Hanmi Pharmaceutical Co., Ltd.’s neutropenia drug Rolontis (eflapegrastim) has been approved in South Korea, making in the 33rd original drug developed by a domestic firm to be approved in the country.
World-First Korean Nod For Hanmi's Neutropenia Contender Rolontis
US Pre-Approval Inspection Bodes Well?
Hanmi’s novel, long-acting neutropenia drug gets world-first approval in South Korea, setting it up to be the first product using the company's proprietary platform technology to be commercialized. An FDA manufacturing inspection also seems to bode well for the pending US approval.
More from South Korea
• By
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.
• 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.
• 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.
• 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.
More from Focus On Asia
• By
CSPC’s SYS6010, the first monospecific EGFR-targeting antibody-drug conjugate in the clinic for advanced NSCLC, has shown Phase I promise, but could face close competition with another China-originated bispecific.
• By
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
• By
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.