In response to the prevention and control of the new crown pneumonia epidemic, there is new information on drug development in China. February 16, the National Center for Drug Evaluation and Approval announced the generic drug Fapiravir “drug registration approval” and “drug clinical trial approval”, clinical trial approval is used for the study of the new crown pneumonia test drug. Informed sources said, by the above two approvals can be seen, Fapiravir is currently used for influenza, not the new crown drug, only approved Fapiravir can do to expand the indications of the trial allowed. Hai Zheng Pharmaceutical (600267.SH) 16 evening also released an announcement that, as a generic drug manufacturer of Fabipravir, it got the “drug registration approval” and “drug clinical trial approval” on February 16th. However, the said source revealed that no new crown drug has been approved for marketing, and neither is Fapiravir. It has only been approved for clinical trials for expanded indications. The current clinical indication for Fapiravir is influenza-like medication. Its “Drug Registration Approval” indicates that the indications of Fapiravir: for the treatment of new or re-emerging influenza in adults (limited to the use of other anti-influenza viral drugs when the treatment is ineffective or ineffective). The provincial bureau is requested to strengthen the tracking and supervision and management of the corrective measures for the defects of the enterprise, and to strengthen the post-listing supervision of the product, and to have the provincial bureau send staff to follow up the whole process of production for the first batch of the product after listing. At the same time put forward the post-launch requirements: 1, pharmacological aspects, stability test data show that the product accelerated 6 months and long-term 12-month tablet dissolution of the initial period (5-10min) decreased by 10%-15%, while the reference preparation dissolution did not decline, the product and the reference preparation there are differences, please pay attention to the combination of API crushing process and particle size control, tablet key step control, research to solve the above problems. In addition, please strengthen the control of particle size of API, adopt reliable method to measure the particle size, accumulate the data of particle size of API in the subsequent batches of products, and consider revising the limit range according to the test results. In addition, in terms of clinical pharmacology, please complete the postprandial bioequivalence study of this product as soon as possible. After the completion of the above studies, the results will be submitted to the review organization of the State Drug Administration in a timely manner. As can be seen from this Drug Registration Approval, there are differences between generic Fabipravir and the reference preparation. The reference preparation is the benchmark product for the consistency evaluation of generic drugs in China, which refers to the control drug used for the consistency evaluation of the quality and efficacy of generic drugs, usually the object to be copied, such as the original drug or the same kind of drug recognized internationally, and the reference preparation should be the drug with reasonable prescription process, stable quality and precise efficacy. Since there is no mandatory requirement for the consistency evaluation of drugs approved and marketed in China in the past, there are some gaps between some drugs and the originator drugs in terms of therapeutic efficacy. So the generic drug consistency evaluation, can make the generic drug in the quality and efficacy with the original drug, in the clinic can replace the original drug, quality consistency evaluation, that is, generic drugs need to be in the quality and efficacy to achieve the same level as the original drug, can not achieve the same level as the original drug will no longer be approved by the state. Hazen Pharmaceuticals got the approval of Fapiravir is also born as a generic drug. Fapiravir is a new RNA-dependent RNA polymerase (RdRp) inhibitor, belonging to the broad-spectrum anti-influenza virus drugs, developed by Fujifilm Group Toyama Chemical Industry Co. The Ministry of Health, Labor and Welfare of Japan approved its marketing in March 2014 under the English trade name Avigan, which is mainly used for the treatment of novel and recurrent influenza and has become a national strategic stockpile drug in Japan. Toyama Chemical Industry Co. Ltd. filed the earliest patent application on August 18, 1999 for the compound of Fapiravir. An exclusive compound patent license agreement was signed in June 2016 between Haisheng Pharmaceuticals and Toyama Chemical Industries, Ltd. of Japan. Haisheng Pharmaceuticals then signed a technical cooperation agreement with the Institute of Toxicology and Pharmaceuticals of the Military Medical Research Institute of the People’s Liberation Army to collaborate on the development of the famipiravir program. “At present, as there is no targeted specific drug for the new coronavirus, the state has also opened a green channel in order to find a new drug. Although this drug and the reference preparation there are still differences, and generic drug consistency evaluation of the requirements there is still a distance, but also still got the approval, the state regulatory authorities still put forward the requirements to complete as soon as possible did not meet the standard of the study.” A pharmacy expert said. In fact, Fapiravir has already launched a clinical trial on the new crown experimental drug. February 15, 2020, in the State Council joint prevention and control mechanism news conference, the Ministry of Science and Technology Biological Center Director Zhang Xinmin said that the scientific research PR group in many rounds of screening based on focusing on chloroquine phosphate, lundecavir (Ridgovir), Fapiravir and a few other drugs, has carried out clinical trials, and some of the current drugs have initially shown good clinical efficacy. Fabipiravir is an overseas listed drug for the treatment of influenza, and is currently undergoing clinical trials in Shenzhen, enrolling more than 70 patients, including the control group, and initially showing more obvious efficacy and lower adverse reactions. On the 3rd to 4th day after treatment, the viral nucleic acid conversion rate of the medicated group was significantly higher than that of the control group. Fapiravir is known to be effective in inhibiting Ebola, yellow fever, chikungunya, norovirus, and enterovirus due to its specific mechanism of action. A recent study showed that its EC50 against chikungunya virus reached 61.88 µM in an in vitro cell line assay. As of February 15, a search of ClinicalTrials.gov and the official website of China Clinical Trial Registry (ChiCTR) showed that three clinical trials have been carried out for the treatment of neocoronavirus with famciclovir. Hai Zheng Pharmaceutical said in its announcement: this time to obtain the “drug clinical trial approval” for new indications, the current clinical trials have yet to be carried out, the follow-up to complete a series of clinical trials steps need to be submitted for review and approval, clinical trial results are uncertain, whether to obtain the new indications of the production of the registration of the uncertainty exists. Source: China Business News