Six biopharmaceutical listed companies have obtained clinical approval or production approval recently

On April 22, it was learned from the State Food and drug administration that six biopharmaceutical listed companies, including shutaishen, Hualan biology and Boya biology, respectively obtained clinical approval or production approval Among them, the new product "human coagulation factor Ⅷ" under development by Boya biology was approved for clinical application, or affected by this favorable effect, the company's stock closed the trading limit strongly in a short time of opening It is worth mentioning that the 3.1 new drug of Yabao pharmaceutical, memantine hydrochloride, has been approved for listing With the expiration of the patent for this product last year, Yabao pharmaceutical is expected to accelerate its occupation of the domestic market at this time It is understood that memantine hydrochloride is a superior product for Yabao pharmaceutical industry to apply for approval The company started to apply for the production approval document in November 2011, and it has been approved for 4 years It is reported that the original manufacturer of memantine hydrochloride is Mertz pharmaceutical company in Germany, which is the only N-methyl-D-aspartate (NMDA) receptor antagonist developed in the world for the treatment of moderate to severe Alzheimer's disease It was listed in the United States in 2003, and its patent expired in 2014 In 2012, its global revenue reached 2.3 billion US dollars Today, the approval of similar varieties of Yabao pharmaceutical will undoubtedly bring great opportunities for the company to layout the domestic market At the same time, Haizheng Pharmaceutical Co., Ltd and Erkang Pharmaceutical Co., Ltd obtained the "quasi birth certificate" A new biological product new drug (acceptance No cxss1300016) of Haizheng Pharmaceutical Co., Ltd obtained the "quasi birth certificate" It is reported that this product is a recombinant human tumor necrosis factor receptor antibody fusion protein for injection, which belongs to 7 national new drugs and is mainly used for the treatment of moderate and severe active rheumatoid arthritis The company began to apply for the production approval document of the drug in June 2013, waiting for approval in the past two years At present, the handling status of the drug is "certificate preparation completed - pending approval document" At the same time, a chemical generic drug (acceptance No cyhs10001056 Xiang) of Erkang pharmaceutical was approved for production According to the information of the State Food and drug administration, the new biological products with the acceptance no of "cxsl1400051 Gan" of Boya biology have been approved for clinical application, and the processing status has been changed to "certificate preparation completed pending approval" The reporter learned that the approved variety was human coagulation factor Ⅷ, and Boya biology submitted relevant application materials in May last year At present, human coagulation factor Ⅷ is produced and sold by enterprises at home and abroad The drug is mainly used for the prevention and treatment of haemorrhagic symptoms caused by hemophilia A and acquired coagulation factor Ⅷ deficiency, as well as the surgical treatment of such patients In addition, Hualan biology and shutaishen have respectively approved a new preventive biological product for clinical use It is understood that the approved strain of Hualan biology is a tetravalent influenza virus split vaccine At present, the company's influenza vaccine is a trivalent vaccine This time, the approved tetravalent vaccine is more than the original one and has a wider range of prevention It is worth noting that shutaishen class 1 new drug, rat nerve growth factor for injection (Product Name: sulithin), is also the main product of shutaishen It is reported that supitonin (rat nerve growth factor for injection) is the first national drug approved product in the field of rat nerve growth factor for injection in China, and it is a national first-class new drug with independent intellectual property rights, which is mainly used to promote the recovery of nerve injury and to treat optic nerve injury At present, the product has entered the 2009 Edition (the latest) national and provincial "directory of drugs for basic medical insurance, industrial injury insurance and maternity insurance" In recent years, the market scale of supisheng of Shutai God has been expanding, and it plays an important role in the market segmentation "The clinical application is to apply for new indications for the product." Insiders told reporters It is expected that the clinical application scope of threotinin will be further expanded.