Ensitrelvir Fumaric Acid

SINGAPORE, March 24, 2024 /PRNewswire/ -- Juniper Biologics (" Juniper"), Singapore-based science-led pharmaceutical company focused on researching, developing, and commercializing novel therapies, celebrates another milestone as it received the award for Best Novel Therapy R&D and Commercialization Company at the APAC Insider Singapore Business Awards 2024. The APAC Insider Singapore Business Awards serves to spotlight companies and entrepreneurs driving growth in the region's business market and strengthening the country's open economy. The award also recognises the commitment of companies that foster a culture of innovation and promote investments in the country and the region. Amidst Singapore's dynamic business landscape, home to various startups and enterprises across industries, Juniper has become a standout presence. Since the founding of Juniper in 2020, the company has demonstrated exemplary commitment and focus toward providing the next generation of life-changing treatments to cater to unmet needs in specialized therapy areas that can make the most difference. This includes areas such as Oncology and Oncology Supportive Care, Gene Therapy, and Rare Diseases. By forging strategic alliances with leading global clinical research institutions, Juniper has broadened its scope, facilitating deals and acquisitions to commercialise pioneering therapies in collaboration with pharmaceutical counterparts worldwide. This collaborative approach empowers Juniper to enhance the accessibility of innovative medicines, thereby enhancing quality of life, and making a real impact on human lives. Singapore has established itself as one of the world's leading pharmaceutical R&D manufacturing and commercial hubs. Capitalizing on the growth potential in Singapore, Juniper has thrived through its strategic approach of targeting specialized areas and broadening access to therapeutics. Most recently, it orchestrated significant acquisitions, including the exclusive rights to license in Singapore an antiviral drug for COVID-19, Ensitrelvir Fumaric Acid ("Ensitrelvir"), aimed at supporting the country's preparedness in countering the evolving virus. "We are deeply honored to receive this prestigious business award," expressed Raman Singh, Founder and Chief Executive Officer of Juniper Biologics. "This achievement reflects our hard work, innovation, and patient-centric focus that defines Juniper Biologics. Through our R&D and commercialisation of therapies, we are motivated to continue growing our portfolio to create wide access to medicines that can make a meaningful impact in the lives of underserved patients. As we continue pushing the boundaries of healthcare excellence, we seek to remain steadfast to raise the standards of patient care, delivering nothing less than quality." With its growing operations spanning Asia, Australia, New Zealand, the Middle East, and Africa, Juniper is set to further strengthen its position as a leading force in the healthcare and pharmaceutical industry. About Juniper Biologics Backed by The Sylvan Group, Juniper Biologics is a science-led healthcare company focused on delivering novel therapies to improve the health and quality of life of patients, by building a growing presence in Oncology and Oncology Supportive Care, Rare/Orphan Diseases and Gene Therapy. It was founded on a vision to provide treatments for unmet medical needs focused on specialist therapy areas in which it can make the most difference. Through bold and transformative science, Juniper Biologics is committed to creating possibilities that have the potential to become the next generation of life-changing medicines for patient communities in China, Japan, Asia, Australia, New Zealand, Middle East, and Africa. Website: LinkedIn: SOURCE Juniper Biologics

The trial met its primary and key secondary endpoints, making ensitrelvir the first antiviral agent to show both clinical symptom improvement and antiviral effect in a predominantly vaccinated population with Omicron infection. The study found that once-daily administration of ensitrelvir led to a statistically significant reduction in the time to resolution of five typical COVID-19 symptoms characteristic of Omicron, runny nose, sore throat, cough, fever and tiredness, versus placebo. More than 90% of patients in the trial had received two or more doses of the SARS-CoV-2 vaccine and patients were included regardless of risk factors for severe disease. “We’re pleased to present the data from our Phase 3 study conducted in Asia in this peer-reviewed article. These results demonstrate accelerated resolution in a range of symptoms, reinforcing the potential of ensitrelvir across multiple patient profiles,” said Takeki Uehara, senior vice president, drug development and regulatory science at Shionogi. “Additionally, ensitrelvir reduced viral RNA levels and time to first negative viral titer, suggesting it could help reduce transmission of SARS-CoV-2. This study was conducted in a largely vaccinated population that included patients infected with Omicron. The patients also had varying risk factors for severe disease. This is relevant as there is a lack of data and a need for additional treatment options for this population.” Known as Xocova in Japan, ensitrelvir received emergency regulatory approval from the Ministry of Health, Labour and Welfare in Japan for the treatment of SARS-CoV-2 infection back in 2022. googletag.cmd.push(function () { googletag.display('text-ad1'); }); In addition, the therapy was approved in Singapore in November 2023, based on the Special Access Route application, but remains an investigational drug outside of Japan and Singapore. Ensitrelvir was also granted Fast Track designation by the U.S. Food and Drug Administration. Despite vaccines and some therapeutics available to treat COVID-19, the World Health Organization has emphasized that more treatment options are still needed for the disease. “We continue to see COVID-19 surges and we need additional treatment options for more patients, irrespective of risk factors for severe disease, as the virus continues to evolve, adapt, infect and re-infect people across the world,” said Yohei Doi, professor of Medicine, Fujita Health University, Japan, and one of the study authors. “Seeing the comprehensive data from the study in Asia signals that ensitrelvir has promising potential to treat patients with many common COVID-19 symptoms.”