Qianhong pharmaceutical's development of new drugs has been frustrated and antithrombotic protein has been withdrawn from trial

Today (November 7), the investors of Qianhong pharmaceutical finally waited for the latest news of the company's heavyweight new drug, recombinant human antithrombotic protein for injection (hereinafter referred to as antithrombotic protein) The company decided to "withdraw the trial" of the drug and make further relevant supplementary research, and then apply after the research is completed The reporter noted that on October 16, the company's declaration of new specifications of heparin sodium injection products was not approved Qianhong Pharmaceutical Co., Ltd -- a new drug to be withdrawn from examination needs supplementary research Qianhong pharmaceutical announced that the company decided to conduct further research on antithrombotic protein As the supplementary research needs a certain period, the company filed a "withdrawal application" to Jiangsu food and Drug Administration on November 5, 2013, and then applied after the completion of the relevant supplementary research The data shows that the antithrombotic protein jointly developed by Qianhong pharmaceutical and Nanjing University is registered as a new drug according to a class of biological products for treatment It was accepted on August 5, 2011 with the acceptance number of "cxsl110048" Antithrombotic protein is a kind of biological products for treatment, and there are no related drugs on the market at home and abroad Through communication with experts from the evaluation center, Qianhong pharmaceutical believes that the product still needs to be supplemented with relevant research to meet the relevant requirements of the state on new drug evaluation Therefore, Qianhong pharmaceutical chose to withdraw from the trial and conduct supplementary research The data showed that the target recombinant human antithrombotic protein could be used in the treatment of cardiovascular and cerebrovascular diseases Using recombinant DNA technology to develop new targeted antithrombotic protein (rhap) drugs is a new biological product with international leading level, which is developed by using protein engineering technology The drug will fundamentally solve the problem of internal bleeding side effects faced by antithrombotic drugs in the current market, and belongs to the first class of new drugs in China High risk of drug development This time, Qianhong pharmaceutical chose to "withdraw from the trial" due to the need for additional research The reporter of "daily economic news" noted that on October 16, Qianhong pharmaceutical announced that after the review of the State Food and drug administration, on October 14, 2013, the office of the board of directors of the company received the notice of approval opinions on the new three specifications of heparin sodium injection products The above three specifications are named heparin sodium injection (sealing solution), with specifications of 5ml: 50 units respectively 5 ml: 500 units and 10 ml: 1000 units, after examination by the State Food and drug administration, considered that the application materials of the company were incomplete, and the supplementary application was not approved Although Qianhong pharmaceutical's withdrawal is only due to the need to supplement relevant research, it is worth noting that the risk of new drug research and development has always been closely related to the interests of pharmaceutical companies On the one hand, pharmaceutical companies can obtain a lot of profits through the emergence of new drugs, on the other hand, they also need to face the risk of failure or approval failure when they invest in the research and development of new drugs As mentioned in the announcement of Qianhong pharmaceutical, the new drug has been submitted for approval for a long time with great uncertainty Investors are kindly requested to make careful decisions.