Joincare’s Generic Seretide Accepted for NMPA Review

China-based Joincare Pharmaceutical Industry Group Co., Ltd (SHA: 600380) has announced that the market filing for its generic version of GlaxoSmithKline’s (GSK, NYSE: GSK) Seretide (salmeterol, fluticasone) has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant milestone for Joincare, which holds the first-mover position for Seretide in China.

Seretide: Market and Reimbursement
Seretide was first approved in China in 2001 and is reimbursed as a Category B drug on the National Reimbursement Drug List (NRDL). The generic version, an inhalable powder mist dosage form of the originator, is used as a regular treatment for reversible obstructive airway disease, including asthma and chronic obstructive pulmonary disease (COPD).

Mechanism of Action
Salmeterol, a long-acting β2 receptor agonist, can permanently relax the bronchus. Fluticasone, a glucocorticoid, is designed to control inflammation and reduce acute attacks. This combination makes Seretide an effective treatment for managing symptoms and improving the quality of life for patients with respiratory conditions.

Sales and Market Impact
Seretide generated significant sales in 2021, with global sales reaching RMB 12 billion (USD 1.76 billion) and domestic sales in China amounting to RMB 863 million (USD 127.1 million). The acceptance of Joincare’s generic version for review by the NMPA could potentially expand market access and increase treatment options for patients in China.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry