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

Eyes Now On J&J's Global Combo Trial

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.

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

More from South Korea

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

 
• By 

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 

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 

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.

Compass’ Bispecific BTC Contender Meets Phase II/III Endpoint

 
• By 

Compass' bispecific antibody tovecimig hits primary efficacy endpoint in Phase II/III top-line data in advanced biliary tract cancer, and may have class side-effect advantages. But additional survival data may be needed to support US approval.

More from Focus On Asia

Asia Deal Watch: Daiichi Taps Into Wayfinder’s RNA-Encoding Platform

Plus deals involving Elix/PRISM, Rege/Syros, Kaken/KalVista, Dr. Reddy’s/Aurigene/Edity, Nissan Chemical/Sanwa, Lupin/Renascience, Shionogi/Link Medicine, Abbisko/Merck & Co., Ono/Reborna and Apollomics/LaunXp.

Japan’s Ciconia Seeks Academic Candidates To Hatch In Global Market

 
• By 

Japanese incubator Ciconia has just started verifying its first drug candidate with a vision of building domestic startups with globally competitive assets.

Henlius In David Versus Goliath Race With Pfizer For First PD-L1 ADC

 

While Henlius Biotech’s PD-L1-targeting antibody-drug conjugate HLX43 is struggling to catch up with Pfizer’s PF-08046054, the global frontrunner in the space, a key differentiation of the China-originated asset could lie in PD-L1-negative patients.