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.
Conditional Global-First Nod For SanBio's Cell Therapy for TBI
But Product Consistency Challenge Looms
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.
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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.
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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.
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Move to acquire profitable Tokyo-based venture part of Japanese major's strategy of building a broader ecosystem for dementia detection and care.
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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.
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RemeGen is planning to complete enrolment in the global Phase III RemeMG study with telitacicept in generalized myasthenia gravis by the end of 2025 or early 2026. The Chinese firm has already sidelined two other global Phase III trials with the molecule to prioritize the indication.
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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.
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Heads of Novartis Biomedical, World Economic Forum and Indian majors like Sun Pharma’s SPARC, among others, discuss generative AI in drug discovery along with pointers for India to leapfrog the R&D process