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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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More from South Korea

Q2 Korea Biotech Roundup: Licensing Deals End, Trials Progress, IPOs Recover

 
• By Jung Won Shin

Aside from several sizable global out-licensing deals, South Korean bioventures saw a cancellation of other alliances, updated their pipelines with losses and gains and reported clinical trial progress in the second quarter, while domestic IPO sentiment also improved.

Global Pharma Interest In Korea Undeterred Despite Political Roller Coaster

 
• By Jung Won Shin

Despite recent political turmoil, outside investor and corporate interest in South Korean biopharma innovation appears robust or even increasing.

Bitcoin Player Parataxis To Acquire Bridge Biotherapeutics After IPF Failure

 
• By Jung Won Shin

After the failure of its lead asset in a Phase II trial earlier this year, Korea's Bridge Biotherapeutics has accepted an acquisition offer from bitcoin group Parataxis.

Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
• By Jung Won Shin

A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges

More from Focus On Asia

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.

Sun’s Alopecia Treatment Debuts In US - Can It Make Up For Lost Time?

 
• By Anju Ghangurde

Sun’s Leqselvi goes up against Lilly's Olumiant and Pfizer's Litfulo, which currently has the broadest label, in the US alopecia market. Can it shake things up early, amid growing activity in the space with several new mechanisms of action being investigated?