This biosimilar approval document is worth 175 million yuan

Article source: Medical Rubik's Cube Info

Author: Shi Bei

On September 28, the official website of the State Food and Drug Administration showed that the marketing application of Hisun Pharmaceutical's infliximab biosimilar was officially approved by the NMPA

Infliximab is a human-mouse chimeric monoclonal antibody that binds with high affinity to the soluble form and permeable form of tumor necrosis factor alpha (TNFα), inhibits the binding of TNFα to the receptor, thereby causing the loss of TNF Physical activity, improve inflammation and autoimmune diseases

Johnson & Johnson Infliximab was first approved for listing in China in February 2007, with the trade name Leike

It is also of great significance for Hisun Pharmaceuticals to successfully obtain the approval of the infliximab biosimilar drug

On June 22, 2019, Hisun Pharmaceutical issued an announcement that its holding subsidiary Hisun Borui intends to increase capital and share shares and transfer some old shares through the introduction of social capital, with a pre-investment valuation of not less than 5.

That is, Hisun Pharmaceuticals and Hisun Hangzhou Company transferred 58% of the shares to strategic investors in total

According to the agreement, if any of the following is triggered, Hisun Pharmaceuticals and its subsidiaries will pay compensation to investors.

Hisun Pharmaceutical Adalimumab was approved by the NMPA on December 10, 2019, without triggering clause (a); now that infliximab is approved as scheduled before the end of September, it avoids triggering clause (b)