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Drugs made in Taiwan snag and expect more market approvals

Source in Chinese: Economic Daily

Taiwan's pharmaceutical companies are maturing, and this year has brought good news regarding new drug approvals from several biopharmaceutical companies, including Polaris Pharmaceuticals, Panion & BF Biotech (PBF), Formosa Pharmaceuticals, Great Novel Therapeutics Biotech & Medicals Corporation (GNTbm), and more. However, the most significant development is the progress made by Oneness Biotech in the development of its diabetic foot ulcer drug, Fespixon.

Oneness's Fespixon was officially included in Taiwan's National Health Insurance (NHI) coverage starting in August this year, and it has been looking to attain regulatory approval in mainland China later this year. 

In addition, GNTbm's breast cancer drug, Kepida®, received regulatory approval from Taiwan's FDA on 28 June this year. It is now available at eight major medical centers in Taiwan, with hopes to capture a 30% market share in Taiwan's TWD$3.5 billion market.

Formosa Pharmaceuticals' asset, APP13007, achieved significant results in its Phase III clinical trials in August 2022. It has applied for market approval from FDA this year. The company will continue to apply for reimbursement from US healthcare and commercial insurance, with the official US launch expected in the third quarter of next year.

Polaris Pharmaceuticals Chairman Howard Chen stated that their lung mesothelioma drug, ADI-PEG 20, succeeded in its Phase III clinical trial unblinding in September last year. They plan to apply for FDA approval in October this year and aim to obtain the drug's approval in the third quarter of next year, entering the US market.

Nephoxil® developed by PBF, has been included in South Korea's national health coverage, and the Thai market is expected to obtain regulatory approval by the end of this year. The second-generation Nephoxil® targeting iron-deficiency anemia has completed Phase III clinical trials in the first quarter of this year, and preparations for the final clinical and regulatory reports in the second quarter are underway. PBF plans to apply for domestic market approval as soon as possible, with the goal of launching in the Taiwan next year.

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