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Domestic Drug Manufacturing: Bridging the "Valley of Death" for Biotech StartupsDec 31, 2025

Hsieh Hsing-pang, Director of the Institute of Biotechnology and Drug Research at the National Health Research Institutes (NHRI), emphasized the need for a "National Drugs, National Manufacturing" ecosystem. He noted that while companies are willing to spend NT$1 billion on clinical trials, they often hesitate to invest NT$100 million in preclinical development. Building domestic R&D capacity is crucial for both national health security and the sustainability of the National Health Insurance (NHI) system.

The Strategy for Health Resilience:

  • Risk-Sharing Model: Hsieh advocates for a division of labor where the state assumes high-risk, early-stage R&D costs. Once a technology matures and reaches the Investigational New Drug (IND) stage, it is transferred to the private sector for commercialization.
  • Proven Success: To date, the Institute has developed 23 candidate drugs, with 13 technology transfers and 8 reaching clinical trials. A prime example is the diabetes drug DBPR108, which successfully moved from the lab to international markets.
  • The South Korean Model: Hsieh suggests Taiwan should adopt South Korea’s "Conditional Approval" system. This allows promising domestic drugs to reach the market after Phase II trials under strict supervision while collecting real-world data, thereby shortening the investment recovery period and benefiting patients sooner.

Resource: 國藥國造 助新藥生技業跨越「死亡之谷」