在中国获取生物制药创新：重新思考策略，以在快速增长和演进的中国生物制药生态系统中竞争并取胜

Rethinking strategies to play and win inChina’s rapidly growing and evolvingbiopharma ecosystem Introduction Over the past five years, China has shifted from being the supportingact in the global biopharma ecosystem to being center stage withrespect to innovation and deal-making. Chinese government initiatives,such as “Made in China 2025” and the development of innovativebiopharmaceutical infrastructure, have fueled a shift to developinginnovativefirst-in-class1and best-in-class drugs.2At the same time,China has seen regulatory reforms – including accelerated new drugapprovals,3Research and Development (R&D) subsidies,4and anincrease in cross-border trial data sharing.5These initiatives havebeen a catalyst for growth in top-tier talent and research institutions6that, coupled with lower costs and a large population with diversedisease profiles,1,7have created opportunities for global players thatsubstantially evolve the risk/benefit trade-off of engaging in China. This changing paradigm may require global pharma companiesto reassess their positioning and strategies for accessinginnovation in China. Understanding the market as afoundation for success Regulatory environment: China continues to make significant strides toestablish an attractive environment for development, though regulatoryrisks and geopolitical uncertainties persist. First, it is important for multinational companies to understand the market and how China has evolvedits regulatory framework to attract investment in pharma innovation. By joining international regulatoryframeworks like International Council for Harmonisation of Technical Requirements for Pharmaceuticalsfor Human Use (ICH) in 2017 and updating its pharmacopeia in 2025,8China has demonstrated itscommitment to global standards, fostering a more favorable environment for international stakeholders.9At the same time, cross-ministry policies such as national anti-corruption campaigns in the pharmaceuticalsector10led jointly by the National Health Commission (NHC), National Medical Products Administration(NMPA), and other ministries, have expanded inspection scope to expand inspection and protectbusinesses operating in the market. Data protection laws and guidelines have similarly been bolstered,including through the establishment of four mechanisms for cross-border transfers of personalinformation, namely: (1) a security assessment; (2) the filing of the standard contract for cross-bordertransfer (“SC”); (3) a personal information protection certification; and (4) exempted scenarios. Thesemeasures, alongside clinical standards that are increasingly aligned with global norms, have helped tocreate a friendlier and more conducive environment for research andtrials.11 Despite these tailwinds, conducting business in China involves certain risks that require carefulassessment. Global players should remain mindful that, even with advances in clinical and data standards,key hurdles persist in data acceptance outside of China, and genetic data and plasma collection. Dataacceptance outside of China continues to be a major concern among these matters: western regulatorshave demonstrated a reluctance to accept China-only data. There’s a handful of examples of FDAapprovals due to lack of non-Chinese patient data.12 Additionally, broader macroeconomic pressures and evolving geopolitical tensions add another layerof uncertainty and volatility that can influence both operations and capital allocation decisions. WhileChina’s evolving regulatory and investment climate has become increasingly attractive for multinationalparticipation, navigating the market requires adapting to its unique business dynamics. Understanding the advancements and innovation driven by Chinese biotech China’s biopharma sector has grown into the world’s second largest, with it accounting for approximately31% of the global innovative drugpipeline.13This growth is underpinned by substantial governmentinvestment, regulatory reforms, and the integration of advanced technologies such as AI, cell and genetherapies, and radioligands. Additionally, Chinese cities like Shanghai14and Suzhou15have becomeinnovation hubs, hosting thousands of life sciences companies and attracting both domestic andinternational capital. China’s growth in volume continues to be primarily driven by me-too and fast-follow products, whichrepresent over 60% of pipeline products (Figure 1). However, research is weighted towards next-genmodalities, establishing China as a future leader in these newmodalities.16By clinical trial volume, Chinais number one for Anti-body Drug Conjugate (“ADC”) biologics globally as well as number two for both Celland Gene Therapies and Bispecific Antibodies / PolyclonalAntibodies.17There is also an upward trend inFirst-in-class launches from China companies, with the National Medical Products Administration (NMPA)approving 48 domestic first-in-class drugs in 2024.18,19 China also continues to demonstrate diversity in thera