Affected by the new policy of CDE, the review of "heparin sodium injection", a heavy chemical drug of Changshan pharmaceutical industry, has fallen back

According to the website of the State Food and Drug Administration (CFDA), the processing status of the heavy-duty drug "daparin sodium injection" declared by Changshan pharmaceutical industry has changed from "in approval" to "in review", which means that the product will be in the final stage of obtaining the production approval document, and the review process will be greatly backward In response, Changshan pharmaceutical staff said that the company has not yet received any information issued by the drug administration, not excluding that there is a problem in the review system Industry insiders predict that this change of state may be related to the latest low molecular weight heparin product review new deal released by CDE Under the influence of this new policy, heparin sodium injection may be required to make clinical trials and delay the listing Many industry insiders said that as one of the low molecular weight heparin products, daparin sodium injection was affected by the new policy When the new policy was issued, the clinical application of daparin sodium in Changshan Pharmaceutical Co., Ltd had been completed and the production site inspection had been completed This review retrogression is likely to be required to make up the pharmacodynamic equivalent research of human body "Pharmacodynamic equivalence is not a difficult clinical trial in itself, but the key is to see whether the approval process of pharmacodynamic equivalence test of this kind of injection required by CDE is the same as the bioequivalence process of solid oral preparation If it is the same, these products in the report will be delayed for many years; if it is not the same, take the form of suspension, and the delay time of product listing may be about half a year ”One person in the industry said
A researcher also said that although there are other reasons for such changes in the review status, it is more difficult to successfully obtain approval for such special varieties as low molecular weight heparin alone "This kind of product is a mixture and it is difficult to prove that the quality of generic drugs is consistent with that of the original research drug It is risky for the FDA to approve the listing of such drugs, which has led to the current imitation of heparin sodium injection The drugs are not on the market " In fact, in recent years, the approval process of low-molecular-weight heparin products has been extremely difficult With the continuous update of foreign guidelines, CDE has also constantly followed up the technical requirements, and the low-molecular-weight heparin varieties declared by enterprises have also been constantly notified and supplemented Changshan Pharmaceutical Co., Ltd is mainly engaged in heparin series products There are only two kinds of heparin preparations: low molecular weight heparin calcium injection and heparin sodium injection When the heparin sodium injection is listed, it will reduce the risk of the company's excessive dependence on two products It was originally expected to be listed in the first half of this year Zhang Wei, Secretary of the board of directors of the company, once said that daparin sodium injection is the first imitation of the company With the help of the hospital departments that have been opened up at present, daparin sodium injection is expected to be accepted by the market in advance after being listed