Winning in the cell and gene therapies market in China

"Winning in the cell and gene therapies market in China" aims to cover the key factors and trends defining the China cell and gene therapies (CGT) industry. When innovation becomes an ever important winning strategy, the CGT eco-system in China with buoyant investors, companies, and researchers all eager to shape – and eventually benefit from – is already leading in many aspects around the globe. Hope you'll be enjoying to read this thoughtful report.
 

Viewpoints / key findings

Key drivers of China’s thriving CGT sector:

• Greater regulatory clarity and industry regulation on quality standards
• Maturing infrastructure for clinical studies spurred by an increase in global multicenter clinical studies
• A booming ecosystem with government-industry collaboration driving basic biomedical research toward highly innovative IPs in CGT
  
  

Challenges and uncertainties faced by the CGT sector in China

• Heavy protection and oversight of local genetic resources
• An increasingly crowded CGT pipeline, especially on the autologous cell therapies side, within a relatively concentrated set of target diseases and biological targets
• High level of local regulatory and market access uncertainties
• A health care provider system that is inexperienced in CGT products
  
  

CGT success: Building a matrix of excellence

Companies aspiring to win in China’s CGT market should consider building a four-pronged matrix of excellence:

• Market entry excellence: Chinese regulations, such as the Negative List and human genetic resources, have created a strong case for CGT entry through partnerships, but one needs to conduct a thorough assessment of potential partners as well as evaluate different partnership models based on risk/reward considerations. Factors such as regulatory compliance, speed-to-market, access to local innovation, protection for IP, and product quality control are critical when deciding on the optimal entry models.
• Portfolio and IP excellence: Companies can achieve CGT portfolio and IP excellence through development programs that differentiate either through technology or through choices of diseases. Diseases with more specific local unmet needs need to be targeted. In China’s CGT market, there are increasing opportunities for in-licensing for both overseas companies as well as leading local biotechs and academics. All companies with leading academics and invest in more translational research in order to build a robust IP portfolio.
• Regulatory excellence: Companies can navigate this all-important area by proactively engaging with the relevant authorities on local registration path and launching optimal clinical programs to ensure maximum speed-to-market in China. In addition, for products already launched in other markets, companies to accumulate precious local data and evidence earlier.
• Commercial excellence: To ensure that scientific advancement can be translated into tangible patient and commercial outcomes, companies will need to consider:

- Building an excellent network of provider capabilities around the optimal use of CGT

­- Localized manufacturing excellence through early process prototyping that allows for optimizations based on inputs from clinical studies

­- Balancing compelling product value while addressing local access gap

­- Building excellent IT platform

The journey to excellence in China’s CGT market may be long and winding, but it is full of promise. Companies and investors with a unique China-focused strategy spun around the matrix of excellence are likely to be a step ahead in the country’s CGT market.