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    Home > Medical News > Medical World News > 5 heavyweight injections approved for market impact on Yangtze River and Hengrui

    5 heavyweight injections approved for market impact on Yangtze River and Hengrui

    • Last Update: 2019-11-21
    • Source: Internet
    • Author: User
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    On November 5, CDE solicited opinions from the industry for the second time on the technical requirements related to the conformity assessment of generic chemical injection, which means that the formal policy document for the conformity assessment of chemical injection is expected to be issued soon However, before the implementation of the policy, some enterprises took the lead in the injection consistency evaluation track, and took the lead in the 4 + 7 belt volume procurement and expansion Source: pharmago At the same time, more and more injection varieties declared by enterprises according to the old chemical classification or new chemical registration classification have also been approved in succession, adding new competitive factors and variables to the consistency evaluation of injection and subsequent volume purchase Today, a number of heavy-duty injection varieties have been approved On November 20, Nanjing Youke pharmaceutical changed its processing status to "approved - to be certified" according to the listing application of "dizoxin injection" (cyhs1401776) declared by the old six categories After being approved, Nanjing Youke Pharmaceutical Co., Ltd will become the second approved enterprise in China after Yangtze River Dizosin is a powerful opioid analgesic, which can relieve postoperative pain Its analgesic intensity, onset time and duration are similar to that of morphine The study shows that the analgesic effect of dizosin is related to the dose The maximum dose of one-time clinical use is 30-50Mg, and the increase of analgesic effect beyond this dose is not obvious Dizosin can be used alone for postoperative analgesia, or in combination with other analgesics to enhance the analgesic effect Before that, dizosin injection was the exclusive product of Yangzi River Data shows that the growth rate of Yangtze River dizosin injection (garonin) has been rapid since it was approved in 2008 The current median bid price is 177.39 yuan / piece (1ml: 10mg) and 92.74 (1ml: 5mg) In 2008, the sales volume of public hospitals exceeded 5 billion yuan 2 Dexmedetomidine hydrochloride injection Chengdu Beite Pharmaceutical Co., Ltd On November 20, Chengdu Beite Pharmaceutical Co., Ltd changed its handling status to "approved - to be certified" according to the listing application of the old 6-class surgical sedative drug "dexmedetomidine hydrochloride injection" (cyhs1600003) Dexmedetomidine, as an α 2-adrenergic receptor agonist, has central anti sympathetic and anti anxiety effects, and can produce sedative effects similar to natural sleep It is mainly used in the clinical application of endotracheal intubation and ventilator for patients' sedation, perioperative anesthesia combined with drugs, and invasive examination or treatment of sedation Right metomidine structure The original research drug of dexmedetomidine hydrochloride injection was developed by hospita company in the United States, trade name: precedex It was approved by FDA on December 17, 1999, and approved to enter the Chinese market in 2009 Sales of precedex in 2018 were $213 million At present, only Yangzijiang company has passed the consistency evaluation, so it won the bid completely "without pressure" in the 4 + 7 centralized mining and the alliance centralized mining, so it is not necessary to kill too much price to win 50% of the collection volume at one stroke Since March 11, Yangtze River has carried out the "4 + 7 volume procurement" in succession In just three months, it has jumped from a small market share to a manufacturer with the largest market share Other enterprises can only strive for the remaining market share According to pharmago, there are eight companies that have launched dexmedetomidine hydrochloride injection, including Sichuan Guorui Pharmaceutical Co., Ltd., Yichang humanwell Pharmaceutical Co., Ltd., Shandong hill Kangtai Pharmaceutical Co., Ltd., Yangtze River Pharmaceutical Co., Ltd., Hengrui Pharmaceutical Co., Ltd., Enhua Pharmaceutical Co., Ltd., Kelun Pharmaceutical Co., Ltd and Chenxin Pharmaceutical Co., Ltd Hengrui also has a good sales base in dexmedetomidine hydrochloride injection In addition, eight other enterprises are in the process of consistency evaluation and are likely to become competitors in next year's volume purchase On November 20, Xintai pharmaceutical changed its status to "approved - to be certified" according to the listing application for sulfondagangui sodium injection (cyhs1400656) declared in the old 6 categories After being approved, Xintai pharmaceutical is the second domestic enterprise to produce fondaparinux injection Fondaparinux can selectively inhibit factor Xa mediated by antithrombin III (ATIII) and show anticoagulant effect It is suitable for the prevention of deep vein thrombosis (DVT) in patients undergoing hip fracture surgery (including lengthening prevention), hip replacement surgery, knee replacement surgery or abdominal surgery, and the treatment of DVT or acute pulmonary embolism with warfarin The original manufacturer of fondaparinux was Merck / GSK / Sanofi, which was approved to be listed in China in 2008 As an artificial pentasaccharide like compound, the synthesis process of fondagangui is very difficult and expensive, so there are few players Hengrui disclosed in May last year that when it obtained the US anda number of the product, its R & D investment was US $79 million IMS database shows that in 2017, the sales volume of fondaparinux injection in the Chinese market was about US $2.94 million, the sales volume in the US market was about US $69.53 million, and the sales volume in the global market was about US $190 million Xintai Pharmaceutical Co., Ltd is a subsidiary of Borui Pharmaceutical Co., Ltd Borui pharmaceutical previously mainly engaged in the export business of high-end API in Europe and the United States The approved fondaparinux injection is also the first injection variety listed in China Hengrui's fondagangui sodium injection was approved on May 23, 2008 as the first one in China, with the domestic bidding price of 135.00 yuan / piece (0.5ml: 2.5mg) Pharmago shows that Hengrui has submitted a supplementary application for conformity assessment to CDE on September 30, 2018 At present, the status is "under review" In addition, Hengrui has also obtained the FDA approval number According to the new 4 categories, there are 2 enterprises in Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd and Zhaoke Pharmaceutical Co., Ltd On November 20, Shanghai Tianwei changed its status to "approved - to be certified" according to the listing application (cyhs1500411) of the anti fungal drug "micafungin sodium for injection" declared by the old 6 categories After being approved, Shanghai Tianwei biopharmaceutical Co., Ltd is the third domestic enterprise to obtain the listing qualification of the product after Haizheng and hausen Micafungin is a lipopeptide compound developed by Astaire through fermentation semi synthesis technology It is also the second echinocandin antifungal drug approved for marketing after caspofungin It is developed from the fermentation product of the fungus cokeophoma empetri Micafungin structural formula Micafungin sodium for injection was first marketed in Japan in December 2002, and passed the FDA certification in March 2005 At present, it is only approved for the prevention and treatment of esophageal candidiasis, bone marrow transplantation and neutropenia in ads patients In April 2006, it was approved in China for the treatment of mycosis, respiratory mycosis and gastrointestinal mycosis caused by Aspergillus and Candida To ferment semi synthetic drugs, we need to first obtain the main ring crude products through fermentation technology, then obtain the intermediate products through separation and purification, then take the intermediate products as the starting materials, use the synthesis technology to complete the side chain splicing, and finally obtain the target components Because "fermentation semi synthesis" products need to go through many technical links, such as fermentation, separation and purification, synthesis, etc., the technical route and process parameter control are very complex Haizheng Pharmaceutical Co., Ltd is one of the leading enterprises of fermentation semi synthesis technology in China It was approved to take the first imitation of micafungin sodium for injection on April 12, 2018; hausen was approved to be listed on May 23, 2018 In addition, at present, there are four companies applying for listing of the product, namely Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., Xintai Pharmaceutical Co., Ltd., aosaikang Pharmaceutical Co., Ltd and Sichuan Pharmaceutical Co., Ltd., and the micafungin sodium for injection of Haizheng Pharmaceutical Co., Ltd is also in the application for consistency evaluation On November 20, Zhengda Fenghai changed its status of application for listing of esomeprazole sodium for injection (cyhs1500411) declared in the old six categories to "approved - to be certified" Esomeprazole is the S-isomer of omeprazole, which can reduce gastric acid secretion through specific targeting mechanism and is a specific inhibitor of proton pump in parietal cells The clinical indications are mainly the replacement therapy of gastroesophageal reflux disease when oral therapy is not applicable The original manufacturer of the drug is AstraZeneca, and the trade name is Nexium Nexium's sales reached $2.4 billion in 2018 Since its approval in China in 2016, the sales volume of azupine (asomeprazole sodium) of Zhengda Tianqing has reached 750 million yuan in 2018 and is expected to exceed 1 billion yuan in 2019.
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