The Shift East

15 years ago, just after Alacrita got going, we wrote a piece called "We are all biotech now?" (published as "An Alternative Future for the Pharmaceutical Industry" in Business Development & Licensing Journal (2011) 15:6-8). If we were starting today, we would probably write a piece called "We're all China now?".

A year after that article, my co-founder Robert Johnson made a business development trip to China ("go East, young man"), but the market then wasn't receptive to our service model. There was very little innovation in the Chinese biopharma sector, but there were signs that things were brewing through talk of returning Chinese nationals who had earned university degrees and gained experience working in the US and European biotech and pharma (and other) industries. That strategy, combined with a boost in state investment in the sector, seems to have paid off handsomely.

There has been a surge in early-stage partnerships as Chinese biotechs have become increasingly attractive partners for Western pharma and biotech, especially in early-stage clinical (Phase I/II) and even some preclinical licensing deals. Western firms are acquiring rights to oncology, antibody-drug conjugates (ADCs), and other innovative assets sometimes when only initial human or robust animal data are available. In 2024 alone, Chinese biotech companies signed 94 license-out deals worth $51.9B. The first quarter of 2025 saw 33 deals, many based on Phase I/II data. The trend increasingly includes multi-regional clinical trials run in parallel, enabling rapid data gathering and cross-border expansion. For example:

• Ivonescimab Partnership One of the most high-profile examples is the partnership for Ivonescimab, a bispecific antibody developed by Akeso (China) and subsequently partnered with Summit Therapeutics (US/UK). The deal was initiated based on promising early-phase data in lung cancer, and led to rapid expansion into US and global clinical programs by leveraging the fast-moving initial trials conducted in China.
• Dizal Pharma Success Dizal Pharma, based in China, developed the lung cancer drug sunvozertinib, securing FDA approval for EGFR exon20ins-mutated non-small cell lung cancer. The global development included partnerships with Western institutions and was driven by multinational early-phase trial data, sometimes before complete clinical datasets were available.
• AstraZeneca's Gracell Acquisition In early 2024, AstraZeneca announced a definitive agreement to acquire Gracell Biotechnologies, a Chinese cell therapy pioneer. The deal is valued at up to $1.2B and was triggered by very promising early clinical results from Gracell's lead cell therapy candidate.

China Speed

People are now talking about "China speed": enabled by high patient density and strong clinical infrastructure, means generating early-phase oncology and immunology trials can outpace Western timelines and attract international attention. Importantly, China's regulatory framework has undergone dramatic reforms over the past decade, resulting in one of the fastest and most efficient systems globally for launching clinical trials and approving innovative medicines. In 2025, China's National Medical Products Administration (NMPA) proposed halving the clinical trial application review period for innovative drugs to 30 working days (down from 60), which would match the U.S. FDA standard.

The process uses an objection-based mechanism: if no regulator objection is raised within the deadline, trials can automatically proceed—hugely reducing uncertainty and delays. Special fast-track pilot programs in cities like Beijing and Shanghai further accelerated approvals for novel drugs with global or high-priority status.

A recent FDA Roundtable on Cell and Gene Therapy (June 2025) included a clear message from both FDA leadership and administration officials that the agency is open to relaxing regulations, particularly for rare disease gene therapies. This includes a willingness to be "flexible" and consider the perspectives of patients and families, aligning with "right-to-try" principles. There was explicit talk of "the China model" at the meeting, and a general feeling that something like that is needed to remain competitive.

In July, the UK's MHRA announced new regulations effective today which will make it faster and easier for cutting-edge cancer treatments and personalised gene therapies to be made right where patients are treated – another step toward China's approach that has been welcomed by patients, healthcare practitioners and industry.

Role Reversal

Western biopharma companies are also increasingly adopting strategies pioneered by China to accelerate drug development and regulatory approval. In recent years, China has transformed its biopharmaceutical sector by streamlining its regulatory framework, making processes more transparent, and expediting the approval of innovative drugs. The Chinese regulatory agency, NMPA, implemented priority review routes and conditional approvals that enabled faster market access for drugs addressing unmet medical needs.

This resulted not only in reduced bureaucratic hurdles for domestic firms but also created an attractive environment for Western companies seeking speed and efficiency in clinical development.

Driven by these reforms, China has doubled its share of global commercial clinical trials since 2018, now accounting for around 18% of all such activity. Western countries, recognizing their own slower timelines, are increasingly learning from and emulating aspects of China's approach—especially in how trials can be initiated and scaled quickly without compromising quality.

These regulatory reforms, such as streamlined approval channels and the acceptance of foreign clinical trial data, have led to a wave of partnerships and licensing deals, with major US and European drugmakers rushing to collaborate with Chinese biotechs, hoping to benefit from speedy development and regulatory clarity.

For regulators and companies in the US and Europe, China's clinical development model is setting new benchmarks for efficiency and speed. Agencies such as the FDA and EMA are under pressure to update their practices, adopting lessons on operational streamlining, faster review processes, and conditional approvals, without placing patients at greater risk—mirroring recent moves made by China.

This shift reflects a reversal of roles: rather than China simply importing Western drugs, Western firms are now importing Chinese innovations and even considering launching products in China first to capitalize on swift regulatory pathways. More broadly, China's regulatory reforms signal a global movement toward reducing barriers to critical, innovative medicines, with the West increasingly looking to China's playbook for inspiration.

The central question for leadership teams is shifting: regulatory efficiency is becoming an important factor in global competition, with China's reforms having become a gravitational center for global efficiency standards.

For Further Reading

The implications of this shift run deeper than individual company strategies. Our follow-up piece, "Regulatory Contagion: How China's Reforms Are Influencing Drug Development Strategy," explores how regulatory efficiency is becoming a competitive battleground, and what that means for companies trying to navigate an increasingly complex global landscape where speed, geopolitics, and innovation intersect in ways we haven't seen before.