Evidence generation and launch strategies in China

Written by Jeff Weisel

APAC markets are evolving in ways that are challenging established approaches to policy, access, value, and evidence that have achieved acceptable levels of success in the past, says Jeff Weisel, Managing Director, APAC.

In this excerpt from a white paper published by Fishawack Health, Jeff shares examples from China to highlight several implications for evidence generation and launch strategies. 

More biopharmaceutical companies are finding ways to navigate APAC markets 

There is a growing focus and spending in Asia-Pacific (APAC) markets, particularly China. 

This is, in part, driven by pro-innovation and probiotechnology policy trends in the region, which make the country an increasingly important and attractive market for biopharmaceutical manufacturers globally. 

To put the size of the opportunity in APAC into context, Asia comprises about 60% of the global population but only accounts for about 30% of all global pharmaceutical spending.1 This figure, however, is steadily increasing as several APAC countries, including China, are actively developing their own R&D-based biopharma sector, the region’s healthcare burden rises, and more companies are finding ways to navigate APAC markets. 

Biopharmaceutical companies have shown a growing interest in China over the past decade 

While some APAC markets, such as Japan and Australia, have been on the industry radar for decades and have mature healthcare and payer systems, China has emerged and evolved significantly, especially in the past decade. 

International manufacturers have been adapting to the value and opportunity there, moving beyond an earlier focus on marketing established products to now regarding China as a potential market for their latest innovative medicines and a strategic global opportunity alongside their home markets in the USA and Europe. 

There continues to be significant investment in the development of China’s healthcare industry, with a commitment from the Chinese government to continue laying the groundwork for an innovative and thriving biopharma sector. This includes: 

  • repatriating key talent working overseas 

  • funding global research and development programs 

  • changing market access regulations and regulatory requirements for urgently needed medical innovations. 

Consequently, some of the historical challenges associated with the Chinese healthcare, regulatory, and payer systems have become less complicated to navigate, including: 

  • China’s notoriously long regulatory and access pathway can now be negotiated much more rapidly, especially for specialty products in areas of unmet need 
     
  • intellectual property (IP) protection, particularly for biotech companies, has vastly improved as China sees IP as critical in the development of their homegrown companies into global competitors 
     
  • competitive intensity against domestic companies is being managed by more partnerships between local and international manufacturers. A good example of such a collaboration is the partnership between Johnson & Johnson and Legend Biotech to develop, manufacture, and commercialize Carvykti – a CAR-T therapy to treat multiple myeloma. 

 

The increasing attention on China has highlighted several implications for evidence generation and launch strategies 

Global biopharmaceutical manufacturers have been finding success in this market, but this success has not come overnight; these companies have made inroads built on significant time and investment. The increasing attention on China from the global industry has illuminated several implications for evidence-generation and launch strategy: 
 

  • The importance of partnerships: Partnerships between Chinese and multinational manufacturers are becoming more common, ensuring deep expertise in the complex commercialization processes in different regions, including insights on the market landscape, expertise in the regulatory and access pathways, and valuable connections with key stakeholders, such as payers, physicians, key treatment centers, and patient groups to drive advocacy 
     
  • Volume-based procurement and National Reimbursement Drug List (NRDL): the policy shift towards volume-based procurement for off-patent products has significantly impacted the established business in China for many international companies, leading to different risk calculations when approaching NRDL listings for new products when considering trade-offs between price levels and patient volumes 
     
  • Complex access and regulatory pathways: Unlike in Europe, regulatory harmonization across APAC is still in early days. While some mature markets, such as Australia and Japan, conduct their regulatory process in parallel with the US or EU, most others still follow on from FDA or EMA approvals to start their process. As mentioned, China has instituted reforms to speed up what was previously one of the world’s longest approval timelines for innovative products and now offers early access schemes that can enhance submissions for the NRDL. 

 

This new two-step approach to archetyping is the foundation of tailored commercialization in the modern market 

These APAC insights feature in the Fishawack Health paper: “Archetyping: rethinking go-to-market expectations to drive commercial success. 

In the paper, experts provide an in-depth introduction to archetypes and share a new two-step archetyping framework. This framework ensures the market and product opportunity is robustly analyzed and clear actions are defined to deliver commercialization success, from asset and trial strategy through go‑to‑market model development, investment decisions, and launch. 

You can read the paper at www.fishawack.com. Or, for a confidential conversation about your specific policy, access, value, and evidence needs in the Asia-Pacific region, please get in touch.

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