Inflix (infliximab biosimilar) / Mabpharm Limited, Sorrento, Shandong Kexing Bioproducts - LARVOL DELTA

Characterization of Anti‑Drug Antibody Responses in Healthy Volunteers Following XTMAB‑16 Administration & Implications for Clinical Development in Pulmonary Sarcoidosis (WASOG-AASOG 2025) - P1 | "Given the known risk of anti-drug antibody (ADA) formation with chimeric mAbs often driven by murine sequences and influenced by sex, dose, and immunosuppressant use (Bensalem and Ternant, 2020; Herskovitz et al, 2017), Xentria prioritized ADA surveillance early in XTMAB-16 development to support participant safety and robust immunogenicity and dosing profiling.Methods ADA and neutralizing antibodies (nAbs) were measured using validated electrochemiluminescence ligand binding assays (ECL-LBA and ECL-competitive LBA) developed by Xentria for use in therapeutic clinical trials...For clinical studies, ADA assessments will be strategically timed relative to drug concentrations and assessed in the context of concurrent methotrexate and corticosteroids...Physicochemical Characterization and Phase I Study of Cmab008, an Infliximab Biosimilar Produced by a Different Expression System...2017; 19(2):447-455. doi:10.1208/s12248-016-0026-8"

Clinical • Chronic Cough • Cough • Immunology • Respiratory Diseases • Sarcoidosis

…APPROVAL FROM THE INDONESIAN NATIONAL AGENCY OF DRUG AND FOOD CONTROL ON THE MARKETING AUTHORIZATION OF OUR CORE PRODUCT, CMAB008 (INFLIXIMAB FOR INJECTION) (HKEXnews) - "The board of directors...of the Company is pleased to announce that the marketing authorization of CMAB008 (infliximab for injection), a core product of the Company and a recombinant anti-tumor necrosis factorα ('TNFα') human-mouse chimeric monoclonal antibody independently developed by the Company, was recently approved by the Indonesian National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan) for the treatment of: ulcerative colitis in adults; ankylosing spondylitis; rheumatoid arthritis; Crohn’s disease in adults and pediatric patients aged above 6 years old; fistula Crohn’s disease; and psoriasis."

Approval • Ankylosing Spondylitis • Crohn's disease • Immunology • Psoriasis • Rheumatoid Arthritis • Ulcerative Colitis

INSIDE INFORMATION ANNOUNCEMEN APPROVAL FROM THE MINISTRY OF HEALTH OF PERU ON THE NEW DRUG APPLICATION (NDA) OF OUR CORE PRODUCT, CMAB008 (INFLIXIMAB FOR INJECTION) (Mabpharm Press Release) - "This announcement is made by Mabpharm Limited...The board of directors (the 'Board') of the Company is pleased to announce that the new drug application of CMAB008 (infliximab for injection), a core product of the Company and a recombinant anti-tumor necrosis factorα ('TNFα') human-mouse chimeric monoclonal antibody independently developed by the Company, was recently approved by the Ministry of Health of Peru (Ministerio de Salud)..."

Approval • Crohn's disease • Immunology • Inflammatory Bowel Disease • Rheumatoid Arthritis • Ulcerative Colitis

Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Pediatrics

Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients (clinicaltrials.gov) - P4 | N=30 | Not yet recruiting | Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd

New P4 trial • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Pediatrics • CRP

Efficacy and Safety of CMAB008 Compared with Innovator Infliximab in Patients with Moderate-to-Severe Rheumatoid Arthritis Receiving Concomitant Methotrexate: A Randomized, Double-blind, Multi-center, Phase III Non-inferiority Study. (PubMed, Rheumatol Ther) - P3 | "Non-inferior efficacy of CMAB008 to innovator infliximab is illustrated with similar early and lasting therapeutic effects, and the equivalence is further demonstrated. CMAB008 is well tolerated and has semblable safety compared with the innovator infliximab."

Clinical • Head-to-Head • Journal • P3 data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Population Pharmacokinetics of CMAB008 (an Infliximab Biosimilar) and Remicade in Healthy Subjects and Patients with Moderately to Severely Active Rheumatoid Arthritis. (PubMed, Adv Ther) - P1, P3 | "The pharmacokinetic characteristics were similar between CMAB008 and Remicade in healthy subjects and patients with RA. CMAB008 can be considered bioequivalent to Remicade."

Journal • PK/PD data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Randomized, Double-Blind, Parallel Controlled, Single-Dose Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of the Infliximab Biosimilar CMAB008 and the Reference Product in Healthy Chinese Male Subjects. (PubMed, Clin Pharmacol Drug Dev) - "The PK profile of the 2 groups is statistically equivalent. The preliminary safety and immunogenicity evaluation of the 2 drugs are comparable."

Clinical • Journal • P1 data • PK/PD data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Sorrento Announces Its Partner Mabpharm Has Received Marketing Approval In China For Infliximab Biobetter (GlobeNewswire) - "China National Medical Product Administration (NMPA) has granted Mabpharm approval to market INFLIXIMAB biobetter in China...The Chinese approval covers 6 different indications including adult ulcerative colitis, ankylosing spondylitis, rheumatoid arthritis, adult and childhood Crohn’s disease, fistula Crohn’s disease, and psoriasis."

Non-US regulatory • Ankylosing Spondylitis • Crohn's disease • Immunology • Inflammatory Bowel Disease • Rheumatoid Arthritis • Ulcerative Colitis

Kexing Pharmaceuticals is the exclusive agent of Inflix's first generic drug for the treatment of rheumatoid arthritis [Google translation] (STCN) - "Kexing Pharmaceutical issued an announcement that the company signed the 'CMAB008 International Exclusive Commercialization License Agreement' (hereinafter referred to as the 'Framework Agreement') with Taizhou Maibote Pharmaceutical Co., Ltd...and the company exclusively represented CMAB008 Exclusive commercial license in all countries and regions except China, Japan, Europe and North America...the infliximab biosimilar drug for adult ulcerative colitis is expected to obtain drug marketing authorization in Mainland China in 2021."

Licensing / partnership • Non-US regulatory • Crohn's disease • Immunology • Inflammatory Bowel Disease • Rheumatoid Arthritis • Ulcerative Colitis

The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety (clinicaltrials.gov) - P1; N=90; Completed; Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd

Clinical • New P1 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

CMAB008 With MTX Therapy in Adult Patients With Moderately to Severely Active Rheumatoid Arthritis (clinicaltrials.gov) - P3; N=390; Completed; Sponsor: Shanghai Biomabs Pharmaceutical Co., Ltd.; Active, not recruiting ➔ Completed

Clinical • Trial completion

CMAB008 With MTX Therapy in Adult Patients With Moderately to Severely Active Rheumatoid Arthritis (clinicaltrials.gov) - P3; N=390; Active, not recruiting; Sponsor: Shanghai Biomabs Pharmaceutical Co., Ltd.; Recruiting ➔ Active, not recruiting; Trial completion date: Jul 2019 ➔ Oct 2019

Clinical • Enrollment closed • Trial completion date

Physicochemical characterization and phase I study of CMAB008, an infliximab biosimilar produced by a different expression system. (PubMed, Drug Des Devel Ther) - "Also, no injection-site reactions were observed in the experiment. In summary, CMAB008 might have the potential to be an effective drug compared with infliximab."

Journal • P1 data