[good medicine record] another heavyweight variety of Hengrui passed the consistency evaluation; in the 289 catalog variety rush report, three new enterprise injection consistency evaluation reports were undertaken by CDE

According to the drug intelligence data, up to now, there are 372 acceptance numbers of CDE acceptance consistency evaluation, 66 of which have passed the acceptance number This week (September 13-20), 24 acceptance numbers were added to the consistency evaluation, involving 15 varieties of 16 enterprises In addition, Hengrui has entered the catalogue of Chinese listed drugs, which is deemed to have passed the consistency evaluation Another variety of Jiangsu Hengrui passed the consistency evaluation recently, the taxol for injection (albumin binding type) of Jiangsu Hengrui was included in the catalogue of Chinese listed drugs According to the relevant policies of consistency evaluation, it is deemed to have passed the consistency evaluation and become the second enterprise of the variety Paclitaxel for injection (albumin binding type) is a new dosage form of paclitaxel, which is a classical anti-tumor drug It is suitable for the treatment of metastatic breast cancer which failed in combination with chemotherapy or breast cancer which recurred within 6 months after adjuvant chemotherapy Other indications approved abroad include: combination with carboplatin in the treatment of advanced or metastatic non-small cell lung cancer, combination with gemcitabine in the treatment of metastatic pancreatic cancer and metastatic gastric cancer The original research company of paclitaxel for injection (albumin binding type) is the new base pharmaceutical industry in the United States It was approved to be listed in the United States in 2005 It was imported into China in 2008 and sold rapidly in the market It is reported that in 2017, the global sales volume of imported original research drug Abraxane is 992 million US dollars, and the annual sales volume of domestic market is estimated to exceed 250 million RMB According to the pharmaceutical intelligence data, up to now, there are 2 domestic approvals for paclitaxel for injection (albumin binding type) in China, and the production enterprises are Ouyi and Jiangsu Hengrui The products of both enterprises have successively entered the catalogue of Chinese listed drugs, which are deemed to have passed the consistency evaluation Therefore, it is expected to break the monopoly of the original research enterprise in the market, and even in the support of procurement policy, it will directly impact the original research varieties 15 varieties were undertaken, 289 catalog products added 3 enterprises declared this week (September 13-20), another 16 Enterprises' 24 acceptance numbers and 15 varieties consistency evaluation were undertaken by CDE Among them, six varieties are the first to be declared, namely, doxofylline injection of Hansheng Pharmaceutical Co., Ltd of Zhejiang Beisheng Pharmaceutical Co., Ltd., oral rehydration salt powder (Ⅲ) of Xiamen Encheng Pharmaceutical Co., Ltd., finasteride tablets of Beijing Hanmei Pharmaceutical Co., Ltd., piperacillin sodium tazobactam sodium for injection of qilutian and Huishi Pharmaceutical Co., Ltd., sildenafil citrate tablets of Baiyunshan Pharmaceutical Co., Ltd., calcium dobesilate capsules of Ningxia Kangya Pharmaceutical Co., Ltd.; in addition In addition, three new enterprises applied for three 289 catalog varieties, including paroxetine hydrochloride tablets of Tianjin Sike Pharmaceutical Co., Ltd., cefuroxime ester tablets of Hebei Huamin Pharmaceutical Co., Ltd and risperidone tablets of Jiangsu Enhua Pharmaceutical Co., Ltd On September 19, the application for consistency evaluation of doxofylline injection of Hansheng Pharmaceutical Co., Ltd of Zhejiang Beisheng Pharmaceutical Co., Ltd was undertaken by CDE Doxofylline injection, a derivative of methylxanthine, is a phosphodiesterase inhibitor, which is used in asthma, asthmatic chronic bronchitis and other respiratory difficulties caused by bronchospasm The original research enterprise is abcfarmaceticispa In 1997, doxofylline preparation was introduced from Heilongjiang Fuhe Pharmaceutical Co., Ltd According to the pharmaceutical intelligence data, there are 27 domestic approvals for doxofylline injection in China, involving 13 manufacturers, and only Hansheng pharmaceutical of Zhejiang Beisheng Pharmaceutical Co., Ltd has applied for the conformity assessment On September 19, the consistency evaluation of oral rehydration salt powder (Ⅲ) of Xiamen Encheng pharmaceutical was undertaken by CDE Oral rehydration salt powder (Ⅲ) is the third generation formula of oral rehydration salt It is a new formula recommended by the World Health Organization (who) and the United Nations Children's Fund (UNICEF) in 2006 It is used to replenish the lost water of water, sodium and potassium Treat acute diarrhea According to the pharmaceutical intelligence data, there are 11 market approvals for oral rehydration salt powder (III) in China, involving 10 manufacturers, of which only Xiamen Encheng pharmaceutical applied for conformity assessment and was accepted On September 19, the application for conformity evaluation of paroxetine hydrochloride tablets of Tianjin Shike Pharmaceutical Co., Ltd of China and the United States was undertaken by CDE Paroxetine hydrochloride tablets, 289 catalog varieties, is a strong, highly selective 5-HT reuptake inhibitor It is a common first-line antidepressant in Europe and the United States, and also a first-line antidepressant in China The original research enterprise is GlaxoSmithKline, which was approved by FDA in 1992 According to the data of PDB sample hospital, the market scale of paroxetine hydrochloride tablets in 2017 is RMB 210 million, and the actual terminal market scale is expected to be about RMB 1.5-2 billion According to the pharmaceutical intelligence data, at present, there are 4 domestic approvals for paroxetine hydrochloride tablets in China, with only 4 manufacturing enterprises in China and the United States, including Tianjin Shike, Huahai pharmaceutical, Jianfeng pharmaceutical and Beijing Wansheng Up to now, 4 enterprises have participated in the consistency evaluation of filing, among which Huahai pharmaceutical has passed the evaluation last year, and the application of Tianjin Shike in China and the United States has been accepted If passed, the products will be sold There are further breakthroughs Finasteride tablets were accepted by CDE on September 19 in Beijing Finasteride is a 4-azasteroidal compound It is a specific inhibitor of intracellular enzyme type II 5A reductase in the process of testosterone metabolism becoming stronger dihydrotestosterone It is the basic drug and the first oral drug for benign prostatic hyperplasia Developed by MSD, it was put on the market in 1992 and approved to be listed in China in 1994 According to the pharmaceutical intelligence data, there are 34 market approvals for finasteride tablets in China, involving 29 manufacturers Up to now, there are 11 enterprises that have been unanimously evaluated and recorded However, the first application of Beijing Korean American drugs has been accepted On September 17, the application for consistency evaluation of cefuroxime axetil tablets, a 289 catalogue variety of Huamin pharmaceutical, Hebei Province, was undertaken by CDE Add another competitor In addition, another acceptance number of cefuroxime ester tablet of Suzhou Sinochem was accepted Up to now, there are three enterprises that have passed the consistency evaluation of cefuroxime ester tablets, including Zhijun (Shenzhen) Pharmaceutical Co., Ltd., Chengdu Beite and Zhuhai United Pharmaceutical Co., Ltd However, it did not stop the enthusiasm of relevant enterprises to continue to declare According to the pharmaceutical intelligence data, up to now, there are 12 enterprises that have participated in the filing of cefuroxime axetil tablets In addition to the three enterprises that have passed the registration, there are four enterprises that have applied for acceptance For details, see the following figure: on September 17, the application for the consistency evaluation of risperidone tablets in the 289 catalogue of Jiangsu Enhua Pharmaceutical Co., Ltd was undertaken Up to now, there are 8 enterprises and 3 enterprises applying for the consistency evaluation of risperidone tablets, among which Huahai pharmaceutical has been the first to pass Whether Qilu pharmaceutical and Jiangsu Enhua can seize the first three passes remains to be seen On September 13, the application for conformity assessment of piperacillin sodium and tazobactam sodium for injection of qilutian and Huishi pharmaceutical was undertaken by CDE Piperacillin sodium and tazobactam sodium for injection, combined with penicillin drugs, were listed in the world in 1992, and entered the Chinese market in 1998 They were used in clinical practice for drug resistance to piperacillin, but they were caused by β lactamase producing bacteria sensitive to piperacillin and tazobactam According to the data published on the Internet, in 2017, the annual sales volume of the company in public hospitals was 850 million yuan, ranking first in the market share of compound penicillin According to the drug intelligence data, up to now, there have been 84 domestic approvals for Piperacillin Sodium and Tazobactarn Sodium for injection, involving 24 manufacturing enterprises, and only 1 enterprise of qilutian and Huishi has applied for consistency evaluation Sildenafil citrate tablets September 13 The application for conformity evaluation of sildenafil citrate tablets of Baiyunshan Pharmaceutical General Factory was undertaken by CDE Sildenafil citrate, also known as Viagra, is a PDE5 inhibitor for the treatment of erectile dysfunction Developed by Pfizer pharmaceutical in the United States, according to network data, the sales volume has been rising steadily since it was approved to be listed in the United States in 1998, among which the sales peak appeared in 2012, with the global sales volume of US $2.051 billion in that year; in 2017, Pfizer pharmaceutical was in China's urban public hospitals, county-level public hospitals, urban community centers, township hospitals (referred to as China's public medical institutions) terminals and China's urban retail In the drugstore terminal chemical market, the total sales of sildenafil has exceeded 2.2 billion yuan According to the pharmaceutical intelligence data, there are 11 market approvals for sildenafil citrate tablets in China, including Pfizer pharmaceutical, Jiangsu Yabang Epson Pharmaceutical Co., Ltd., Baiyunshan Pharmaceutical Co., Ltd., among which Baiyunshan Pharmaceutical Co., Ltd is the first to apply for conformity assessment If it passes the consistency evaluation successfully, it will continue to seize the market share of the original research enterprise On September 13, the application for consistency evaluation of calcium dobesilate capsule of Ningxia Kangya Pharmaceutical Co., Ltd was undertaken by CDE Calcium hydroxybenzenesulfonate is currently recognized as the only mature product (antioxidant) directly used for the prevention and treatment of diabetic microangiopathy, which is developed by ibuprofen, Austria According to the pharmaceutical intelligence data, there are 9 domestic approvals for calcium dobesilate capsules in China, 6 manufacturers, 4 of which are for reference and filing of consistency evaluation, and the first application for consistency evaluation by Ningxia Kangya Pharmaceutical Co., Ltd Information source: drug intelligence network, enterprise announcement and other network public information data sources: drug intelligence database, network public data [good drug record] column for you to track the latest trend of consistency evaluation in a week! 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