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Nature Cell Keeps Hopes Up For JointStem Despite Conditional Approval Rejection

 
• By Jung Won Shin

Nature Cell remains positive on its degenerative osteoarthritis therapy JointStem as it seeks to move on to a Phase III study in South Korea, and reattempts to seek conditional approval after its initial such filing based on Phase II results was rejected earlier this year.

Render illustration of Clinical Trial title on medical documents
NATURE CELL SEEKS PHASE III APPROVAL FOR CELL THERAPY

South Korea's Biostar Stem Cell Research Institute, which is jointly operated by Nature Cell Co. Ltd. and sister firm R Bio, has filed an IND to begin a domestic Phase III study for JointStem, its stem cell therapy for degenerative osteoarthritis (OA), after national regulatory authorities rejected an earlier filing seeking conditional approval of the therapy.

Nature Cell recently filed an objection to the Central Pharmaceutical Affairs Council's decision and is seeking the conditional approval again,...

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A Decade Of Transformation: Dong-A ST Readies For Take Off As An Innovative Pharma

 
• By Jung Won Shin

Korean firm’s head of research talks to Scrip about how it is transforming into an innovative drug developer with a more diverse pipeline across multiple modalities with first-in-class potential.

Korea Q2 Roundup: Global Sales, License Income Boost Yuhan, GC

 
• By Jung Won Shin

Yuhan and GC Biopharma’s performances stood out among South Korean companies reporting Q2 results, boosted by license income, strong global growth and exports, while many others reported generally weaker figures.

With Planned US Facility Acquisition, Celltrion Looks To Avoid US Pharma Tariffs

 
• By Jung Won Shin

Celltrion is set to acquire a US biologics manufacturing facility that will "eliminate" its US tariff risks and provide a ready-made production base for future expansion.

Korean Biopharma Catching Up On AI, But What Are The Challenges?

 
• By Jung Won Shin

While South Korea's biopharma sector has made progress in its digital transformation, including the adoption of AI technologies, a recent report has identified multiple remaining challenges.

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