"U.S.-China tensions are a bigger variable than the FDA."
This is what is being said in the domestic bio industry after the resignation on the 12th (local time) of Marty Makary, Director General of the U.S. Food and Drug Administration (FDA). As Korean corporations are expanding early clinical cooperation and technology deals with Chinese companies, analysts say the domestic industry could be more affected as the United States steps up checks on China.
In fact, Korea's bio industry is rapidly increasing its points of contact with China. In particular, as Chinese pharmaceutical companies accelerate the expansion of their Antibody-Drug Conjugate (ADC) pipelines, word is they have grown more interested in domestic corporations with related technologies. At "Bio China 2026," held in Suzhou, China, in Mar., a Korea Pavilion was set up for the first time, and 21 domestic corporations took part.
◇ the United States launches a speed race amid China's pursuit… FDA reform seen "accelerating"
The industry also sees the recent push for FDA reform as largely a response to China's pursuit. As China has quickly gained competitiveness in clinical expense and development timelines, the United States is shifting 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. It is also reviewing ways to speed up entry into early clinical trials using AI and Organoid, and to simplify biosimilar regulations.
Lee Seung-kyu, vice chair of the Korea Bio Association, said, "The Trump administration could further accelerate reform by appointing a person aligned with its stance as the next FDA chief."
According to market research firm GlobalData, China's share of the global first-in-class (FIC) new drug pipeline expanded from 8% in 2020 to 12% in 2025. It is expected to expand to around 15% to 18% next year.
The competitiveness gap in clinical trials is also narrowing quickly. According to the industry, China's phase 1 trials are on average seven months faster than those in the United States, and expense is 30% to 50% lower. In a report in Mar., the Pharmaceutical Research and Manufacturers of America (PhRMA) assessed that China is no longer staying at the stage of imitating U.S. technology but is emerging as a major pillar in the global bio-innovation race.
The Trump administration has already redefined bio supply chains and technological hegemony as national security issues. In Feb., the U.S. International Trade Commission (USITC) launched procedures to investigate how the Chinese government's support for biotech companies and its pricing policies affect the competitiveness of U.S. industries. It plans to examine whether China's state support and pricing policies in genome sequencing, Synthetic Biology, and active pharmaceutical ingredient (API) manufacturing have distorted the market.
After public hearings on the 27th to 28th, the results report is scheduled to be released in Jan. next year. Depending on the findings, it could lead to trade measures such as anti-dumping duties or countervailing duties.
◇ Korea's bio sector caught in the middle… "phase 2 support is urgent"
Some say Korea's structural weaknesses in bio are being exposed as the United States and China enter a speed race and a regulatory competition. As many domestic bio corporations move to out-license at the phase 2 stage, there are calls 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 bio investment since 2023 through the K-bio and vaccine fund. However, assessments say the supply of capital felt by corporations is limited. As of Sept. last year, a total of 466.6 billion won was raised across funds No. 1 to No. 4, of which 120.8 billion won was executed.
The Financial Services Commission is also pushing the "second megaproject of the Public Growth Fund," but critics say it is focused on supporting phase 3 and out of sync with on-the-ground demand.
An official at the Financial Services Commission said, "Phase 3 requires massive capital, so we judged it aligns with the nature of the Public Growth Fund," while adding, "Phase 2 projects are not excluded from investment targets and can be included depending on promise."