Can step clinical trial of new drugs be approved by nmpa?

On July 3, step pharmaceutical announced that the clinical trial application of recombinant human brain natriuretic peptide for injection (project code: bc003) of its holding subsidiary Shandong Danhong Pharmaceutical Co., Ltd was approved by the State Food and drug administration The company has spent about 35.5 million yuan on research and development in its projects, according to step Step Pharma is bound to win in the announcement According to step Pharma, bc003 project has completed preclinical research and submitted clinical trial application to drug evaluation center of State Food and Drug Administration recently, which was officially accepted The clinical indication of bc003 project is the treatment of acute decompensated heart failure patients with dyspnea during rest or slight activity Human brain natriuretic peptide is a B-type natriuretic peptide, which is an endogenous peptide secreted by human body It is a mechanism of compensatory metabolism produced by human stress after heart failure induced by etiology It can rapidly reduce systemic arterial pressure, right atrial pressure and pulmonary capillary wedge pressure, thus reducing the front and back load of heart, and rapidly reduce the degree of dyspnea and systemic symptoms of patients with heart failure According to the data of minenet, in 2018, the sales volume of terminal recombinant human brain natriuretic peptide injection in public medical institutions in China reached 769 million yuan, an increase of 45.52% year on year According to the announcement, recombinant human brain natriuretic peptide (trade name: neokine) for injection of the same kind of domestic listed varieties has been included in the category B scope of the national directory of basic medical insurance, work injury insurance and maternity insurance drugs (2017 version), with sales volume of about 690 million yuan in 2018 Last year, more than 800 million similar products were sold as the only competitor in the current market of recombinant human brain natriuretic peptide for injection in the future Novobin is a new class of national biological products independently developed by Tibet pharmaceutical industry As a gene engineering drug for the treatment of acute heart failure, novobin can rapidly improve the symptoms and signs of heart failure, improve the quality of life, reduce the cost of hospitalization and shorten the length of hospitalization Tibet pharmaceutical industry is exclusively produced in China, which fills the gap of gene engineering drugs for the treatment of acute heart failure in China According to the 2018 annual report of Tibet pharmaceutical industry, the sales volume of neokine reached 1.1831 million last year, with sales revenue of 886 million yuan, an increase of 36.0% over the same period last year At present, the exclusive promotion right of novobin at home and abroad is mainly controlled by kangzhe pharmaceutical In fact, kangzhe pharmaceutical also acts as the exclusive promotion right of another heavyweight variety of Tibet pharmaceutical, imdo, in the mainland market Under the promotion of kangzhe pharmaceutical, the sales volume of imdo reached 28.506 million boxes in 2018 Boom and bust of step pharmaceutical For step Pharma, the first half of this year is an eventful time Not only is its main production of traditional Chinese medicine injections facing the dilemma of restricted use, but there is also a dispute over the high marketing costs in its sales Although step Pharma later explained the above issues in the inquiry letter of Shanghai Stock Exchange, investors of A-share still expressed distrust A typical example is step pharmaceutical's share price has been in a downturn since its chairman Zhao Tao broke out his scandal For example, on May 4 this year, step pharmaceutical's share price was 35.97 yuan, but it has dropped to 26.35 yuan today, so far there is no sign of rising According to the 2018 annual report of step Pharma, 21 important R & D projects are planned to be carried out in 2019 In addition, step Pharma issued the announcement on the strategic planning of the company's biopharmaceuticals in September last year, which shows that the company has invested 1.72 billion in R & D of biopharmaceuticals, involving the R & D of 10 kinds of biopharmaceuticals, and 5 patents have been applied for in the research projects, including "anti VEGF receptor monoclonal antibody and Its preparation method and application have been authorized by patent The earliest expected time to market is 2021 It can be said that for step Pharma, the above R & D projects will be the core competitiveness of the company in the future In the face of a query, it is necessary to announce the R & D Progress of new products at this time of dispute to boost investor confidence It is questionable how effective this is Nightmare of traditional Chinese medicine injection the limited use of traditional Chinese medicine injection is also a blow to step length pharmacy For a long time, Danhong injection of step Pharma has been a key product According to the prospectus before the listing of step Pharma, the annual sales of Danhong injection reached 4.161 billion, 3.831 billion and 3.36 billion respectively from 2013 to 2015, totaling 11.352 billion Revenue accounts for more than 30% and profit accounts for more than 40% However, in the 2017 national medical insurance catalog, Danhong injection is listed in the class B list of medical insurance, which is strictly restricted to the severe patients with clear evidence of acute attack of ischemic cardio cerebrovascular disease in the secondary and above medical institutions Moreover, due to the frequent occurrence of serious adverse reactions, 26 times were listed in the key monitoring by early warning, and even faced the risk of discontinuation at any time Zhao Chao, President of step pharmaceutical, a deputy to the National People's Congress, said at last year's national two sessions, "the role and significance of drugs are different under different conditions of different diseases and use." Traditional Chinese medicine injection has a very prominent effect in clinical use It has a relatively high bioavailability, precise effect and rapid effect There are many times when there are irreplaceable effects of chemicals " Now, more than a year has passed, the fate of traditional Chinese medicine injection has not improved, and it is more likely to be further restricted On the evening of February 24 this year, CCTV's "focus interview" column disclosed the abuse of auxiliary drugs, making the use of auxiliary drugs, especially traditional Chinese medicine injections, once again become the social focus The column reports the prescription of a people's Hospital for a tibiofibular fracture patient, including 5080 yuan of Trichosanthes injection, 1605 yuan of Guhong injection, 471 yuan of bone and melon extract injection, etc the total drug cost is more than 9700 yuan, but experts believe that only 1000 yuan of drugs really play a therapeutic role Traditional Chinese medicine injection has become a serious disaster area of irrational drug use and benefit delivery Since the beginning of the year, the manual of traditional Chinese medicine injection has been revised more frequently than before, including three kinds of products, including Zhongjiefeng injection, Tongguanteng injection and Chansu injection, which are required to revise the manual in succession to increase the taboo users Therefore, for step pharmaceutical, it is very important to get rid of the shackles of traditional Chinese medicine injection for enterprise performance as soon as possible In fact, the recombinant human brain natriuretic peptide for injection, which obtained nmpa for clinical trial, is also an important step to get rid of However, new drug research and development, as step pharmaceutical said in the announcement, has a long period and many links in the early stage of drug research and development as well as product development, clinical trial approval and production, and is easily affected by some uncertain factors Whether the future research and development process can be smooth , none of which is known.