolizumab pegol). In June 2022, Biogen Inc. and Bio-Thera Solutions, Ltd. presented positive Phase III data for BIIB800 (BAT1806), a biosimilar candidate referencing. The double-blind 52-week Phase III study randomized 621 patients with moderate to severe rheumatoid arthritis to receive either BIIB800 or the reference tocilizumab administered intravenously every 4 weeks at a dose of 8 mg/kg for the first 24 weeks. Data from the Phase III comparative clinical trial demonstrated that the investigational biosimilar candidate BIIB800 has equivalent efficacy and comparable safety and immunogenicity profile to the reference tocilizumab product. In June 2022, Revolo Biotherapeutics announced that it was awarded an Innovative Medicines Designation, or Innovation Passport, from the Medicines and Healthcare products Regulatory Agency (MHRA) for its immune-resetting drug candidate, '1805, for the treatment of patients with moderately to severely active Rheumatoid Arthritis (RA). In February 2022, Revolo Biotherapeutics secured approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to initiate two Phase II trials of its autoimmune disease drug candidate '1805. One of the trials will enrol moderate-to-severe active rheumatoid arthritis (RA) patients while another Phase II trial will have individuals with non-infectious, active, intermediate, or posterior uveitis or panuveitis. In December 2021, Theramex, entered into an agreement with Enzene Biosciences Limited to develop, register, and commercialize a biosimilar drug of Roche's reference medicine RoActemra (Tocilizumab). Tocilizumab, in combination with Methotrexate (MTX), is indicated for the treatment of rheumatoid arthritis. It is planned to be commercialized from 2026 in Europe, the UK, Switzerland, and Australia. Obefazimod is an oral, first-in-class, small molecule being developed by Abivax in Phase II stage of development. Obefazimod generated promising pre-clinical data from collagen-induced arthritis animal models that were the basis for moving into the Phase IIa clinical trial in rheumatoid arthritis (RA). Zunsemetinib, an Investigational Oral MK2 Inhibitor, is being developed by Aclaris Therapeutics. Aclaris initiated study activities and began activating sites in December 2021 in the following two studies: ATI-450-RA-202: Phase IIb clinical trial of zunsemetinib in subjects with moderate to severe rheumatoid arthritis (RA). This is Aclaris' second Phase II clinical trial of zunsemetinib in subjects with moderate to severe RA and is primarily designed to assess the efficacy of multiple doses of zunsemetinib to aid in the selection of an optimal dose to progress in future development. Request a sample and discover the recent advances in rheumatoid arthritis treatment @ Rheumatoid Arthritis Pipeline Outlook The rheumatoid arthritis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage rheumatoid arthritis products, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the rheumatoid arthritis pipeline landscape. Rheumatoid Arthritis Overview Rheumatoid arthritis is classified as an autoimmune disorder. It occurs when the immune system, which is supposed to defend, malfunctions and begins to attack our own tissues. It causes inflammation in the lining of the joints (the synovium). As a result, joints may become red, warm, swollen, and painful, which are common rheumatoid arthritis symptoms. The exact rheumatoid arthritis causes are still unknown. Rheumatoid arthritis can be difficult to detect in its early stages since the early signs and symptoms are similar to those of many other diseases. There is no single blood test or physical finding that can validate the rheumatoid arthritis diagnosis. Rheumatoid arthritis has no known cure. However, rheumatoid arthritis clinical trials show that remission of symptoms is more frequent when rheumatoid arthritis treatment with disease-modifying antirheumatic medicines started early (DMARDs). Find out more about rheumatoid arthritis treatment @ Rheumatoid Arthritis Treatment Drugs A snapshot of the Rheumatoid Arthritis Pipeline Drugs mentioned in the report: Learn more about the novel and emerging rheumatoid arthritis pipeline therapies @ Rheumatoid Arthritis Clinical Trials Rheumatoid Arthritis Therapeutics Assessment The rheumatoid arthritis pipeline report proffers an integral view of rheumatoid arthritis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Rheumatoid Arthritis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-ocular, Intra-articular, Intrathecal, Intravenous, Oral, Parenteral, Ophthalmic, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Interleukin 6 inhibitor, Tumour necrosis factor-alpha inhibitor, CD22 antigen inhibitor, Janus kinase 1 inhibitor, B cell activating factor inhibitor, Granulocyte-macrophage colony-stimulating factor antagonist, Toll-like receptor 4 antagonist, Emt protein-tyrosine kinase inhibitor, Fibroblast growth factor modulators; T lymphocyte inhibitors, Bacteria replacements. Key Rheumatoid Arthritis Companies: Taisho Pharmaceutical, Zhejiang Hisun Pharmaceutical, SinoMab, Jiangsu Hengrui Medicine, RemeGen, GlaxoSmithKline, Modern Biosciences, Jiangsu Alphamab Biopharmaceuticals, Akros Pharma, Hanlim Pharm, Galapagos NV, Chong Kun Dang Pharmaceutical, Bristol Myers Squibb, AstraZeneca, Aclaris Therapeutics, Abivax, AbbVie, Synact Pharma, Gilead sciences, Mesoblast, Rottapharm Biotech, Eli Lilly and Company, Kiniksa Pharmaceuticals, Abcentra, Cyxone, Yungjin Pharm. Co., Ltd. Taiho Pharmaceutical, Oscotec Inc., Pfizer, Janssen Research & Development, Cipher Pharmaceuticals Inc., KLUS Pharma Inc., Revolo Biotherapeutics, Lynk Pharmaceuticals, Beijing Baylx Biotech, Hope Biosciences, Kangstem Biotech, Celltex Therapeutics, I-Mab Biopharma Co. Ltd., Synermore Biologics Co., Ltd, Oryn Therapeutics, Arthrogen, Amgen, Biozeus, Landos Biopharma, Imcyse, Kymera Therapeutics, RedHill Biopharma, 4D Pharma, CV6 Therapeutics, VYNE Therapeutics, MyMD Pharmaceuticals, Brickell Biotech Inc, Worg Pharmaceuticals, Almirall, Standigm, Metrion Biosciences, Jnana Therapeutics, Silo Pharma, SFA Therapeutics, Neutrolis Therapeutics, Ahead Therapeutics, Fresenius Kabi, Kidswell Bio, BioXpress Therapeutics, CinnaGen, Alvotech, Hetero Biopharma, Shanghai Henlius Biotech, Cadila Pharmaceuticals, Innovent Biologics, Torrent Pharmaceuticals, Emcure Pharmaceuticals, mAbxience, Shanghai Junshi Biosciences, Enosi Therapeutics, and others Key Rheumatoid Arthritis Pipeline Therapies: TS152, HS-016, SM03, SHR0302, RC18, Otilimab, NI-0101, MBS2320, KN019, JTE-051, Interleukin 2, HL237, GLPG3970, Elsubrutinib, CKD-506, Branebrutinib, AZD9567, ATI-450, ABX464, ABBV 3373, ABBV 154, AP1189, F8IL10, AMT-101, GS-9876, CR 6086, LY 3462817, KPL-404, Orticumab, Rabeximod, YRA 1909, VIB4920, Varicella Zoster Vaccine, TAS5315, SKI-O-703, SAN-300, PF-06650833, Nipocalimab, CF-101, A223, IRL 201805, LNK 01001, PRTX-100, hUC-MSC infusion, HB-adMSC, LABP-104, VAY736, TJ003234 , SYN060, GS-5718, PF-06835375, Nivolumab, MH004, ORTD-1, ART-I02, FB704A, Amilo 5MER, CKD-374 , CFZ-533, BAY 1830839, AMG 570, JNJ-4703, CT-P47, BZ068, Invossa, LABP-69, ICM-203-R, NX-5948, KT-474 , Clarithromycin/clofazimine/rifabutin (RHB-104), Research programme: small molecule TYK2 inhibitors, MRx0006, CV6 1271, VYN201, MYMD-1, BBI 02, Research Programme: Immune mediated diseases, Foralumab, SPU-21, SFA002, NTR-441, Research programme: autoimmune disease therapeutics, AT_1001, MSB11456, MabionCD20, DMB-3113, GB232, GBS 005, TX17, BX 2922, Cinnora, AVT02, MYL-1401A, and others. Dive deep into rich insights for drugs for rheumatoid arthritis, visit @ Rheumatoid Arthritis Medications Table of Contents For further information on the rheumatoid arthritis pipeline therapeutics, reach out @ Drugs for Rheumatoid Arthritis Related Reports Rheumatoid Arthritis Market 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 rheumatoid arthritis companies including Abivax, UCB, Sierra Oncology, Taisho, among others. Rheumatoid Arthritis Epidemiology Forecast Rheumatoid Arthritis Epidemiology Forecast to 2032 report delivers an in-depth understanding of the disease, historical and forecasted rheumatoid arthritis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Juvenile Rheumatoid Arthritis Pipeline Juvenile Rheumatoid Arthritis Pipeline Insight, 2022 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, 2022 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 Persistent Depressive Disorder Market | Gene Therapy for Ocular Rare Disease Market | Congestive Heart Failure Market | CRISPR Therapies Pipeline | Desmoplastic Small Round Cell Tumors Market | India Healthcare Outlook Report | Psychosis Market | Dental Lasers Market | Primary Immune Deficiency Market I Dyslipidemia Market | Lateral Epicondylitis Disease Market | Castration-Resistant Prostate Cancer Market | Metrorrhagia Market | Global Messenger RNA-based Vaccines and Therapeutics Market | Negative Pressure Wound Therapy Systems Market | US Healthcare Outlook Report | Mucinous Cystic Neoplasms Market | Hot Flashes Market | Varicose Veins - Market | Hemostats Market | Injectable Drug Delivery Devices Market | Breast Pumps Market | Physiotherapy Equipment Market | Trastuzumab Biosimilars Insight | Deep Brain Stimulation Devices Market | Retinoblastoma Market | Venous Stenosis Market | Tumor Ablation Market | Substance Abuse Market | Insulin Glargine Biosimilar Insight | Interspinous Spacers Market | Anti-hypertension Market Latest Healthcare Blogs Knee Osteoarthritis Pipeline Rheumatoid Arthritis Market Scenario Juveline Idiopathic Arthritis Therapy Market About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	NDA/BLA	CN	Hainan Sailemin Biotechnology Co. Ltd.	05 Sep 2023
Non-Hodgkin Lymphoma	Phase 2	CN	Lonn Ryonn PHARMA Ltd.	02 Jul 2012
Systemic Lupus Erythematosus	Phase 2	CN	Sinomab Bioscience Ltd.	-
Alzheimer Disease	Phase 1	CN	Sinomab Bioscience Ltd.	-
Sjogren's Syndrome	Phase 1	CN	Sinomab Bioscience Ltd.	-
Dementia due to Alzheimer's disease (disorder)	IND Application	CN	Sinomab Bioscience Ltd.	15 Nov 2023
Mild cognitive disorder	IND Application	CN	Sinomab Bioscience Ltd.	15 Nov 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2020	Phase 2	Rheumatoid Arthritis CD22	156	SM03 3600mg cumulative dose	iyefalhbsv(wojsdcnrvz) = likttrvvqg awcaqvcgzi (jrsdqycaid )	Positive	03 Jun 2020
				SM03 2400mg cumulative dose	iyefalhbsv(wojsdcnrvz) = bckkbymimd awcaqvcgzi (jrsdqycaid )

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