Cinda has voluntarily withdrawn the application for listing of PD-1! Yu Dechao responds. Who is the "first child" in this new drug tide?

On March 27, the news of "Xinda mAb was dissuaded" came out of the circle of friends Today, e-drug managers confirmed from reliable channels that Cinda biology did withdraw its application for listing of PD-1 monoclonal antibody products at the end of February 2018 It is currently in the supplementary materials and may be submitted again soon On December 13, 2017, Cinda biology submitted to CFDA a new drug listing application of its PD-1 monoclonal antibody, Cindi monoclonal antibody injection, with the indication of Hodgkin's lymphoma It is almost the same as the application time of opdivo BMS submitted the listing application of the variety on November 2, 2017 This also makes XinDa bio become the first local innovative pharmaceutical company to be listed on PD-1 in China 1 "We will see the results in a while." e drug manager asked Xinda biology about the application of canceling the listing of the product and asked three questions: "1 What are the main supplementary materials that Xindi mAb needs to submit? How long will Cinda be ready and submitted? 2 Has the listing expectation of the variety changed? Will the experience of this variety affect the application process of other varieties of Cinda? 3 What does Cinda want the outside world to think about it now? " "It is not convenient for the company to respond to the product at present, and we will give you feedback as soon as possible if there is any progress," said Xinda's foreign relations personnel People familiar with the matter told the e-drug manager that Cinda had communicated with CDE for many rounds, and finally decided to withdraw and apply after adding materials It is a normal procedure and should be treated rationally, and "it seems that it is going to declare again" The submission of listing application makes Xinda's PD-1 product the closest to the end of this round of new drug fever in China This naturally attracted the high-density attention of xindimab injection One of the concerns is the "rapidity" of xindimab injection from clinical trial stage to market application stage According to Ding Xiangyuan insight database, since CDE undertook the clinical application submitted by Cinda biology on January 25, 2016, the variety was approved for clinical application on August 17, 2016, with the project name of ibi308 As of December 13, 2017, after xindimab injection entered the special variety evaluation channel, it took 1 year, 11 months and 9 days from clinical application to listing application On December 21, 2017, Cinda biology posted the statement on clinical progress of PD-1 drug on the official wechat of the company as a response to the suspected clinical quality due to the rapid progress Ding Xiangyuan's insight database staff said that the supplementary information mainly focused on pharmacology, toxicology and clinical aspects How much should be supplemented depends on the specific situation, "it may be a table or more" It is difficult to predict the duration of this process through data supplement and CDE review While waiting for the above reply, the manager of e-medicine tried to contact Yu Dechao, the founder, chairman and President of Cinda biology, directly to inquire about the voluntary withdrawal Yu did not directly avoid, he replied: "thank you for your concern and support, you will see the results in a while." There is a useful information to help understand the action that Cinda applied for again after deciding to supplement the materials On January 15, 2018, a news report was posted on CDE website, introducing the "Symposium on the requirements for application materials of anti-PD-1 / PD-L1 McAb" Shao Dao, media of the press release: in order to guide the research and development of innovative drugs with the concept of "science as the basis and patient as the core" and speed up the listing of drugs urgently needed in clinical practice, the drug Audit Center held a special seminar on the requirements of application materials in Beijing on January 12, 2018, aiming at the most active variety of anti-PD-1 / PD-L1 monoclonal antibodies in the field of anti-tumor immunotherapy The meeting was presided over by Xu Jiaqi, director of CDE, and invited some representatives of domestic enterprises who have carried out clinical trials at present, as well as the main researchers and clinical experts in different tumor types of clinical research Relevant members of tumor indication team of drug audit center also attended the meeting The purpose of this symposium is to take the anti-PD-1 monoclonal antibody, which has made rapid progress in research, as a case, discuss the problems in research and development and the preparation of application materials through enterprises, clinical experts and review teams, so as to form the basic requirements for application materials of this kind of products At the same time, the press release also pointed out that in order to ensure the scientific, efficient, fair and open technology review, the follow-up CDE will publish the basic requirements for reference in the research and development of similar drugs and the preparation of application materials 2 Halo and pressure since the drug trial reform in 2015, China's original new drugs have finally received policies, capital and talents So after everything is ready, we only owe new drugs XinDa is one of the representative enterprises in the current "local innovation boom", but its external attention and capital recognition are comparable to those of the same period Screenshot of the app from the enterprise survey: Yu Dechao and his Xinda biology met almost all expectations of this round of Chinese original new drugs: returned star scientists created and locked in the field of Biopharmaceutics, which is believed to be the first time for China to have the opportunity to compete with the world, authorized their new drug rights and interests to multinational pharmaceutical companies for many times, and many domestic and foreign investment institutions to hold In March and October 2015, Cinda and Lilly reached strategic cooperation in the development of six compound molecules in two times The total amount of down payment and milestone was 3.3 billion US dollars, the highest in history In the first issue of scientist special issue of e-medicine manager magazine in 2017, Yu Dechao once introduced to e-medicine manager that "five of the six molecules cooperated with Lilly are independently developed by Cinda" On November 29, 2016, Cinda completed the D round of financing, with an amount of 262 million US dollars, about 1.7 billion yuan, the highest amount of financing for China's biopharmaceutical field In 7 years since its establishment, Xinda biological's product line covers four major diseases, namely, tumor, fundus disease, autoimmune disease and cardiovascular disease, with a total of 13 new drug varieties In the industrial base, two 1000L production lines have been completed and audited Xinda biology is fully open in the corresponding field, and the pressure will certainly follow The risk pressure of new drug research and development, the return pressure of capital on the investment target and the pressure of public opinion under high exposure can make any enterprise walk on thin ice In the last article of the above-mentioned public statement, Cinda biology has strict wording and reserves the right to use legal weapons against "anyone with ulterior motives" This is almost unprecedented On the one hand, this shows that XinDa has full confidence in its R & D; on the other hand, it also makes the outside world feel for the first time that there is some tension and anxiety in this innovative local pharmaceutical company In the previous communication with an industry insider, the other side expressed a concern like the e-drug manager to the effect that he believed that the failure probability of new drug research and development would not be due to changes in China, but the more important question is whether all participants are ready to accept the setbacks or even failures of local new drugs The great emotion caused by the agitation of Xinda new drug may indicate that, at present, everyone seems to be still in the process of adaptation and preparation in the face of the pioneers in the new drug tide in China But whether it's business or science, success or failure depends on results There are no exceptions to China's indigenous innovative drugs and the creations behind them At present, in addition to Xinda biology and BMS, there are two other PD-1 / PD-L1 that submit the application for listing: terripril monoclonal antibody (js001) of Junshi biology and keytruda of mosadong According to Southwest Securities Research Report, there are more than 10 domestic enterprises in the research of PD-1 / PD-L1 antibody drugs, including Hengrui medicine and Baiji Shenzhou So who will be the first PD-1 listed company in China? We'll see When the innovative medicine is really becoming the norm in China, maybe a lot of current emotions will disappear.