1. Scrip
  2. >>Focus On Asia
  3. >>Japan

Conditional Global-First Nod For SanBio's Cell Therapy for TBI

But Product Consistency Challenge Looms

 
• By Lisa Takagi

SanBio’s lead cell therapy asset has been on a bumpy journey to its global-first approval and while a nod has now come in Japan in a high-need indication, a commercial launch is conditional on additional data to establish product equivalence and manufacturing consistency. 

SanBio's Akuugo can be the global first pharmaceutical product approved for TBI treatment.
• Source: Shutterstock

Japan has cautiously granted a conditional, global-first approval to SanBio Co., Ltd’s autologous mesenchymal stem cell (MSC)-based therapy Akuugo (vandefitemcel; SB623) for traumatic brain injury (TBI), setting the stage for a market debut after development setbacks in other settings. 

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
Start Free Trial

Already a subscriber?

More from Japan

Japan’s Ciconia Seeks Academic Candidates To Hatch In Global Market

 
• By Lisa Takagi

Japanese incubator Ciconia has just started verifying its first drug candidate with a vision of building domestic startups with globally competitive assets.

US-China Tariff War Pressures Pharma’s Complex Supply Chain

 
• By Lisa Takagi

Although pharmaceuticals are exempt from the US reciprocal tariff policy, for now, the escalating global trade war is already posing practical on-the-ground problems for some companies, Scrip hears.

AstraZeneca Logs Japan Growth Despite Price Cuts

 
• By Lisa Takagi

AstraZeneca logs growth in Japan despite a big reimbursement price cut for one of its top sellers and expects 40 approvals in the country over the next six years.

Sumitomo Offloads Asia Pharma Ops To Marubeni For $480m

 
• By Ian Haydock

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.

More from Focus On Asia

Asia Deal Watch: Daiichi Taps Into Wayfinder’s RNA-Encoding Platform

 
• By Jung Won Shin, Lisa Takagi, Joseph Haas, Anju Ghangurde, and Vibha Ravi

Plus deals involving Elix/PRISM, Rege/Syros, Kaken/KalVista, Dr. Reddy’s/Aurigene/Edity, Nissan Chemical/Sanwa, Lupin/Renascience, Shionogi/Link Medicine, Abbisko/Merck & Co., Ono/Reborna and Apollomics/LaunXp.

Japan’s Ciconia Seeks Academic Candidates To Hatch In Global Market

 
• By Lisa Takagi

Japanese incubator Ciconia has just started verifying its first drug candidate with a vision of building domestic startups with globally competitive assets.

Henlius In David Versus Goliath Race With Pfizer For First PD-L1 ADC

 
• By Dexter Jie Yan

While Henlius Biotech’s PD-L1-targeting antibody-drug conjugate HLX43 is struggling to catch up with Pfizer’s PF-08046054, the global frontrunner in the space, a key differentiation of the China-originated asset could lie in PD-L1-negative patients.