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Gene And Cell Therapies In Asia: Can China Deliver Despite Murky Regulations?

 
• By Brian Yang

The first country ever to approve a gene therapy, China has been lagging in the area since due to a lack of clear regulatory pathways and insufficient financial incentives. Now a new crop of developers are aiming to revitalize ambitions and make the country a major power for promising novel treatments for rare neurodegenerative conditions, retinal dystrophy, HIV and cancer.

NIFDC'S FOURTH CHINA GENE THERAPY FORUM IN BEIJING 18-19 OCTOBER • Source: Shutterstock

In October, a deal between a Chinese vaccine developer and a US gene therapy firm caught industry attention. Tianjin-based CanSino Biotech teamed up with Pennsylvania bioventure Ocugen Inc. to develop and commercialize Ocugen’s OCU400, a gene therapy for genetic retinal conditions discovered by Harvard University Medical School’s Neena Haider.

CanSino will support clinical development including chemical, manufacturing and controls (CMC), and gained the rights to commercialize the gene therapy in the greater China market

More from China

Chinese Firms Build Obesity Clinical Pipeline But Face Wider Hurdles

 
• By Xu Hu

Despite the ability to initiate clinical trials quickly and having strong manufacturing capacity, Chinese companies are facing multiple challenges in the obesity space.

Transient FY26 For Syngene But Momentum In China +1 Projects

 
• By Anju Ghangurde

As biopharma derisks its business with China ‘rebalancing’ strategies, Syngene could convert majority of such pilots into full program contracts amid a challenging FY2025. The CRDMO also expects business discussions pertaining to a newly acquired US biologics site to mature into commercial opportunities.

Zai’s R&D Head Touts ‘Beauty’ Of Novel Internal Assets

 
• By Dexter Jie Yan

Two potentially first-in-class molecules signify Zai Lab’s renewed drive for the in-house discovery of drugs that it requires “to be innovative, differentiated and to have the potential to make a big difference for patients,” its global R&D head tells Scrip.

CSPC’s Global-First Monospecific ADC Promising In Advanced NSCLC

 
• By Xu Hu

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.

More from Focus On Asia

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.

Zai’s R&D Head Touts ‘Beauty’ Of Novel Internal Assets

 
• By Dexter Jie Yan

Two potentially first-in-class molecules signify Zai Lab’s renewed drive for the in-house discovery of drugs that it requires “to be innovative, differentiated and to have the potential to make a big difference for patients,” its global R&D head tells Scrip.

CSPC’s Global-First Monospecific ADC Promising In Advanced NSCLC

 
• By Xu Hu

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.