Formosa Biomedical Technology is positioning itself to become Taiwan’s first company to commercialize a cellular drug, citing promising results from late-stage lung cancer trials as it races to complete manufacturing certifications by late 2025.
The subsidiary of industrial conglomerate Formosa Plastics Group announced at the Asia Bio Expo that its unit Ivy Life Sciences has developed an immune cell therapy called IKC, which showed significant outcomes in Phase II trials for advanced lung cancer patients. The treatment combines four cell types including T-cells and natural killer cells, representing two decades of development work.
General Manager Liu Hui-chi told reporters the company expects to complete Good Manufacturing Practice certification by end-2025 and secure temporary approval the following year under Taiwan’s Regenerative Medicine Act, which provides a dual regulatory pathway for cell therapies. The legislation, passed in June 2024, aims to accelerate clinical applications while maintaining safety standards.
Taiwan’s regulatory framework allows certain well-established cell therapies to benefit from expedited approval processes, including autologous immune cell therapy. However, companies must demonstrate safety and efficacy through clinical trials or provide supporting literature for treatments not on the fast-track list.
The announcement comes as Formosa Biomedical expands beyond traditional petrochemicals into biotechnology under chairman Wang Rui-yu’s leadership, with plans to invest NT$1 billion to NT$1.5 billion (US$31 million to US$47 million) in a new Yilan biotech park.
Beyond cell therapy, the company is developing microalgae technology for producing algae oil and health supplements. Liu said algae oil certification is expected next year, followed by commercial production lines with initial capacity of 40,000 tons annually. The company targets entry into the sustainable aviation fuel market by 2027.
Ivy Life Sciences has completed Phase I trials for liver cancer and finished patient enrollment for non-small cell lung cancer Phase II studies. The subsidiary is also advancing exosome research for neurological conditions, with cell and animal studies showing protective effects for Parkinson’s disease.
Taiwan’s cell therapy sector has gained momentum following regulatory reforms that mirror approaches in Japan and South Korea. The government adopted a dual-track system to promote patient access while ensuring manufacturing consistency and improving oversight, though experts note challenges including limited approved techniques and quality control requirements.
Formosa Biomedical’s push into regenerative medicine reflects broader industry trends as traditional manufacturers seek growth in biotechnology. The company’s industrial background could provide manufacturing advantages in scaling cell therapy production, though success will depend on navigating complex regulatory requirements and proving clinical efficacy.
