Yangtze River Receiving Another 2 Clinical Trial Implied Permissions

BY: Xiaoyaowan

According to the latest disclosure of the Center for Drug Evaluation, NMPA (CDE) recently, the Class 3 generic drug application of pomalidomide capsules filed by Yangtze River Pharmaceutical has received 2 clinical trial implied permissions, with the indication being adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy.

Source: CDE

Blockbuster immunomodulatory agent in the multiple myeloma therapeutic area

Pomalidomide has multiple mechanisms of action in vivo: it can enhance the immunity mediated by T cells and natural killer (NK) cells, regulate the production of various cytokines and also inhibit the hematopoietic tumor cell proliferation.

As a third-generation thalidomide analog, pomalidomide is now used as a small molecule oral immunoregulatory agent and has the antitumor activity, being the immunoregulatory agent with the strongest activity so far.

The original pomalidomide capsules developed by Celgene was approved by the U.S. FDA for marketing in Feb. 2013, with the trade name being Pomalyst and the indication being relapsed and refractory multiple myeloma in adult patients who have received at least 2 prior therapies and have demonstrated disease progression on the last therapy. Celgene's pomalidomide was approved by the EMA for marketing in Europe in Aug. 2013 with the trade name being Imnovid.

Both lenalidomide and thalidomide are classic therapeutic drugs in the multiple myeloma (MM) therapeutic area. Compared to them, pomalidomide can effectively treat MM with a very low dose that has a significant advantage of greatly reducing the adverse drug reaction risk; more importantly, pomalidomide has shown a very good response in MM patients who failed lenalidomide and thalidomide and also a high response rate in MM patients refractory to other new drugs.

Source: Public data

Pomalidomide has become the world’s 3rd blockbuster immunoregulatory agent to treat MM following thalidomide and lenalidomide based on the above clinical advantages.

Striking performance

The global sales of Celgene’s pomalidomide exceeded USD2 billion in 2018, ranking 59th among the global best-selling drugs of the year; in 2019, pomalidomide grew by 24% year on year, with global sales reaching USD2.525 billion.

Besides MM, Celgene has conducted multiple clinical trials to develop new indications of pomalidomide against other cancer types at the same time. It is worth mentioning that pomalidomide was granted a breakthrough designation by the FDA in May 2019 for use as treatment for both patients with HIV-positive Kaposi sarcoma who have had prior chemotherapy and patients with HIV-negative Kaposi sarcoma. If you are looking for medical supplies manufacturers who manufacture this drug, then Pharmasources, a professional pharmaceutical platform, would be your best choice.

As a new-generation product in the MM therapeutic area, the market is quite optimistic about the follow-up explosiveness of pomalidomide.

The battle for the first generic has begun in China although the original drug has not been marketed in China

Celgene filed a clinical trial application for pomalidomide to the CFDA in Nov. 2013, which was approved, however, the original pomalidomide has still not been approved for marketing in China.

Source: CDE

In the generic drug development battle of Chinese pharmaceutical enterprises, Chia Tai Tianqing, Yangtze River Pharmaceutical and Qilu Pharmaceutical have successively completed the human bioequivalence tests of pomalidomide capsules. Chia Tai Tianqing took the lead in filing the Class 3 generic drug marketing application of pomalidomide in 2018, including 2 acceptance numbers for 1mg and 4mg specifications, and received the priority review in August of the same year; Yangtze River Pharmaceutical followed it closely, and Qilu Pharmaceutical became the third Chinese pharmaceutical enterprise that filed the Class 3 generic drug marketing application in China. The battle for the first generic of pomalidomide has begun where Chia Tai Tianqing is expected to come out on top. Yangtze River Pharmaceutical’s receiving of 2 clinical trial implied permissions this time will further intensify the battle.

It is learned that 20 Chinese companies have also filed clinical trial applications for pomalidomide besides those 3 companies.

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