China's Biotech Evolution:
In recent years, the global biotech community has witnessed the remarkable development of Chinese biotech companies. Novotech, through its platform ChinaTrials, has actively engaged with Chinese experts in discussions on innovative therapies, including cell therapy, chimeric antigen receptor T-cell (CART) immunotherapy, and antibody-drug conjugates (ADC). This year, our focus is on maximizing innovation potential through licensing-out strategies.
The Shift towards Licensing-Out
Licensing-out and globalization are no longer optional considerations but imperative for the survival and long-term development of Chinese biotech companies. This shift is driven by several factors, including the impact of a challenging investment environment, adjustments in national policies, and intensifying competition in the domestic market from homogenized products.
Rising Research and Development Capability
The encouraging news is the significant improvement in the research and development capability of Chinese pharmaceutical enterprises. Investments in new drug research and development have increased annually by 20%-30%, reaching hundreds of billions of yuan. This surge in innovation is evident in the approval of Class I innovative drugs by the National Medical Products Administration (NMPA) and the diversification of novel drugs targeting new pathways.
Chinese pharmaceutical companies are actively engaging in licensing-out deals, marking a shift from the previous focus on licensing-in. The number of licensing-out deals has seen a substantial increase, with over 30 recorded in 2022 and 2023. The trade volume has soared, reaching 14.3 billion US dollars in 2023, exemplified by notable deals like Hengrui and Merck.
Enhanced Global Presence
The article also highlights the growing role of Chinese Key Opinion Leaders (KOLs) and Principal Investigators (PIs) in international multicenter clinical trials. Chinese PIs are now leading 12 to 13 global Phase 2 and Phase 3 clinical trials, reflecting an elevation in China's research and development capabilities on the global stage.
Challenges in Global Expansion
While opportunities abound for Chinese biotech companies to expand internationally, challenges exist. Setbacks, such as insufficient data from the United States and disruptions due to the pandemic, underscore the complexities of global expansion.
Novotech's Role and Expertise
Novotech, as a global CRO, is positioned to support Chinese biotech companies in overcoming these challenges. The company has expanded its operational teams, talent, and expert resources in the United States and Europe. Novotech emphasizes the importance of addressing unmet medical needs, fostering genuine innovation, and navigating global clinical development as key areas for industry reference.
Unique Services from Novotech
Novotech's commitment to innovation is reinforced through its unique service, the Novotech Drug Development Consultation. With a team of 50 global experts, Novotech provides comprehensive assistance in regulatory strategies, clinical R&D, and maintaining positive relationships with regulatory bodies.
In conclusion, the global landscape for Chinese biotech companies is evolving rapidly. Novotech is dedicated to assisting these companies in their journey towards global innovation. The insights shared today by industry experts and Novotech's team aim to provide valuable guidance for navigating the intricate world of global clinical trials. We extend our gratitude to everyone for attending our seminar and hope that you have gained valuable insights to propel your endeavors in the global biotech arena. Congratulations on the success of our seminar, and thank you all!
By: Andy Liu, Head of China, Novotech
데이빗 제임스 (David James)
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