[exclusive] Q4 sprint: important products of famous enterprises such as Hengrui, Fosun, hausen, Huahai, dongyangguang and Xinda will be available

September is coming to an end Which blockbuster drugs are expected to be launched in the fourth quarter of 2018? Let's look at the following: competition for the first listing of new drugs Hengrui, Xinda and Junshi PD-1 in China Figure 1 registration application of Hengrui, Xinda and Junshi PD-1 monoclonal antibody is a hot target in the field of cancer PD-1 has attracted much attention Currently, only opdivo and keytruda are available in China Domestic enterprises are actively competing for the first listing, among which Junshi (Suzhou Zhonghe biological declaration), Xinda and Hengrui (Suzhou shengdia biological declaration) are making the fastest progress, and their listing applications have been accepted successively At first, Xinda biology was the first enterprise to apply for listing, but at the beginning of March this year, Xinda's anti-PD-1 McAb listing application was withdrawn After the supplementary materials were submitted again, its acceptance has ranked behind Junshi biology However, the acceptance time of the three enterprises is not very different According to the timeline of drug intelligence registration, at present, Hengrui and Xinda have been reviewed successively in September, and it can be predicted that they will be approved in the same period of time Junshi biology has not completed the review, which is expected to be later than Xinda and Hengrui However, all three mAbs are expected to be available in the fourth quarter of 2018 Fig 2 registration time axis of carrizumab for Hengrui injection (shr-1210) Fig 3 registration time axis of xindaxindilimab injection (ibi308) Fig 4 registration time axis of js001 registration time axis of Shanghai Fuhong hanlinlituximab Fig 5 registration application of rituximab Rituximab was jointly developed by Baijian and Roche (including Genentech in the United States and Chinese and foreign pharmaceuticals in Japan) It was approved by FDA on November 26, 1997, EMA on June 2, 1998, PMDA on June 20, 2001 and China on April 21, 2008 Listed in the U.S., Europe, Japan, and China by Parken and Roche under the names of rituxan and mabthera Rituximab is a monoclonal antibody targeting CD20 Its approved indications are non Hodgkin's lymphoma, chronic lymphoblastic leukemia, rheumatoid arthritis, granulomatous vasculitis and microscopic polyangitis At present, only Shanghai Fuhong Hanlin, a subsidiary of Shanghai Fosun, has reported production in China Now the three in one review has been completed and will be approved soon Fig 6 Registration Application of rituximab for a new class 1 triaxial drug coremycin tablet Fig 7 registration application of coremycin tablet coremycin is a macrolide antibiotic for bacterial infection, with three national patents It was developed by Institute of pharmaceutical biotechnology, Chinese Academy of Medical Sciences, and then transferred to Shenyang Tonglian Pharmaceutical Group In September 2010, the compound was jointly declared by the Institute of pharmaceutical biotechnology, Chinese Academy of Medical Sciences, Shenyang Tonglian and Beijing Shouke group as a new class 1.1 drug The drug applied for supplementary application in 2015 and reexamination application in 2017 It is expected to be available by the end of the year at the normal process rate Fig 8 time axis of registration of clindamycin tablet Fig 9 R & D process of clindamycin tablet class 1 new drug losenapeptide Fig 10 registration application of pegylated losenapeptide pegylated losenapeptide is a long-acting GLP-1 receptor agonist independently developed by hausen, which only needs to be injected once a week for the treatment of type 2 diabetes At present, most of the GLP-1 receptor agonists approved for marketing in China are short-acting preparations, such as exenatide (twice a day), lilalutide (once a day), benalutide (three times a day) and lisnertide (once a day) However, at the end of 2017, AstraZeneca's exenatide microspheres for injection obtained import approval, becoming the first long-term GLP-1 preparation in China At present, hausen's losenapeptide has completed the supplementary application If it is approved in the fourth quarter according to the normal procedures, hausen will become the first domestic long-term GLP-1 preparation listed on the market Fig 11 in addition to the above new drugs, vasastar applied by fabergin (China) is also expected to be approved in the fourth quarter In the first three quarters of 2018, due to the guidance of national policies, the approval speed and efficiency of new drugs have been greatly improved, and more and more good drugs have been put on the market Zhengda Tianqing, Hengrui and Hutchison Whampoa's heavyweight new drug products have attracted wide attention In the last quarter, there will be a rush of heavyweight products, which will bring a successful end to 2018 Figure 12 application for registration of imported glibenclamib Belimumab was developed by GlaxoSmithKline (GSK), approved by FDA on March 9, 2011, and approved by EMA on July 13, 2011, and sold by GSK in the U.S and European markets Belimumab is a specific inhibitor of B lymphocyte stimulating factor (BLyS), which can prevent BLyS from binding to B cell receptor, promote B cell apoptosis and reduce B cell differentiation to plasma cell secreting antibody Indications for approval of the drug: systemic lupus erythematosus with positive active autoantibody after standard treatment At present, the domestic application of the drug has been reviewed and is expected to be approved in the fourth quarter Figure 13 in the last quarter of the registration time of baileyuzumab, apart from baileyuzumab, the lablehai for injection declared by Sanofi is also worth looking forward to In view of the complexity and difficulty in the review and approval of children's drugs, and the lack of large drugs in the market, the approval of the drug is more concerned, and it is expected that high-quality imported drugs can be listed in China as soon as possible to benefit patients Melphalan (Research and development of GlaxoSmithKline) is a Racemic Phenylalanine nitrogen mustard, which can be used for tumor It is the first choice drug for multiple myeloma in single chemotherapy and combined chemotherapy At present, no generic drugs have been listed in China, only Xi'an Libang pharmaceutical has applied for listing, and it has been included in the priority review for children's drugs and rare disease drugs At present, the review has been completed, and the next step is to enter the approval process, which is expected to be listed in the fourth quarter FIG 15 registration and application of metformin hydrochloride sustained-release tablets of mefalen FIG 16 registration and application of metformin hydrochloride sustained-release tablets metformin was used in type II diabetic patients with unsatisfactory diet control, especially obesity and hyperinsulinemia As a first-line drug for the treatment of type II diabetes, metformin is often used in combination with other oral hypoglycemic drugs, and in principle, it should always be kept in the medication list It was listed in Canada in 1972 and in the United States in 1994 At present, there are 44 domestic manufacturers of metformin hydrochloride sustained-release tablets, and 6 enterprises have applied for conformity assessment, none of which has been approved The generic applications of Ouyi and Shanghai xuantai Haimen Pharmaceutical Co., Ltd belong to the same line to internal application At present, Shanghai xuantai Haimen Pharmaceutical Co., Ltd has completed the review and is expected to be approved in the fourth quarter If approved, it is likely to be the first enterprise that has passed the consistency evaluation Figure 17 progress of consistency evaluation of metformin hydrochloride sustained-release tablets Figure 18 registration timeline of metformin hydrochloride sustained-release tablets of Shanghai xuantai Haimen Pharmaceutical Co., Ltd figure 19 registration timeline of Ouyi metformin hydrochloride sustained-release tablets Figure 20 registration application of alendronate sodium tablets of Binjiang, Minsheng Alendronate sodium tablets are developed and produced by Merck (Merck in the United States and Canada) Alendronate sodium tablet is one of the drugs with the longest application history in the treatment of osteoporosis It is the first bisphosphonate drug approved by the U.S Food and Drug Administration (FDA) for the treatment of postmenopausal osteoporosis, and also the first drug approved by the U.S FDA for the treatment of male osteoporosis At present, a total of 19 domestic alendronate sodium tablets have approval documents The alendronate sodium tablets of Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd have been listed in the United States in 2009, and now apply for listing in China At present, they have been reviewed and are expected to be approved in the fourth quarter According to the common line products and the declaration according to the new registration classification, it will be regarded as passing the consistency evaluation, and Minsheng Binjiang will also seize a large market share Figure 21 registration application of alendronate sodium tablets for donepezil hydrochloride in Zhejiang Huahai Figure 22 registration application of donepezil hydrochloride tablets Donepezil hydrochloride was developed by Eisai, which was approved by FDA on November 25, 1996, and then approved by PMDA on October 8, 1999 It was marketed by Eisai in the United States and Japan Its trade name is Aricept The medicine is suitable for the treatment of Alzheimer's dementia It is effective for mild, moderate and severe Alzheimer's dementia At present, 6 domestic enterprises have production approval documents for tablets of the drug, and only Chongqing Zhien Pharmaceutical Co., Ltd has applied for consistency evaluation Huahai has been listed in the United States in 2011, and is a common product Now it is applied according to 4 categories of new registration It is currently under approval, and it is about to be approved It is expected to be directly regarded as passing the consistency evaluation and ahead of other enterprises Figure 23 registration time axis of donepezil hydrochloride tablet figure 24 application for consistency evaluation of Chongqing Zhien pharmaceutical industry figure 25 application for registration of levofloxacin tablet levofloxacin is the second generation of fluoroquinolones, and it is the left-handed body of ofloxacin It can inhibit the activity of DNA helicase, prevent the synthesis and replication of bacterial DNA and lead to bacterial death Both levofloxacin and its racemate, ofloxacin, were developed by daiichiseiyaku The pure levofloxacin produced in 1985 showed less cytochrome toxicity In 1993, the product was first listed in Japan under the trade name of Cravit; in 1996, it was listed in the United States under the trade name of levaquin At present, there are many approvals on levofloxacin in China, and the tablet dosage form is only owned by the first three co pharmaceuticals (Beijing) The two specifications of the tablet applied by Dong Yangguang have been listed in the European Union in 2014 As a co product applied in China, it is expected to occupy a large market if passed Qilu relying on corxi figure 26 relying on corxi registration application etoricoxib, developed by MSD, was approved for listing by MHRA on April 15, 2002, under the trade name of Arcoxia Etocoxib is a selective cyclooxygenase-2 (COX-2) inhibitor for the relief of pain and inflammation related to osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis and acute gouty arthritis (GA) At present, there are only imported drugs in China In addition to Qilu's application for listing, there are also four kinds of listing applications of chemical drugs of Chengdu Yuandong biology, which have entered the review sequence and are still under review and approval In addition, six generic drug listing applications of Nanjing Xiansheng Pharmaceutical Co., Ltd., Beijing Taide Pharmaceutical Co., Ltd and Hunan Fangsheng Pharmaceutical Co., Ltd have been approved for clinical use Qilu is the fastest growing company in the world It has been reviewed and is expected to be listed in the fourth quarter, becoming the first imitated company Figure 27 application for registration of alfentanil hydrochloride in Yichang humanwell and alfentanil hydrochloride injection based on corxi figure 28 application for registration of alfentanil hydrochloride injection as a powerful analgesic for anesthesia, suitable for short-term surgery At present, the drug is not on the market in China According to the data of pharmaceutical intelligence, only Yichang humanwell has applied for listing, and the class 3.1 new drug declared by Jiangsu Enhua Pharmaceutical Co., Ltd has been approved