"The U.S.-China conflict is a bigger variable than the FDA."
This is what is being said in Korea's biotech industry after the resignation of Marty Makary as Director General of the U.S. Food and Drug Administration (FDA) on the 12th local time. As Korean corporations are expanding early clinical collaborations and technology deals with Chinese companies, some say the stronger the U.S. push to check China, the greater the impact on the domestic industry.
In fact, Korea's biotech industry is rapidly increasing its touchpoints with China. In particular, as Chinese drugmakers accelerate the expansion of their Antibody-Drug Conjugate (ADC) pipelines, interest has grown in domestic corporations with related technology, according to accounts. At Bio China 2026, held in Suzhou in Mar., a Korea pavilion was set up for the first time, and 21 domestic corporations participated.
The industry sees China as no longer just a low-cost production base but as rising to a core pillar of global new drug development. In Shanghai's Zhangjiang, research hubs of global pharmaceutical companies including Pfizer, Roche, AstraZeneca, and Novartis are already clustered.
◇ U.S. launches a speed race amid China's chase… FDA reform seen accelerating
Industry officials also view the recent trend of FDA reform as largely a response to China's pursuit. As China quickly secured competitiveness in clinical expense and development timelines, the United States is changing its regulatory framework to shorten new drug development and approval procedures. The FDA is pushing a "real-time clinical" system in which it receives and reviews clinical data in real time from the development stage. Measures to speed entry into early clinical trials using AI and Organoid models, and to simplify biosimilar regulations, are being pursued in tandem.
Lee Seung-kyu, vice chair of the Korea Biotechnology Industry Organization, said, "The Trump administration could further increase the pace of reform by installing a person aligned with its stance as the next FDA chief."
America's sense of crisis shows up in the numbers. According to market research firm GlobalData, China's share of the global first-in-class (FIC) pipeline expanded from 8% in 2020 to 12% in 2025 and is expected to grow to 15%–18% next year. In clinical speed, China is on average seven months faster than the United States at the phase 1 stage, and expense is 30%–50% lower. The Pharmaceutical Research and Manufacturers of America (PhRMA) released a report early this year stating that China has moved beyond merely imitating U.S. technology and is emerging as a key pillar in the global bio-innovation race.
The expansion of technology exports from China is another factor provoking the United States. Bristol Myers Squibb (BMS) on the 12th signed a joint development and licensing deal worth up to $15.2 billion with China's Hengrui Pharmaceuticals. Korean corporations are also continuing to bring in Chinese technologies. JW Pharmaceutical last month signed an exclusive domestic license-in deal with China's Gan & Lee Pharmaceuticals for the GLP-1 receptor agonist candidate "Bofanglutide." HK inno.N also brought in domestic development and commercialization rights for the GLP-1 analog "Ecnoglutide" from China's Sciwind.
The United States has ultimately redefined bio supply chains and technological hegemony as national security issues. The U.S. International Trade Commission (USITC) in Feb. launched a process to investigate how China's support for its biotech companies and its pricing policies affect the competitiveness of U.S. industries. Genome sequencing, Synthetic Biology, and active pharmaceutical ingredient (API) manufacturing are those surveyed. After public hearings on the 27th–28th, results will come out in Jan. next year, and there is talk it could lead to trade measures such as anti-dumping duties.
China, unfazed, is speeding up AI-based new drug development. The government and state-owned funds are injecting large sums into bio-AI convergence companies. Beijing-based DP Technology raised $114 million late last year. While the United States builds a containment net, China is effectively betting on next-generation technologies.
◇ Korean biotech caught in the middle… "Phase 2 support is urgent"
Some say this is exposing the structural weaknesses of Korean biotech. As many domestic biotech corporations pursue technology exports at phase 2, voices are growing for concentrated support in this segment. Lee said, "In the global market, Korea is still around 9th to 15th," adding, "Investment and policy support are needed so corporations can get past phase 2a and 2b."
The government is responding through related funds. The Ministry of Health and Welfare has been expanding early-stage biotech investments through the K-Bio and Vaccine Fund since 2023. But the impact feels limited. As of Sept. last year, a total of 466.6 billion won had been raised across tranches 1 to 4 of the fund, but only 120.8 billion won had been executed. There is also criticism that the Financial Services Commission's Public Growth Fund second megaproject is focused on phase 3 support, creating a gap with on-the-ground demand.
An official at the Financial Services Commission (FSC) said, "Phase 2 projects are not excluded and can be included depending on their promise." Still, the industry says a separate, phase-2-dedicated support framework is needed. While the United States and China each speed up in their own ways, the industry says Korean biotech does not have much time to remain stuck in the middle.