1. Scrip
  2. >>Focus On Asia
  3. >>South Korea

Korean Authorities Mull New Steps, Probe Over Olmutinib Events

 
• By Jung Won Shin

Additional safety measures including a possible sales suspension are to be discussed by a review committee in South Korea on Oct. 4 that will help decide the fate of Hanmi’s EGFR inhibitor olmutinib. Financial authorities in the country are also launching a probe into the timing of the disclosure of several cases of serious adverse events with the drug.

Drugs question mark

South Korea’s Ministry of Food and Drug Safety (MFDS) has distributed safety letters to inform domestic medical professionals, patients and consumer groups about the occurrence of serious adverse skin reactions during clinical trials with Hanmi Pharmaceutical Co. Ltd.'s cancer drug olmutinib, which was launched for the first time globally in the country earlier this year.

The adverse reactions include one case of Stevens Johnson syndrome (SJS) and two cases of toxic epidermal necrolysis (TEN) and...

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 South Korea

MetaVia Sees Obesity Opportunities Despite Challenging US Market

 
• By Jung Won Shin

Despite new challenges related to obesity drug insurance coverage in the US, MetaVia's CEO is confident in the company's novel contender, which unlike rival GLP-1 therapies doesn’t require dose titration.

Korea Q1 Roundup: Mixed Earnings, Gearing For Possible US Tariffs

 
• By Jung Won Shin

South Korean biopharma companies report a mostly solid first quarter, marked by US growth for original drugs, with several also making preparations for possible US pharma tariffs.

Tech Convergence, Quality Data Needed To Accelerate Korea’s AI-Powered R&D

 
• By Jung Won Shin

AI-powered drug development was a major topic at the recent Bio Korea meeting, where experts discussed how the technology is changing R&D activities and the challenges being faced by Korean firms as they look to catch up with their global competitors.

Celltrion Sees Multiple Biosimilar Opportunities From Trump’s Pricing EO

 
• By Jung Won Shin

Biosimilars giant Celltrion tells shareholders there could be multiple opportunities for its business under US President Donald Trump’s latest executive order on drug pricing.

More from Focus On Asia

Public Health And Innovation: Addressing Gaps, Pharma’s Role

 
• By Anju Ghangurde

Expert panel including Ashok Venkitaraman, director of the Cancer Science Institute of Singapore, discusses public health challenges and innovations to help address these. Long-acting drugs, intercepting cancer early and “design thinking” by ophthalmologists in India were among the talking points.

Loss Of Exclusivity Product Launches To Fuel Aurobindo’s FY26 Europe Growth

 
• By Vibha Ravi

Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now

Korea Q1 Roundup: Mixed Earnings, Gearing For Possible US Tariffs

 
• By Jung Won Shin

South Korean biopharma companies report a mostly solid first quarter, marked by US growth for original drugs, with several also making preparations for possible US pharma tariffs.