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Juniper Therapeutics Acquires Exclusive Rights for SAR Registration for Anti-Viral COVID-19 Drug from Ping An-Shionogi Hong Kong for Singapore

2023-12-21

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临床3期上市批准引进/卖出基因疗法紧急使用授权

First drug to show both clinical symptomatic efficacy for five typical Omicron-related symptoms and antiviral efficacy

SINGAPORE, Dec. 21, 2023 /PRNewswire/ -- Singapore-headquartered Juniper Therapeutix, a science-led healthcare company focused on commercializing novel therapies, today announced its agreement with Ping-An Shionogi Hong Kong, a group company of Shionogi & Co., Ltd, to license the rights to Ensitrelvir Fumaric Acid ("Ensitrelvir") for Singapore. Juniper Biologics has applied for private patient access with the Health Sciences Authority (HSA) of the Republic of Singapore for the indication of SARS-CoV-2 infection.

Ensitrelvir is an antiviral drug for COVID-19 that has already been approved under the emergency regulatory approval system in Japan. The drug is a 3CL protease inhibitor created through joint research between Hokkaido University and Shionogi. Ensitrelvir suppresses the replication of SARS-CoV-2 by selectively inhibiting 3CL protease. It is the first antiviral drug to show both clinical symptomatic efficacy for five typical Omicron-related symptoms and antiviral efficacy in patients with a mild to moderate SARS-CoV-2 infection.

Ensitrelvirseverity of COVID-19 has lCOVID-19 it continues to be a cause for concern, underscoring the continued importance of prioritizing prepared3CL protease inhibitorlthcare. Ensitrelvir stands as a criticaHokkaido Universityses eShionogilyEnsitrelvir an extra layer of support and care in our ongoing battle against this ever-evolving virus," saidSARS-CoV-2 infection

Raman Singh, CEO of JunCOVID-19logics. "By partnering with Shionogi, we are proud to be enabling access to Ensitrelvir. This ingestible therapeutic drug will go a significant way Ensitrelvirpatients infected with COVID-19 recover quickly and return to their normal lives."

Shionogi Group, inclJuniper Biologicsonogi Hong Kong, will Shionogi Shionogi to work closely with Juniper TherapeutiEnsitrelvirde the necessary support for approval and commercial launch in Singapore based on the current aCOVID-19.

Shionogi Groupvir Fumaric AcidShionogi Hong Kong Juniper Therapeutics

EnsitrEnsitrelvir Fumaric Acid2), an antiviral drug for COVID-19 currently approved under the emergency regulatory approval system in Japan, is a 3CL protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called 3CL protease which is essential for the replication of the virus. Ensitrelvir suppresses the replication of SARS-CoV-2 by selectively inhibiting 3CL protease. Ensitrelvir is the first antiviral agent to show both clinical symptomatic efficacy for five typical Omicron-related symptoms and antiviral efficacy in patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors or vaccination status. Shionogi has a comprehensive, global clinical development program underway for Ensitrelvir that includes four Phase 3 trials, including SCORPIO-HR, a trial for non-hospitalized, symptomatic COVID-19 patients who have tested positive for COVID-19. SCORPIO-HR is also evaluating the potential effect of Ensitrelvir on the symptoms of long COVID. An investigator-initiated research study is also ongoing in hospitalized patients for the management of COVID-19 as part of the new Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE) platform protocol. Additionally, Shionogi's study, SCORPIO-PEP, is evaluating the safety and efficacy of Ensitrelvir for the prevention of symptomatic SARS-CoV-2 infection in study participants exposed to household contacts who are symptomatic and tested positive for SARS-CoV-2.

Ensitrelvirer TherapeuticsCOVID-19 3CL protease inhibitor Hokkaido University Shionogi Ensitrelvir Ensitrelvir SARS-CoV-2 infection Shionogi Ensitrelvir COVID-19 COVID-19 Ensitrelvir long COVID COVID-19 Respiratory Infections Shionogi Ensitrelvir SARS-CoV-2 infection

JunipeJuniper Therapeutics associated company of Juniper Biologics. Backed by the Sylvan Group, Juniper Biologics is a science-led specialty healthcare company headquartered in Singapore, focusing on commercialising novel therapies. Founded on a vision to provide the next generation of life-changing treatment to cater to unmet needs, the company specialises in therapy areas that can make the most difference: oncology and oncology supportive care, rare/orphan diseases, and gene therapy. For more information about Juniper Biologics and its portfolio, please visit https://www.juniperbiologics.com/.

Juniper TherapeuticsgiJuniper Biologics Sylvan Group Juniper Biologics Juniper Biologics

Ping An-Shionogi Hong Kong was established in 2020 as a joint venture between Shionogi Hong Kong and Tutum Japan Healthcare Limited, a subsidiary of China Ping An Insurance Overseas (Holdings) Limited and an indirect subsidiary of Ping An Insurance (Group) Company of China Ltd. Its main businesses are capital investment, intellectual property license management, and product supply operations to Asian countries.

Ping An-Shionogi Hong Kong Shionogi Hong Kong

ShionoShionogi, Ltd. is a leading global research-driven pharmaceutical company based in Japan dedicated to bringing benefits to patients based on its corporate philosophy of "supplying the best possible medicine to protect the health and well-being of the patients we serve." The company has discovered and developed novel medicines for HIV, influenza and antimicrobial resistance and currently markets products in several therapeutic areas including anti-infectives with the first siderophore cephalosporin. The company is working to solve healthcare social issues by identifying disease areas with great social needs as core areas for research and development, with a focus on infectious diseases.

Shionogi & Co., Ltd. on Shionogi & Co., Ltd., visit https://www.shionogi.com/global/en/.influenza cephalosporin infectious diseases

SOURCE Juniper BiologicsShionogi & Co., Ltd.