Smoore International's subsidiary, Transcend Biopharma, has its ANDA accepted by the FDA, potentially granting it 180 days of market exclusivity

Key Points:

·Development of the Event: Smoore International (6969.HK) wholly-owned subsidiary, ChuanSi Biotech, has had its generic version of Breo® Ellipta® 100/25, fluticasone furoate / vilanterol inhalation powder ANDA, accepted by the U.S. FDA. 

·Uniqueness of the application: According to FDA public records, ChuanSi Biotech claims to be the first company to submit an ANDA with a Paragraph IV Certification under the Hatch-Waxman Act. 

·Market potential and scale: If the ANDA is approved, ChuanSi Biotech expects to have 180 days of market exclusivity; the branded drug Breo® Ellipta® had annual sales of $2.02 billion in the U.S. in 2024 (IQVIA data), and is used for maintenance treatment in asthma and COPD patients. 

·Corporate layout support: Smoore International's mid-term report shows that ChuanSi Biotech has established an inhalation product R&D center near Miami, Florida (with full process development capabilities), and has partnered with a top CDMO to build manufacturing capabilities for pharmaceutical devices in the U.S.

On September 25, 2025, Smoore International (6969.HK) announced via Globe Newswire and social platform X News that its wholly-owned subsidiary, Transpire Bio, had its Abbreviated New Drug Application (ANDA) for a generic version of the fluticasone furoate/vilanterol inhalation powder (Breo® Ellipta®1 100/25) accepted by the US Food and Drug Administration (FDA).

According to FDA public records, Transcend Biologics believes it is the first company to submit an ANDA with a Paragraph IV Certification under the Hatch-Waxman Act.

According to a press release by Chuant Biotech, if their ANDA is approved by the FDA, they expect to be eligible for a 180-day market exclusivity period. In the United States, Breo® Ellipta® is approved for maintenance treatment of asthma patients as well as maintenance treatment for patients with chronic obstructive pulmonary disease (COPD). According to IQVIA data, Breo® Ellipta® had annual US sales of $2.02 billion in 2024.

In its mid-year report for 2025, Smoore International stated that its nebulization subsidiary, Transcend Biotech, has established an outstanding inhalation product research and development center near Miami, Florida. The center possesses all capabilities for product development, and Transcend Biotech is actively collaborating with leading Contract Development and Manufacturing Organizations (CDMOs) worldwide to establish manufacturing capabilities for drug-device combination products in the United States.