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.

Licensing-Out Trends

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


Media contact

데이빗 제임스 (David James)

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노보텍은 연구소, 임상1상 시험 기관, 약물 개발 컨설팅 서비스(DDC, Drug Development Consulting) 그리고 FDA 규제 전문성을 갖춘 임상 CRO 기업으로 1상에서부터 4상까지의 임상시험과 생물학적 동등성 시험을 포함하여 5,000건 이상의 임상 프로젝트에 참여한 경험이 있습니다.  노보텍은 아시아 태평양, 미국, 유럽에서 임상시험을 수행하고자 하는 바이오텍 고객들에게 서비스를 제공할 수 있습니다. 노보텍은 전 세계적으로 3,000명 이상의 직원과 34개의 사무실을 보유하고 있습니다.

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