Intech Biopharm announced yesterday that it has been granted its first drug license for a fixed-dose combination (FDC) nasal spray in Taiwan. This marks a major milestone as the first product to be commercially manufactured at Intech Biopharm’s own cGMP facility.

• Clinical & Market Strategy: The FDC nasal spray, co-developed with a North American partner, is indicated for moderate-to-severe allergic rhinitis in patients aged 6 and older. Following AAAAI guidelines, FDCs offer faster onset and superior symptom relief compared to monotherapy.
• Manufacturing Evolution: General Manager Dr. Chawla emphasized that this transition from a purely R&D-focused site to a commercial-scale manufacturing plant strengthens Intech Biopharm's role in national drug resilience and respiratory specialty medicine.
• Global Outlook: With the Taiwan license validating its quality and efficacy, Intech Biopharm is preparing for a U.S. FDA filing. The U.S. market for this segment is currently valued at $67 million (approx. NT$2.14 billion) with an 8.29% CAGR, with a long-term total addressable market (TAM) projected at $730 million.

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