Dishube monoclonal antibody, recombinant herpes zoster vaccine approved for marketing

On May 23rd, in order to implement the spirit of the State Council executive meeting, the State Food and Drug Administration continued to promote the urgent need for overseas listed drugs to be imported and registered in China. Recently, the State Drug Administration has conditionally approved the application of Shuxu Kang injection. Name: Denosumab Injection) and Herpes zoster vaccine (recombinant, adjuvant) import registration application.

Giant cell tumor of bone is an extremely rare and rapidly progressing primary bone tumor rich in human nuclear factor activating factor receptor ligand (RANKL), which is manifested in the metaphysis and ankle of the long bone or the spine or humerus. Eccentric melting lesions. The lesions are characterized by highly vascularized and invasive osseopathic lesions with blurred borders and a wide transition zone. Mononuclear stromal cells expressing RANKL are tumor components of giant cell tumor of bone. Based on the current hypothesis, the role is to recruit osteoclast-like giant cells, causing invasive osteolytic activity of the tumor.

Desmoxa is a novel RANKL inhibitor developed by Amgen. It is a fully humanized monoclonal IgG2 antibody of RANKL with high affinity and specificity for soluble, transmembrane form of human RANKL. In patients with giant cell tumor of bone, inhibition of RANKL secreted by tumor matrix components by dishutumab can significantly reduce or eliminate osteoclast-like tumor-associated giant cells. As a result, osteolysis is reduced, giant cell tumor progression is slowed, and proliferative stroma is replaced by dense non-proliferative, differentiated, woven new bone, thereby improving clinical outcomes. Dizumab can be used as a targeted treatment for giant cell tumor of bone and may be an important therapeutic option to fill the unmet medical needs of this disease. The variety is supported by overseas clinical data to support the application for clinical import registration in China. The main supporting clinical data provided by the applicant are obtained overseas. Therefore, the State Food and Drug Administration integrated the opinions of various technical departments, and conditionally approved the listing of this product on May 21, and required the applicant to continue clinical research in China after the approval of this product, and formulate and strictly implement the risk management plan.

Herpes zoster is an infectious disease caused by varicella-zoster virus, usually manifested as a rash that appears on the unilateral side of the body with pain and itching. It lasts for two to four weeks and increases with age. high. The common complication is post-herpetic neuralgia, which can last for several months to several years, seriously affecting the normal work and life of patients. In China, nearly 3 million adults are affected by herpes zoster each year. Due to the lack of effective prevention and treatment methods for the disease in China, the State Food and Drug Administration and the National Health and Health Commission have included the recombinant herpes zoster vaccine in the first batch of 48 clinically urgently needed new drugs to speed up the review and approval process. In order to improve the efficiency of the evaluation, the Drug Evaluation Center of the State Food and Drug Administration conducted a large number of in-depth and meticulous communication and communication work with the applicants, and held two expert consultation meetings to conduct collective research and scientific assessment of overseas data (including Asian subgroups). Under the premise of fully demonstrating the safety and effectiveness, combined with the characteristics of the product, conditionally approve the listing of this product in China.

This product uses DNA recombination technology to express varicella zoster virus glycoprotein E in Chinese hamster ovary cells. It is prepared by culture, harvesting, purification and lyophilization. It has good protective effect on herpes zoster and is suitable for 50. Prevention of herpes zoster in adults over the age of. This product has two doses of immunization, intramuscular injection, common adverse reactions are pain, redness, swelling, as well as myalgia, fatigue, headache, fever and gastrointestinal symptoms. The State Food and Drug Administration requires the approval of this product at the same time as it is required to apply for the product, although it has been listed overseas but lacks comprehensive domestic epidemiological data, and whether the use of new adjuvants may lead to the risk of potential immune-mediated diseases . People continue to do a comprehensive post-marketing study, timely conduct drug warnings, update clinical safety and efficacy data at home and abroad, and improve the instructions to fully ensure that patients are safe, effective, and risk-controlled.

Since the publication of the first batch of urgently needed overseas listed drugs , the State Food and Drug Administration has approved the registration of 15 varieties of imports. In the next step, the State Food and Drug Administration will continue to implement the relevant requirements for deepening the reform of the drug review and approval system, and continuously accelerate the listing of clinically urgently needed drugs in China to better meet the needs of the people.