Japan Again Postpones Approval Of Shionogi COVID Antiviral

Decision To Await Phase III Data

Xocova’s emergency approval stymied by uncertainties over efficacy and other characteristics that could effectively limit its use, prompting decision to await Phase III data later this year.

MHLW's Discussion gathered nation-wide attention in Japan
Two-hour long discussion by MHLW gathered nation-wide attention • Source: Lisa Takagi

Advisory review committees of Japan’s Ministry of Health, Labour and Welfare (MHLW) have decided for the second time in the past month not to grant an emergency approval to Shionogi & Co. Ltd.’s oral COVID-19 drug Xocova (ensitrelvir; S-217622), casting further questions around the 3CL protease inhibitor's path to market.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Japan

Sumitomo Offloads Asia Pharma Ops To Marubeni For $480m

 
• By 

The latest in a long line of restructuring measures will see Sumitomo Pharma making a stepped sale of its pharma operations in Asia to major Japanese trading house Marubeni.

Japan T-Reg Venture RegCell Raises New Funds, Relocates To US

 
• By 

Kyoto-based venture moves HQ to California to expand R&D and business outreach for its regulatory T-cell technology, as it raises around $46m in public and private funding.

Eisai Expands Dementia Ecosystem Via EcoNaviSta Acquisition

 
• By 

Move to acquire profitable Tokyo-based venture part of Japanese major's strategy of building a broader ecosystem for dementia detection and care.

Multiple Factors Behind Accelerating Private Equity Plays In Japan, APAC

 

With two major deals since just the beginning of the year in Japan, private equity groups appear to be ramping up their presence in the country's biopharma sector, amid ongoing activity across the wider APAC region.

More from Focus On Asia

China Deal-Making Matures As Foreign Partners Derisk Asset Acquisition

 
• By 

Chinese biopharma companies’ alliance strategies are transitioning from immediate cash needs to more strategic management of portfolios, as MNCs continue to hunt for derisked assets.

Vocal For ‘Glocal’: How Menarini Is Adapting To Outperform In The Asia Pacific

 

Menarini's Asia-Pacific CEO talks to Scrip about how the Italian group is tailoring its portfolio and pricing approach to local markets making strong strides in primary care and consumer health, while also charting a distinct path in rare diseases and oncology. The China market is also a key focus including as a potential source of innovation as is partnering, where the group has a rich history.

US Tariff Impact On Korea Dissected As Country Gears For Presidential Election

 
• By 

Analysts expect a limited impact on South Korean pharma from US tariffs, even if imposed at a later date. Meanwhile, the early June domestic presidential election is set to determine the direction of policies in the sector.