[dry goods] review of national class 1 chemical drugs approved for production from 1985 to 2000

After the reform and opening up, the situation of drug examination and approval in China was once chaotic From 1978 to 1985, except for major innovative varieties and domestic unproductive radioactive drugs, narcotic drugs, Chinese medicine synthetic products and contraceptives, other new drugs were examined and approved by the provincial health administrative departments At that time, there was no unified and specific technical standards and requirements for the approval of new drugs, and the scale of the approval of new drugs by the local health administrative departments was different, so the contradiction of drug evaluation continued to expand After the promulgation of new drug examination and Approval Measures in 1985, new drugs were submitted to the Ministry of health for centralized examination and approval, and the examination and approval of new drugs were gradually standardized In 1998, the State Drug Administration was officially established, and drug evaluation began to go on the right track The following is a compilation of the data of national first-class new drugs approved by the Ministry of health or the State Drug Administration from 1985 to 2000 If there is any omission, please correct it Table 1: national class I new drugs approved by the Ministry of health or the State Drug Administration from 1985 to 2000 note: according to the literature, only national class I chemical drugs independently developed and approved for marketing in China are counted 1) After artemisinin and its derivative Tu youyou won the Nobel Prize in physiology or medicine in 2015, artemisinin once again attracted public attention Artemisinin crystal was first obtained by Tu youyou group in November 1972 The chemical structure of artemisinin was determined at the end of 1975 The results show that artemisinin is a new drug with nitrogen-free structure which is totally different from chloroquine In 1977, with the approval of the Ministry of health, the research paper was published in the scientific bulletin in the name of "artemisinin structure research collaboration group", and reported the major original achievement of artemisinin to the world for the first time In October 1986, artemisinin obtained the new drug certificate issued by the Ministry of health In September 1973, Tu youyou's research group first found a better artemisinin derivative, dihydroartemisinin In 1992, dihydroartemisinin tablets, a new artemisinin drug developed by her for many years, obtained the new drug certificate and was approved for trial production It was put into production in 1997 At present, the approval belongs to Beijing Wanhui Shuanghe Pharmaceutical Co., Ltd Table 2: historical approval of artemisinin and its derivatives 2) benflumetol is mainly used for the treatment of falciparum malaria, especially for the treatment of anti chloroquine falciparum malaria It was developed by the Academy of Military Medical Sciences of the people's Liberation Army of China and obtained the new drug certificate issued by the Ministry of health in 1987 It is a new mefloquine drug created in China It has obvious killing effect on sexual and asexual bodies of Plasmodium vivax and good prevention effect on it 3) Carboprost methyl ester carboprost methyl suppository is a drug for termination of pregnancy, and its trade name is carboprost It was developed by Institute of medicine of Chinese Academy of Medical Sciences and Northeast Pharmaceutical General Factory Carboprost methyl ester, a derivative of prostaglandin F2a, has a strong contractile effect on uterine smooth muscle It is often used to prevent and reduce postpartum hemorrhage after cesarean section New drug certificate was obtained in 1987, trial production was approved in 1991, and formal production was changed in 1995 4) DIHYDROETORPHINE HYDROCHLORIDE DIHYDROETORPHINE HYDROCHLORIDE sublingual tablets (formerly DIHYDROETORPHINE HYDROCHLORIDE TABLETS), this product is only used for pain relief of various severe pain after trauma, surgery and diagnosis, including those who are not effective for morphine or pethidine Developed by the Academy of Military Medical Sciences of the people's Liberation Army in the 1980s, it is a kind of new drug with the lowest dosage and the strongest analgesic effect in the world 5) Ethoxybenzamide ethoxybenzamide ointment, the trade name of adit, is suitable for chronic eczema and neurodermatitis It is a new drug developed by our country A class of new drugs jointly developed by Shenyang Pharmaceutical University, Daqing Oilfield General Hospital and Shandong Xinhua Pharmaceutical Co., Ltd In June 1997, it obtained the new drug certificate, and in September of the same year, it was put into production and listed by Shandong Xinhua Pharmaceutical Co., Ltd 6) Etimicin sulfate etimicin sulfate is a new aminoglycoside antibiotic developed in China In 1997, etimicin sulfate, etimicin sulfate injection and etimicin sulfate for injection respectively obtained the approval number of trial production At present, there are 32 approval numbers of etimicin sulfate Table 3: historical approval of etimicin sulfate 7) ipratropium tablets, trade name Chuanliu, is a selective and non competitive steroid II 5 α - reductase inhibitor for the treatment of BPH In July 1993, it was jointly developed by China Medicine University, Shanghai Institute of organic chemistry of Chinese Academy of Sciences and Yangzhou pharmaceutical factory In 1996, aprete was approved to enter the clinical research stage In August 1999, it obtained the certificate and production approval of new drug for API and tablet issued by the original SDA In 2001, it was officially produced (API: GDZZ X20010668, tablet: GDZZ X20010669) In 2002, the approval number (API: gyzz h20010668, tablet: gyzz h20010669) was changed Now the approval belongs to Jiangsu Lianhuan Pharmaceutical Co., Ltd 8) Hematoporphyrin hematoporphyrin is the first photosensitizer in China, which belongs to a new drug, known as "photochemical missile", and is suitable for the treatment of oral cavity, bladder and other parts and superficial cancer In 1998, it was approved by the Ministry of health for pilot production (API: (98) wysz x-25, injection: (98) wysz x-36 (1), (98) wysz x-36 (2)) The applicant is Beijing Institute of medical technology and experimental pharmaceutical factory In 2003, Chongqing Huading modern biopharmaceutical Co., Ltd obtained the production approval issued by the original SDA, with the exclusive production and listing, and the trade name of Xibo branch * the drug is administered intravenously and reaches the malignant tissue with the circulation of blood, and it accumulates and stays in it During the treatment, it is necessary to irradiate these tumor parts with a specific wavelength of laser, so that the drug will have a photochemical reaction, produce a monovalent oxygen, directly kill the malignant tumor tissue, the whole process does not cause much damage to normal human tissue Whether for primary cancer or recurrent cancer, it can achieve the purpose of treatment or improvement Friendly tips: for the class 1 new drugs launched in China after 2000, you can get them by querying the drug intelligence data https://db.yaozh.com/ In order to solemnly commemorate the 40th anniversary of reform and opening up, to record the hard course of Chinese pharmaceutical enterprises' pharmaceutical research and development in the past 40 years; to record the Chinese pharmaceutical people's spirit of striving for the development of Chinese pharmaceutical industry, the big data of Chinese pharmaceutical research and development in the past 40 years, which was created by pharmaceutical intelligence network and China Pharmacy magazine, will be published soon This book will show the reform, progress, achievements and problems in the field of Chinese pharmaceutical research and development in the 40 years of reform and opening up in a panoramic and epic way, and comprehensively analyze the trend of future pharmaceutical research and development from the perspective of globalization in the new era, so as to draw a prospective vision for the next step of Chinese pharmaceutical research and development The compilation, publication and distribution of "China's pharmaceutical R & D 40 years big data" is the common vision of the Chinese pharmaceutical industry and Chinese pharmaceutical people, which requires more powerful and responsible units and individuals to invest and support What do you think of the 40 years of reform and opening up in China's pharmaceutical research and development? 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