HLB LifeScience Co., Ltd. and Jiangsu Hengrui Medicine Co., Ltd.’s combination therapy for liver cancer has hit a stumbling block in the form of a US complete response letter (CRL), mainly related to issues around chemistry, manufacturing and controls (CMC), along with bioresearch monitoring (BIMO).
Glitch For HLB/Hengrui’s Liver Cancer Combo After US CRL
Quick Resolution Of CMC Issues Expected
The US approval of HLB and Hengrui’s liver cancer combination therapy looks set to be delayed after the FDA issues a CRL related mainly to CMC data, but the two companies appear positive on a quick resolution to the setback given a lack of other efficacy or safety concerns.
More from South Korea
• By
South Korea's LigaChem is kickstarting a growth and globalization drive through a potential future acquisition of UK ADC player IKSUDA.
• By
A new report from a domestic institute on South Korea’s biopharma M&A trends shows a pickup in activity, but that this remains relatively weak and small-scale. It calls for broader domestic government support to build expertise, drive innovation and globalization.
• By
Cross-Asian initiative has already brought several South Korean gene and cell therapy startups and Japanese VCs closer, with further hopes for product development and launches in Japan, regulatory harmonization and gliobalization.
• By
The latest activity in the South Korean biotech sector includes IPOs by Orum and Dongkook Life, as well as progress with ADCs at multiple firms.
More from Focus On Asia
• By
Heads of Novartis Biomedical, World Economic Forum and Indian majors like Sun Pharma’s SPARC, among others, discuss generative AI in drug discovery along with pointers for India to leapfrog the R&D process
• By
Lilly’s Mounjaro arrives in India, with the 2.5mg vial priced at under $41 in a market that has over 100 million diabetics and increasing obesity rates. Will the product see sharp demand like in China, carving out a chunk of the pie ahead of the potential arrival of semaglutide generics and could there be concerns of ‘suitcase' exports?
• By
South Korea's LigaChem is kickstarting a growth and globalization drive through a potential future acquisition of UK ADC player IKSUDA.