Good News | China Grand Pharma's Umeclidinium/Vilanterol Inhalation Powder for Dryness (First Generic) Approved for Market — As the Starting Material Supplier, We Join Forces to Drive New Breakthroughs in Chronic Respiratory Disease

According to the delivery record of the drug approval certificate dated October 22, 2026, Umeclidinium/Vilanterol Inhalation Powder for Dryness developed by China Grand Pharma Group Co., Ltd. has been approved for market entry, with NMPA Approval No. H20266331.

About Umeclidinium/Vilanterol Inhalation Powder for Dryness

Umeclidinium/Vilanterol Inhalation Powder for Dryness is a bronchodilator formulated as a combination of umeclidinium and vilanterol, primarily used for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD), taken once daily to relieve patient symptoms. Available data indicate that, globally, the two classes of bronchodilators — long-acting muscarinic antagonists (LAMA) and long-acting β₂-receptor agonists (LABA) — are currently recommended as core drugs for the treatment of stable COPD, and that their combined use is more effective than monotherapy in improving patients' clinical symptoms.

Public information indicates that Umeclidinium/Vilanterol Inhalation Powder for Dryness was developed by GSK, with the originator product first entering the Chinese market in 2018. In 2024, GSK's global sales of Umeclidinium/Vilanterol exceeded £570 million (approximately USD 700 million at the prevailing exchange rate).

According to data from Minne.com, in 2023, the combined sales of Umeclidinium/Vilanterol Inhalation Powder for Dryness across China's three major terminal and six major markets exceeded RMB 120 million, and continued to grow by 13.85% in the first half of 2024, showing considerable potential.

Domestic Sales of Umeclidinium/Vilanterol (Unit: RMB 10,000 yuan)

(Source: Minne.com data)

China Grand Pharma Group had submitted a Class 4 generic marketing application for this product as early as 2018, which was ultimately approved for clinical trials. The company then achieved breakthroughs in key core technologies, took the lead in China in completing bioequivalence studies, resubmitted a generic marketing application in February 2025, and secured the first domestic generic approval for Umeclidinium/Vilanterol Inhalation Powder for Dryness in October 2026.

Note: Minne.com, "Competition Landscape of Drugs in China's Three Major Terminals and Six Major Markets" — Statistical scope covers: urban public hospitals and county-level public hospitals, urban community health centers and township health clinics, urban brick-and-mortar pharmacies and online pharmacies. It excludes private hospitals, private clinics, village health stations, and county/rural/village pharmacies. The sales figures above are calculated based on the average retail price of the product at the terminal level.

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