HealthYuan Secures Clinical Approval for First-to-File Generic Salmeterol Fluticasone Inhalation Powder

On April 13, Joincare announced that its generic drug application (Category 4) for Salmeterol and Fluticasone Propionate Inhalation Powder had been approved for clinical use. Data from Menet shows that sales of Salmeterol and Fluticasone Propionate in China's public medical institutions exceeded 1.5 billion yuan in 2020. In 2021, Joincare added 577 million yuan in revenue from the respiratory field, and currently, three of its inhalation preparations have been included in the fifth batch of centralized procurement.

Salmeterol and Fluticasone Propionate Powder for Inhalation is used for the regular treatment of reversible obstructive airway diseases, including adult and pediatric asthma. The original research company is GSK, and this drug was first approved for import in China in 2001. In recent years, it has maintained impressive sales in the Chinese market.

Data from Menet shows that in 2020, the sales of Salmeterol and Fluticasone Propionate at terminals of urban public hospitals, county-level public hospitals, urban community health centers, and township health centers in China (referred to as Chinese public medical institutions) exceeded 1.5 billion yuan, with a year-on-year increase of 5.75% in the first half of 2021. Currently, there are no generic versions of Salmeterol and Fluticasone Propionate available on the Chinese market, but several domestic companies such as Joincare, Changfeng Pharmaceuticals, Primo Pharma, Runsheng Pharmaceuticals, Zhengdatianqing, and Hengrui are planning to develop generic drugs.

Sales of Salmeterol Tiotropium in Chinese Public Medical Institutions (Unit: 10,000 Yuan)

Source: Terminal Competition Pattern of Public Medical Institutions in China, MiNe Network

In recent years, the inhaled preparations market has drawn significant attention. Data from Menet shows that the sales scale of chemical drug inhaled preparations in China's public medical institutions approached 20 billion yuan in 2020, with a year-on-year increase of 37.61% in the first half of 2021. Among Chinese manufacturers, products from Hengrui, Zhengdatianqing and other enterprises are relatively mature, while Joincare, Prd (Purite) and others are also making continuous efforts.

Joincare's Inhalation Preparations Enter Harvest Phase. According to the annual report, in 2021, the company's respiratory sector achieved an additional sales revenue of 577 million yuan, marking a significant year-on-year increase. Currently, Joincare has received approval for the market launch of four inhalation preparations (covering seven product specifications). Among these, three inhalation products—Ipratropium Bromide Inhalation Solution, Budesonide Suspension for Inhalation, and Compound Ipratropium Bromide Inhalation Solution—have been included in the fifth batch of centralized procurement in China.

In addition, Joincare's Acetylcysteine Inhalation Solution, Tobramycin Inhalation Solution, Formoterol Inhalation Solution, and Terbutaline Sulfate Nebulizer Inhalation Solution have been submitted for production and are expected to be approved for marketing in 2022. Among them, the Tobramycin Inhalation Solution is expected to become China’s first inhaled antibiotic; Formoterol Aerosol and Mometasone Formoterol Aerosol are currently in the clinical stage, while Salmeterol Tiotropium Inhalation Powder and Aclidinium Bromide Powder have obtained clinical approval.

Source: MiNeiNet database, Annual reports of enterprises

Note: Data statistics are as of April 13th. If there are any omissions, corrections are welcome!