2015年-数据局_德勤：中国医药研发趋势本地化发展的机遇与影响_8页_598kb

Summary of Deloitte's Report: Pharmaceutical R&D Trends in China

Core Content

The report outlines the evolving landscape of pharmaceutical R&D in China, emphasizing the need for multinational pharmaceutical companies (MNCs) to adopt more localized and integrated R&D strategies. The Chinese government is actively investing in the local R&D industry, which is increasing in size and innovation, and is becoming a key player in global and regional clinical study submissions. This shift presents both opportunities and challenges for MNCs.

Main Points and Key Information

1. Opportunity and Influence for Localized Development

• The Chinese government is addressing gaps in healthcare quality and access through support for the local R&D industry.
• The strategy includes:
  • Developing innovative capabilities
  • Upgrading applicable technologies
  • Attracting, developing, and retaining a strong talent base
• This strategy is reshaping the traditional, global-centric R&D models and creating new opportunities for MNCs.

2. A Shifting Landscape – Key Implications

• Regulatory reforms are accelerating, but the process remains volatile.
• Traditional barriers to launching drugs in China, such as the requirement for foreign registration and longer IND/NDA approval times, are being re-evaluated.
• The CFDA has introduced pilot reforms, such as reducing IND approval times for oncology drugs to 60 days, which may impact global programs.
• The uncertainty in regulatory timelines requires MNCs to adapt their global R&D models to mitigate risks.

3. Growing Need for "Made for China" Drugs

• The CFDA is prioritizing drugs that address unmet needs specific to Chinese patients.
• Therapeutic areas with high prevalence in China, such as liver and gastric cancer, are benefiting from fast-track approvals.
• Xalkori (Crizotinib) was the first personalized medicine for lung cancer approved in China, launched 1.5 years after the US due to its use of the CDE fast-track channel.
• Companies are encouraged to develop R&D models that focus on "Made for China" products to capitalize on local needs and regulatory support.

4. Alternative R&D Models – Local Integration

• MNCs are shifting from traditional global models to localized, partner-based R&D approaches.
• These models include:
  • Local-MNC development partnerships
  • Out-licensing strategies to local companies
  • Collaborations with local Contract Research Organizations (CROs)
• Partnerships offer flexibility, risk mitigation, and the ability to leverage local efficiencies and regulatory familiarity.

5. Increasing Competition from Local Players

• Chinese companies are becoming more competitive due to government investment and local R&D capabilities.
• Examples include:
  • Zhejiang Beta Pharma's Conmana, which achieved significant sales quickly
  • Kanghong's Conbercept, the first innovative monoclonal antibody approved by the CFDA for Macular Degeneration
• These companies are utilizing cost-effective R&D methods and strong local regulatory knowledge to gain a competitive edge.

6. Challenges and Mitigation

• IP and Regulatory Challenges: Perceived gaps in IP regulations and enforcement remain a concern for MNCs.
• Talent Shortages: There is a shortage of specialized R&D professionals, including pharmacologists and toxicologists.
• Governance Complexity: The dynamic regulatory environment requires clear and strong governance structures to ensure successful partnerships.
• Mitigation Strategies:
  • Staged, balanced R&D investments
  • Targeted capability assessments
  • Robust governance frameworks

7. Summary and Outlook

• The R&D landscape in China is rapidly evolving, with increased local capabilities and regulatory changes.
• MNCs must be agile and adopt localized strategies to remain competitive.
• Partnerships are seen as the most effective way to navigate this environment, but they require careful planning and execution.
• The Chinese government's focus on improving healthcare quality and affordability is creating a favorable environment for innovation and collaboration.

Conclusion

The report highlights the importance of localized R&D strategies for MNCs in China. As the local industry grows and regulatory reforms continue, MNCs must adapt their models to align with the new environment, leveraging partnerships and localized capabilities to reduce time-to-market and manage risks effectively. A balanced, staged approach with strong governance will be critical for long-term success in this dynamic market.