JS010 / Shanghai Junshi Bioscience - LARVOL DELTA

Preparation and characterization of the affinity and neutralization abilities of human monoclonal antibodies against bunyavirus SFTSV glycoprotein C. (PubMed, Infect Med (Beijing)) - "By analyzing the RNA level of M segment by reverse transcription-polymerase chain reaction, the SFTSVs' RNA levels were decreased, specifically, the RNA of SFTS virus JS3, SFTS virus JS4 and Phlebovirus JS2010-014 was reduced by 79%, 80% and 87% respectively for hIgG4, and the value was 88%, 87% and 89% for hIgG5. According to the observation of the cytopathic effect, the minimal protective concentration of hIgG4 and hIgG5 was 62.5 μg/mL and 31.25 μg/mL respectively. hIgG4 and hIgG5 possess potent neutralizing effects, showing great potential as candidate therapeutic hmAbs for SFTS treatment."

Journal • Hematological Disorders • Thrombocytopenia

A Clinical Trial Evaluated the Safety and Tolerability, Pharmacokinetic and Pharmacodynamics Profile, and Immunogenicity of a Single Dose of JS010 Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Recruiting ➔ Completed

Trial completion • CNS Disorders • Migraine

A Clinical Trial Evaluated the Safety and Tolerability, Pharmacokinetic and Pharmacodynamics Profile, and Immunogenicity of a Single Dose of JS010 Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P1 trial • CNS Disorders • Migraine • Pain

Junshi Bio: The clinical trial application for JS010 injection was approved [Google translation] (Daily Economic News - NBD) - "...on March 17, Junshi Biological announced that the application for clinical trials of JS010 injection was approved. JS010 is a recombinant humanized anti-CGRP monoclonal antibody injection independently developed by the company, which is mainly used for the preventive treatment of migraine in adults."

New trial • CNS Disorders • Migraine

Chinese Regulator Accepts Shanghai Junshi Biosciences' New Drug Application for Migraine Treatment (Market Screener) - "China's National Medical Products Administration accepted Shanghai Junshi Biosciences...investigational new drug application for its JS010 injection, according to a Friday disclosure. The recombinant humanized anti-CGRP monoclonal antibody injection is mainly used to treat migraine in adults."

New trial • CNS Disorders • Migraine • Pain

B-JS010 - HRS/HFSA Joint Session: Frying Pan to Fire? Managing the Advanced HF Patient Who Develops Arrhythmias (RHYTHM 2021) - "Using a case-based approach and panel discussion this session will explore management of patients with severe HF requiring vasopressor support, LVAD, and after heart transplant. A Joint Session presented by the Heart Failure Society of America (HFSA)."

Clinical • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure • Transplantation

Susceptibility of spotted doves (Streptopelia chinensis) to experimental infection with the severe fever with thrombocytopenia syndrome phlebovirus. (PubMed, PLoS Negl Trop Dis) - "Our results suggest that spotted doves, one of the most abundant bird species in China, could be a competent amplifying host for SFTSV and play an important role in its ecology. Between the two SFTSV strains, the strain of the Japanese lineage caused mortality, higher viremia titers in infected birds over a longer time period than did the Chinese strain. Our observations shed light on the ecology of SFTSV, which could benefit the implementation of surveillance and control programs."

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