How difficult is it for Seretide's generic drug to be marketed?

Recently, Hengrui issued an announcement stating that in accordance with the latest policy of the State Food and Drug Administration on drug review and approval, combined with the company's actual situation, it has submitted to the State Food and Drug Administration an application for withdrawal of salmeterol ticasone powder inhalation drug registration
.

(Source: Juchao Information Network)

Hengrui stated that the withdrawal is based on the adjustment of the company's internal R&D program
.

After the subsequent completion of the BE experiment, Hengrui will re-apply according to category 4 of the new chemical drug registration classification

No generic drugs are listed in China

Salmeterol ticasone powder inhalation in the form of a combination (bronchodilator and inhaled corticosteroids) is intended for the regular treatment of reversible airway obstructive airway diseases, including asthma in adults and children
.

Salmeterol and fluticasone propionate powder inhalation contains salmeterol and fluticasone propionate, which have different modes of action.

Salmeterol ticasone powder inhalation was developed by GSK.
It was first marketed in the UK in March 1999 and was approved by the US FDA in August 2000 under the trade name Advair Diskus
.

In 2001, salmeterol ticasone powder inhalation was approved to enter the Chinese market, and its indication was chronic obstructive pulmonary disease (COPD), and its trade name was seretide; in 2010, a new indication for asthma was added in China
.

According to the Evaluate Pharma database, Seretide's sales in the global market have been declining in recent years, with global sales of US$2.

In 2013, the seretide compound patent expired in China
.

At present, domestic companies such as Chia Tai Tianqing, Hengrui, Tianjin Xinnuo, Prit, and Runsheng Pharmaceutical have submitted listing applications

       (Source: CDE official website)

       However, since Seretide is a combination product of medicine and equipment, the development of such inhaler generic products is far more difficult than that of oral solid preparations.
The first generic drug in the world was not approved by the FDA until February 2019.
Wixela Inhub developed by Mylan
.

However, domestic generic drugs have not yet been approved

       It is worth mentioning that CP Tianqing’s salmeterol inhalation powder mist , which had entered the priority review on the grounds of "major special project", was only one step away from the market
.

The drug's marketing application (acceptance number: CYHS1700680, 681) was changed to "approval completed-pending certification" in June 2019.

       In January of this year, some insiders pointed out that Hengrui's salmeterol ticasone powder inhaler will be approved this year, but now it is unlikely
.

       Two consecutive pharmaceutical giants have broken down.
It takes time to test whether Prit, Runsheng Pharmaceutical and Tianjin Cigna can be successfully approved, and which one wins the first imitation
.

However, the author wants to emphasize that the withdrawal and the issuance of supplements do not mean that there is no chance to go public.

       Public data shows that in 2019, the global sales of inhaled preparations hospital port was 48 billion U.
S.
dollars, and the market size is expected to expand to 59.
2 billion U.
S.
dollars in 2023
.

At the same time, the proportion of domestic inhalation preparations is also steadily increasing.