Anjianning (adalimumab biosimilar) / Zhejiang Hisun Pharmaceutical, BioRay Biopharmaceutical - LARVOL DELTA

Real-World Efficacy and Safety of Adalimumab Biosimilar (HS016) in Biologic-Naïve Patients with Perianal Fistulizing Crohn's Disease: A Prospective, Single-Arm, Observational Study. (PubMed, Drug Des Devel Ther) - "During treatment, 3 patients (5%) developed transient rashes, with no treatment discontinuation required. HS016 exhibits significant efficacy and an acceptable safety profile in biologic-naïve PFCD patients, though the incremental maintenance strategy shows limited efficacy."

Journal • Observational data • Real-world evidence • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • Oncology • TNFA

A Multicenter, Single-arm Study to Evaluate the Efficacy and Safety of Anjianning® in Adult Patients with Moderately to Severely Active Crohn 's Disease in the Real-world (ChiCTR) - P4 | N=60 | Not yet recruiting | Sponsor: The Second Affiliated Hospital of AFMU; Bioray Pharmaceutical (Hangzhou) Co., Ltd

New P4 trial • Real-world evidence • Crohn's disease • Gastroenterology • Immunology

A Multicenter, Open-Label Study on the Effectiveness and Safety of Anjianning® (Adalimumab Biosimilar) in Treating Pediatric Patients with Severe Psoriasis in Real-World Settings (ChiCTR) - P4 | N=60 | Not yet recruiting | Sponsor: The First Affiliated Hospital of China Medical University; Bioray Pharmaceutical (Hangzhou) Co., Ltd

New P4 trial • Real-world evidence • Dermatology • Immunology • Pediatrics • Psoriasis • Psoriatic Arthritis

The effectiveness and safety of Anjianning(adalimumab) for the treatment of autoimmune diseases in the real-world: A multicenter, prospective, observational study (ChiCTR) - P4 | N=10000 | Not yet recruiting | Sponsor: ShangHai GuangHua Hospital of Integrated Traditiona.Chinese and Western Medicine; Bioray Pharmaceutical (Hangzhou) Co., Ltd

New P4 trial • Real-world evidence • Ankylosing Spondylitis • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Development of an in-line Raman analytical method for commercial-scale CHO cell culture process monitoring: Influence of measurement channels and batch number on model performance. (PubMed, Biotechnol J) - "In this study, an in-line Raman analytical method was developed for monitoring glucose, lactate, and viable cell density (VCD) in the Chinese hamster ovary (CHO) cell culture process during commercial production of biosimilar adalimumab (1500 L). Further, the influence of the number of batches used for model calibration on model performance was also studied to determine how many batches are needed basically for method development. The proposed Raman analytical method development strategy and considerations will be useful for monitoring of similar bioprocesses."

Journal • Preclinical

Efficacy and safety of adalimumab biosimilar (HS016) in inflammatory bowel disease from the real-world study. (PubMed, Front Pharmacol) - "Elevations of serum anti-drug antibodies occurred in one additional patient (4.3%). ADA biosimilar HS016 had good efficacy and safety in Chinese IBD patients."

Journal • Real-world • Real-world evidence • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • TNFA

H NMR-based process understanding and biochemical marker identification methodology for monitoring CHO cell culture process during commercial-scale manufacturing. (PubMed, Biotechnol J) - "Additional potential metabolic pathways that might influence the cell culture phase transitions were demonstrated. The workflow proposed in this study demonstrates that the combination of MVDA tools and H NMR technology is highly appealing to the research of the biomanufacturing process, and applies well to provide guidance in future work on consistency evaluation and biochemical marker monitoring of the production of other biologics."

Journal • Preclinical

Comparative assessment of pharmacokinetic parameters between HS016, an adalimumab biosimilar, and adalimumab (Humira®) in healthy subjects and ankylosing spondylitis patients: Population pharmacokinetic modeling. (PubMed, Adv Clin Exp Med) - "The systemic exposure of HS016 was similar to that of adalimumab in healthy subjects and AS patients, demonstrating PK similarity."

Clinical • Journal • PK/PD data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Physicochemical and functional characterization of HS016, a biosimilar of adalimumab (Humira). (PubMed, J Pharm Sci) - "However, no differences in antigen binding activity, Fc receptor affinity, antibody-dependent cell-mediated cytotoxicity or complemented-dependent cytotoxicity were found. The primary and higher order structures, physicochemical properties, and biological activity of HS016 and adalimumab were similar."

Journal

Evaluation of adalimumab biosimilar candidate (HS016) in Chinese patients with active ankylosing spondylitis based on a health survey: sub-analysis of a phase 3 study. (PubMed, Clin Rheumatol) - "This trial demonstrated that both HS016 and adalimumab produced rapid improvements in symptoms during the first 2 weeks of treatment. These findings suggest that HS016 is an alternative economical treatment for Chinese AS patients producing a rapid amelioration of symptoms, aiding them to recover their lifestyle satisfaction."

Clinical • Journal • P3 data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Changes in Efficacy Indicators for Adalimumab Biosimilar Candidate (HS016) for the Treatment of Active Ankylosing Spondylitis at Various Time Points. (PubMed, Front Pharmacol) - " The response trajectory of most individual efficacy indicators was comparable between HS016 and adalimumab at each time point during the 24 weeks of the trial. Clinical Trial Registration: http://www.chictr.org.cn/showproj.aspx?proj=37910, identifier [ChiCTR1900022520]."

Clinical • Journal • Ankylosing Spondylitis • Back Pain • Immunology • Inflammatory Arthritis • Musculoskeletal Pain • Pain • Rheumatology • Seronegative Spondyloarthropathies

A Randomized, Double-Blind, Parallel-Group, Phase 1 Clinical Trial Comparing the Pharmacokinetic, Safety, and Immunogenicity of the Biosimilar HS016 and the Originator Adalimumab in Chinese Healthy Male Subjects. (PubMed, Clin Pharmacol Drug Dev) - "The pharmacokinetic profile of HS016 was equivalent to that of the originator, adalimumab, with similar safety and immunogenicity profiles. HS016 may be considered for assessment in the treatment of patients with ankylosing spondylitis."

Clinical • Journal • P1 data • PK/PD data • Ankylosing Spondylitis • Immunology • Rheumatology

Comparison of the Efficacy and Safety of Adalimumab (Humira) and the Adalimumab Biosimilar Candidate (HS016) in Chinese Patients with Active Ankylosing Spondylitis: A Multicenter, Randomized, Double-Blind, Parallel, Phase III Clinical Trial. (PubMed, BioDrugs) - "HS016 resembled adalimumab in efficacy and safety over the 24-week treatment period."

Clinical • Journal • P3 data

Development and Qualification of a Scale-Down Mammalian Cell Culture Model and Application in Design Space Development by Definitive Screening Design. (PubMed, AAPS PharmSciTech) - "In this study, a scale-down model representing commercial-scale cell culture process of adalimumab biosimilar HS016 was first developed based on constant power per volume (P/V) principle and then qualified by multivariate data analysis (MVDA) and equivalence test method. The design space was finally developed using a probability-based Monte Carlo simulation method and was verified with the operation setpoint and worst-case condition. The case study presented in this report shows a feasible roadmap for cell culture process characterization."

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