FDA refuses to approve the listing of ponabrin, Wanchun Pharmaceutical Co., Ltd. plummets 60%, Hengrui drops slightly by 1.92%

On December 1, Wanchun Pharmaceutical issued an announcement stating that the listing application of Pranabrin for the treatment of chemotherapy-induced neutropenia (CIN) received a complete response letter (CRL) from the FDA

Plinabulin (Plinabulin) is based on the structure of the natural product Phenylahistin isolated from the marine Aspergillus pyogenes, and optimized the diketopiperazine class of tubulin inhibitors

According to the announcement, the FDA believes that a Phase III registered clinical trial cannot fully prove the benefit of treatment, and requires a second registered clinical trial to obtain sufficient evidence to support the approval of the CIN indication

Affected by this news, Wanchun Pharmaceutical's stock price plummeted by more than 60%, and its market value fell to less than US$200 million

It is worth noting that as early as August this year, Hengrui Pharmaceuticals and Wanchun Pharmaceuticals reached a cooperation agreement, 100 million yuan to subscribe for the shares of Wanchunbulin, and at the same time obtain the rights and interests of Punabulin in the Greater China region, Hengrui Pharmaceuticals The total down payment plus milestone payment shall not exceed RMB 1.

In addition, on the morning of December 2nd, Hengrui Pharmaceuticals issued an announcement stating that the company planned to acquire shares in Dalian Wanchun and obtain joint development and exclusive commercialization of punabulin in the Greater China region

At the same time, Hengrui Medicine stated that, in accordance with the "Panabulin Product Cooperation Agreement", the company has paid Dalian Wanchun a down payment of 200 million yuan and has not yet carried out any clinical research on Panabulin

As of press time, Hengrui Medicine dropped slightly 1.