"China class 1" new drugs approved for market in recent years (biological medicine)

Innovative drug research and development is the only way for China to move from a big pharmaceutical country to a powerful pharmaceutical country Whether it is the "863 Plan", "973 Plan" or today's "National Science and technology major project", the state has placed high hopes on new drug research and development and has given various encouragement and support Domestic pharmaceutical enterprises are also worthy of expectations and shoulder the task of new drug creation After years of accumulation and development, each new drug product with independent intellectual property rights was born and successfully launched, "China class 1" new drug family is gradually growing, and China's new drug independent innovation ability is blooming In the last "inventory: China's class 1" new drugs approved for marketing in recent years (chemical articles) ", the editor briefly introduces China's class 1 small molecular drugs approved for marketing in recent years This article will focus on the" China's class 1 "large molecular biological drugs approved for marketing in recent years, hoping to be beneficial to you In recent years, what are the "China class 1" macromolecular biological drugs approved for listing in China? Through the joint query and summary of Yaodu data and other professional databases, since 2001, there are 23 "China class 1" macromolecular biopharmaceuticals independently researched and developed by domestic enterprises, and then approved by the State Food and Drug Administration for listing See Table 1 for details Brief introduction of "China class 1" macromolecular biopharmaceuticals approved for Listing 1) recombinant Ebola virus disease vaccine (adenovirus vector), jointly developed by the Institute of bioengineering of the Academy of Military Medical Sciences and Tianjin kangxinuo biological Co., Ltd., with full independent intellectual property rights, was approved for listing by China's CFDA in October 2017 and is a class 1 biological product for prevention This strain can express Zaire type Ebola virus envelope glycoprotein gene replication defect human type 5 adenovirus, after amplification, purification, adding suitable stabilizer freeze-dried, as a milky white loose body, vaccination, can make the body produce immune response, used to prevent Ebola virus disease caused by Ebola virus Since CFDA accepted the application for clinical trial of this product in February 2015, the general administration immediately launched a special approval procedure, established a special working group to conduct on-site verification, technical review and sample inspection simultaneously, and approved the clinical trial of this product on February 13 of the same year The World Health Organization has invited China's drug regulatory authorities and research and development teams to Geneva for many times to participate in the thematic discussion on the prevention and control of Ebola epidemic, and included the vaccine in the World Health Organization's guidelines on the quality, safety and effectiveness of Ebola virus vaccine In April 2017, the variety officially applied for production registration, and the food and drug administration immediately incorporated the application into the priority review process During the technical review process, the State Food and Drug Administration organized and held many communication meetings and expert meetings to fully communicate with the applicant about the problems in the application and registration process, so as to ensure the smooth development of product R & D registration In 2017, CFDA officially approved the variety's registration This is also the first recombinant Ebola virus vaccine approved in China 2) benalutide injection (yishengtai) Benaluptide injection, independently developed by Shanghai Renhui biopharmaceutical Co., Ltd for 18 years, is the first original biological new drug (in addition to traditional Chinese Medicine) in the field of diabetes in China and the first GLP-1 drug with full human amino acid sequence in the world It was approved to be listed by China's CFDA in December 2016, with the indication of type 2 diabetes and sold by the company in the Chinese market The product is yishengtai ® 。 Benalutide is a recombinant human glucagon peptide-1, which is essentially an incretin secreting peptide It can promote the release of Glucose dependent insulin and reduce the secretion of glucagon The most obvious therapeutic effect of the drug for type 2 diabetic patients is to effectively reduce the blood glucose level of the patients under the condition that it is not easy to have hypoglycemia risk, and significantly reduce the body weight index and improve the blood lipid level Compared with the imported drugs of the same kind, the risk of producing antibody in long-term use is smaller due to the characteristics of human origin PS: the initial dose of yishengtai ® is 0.1mg (50ul) three times a day, subcutaneous injection 5 minutes before meal, the injection site can be abdomen, thigh or upper arm; after 2 weeks of treatment, the dose should be increased to 0.2mg (100ul) three times a day 3) pegylated interferon α - 2b (pegabin) pegylated interferon α - 2b, developed by Xiamen Tebao Bioengineering Co., Ltd for 14 years, is the first domestic long-acting interferon variety approved by China It was approved by China's CFDA for listing in September 2016, and is used to treat adult chronic hepatitis C, and its trade name is pegabin ® The drug is a 40 kdy type pegylated recombinant interferon In the mid-term results of the phase III clinical trials of chronic hepatitis C, the virus response rate of the patients with chronic hepatitis C is high The project is a national major new drug creation clinical research project of the 11th Five Year Plan and the 12th Five Year Plan Xiamen Tebo has obtained the recent achievements in the United States, Europe, Japan, Australia, China, etc Patent licensing in 30 countries PS: the recommended dose of pegabin ® is 180 μ g once a week, subcutaneously injected into abdomen or thigh; ribavirin is taken orally at the same time of combined treatment 4) enterovirus 71 inactivated vaccine Enterovirus 71 inactivated vaccine is a class 1 new preventive biological product developed independently in China In 2015, two varieties were approved for marketing, namely enterovirus 71 inactivated vaccine (human diploid cell) produced by Institute of medical biology, Chinese Academy of Medical Sciences and enterovirus 71 inactivated vaccine (Vero cell) produced by Beijing Kexing biological products Co., Ltd The advent of the vaccine is of great significance to effectively reduce the incidence rate of children's hand foot mouth disease, especially to reduce the severe and fatal cases of the disease and protect the health of children in China   The inactivated vaccine (human diploid cells) of enterovirus 71 (EV71), a new class I new drug for national preventive biological products independently developed by Institute of medical biology, Chinese Academy of Medical Sciences, obtained the new drug certificate and production number approved by CFDA in December 2015, the first batch of vaccines was approved and issued the qualification report on March 15, 2016, and the first vaccination ceremony was officially held in Beijing on March 22, 2016 EV71 inactivated vaccine (human diploid cells) developed and produced is the only EV71 vaccine product produced by human cell matrix This vaccine is used to prevent HFMD caused by EV71 infection The pre marketing clinical research data shows that the protection rate of HFMD caused by EV71 is 97.3%, and the protection rate of HFMD caused by EV71 is 100% PS: children aged 6 months to 5 years old were vaccinated with two doses of basic immunization procedure, with an interval of 1 month; the dose for human use was 0.5ml each time, and intramuscular injection of deltoid muscle of upper arm was recommended for this vaccine The enterovirus 71 inactivated vaccine (Vero cell) produced by Beijing Kexing Biological Products Co., Ltd was approved for marketing in January 2016 It took 8 years to develop and invest RMB 500 million to prevent HFMD caused by enterovirus 71 (EV71) in 6-3-year-old infants 5) Sabin polio inactivated vaccine (EBV) Sabin polio inactivated vaccine, developed by the Institute of medical biology, Chinese Academy of Medical Sciences for nearly 30 years, is the first Sabin polio inactivated vaccine in the world It was approved by China's CFDA for listing in January 2015, and is clinically used for the prevention of poliovirus infection in children Its trade name is EBV ® The vaccine is produced by using Sabin strain, which is the current live attenuated poliovirus vaccine It is cultured in Vero cell bioreactor to harvest the virus Combined with the production process of inactivated vaccine, it will play an important role in the complete eradication of polio in China PS: 0.5ml for each bottle, 0.5ml for each dose; the amount of virus antigen contained in each dose should not be less than: 30du for type I, 32du for type II, 45du for type III; the best recommended injection route of this product is intramuscular injection, the best site of intramuscular injection for infants is the anterolateral middle part of thigh, and deltoid for children, adolescents and adults; dosage: according to the results of clinical trials in China, routine immunization is recommended Vaccination procedure: basic immunization was carried out at the age of 2, 3 and 4 months, 0.5ml for each time and 0.5ml for the first time at the age of 18 months 6) conbercept (Langmu) conbercept, developed by Chengdu Kanghong Biotechnology Co., Ltd., was approved by China's CFDA for listing in November 2013, and sold by Chengdu Kanghong Biotechnology Co., Ltd in the Chinese market for the treatment of neovascular (wet) age-related macular degeneration It is the first independently developed drug for the treatment of this disease in China, with the trade name of Langmu ® Conbercept is a recombinant fusion protein produced by Chinese hamster ovary (CHO) cell expression system, which is composed of immunoglobulin like region 2 in VEGF receptor 1 and immunoglobulin like regions 3 and 4 in VEGF receptor 2 and fused with human immunoglobulin Fc fragment It can inhibit the formation of new blood vessels by blocking the binding of VEGF to endothelial cell surface receptor 。 It is worth mentioning that kanghonglangmu, which is specially supported by new drugs, is exempt from phase I and phase II clinical research and directly obtained the "FDA phase III registered clinical research", which has become a milestone in the history of pharmaceutical innovation in China PS: Ramulus ® is a solution for intravitreal injection, each containing 10mg / ml of conbercept; the recommended dose is 0.5mg/eye/time for the initial 3 months, and then once every 3 months 7) pegylated recombinant human granulocyte stimulating factor injection (jinyouli) pegylated recombinant human granulocyte stimulating factor injection, developed by Baike (Shandong) biopharmaceutical Co., Ltd of Shiyao group, was approved by CFDA for listing in March 2012 It is clinically used for the prevention of neutropenia after chemotherapy The trade name is jinyouli ® The mechanism of action of jinyuli ® is that granulocyte stimulating factor binds with the surface receptor of hematopoietic cells to stimulate proliferation and prevent the proliferation of functional activated cells The study of receptor binding mechanism and neutrophil function shows that PEG rhG CSF and rhG CSF have the same mechanism of action Compared with rhG CSF, PEG rhG CSF can reduce plasma clearance rate and prolong half-life PS: jinyuli is injected subcutaneously 48 hours after the end of chemotherapy drug administration, and the recommended dosage is 100 μ g / kg subcutaneously, once per chemotherapy cycle; the dosage of 100 μ g / kg cannot be used for infants, children and minors whose weight is less than 45 kg 8) recombinant (E.coli) hepatitis E vaccine (econin) recombinant (E.coli) hepatitis E vaccine, developed by Xiamen Wantai Canghai Biotechnology Co., Ltd., is the first approved hepatitis E vaccine in the world It was approved by China's CFDA for listing in December 2011, and is clinically used to prevent hepatitis E virus infection Its trade name is econin ® The recombinant (E.coli) hepatitis E vaccine took 14 years of research and development, with a total investment of about 500 million yuan It is highly original and has full independent intellectual property rights It has successively obtained support from the National 863 program, the national science and technology innovation fund for small and medium-sized enterprises, the international science and technology cooperation program, the national science and technology major junior college program (infectious disease prevention and control), the major science and technology projects of Fujian Province and the major industrial science and technology projects of Xiamen city Hold PS: a 0.5ml recombinant hepatitis E vaccine contains 30 micrograms of protein like virus particles 9) iodine [131I] metuximab (ricardine) iodine [131I] metuximab, developed by Chengdu Huashen Biotechnology Co., Ltd., was approved by China's CFDA for listing in May 2011, which is used for the treatment of liver cell carcinoma, and the commodity is ricardine ® I [131I] metuximab is one