en.Wedoany.com Reported - The number of China's self-developed First-in-Class (FIC) drug candidates entering clinical trials grew from 9 in 2015 to approximately 120 in 2024, an increase of more than 12-fold in less than a decade. By 2025, Chinese companies accounted for about 24% of the global FIC pipeline, second only to the United States. According to an analysis by the Council on Foreign Relations, when measured by a broader range of innovative drug candidates, China's share of the global pipeline in 2025 was approximately 30.5%, compared to 33% for the United States, a gap of 2.5 percentage points, down from 13 percentage points two years earlier.
Chinese biotech companies generated a record $135.7 billion in licensing deal value in 2025, nearly three times the previous year. Goldman Sachs estimates that China accounted for about half of global licensing deal value that year. Approximately 46% of all new drug molecules entering human trials in the first half of 2025 came from Chinese companies. Large pharmaceutical companies now source nearly one-third of their externally acquired drug candidates from China.
The core of the bullish argument lies in speed: China's 2015 regulatory reforms shortened the time for first-in-human trial approval from about 500 days to under 90 days. A Chinese biotech company can advance a molecule from discovery to clinical stage in 12 to 20 months, compared to a global average of 24 to 26 months. R&D costs are estimated to be 30% to 40% lower than in the United States or Europe. Licensing a Chinese Phase II asset can cost 60% to 70% less upfront than comparable Western deals. Chinese companies currently lead global development in antibody-drug conjugates (ADCs), accounting for about 54% of the pipeline, and about 48% in cell therapy.
The bearish argument contends that no drug proven effective in Chinese trials has yet been validated in globalized trials. In 2022, Eli Lilly and Innovent submitted a China-only data package for the PD-1 inhibitor sintilimab to the FDA; an advisory committee voted 14 to 1 against it, and the FDA's oncology chief called China-only trials a "step backward." Approximately 58% of Chinese pivotal trials use single-arm designs without a control group, compared to 37% in the United States; fewer than one-third of trials include international sites, while about 80% of U.S. Phase III programs include international sites.
Ivonescimab best exemplifies this tension. In 2022, Summit Therapeutics paid Akeso $500 million upfront, with a total deal value of up to $5 billion, for rights to the PD-1×VEGF bispecific antibody in certain overseas markets. In the HARMONi-2 trial conducted in China, ivonescimab beat Merck's Keytruda in progression-free survival (PFS) for first-line lung cancer. However, the global HARMONi trial failed to achieve statistical significance on the co-primary endpoint of overall survival (OS), causing Summit's stock to drop sharply. The drug has been approved in China, and its value depends on whether local data can be replicated in multinational trials.
The BIOSECURE Act, signed into law in December 2025, restricts U.S. federal funding to "concerned" Chinese biotech companies, making geopolitics a variable in every China deal model. A usable litmus test has thus emerged: bubble-type deals tend to feature value dominated by late-stage milestones, efficacy reliant on single-arm or China-only data, and PFS celebrated while OS remains untested; substance-type deals feature multinational trials including Western sites, OS endpoints met, differentiated mechanisms in China-leading modalities such as ADCs and bispecific antibodies, and buyers paying upfront based on science rather than cheapness.
Several major deals collectively shape the landscape of this wave. Akeso's licensing of ivonescimab to Summit Therapeutics (2022, $500 million upfront/$5 billion total) set a precedent, with global data now serving as a test of reproducibility. Innovent's collaboration with Eli Lilly on sintilimab in 2015, followed by the FDA's rejection in 2022 due to a China-only data package, became a cautionary tale for all subsequent deals. RemeGen licensed a cancer ADC to AbbVie in 2026 for a total value of up to $5.6 billion, a direct vote of confidence in China's leading ADC engineering capabilities. CSPC's licensing of obesity/chronic disease assets to AstraZeneca in 2025/26 for a total value of up to $18.5 billion demonstrated that purchasing has expanded from oncology to metabolic diseases. Meanwhile, BioNTech and Bristol Myers Squibb's collaboration in 2024 on a PD-L1×VEGF competitor, with a total value of approximately $11 billion, indicates that the mechanism class and the underlying Chinese innovation logic are being bid up globally.
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