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. 

But regulatory authorities have said the regenerative medicine cannot be marketed until product equivalency between manufacturing batches can be properly...

Welcome to Scrip

Create an account to read this article

Already a subscriber?

More from Japan

China Sentences Astellas Employee To 3.5 Years In Prison On Spy Charges

 
• By Lisa Takagi

An employee of Astellas faces three and a half years in prison after sentencing by a court in China on espionage charges.

Activist Investor Vs. Japan Pharma: ASKA Plans Poison Pill As Dalton Pushes For MBO

 
• By Lisa Takagi

While ASKA plans to dilute the holding of largest investor Dalton by issuing new shares, the US investment firm continues to push a management buyout option to the mid-sized Japanese pharma company.

Taiho’s Oral, Mutation-Agnostic DMD Candidate Misses Phase III Endpoint

 
• By Lisa Takagi

The oral, twice-daily candidate was expected to control decline in motor function in DMD patients regardless of their gene mutations.

Beyond AI Hype: Tokyo-1’s Real Answer On How To Innovate Pharma R&D

 
• By Lisa Takagi

Bringing supercomputing power to bear on large-scale calculations for pharma R&D, Tokyo-based Xeureka explains the practical use of AI to empower innovation beyond the hype.

More from Focus On Asia

Cipla CEO On Tariff Threat: ‘We Have One Of The Most Well Diversified Models’

 
• By Anju Ghangurde

Cipla's leadership fields shareholder queries on the specter of US tariffs and also outlines how the firm is nurturing the business for the future in areas like mRNA and point-of-care diagnostics, while building on its strength in the respiratory space.

Sino Biopharm Scoops LaNova In Chinese Pharma’s Biggest Biotech Buyout So Far

 
• By Dexter Jie Yan

Sino Biopharm will pay almost $1bn to acquire what target LaNova’s CEO described as an “exploding” pipeline, which includes six clinical-stage candidates in the oncology area.

China Sentences Astellas Employee To 3.5 Years In Prison On Spy Charges

 
• By Lisa Takagi

An employee of Astellas faces three and a half years in prison after sentencing by a court in China on espionage charges.