Introduction:Global First! The UK Approves Second-Generation Vaccine Targeting Omicron; Monkeypox May Cause Asymptomatic Infections; Sinopharm Group: Omicron Variant mRNA Vaccine Clinical Application Submitted... BioExploration keeps you updated on "Pharma" news, exploring the value of biotechnology!
01Global First! UK Approves Second-Generation Vaccine Targeting Omicron
On August 15, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved an mRNA bivalent vaccine produced by the US pharmaceutical company Moderna that targets both the Omicron variant and the original strain of the coronavirus. This makes the UK the first country in the world to approve a booster vaccine targeting the Omicron variant. The UK regulatory agency stated that this decision was based on clinical trial data. Moderna's clinical data showed that as a booster shot, this vaccine can elicit a strong immune response against both the Omicron BA.1 variant and the original strain of the coronavirus.
On the same day, China National Pharmaceutical Group (Sinopharm) announced that the mRNA vaccine developed by its subsidiary China Biologic Products targeting the Omicron variant has also been submitted for clinical application.
02Monkeypox may cause asymptomatic infections
It was previously believed that monkeypox infections rarely involved asymptomatic cases, meaning that symptoms always followed infection and that transmission only occurred after symptoms appeared. However, the 2022 monkeypox virus behaves differently.Nature MedRelevant research papers in the NEJM have reported various characteristics of the 2022 monkeypox virus. The ITM Monkeypox Study Group, a Belgian monkeypox research project, has recently come online.Nature MedReports Three Cases of Asymptomatic Monkeypox Infections.
Belgian health authorities detected four cases of 2022 Monkeypox virus DNA positivity from 224 STI screening samples using the PCR method. Among them, one individual exhibited rash symptoms characteristic of monkeypox, while the other three were asymptomatic infections. During the subsequent 21-37 days, these three patients did not develop any clinical symptoms. Antibody testing was conducted using the patients' serum, confirming that all three were infected with the 2022 Monkeypox virus. More importantly, the 2022 Monkeypox virus was isolated and cultured from two asymptomatic patients, a gold-standard experiment suggesting that these two patients’ samples may be infectious. This study, combined with previous findings in Portugal,Nature MedThe article published on, pointed out that the 2022 monkeypox virus causes monkeypox infections with very different clinical manifestations compared to previous monkeypox viruses.
03Sinopharm Group: Omicron Variant Chinese-produced mRNA Vaccine Clinical Application Submitted
According to news on August 15, at the media briefing held by China National Pharmaceutical Group (Sinopharm) on the same day, Zhu Jingdong, Party Secretary of Sinopharm's China Biologic Products, stated that China Biologic is currently advancing its scientific and technological efforts in combating the pandemic. The inactivated vaccine for the Omicron variant and the second-generation recombinant protein COVID-19 vaccine have both received clinical trial approvals. The Omicron variant mRNA vaccine has also been submitted for clinical application. The therapeutic drug, specific immunoglobulin for COVID-19, is continuously being supplied to areas severely affected by the pandemic. Monoclonal antibodies F61, 2B11, and DXP604 have successively entered clinical trials. A diagnostic kit for the newly prevalent monkeypox virus has received EU CE certification. These scientific achievements and research data will be publicly released and shared with the world.
04Antengene's ATG-018 Completes First Patient Dosing in Australia
On August 16, Antengene Corporation announced that the Phase I ATRIUM study evaluating ATG-018 as a monotherapy for the treatment of advanced solid tumors and hematologic malignancies has dosed its first patient in Australia. ATG-018 is an oral, potent, and selective small molecule inhibitor of ATR. By inhibiting the ATR kinase, ATG-018 can suppress the ability of tumor cells to repair damaged DNA. This mechanism of action is commonly referred to as synthetic lethality, also known as DDR.
The ATRIUM study is a multicenter, open-label, Phase I dose-finding study designed to evaluate the safety and efficacy of ATG-018 as a monotherapy for patients with advanced solid tumors and hematological malignancies. The primary objective of this study is to assess the safety and tolerability of ATG-018 in order to determine the maximum tolerated dose and/or the recommended Phase II dose and/or the biologically effective dose, and to evaluate the preliminary efficacy of the drug where conditions permit. The secondary objective is to determine the pharmacological properties of ATG-018.
05Sanofi's New Pompe Disease Drug Granted Priority Review
On August 15, the CDE website indicated that Sanofi's application for the domestic market entry of Avalglucosidase Alfa Injection is proposed to be included in the priority review, intended for long-term enzyme replacement therapy in patients with Pompe disease (acid alpha-glucosidase [GAA] deficiency).
Avalglucosidase alfa for injection, developed by Sanofi as a second-generation enzyme replacement therapy, is intended for patients with Pompe disease. Based on the age of onset, affected organs, and disease progression rate, Pompe disease is divided into infantile-onset Pompe disease and late-onset Pompe disease. According to relevant information, avalglucosidase alfa for injection was approved by the FDA in June 2021 for the treatment of late-onset Pompe disease in patients aged one year and older; in June this year, it received approval from the European Commission for the long-term treatment of Pompe disease, including both infantile-onset and late-onset forms.
Compiled by Muzi Jiu
Typesetting | Muzi Jiu
