On December 1, after the inquiry of Yaorongyun, the listing application of Apts tablets submitted by #China Resources Shuanghe #Pharmaceutical/Nanjing Sea Whale has entered the administrative approval stage, and if it is successfully approved this time, it will become the first imitation of this variety in China. Previously, there were also many enterprises such as Zhaoke Pharmaceutical and #Qilu Pharmaceutical to imitate the new 3 types of production, but they were all folded into sand and were not approved.
Screenshot source: Yaorongyun China Drug Review Database
Apomecist tablets were originally developed by #Celgene and released in the United States in 2014 (trade name: Outira Otezla). Globally, apomelist tablets have been approved in more than 50 countries and markets, and their approved indications in the United States include for the treatment of adult active psoriatic arthritis, for the treatment of adult patients with moderate to severe plaque psoriasis who meet the indications for light therapy or systemic therapy, and for the treatment of adult #mouth ulcer # patients associated with Behcet's disease.
In August 2019, Amgen acquired a global interest in Apumist for up to $13.4 billion. In February 2021, Amgen submitted an application for the listing of Aptmikast in China and was included in the priority review and approval, and in August this year, it was approved for listing for the treatment of adult patients with moderate to severe plaque psoriasis who meet the indications for light therapy or systemic therapy. This is the first oral phosphodiesterase 4 (PDE4) inhibitor approved for the treatment of plaque psoriasis in China.
According to The Global Drug Discovery Database, the global sales of this product have reached 2.195 billion US dollars. There are about 6.5 million patients with psoriasis in China, and about 57.3% are moderately and severely ill. It goes without saying that the sales prospects of the product in China are highly optimistic. Therefore, there are many domestic enterprises for active layout.
At present, Zhu Yangxin Pharmaceutical, China Resources Shuanghe, Guilin Southern Medicine, CSPC Ouyi, Qilu, Zhaoke Pharmaceutical, Jiangxi Qingfeng Pharmaceutical, etc. have submitted listing applications, but no enterprises have yet been approved. After Amgen was approved for listing in China in August this year, many of these companies re-reported production in the new 4 categories (see the table below). At the same time, a number of companies have been approved for clinical trials or are conducting BE trials.
Alpmist tablets are currently reported in production
(Acceptance numbers that have not passed the approval have been screened out; marked in red as "In approval" status)
Data source: Yaorongyun China Drug Review Database
In the next 2-3 years, Apomist's domestic generic drugs will usher in a blowout period of approval, and it can be expected that its competition will be fierce.
—END—