Spine Takes Yuhan’s Peptide Into US Phase III For High-Need DDD

Second Asset In Global Pivotal Trials

Major Korean firm Yuhan is seeing progress across multiple novel drug candidates licensed out to global partners, with two now entering pivotal trials. An innovative therapy for degenerative disc disease licensed to Spine BioPharma has received an FDA nod for a Phase III program and may change the standard of care for chronic low back pain patients.

back pain
Treatment Aims To Change Standard Of Care For CLBP patients • Source: Alamy

Yuhan Corporation’s first-in-class novel peptide drug candidate for degenerative disc disease (DDD), licensed out to US company Spine BioPharma in 2018, is now set to move into a Phase III trial in the US, marking the South Korean pharma firm’s second global pivotal stage program following the novel lung cancer drug lazertinib, being developed by Janssen Pharmaceutical Cos.

YH14618 (coded SB-01 by Spine) is a 7-amino acid chain peptide that binds to and induces down-regulation of transforming growth...

Scrip Podcast

Keep up with the top pharma business news of the week. On the go.

Scrip brings you a weekly bulletin of top picks.

More from South Korea

Emerging Modalities Stand Out In Recovering Korean Deal Market

 
• By 

While Korean biopharma companies’ out-licensing deals have remained lackluster in the past couple of years, activity around emerging modalities, led by ADCs, have been increasing in line with global trends.

Korean Biopharma Financings Remain In Doldrums But Recovery In Sight?

 
• By 

As investor sentiment around Korean biopharma IPOs and financings remained tepid in the second quarter, companies turned to other ways of raising money, including rights offerings. But there are signs of recovery and upcoming catalysts, while on the M&A front Boryung divested a vaccine subsidiary to a private equity consortium. 

Korea Q2 Roundup: Hanmi Dispute Simmers, Emerging Obesity Focus

 
• By 

As it reported mixed second-quarter earnings, South Korea's pharma industry is increasingly turning to obesity pipeline assets. Meanwhile, leadership disputes among family members within Hanmi are resurfacing.

S.Biomedics’ Parkinson's Cell Therapy Shows Early Clinical Promise

 
• By 

A novel stem cell therapy for Parkinson’s disease developed by a Korean firm has shown what Citeline analysts describe as "very promising" early clinical results at a low dose after one year.

More from Focus On Asia

India Rare Diseases: Court Shows Path For Policy Action, Funding, Price Issues-- Test-2

A court order encompassing funding, drug pricing, clinical trials and overall policy implementation aspects is expected to bring about a paradigm shift in the treatment of rare diseases in India. Sarepta, Roche and Sanofi are among the key players that have been part of pricing discussions.

Innovent/GenFleet Score China’s First KRAS G12C Inhibitor Approval

 

The nod will help unlock a national market for the partners’ Dupert (fulzerasib) in which roughly 50,000 people are expected to be newly diagnosed with lung cancer harboring the KRAS G12C mutation in 2025. Meanwhile, two other homegrown rivals are also closing in on marketing clearances in China.

As More DLL3 Bispecifics Advance, Doctors Are Adjusting To CRS, ICANS

 
• By 

Amgen’s Imdelltra for small-cell lung cancer is one of two bispecific T-cell engagers approved for solid tumors, but data at the WCLC meeting show other DLL3-targeting BiTEs may be on the way.