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World-First Nod For Yuhan's Lung Cancer Drug, In Korea

Eyes Now On J&J's Global Combo Trial

 
• By Jung Won Shin

The leading Korean pharma firm’s oral, third-generation EGFR-TKI is approved in the country, providing a new option for patients with advanced NSCLC and increasing hopes for global approvals given an ongoing global Phase III combination trial led by partner J&J.

Red Approved Stamp with Wooden handle Rubber Stamper Isolated on White Background.
LECLAZA Becomes Korea’s 31st Approved New Drug • Source: Shutterstock

Yuhan Corporation’s novel drug lazertinib has received approval from South Korea’s Ministry of Food and Drug Safety for second-line use in advanced lung cancer, as Leclaza, in the process becoming the 31st original new medicine to be originated, developed and approved in the country.

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More from South Korea

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
• By Jung Won Shin

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

Korea State R&D Fund Seeks Continuity To Enable Seamless Support

 
• By Jung Won Shin

The CEO of a South Korean state-run drug R&D support fund urges the renewal of the initiative as it increasingly focuses on new modalities and novel targets.

Korean Biotech Roundup: GNT Set For First Direct Korean Biopharma IPO On Nasdaq

 
• By Jung Won Shin

GNT Pharma prepares for the first listing of a Korean biotech on Nasdaq, while others sign major global out-licensing deals with large multinational partners.

US Tariff Impact On Korea Dissected As Country Gears For Presidential Election

 
• By Jung Won Shin

Analysts expect a limited impact on South Korean pharma from US tariffs, even if imposed at a later date. Meanwhile, the early June domestic presidential election is set to determine the direction of policies in the sector.

More from Focus On Asia

NIH Funding Cut Left Less Money On R&D Table, Tariffs Would Add To Woes: Aragen’s CEO

 
• By Vibha Ravi

Funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, GCC partnerships and talks with the Indian government to solve intellectual property challenges are discussed in an interview with Aragen’s CEO, who is also keenly watching the Trump administration’s moves on pharma tariffs

Akeso Explains Ivonescimab Prelim OS Data After Investors’ Negative Reactions

 
• By Dexter Jie Yan

Akeso explains the circumstances behind the release of preliminary overall survival data from a head-to-head Phase III trial with ivonescimab in lung cancer, which some investors viewed as disappointing.

Novotech CEO On Flexible Trial Solutions Amid Tariff, Geopolitical Tensions

 
• By Anju Ghangurde

Novotech's CEO talks about rising interest for trials in regions with “regulatory agility” and “strategic insulation” from geopolitical complexity, especially among emerging and mid-sized biotech sponsors. Operational "reassessment” among some sponsors on exposure to China-based CROs/CRDMOs is another area he discussed.