[Yao Kejun] the first-line medicine for lung cancer is imitated. Zhengda Tianqing, Haosen, Qilu, Kelun and Yangtze River are competing for it! 2. Collinear drugs should be included in the priority review, and the consistency evaluation should be accelerated

Focus on 1.2 collinear generic drugs to be included in the priority review, and fierce competition for consistency evaluation; 2 Entecavir children's dosage forms to be included in the priority review; 3 The first potential generic dosage forms of high pharmaceutical industry and Enright pharmaceutical industry to be accepted; 4 Zhengda Tianqing 2 heavy potential first generic varieties to be accepted; 5 There is an urgent need for overseas new drug policy promotion in clinical practice Less than April after the application, Lilly heavy weight tumor orphan drug will arrive The review and approval acceptance dynamics this week (March 12-march 29) has a total of new acceptance number up to 26 acceptance number, including 5 acceptance number for imported drugs and 21 acceptance number for generic drugs In addition, it is worth noting that there are 5 acceptance 3 drugs to be included in the priority review this week To be included in the priority review of yangzhikang medicine metformin hydrochloride tablets March 29, CDE announced that the metformin hydrochloride tablets of yangzhikang medicine in Dongguan City will be included in the priority review Metformin is the first-line treatment for overweight or obese patients with type 2 diabetes, which has a strong and effective hypoglycemic effect Metformin is the only oral antidiabetic drug approved by the U.S Food and Drug Administration (FDA) for children with type 2 diabetes It has been recommended by many international diabetes academic groups as the first choice of treatment drugs for all new type 2 diabetes patients At present, it is the second largest oral antidiabetic in Europe In recent years, the domestic diabetes treatment guidelines also recommend it as the first-line medication for type 2 diabetes patients At present, 114 domestic enterprises hold the production approval documents of metformin hydrochloride tablets, and 24 enterprises apply for conformity evaluation 3 enterprises approve the supplement and pass the conformity evaluation The metformin hydrochloride tablets of yangzhikang medicine have been listed in the United States in 2018 Now they are declared in China If they pass the declaration, they will pass the conformity evaluation of overtaking and get the market opportunity (due to the limited space, click "read the original" for the complete data, and enter the database of drug intelligence consistency evaluation for query.) prednisone, Tianjin TIANYAO prednisone tablet, is an adrenocortical hormone drug with strong anti-inflammatory, antitoxin, immunosuppressive and other effects The purification and structure identification of prednisone was completed in 1950 In 1955, Schering laboratory was suitable for industrial production At present, there are only a few studies on this product in the field of combined drug use in China, such as the study of prednisone in the treatment of IgA nephropathy by Xu Lin of Shandong University in 2014 The dosage forms of prednisone listed in the United States include tablets, syrups and oral solutions; in Germany and Spain in Europe, there are only tablets listed in the MRP program; domestic approvals are in the form of acetate, mainly tablets, involving 185 enterprises holding approvals, and there is no conformity assessment declaration enterprise Tianjin TIANYAO has applied for chemical medicine category 3 and is a common product If it is approved, it will have a new advantage in the domestic market Entecavir granules, developed by Bristol Myers Squibb (BMS), was approved by the US Food and Drug Administration (FDA) on March 29, 2005 and marketed under the name of Baraclude Entecavir (ETV) is one of the first-line antiviral drugs for patients with chronic hepatitis B (CHB) In 2005, the United States Food and Drug Administration (FDA) and the former China food and Drug Administration (CFDA) approved ETV for CHB treatment At present, domestic entecavir preparations mainly include tablets, dispersible tablets and capsules For the time being, there is no granule type, and only Hunan Warner Pharmaceutical Co., Ltd is the enterprise applying for the listing of granule generic drugs, which shall be applied in accordance with class 2.2 new drugs It is proposed to be included in the priority review for "children's drug use" If approved, it will be the first manufacturer of entecavir granules in China On March 25, the generic drug application of orotadine hydrochloride granules of Jiangsu wangao Pharmaceutical Co., Ltd was accepted Olotadine hydrochloride was developed by Kyowa Hakko Kirin It was first approved by the U.S Food and Drug Administration (FDA) on December 18, 1996 and marketed in the United States by Alcon The product is patanol Olotadine hydrochloride is an antihistamine (as well as an anticholinergic and mast cell stabilizer) for the treatment of allergic conjunctivitis At present, domestic customized orlota hydrochloride is mainly eye drops, with 7 enterprises holding approval documents, followed by 3 enterprises holding approval documents for tablets and 1 enterprise holding approval documents for capsules There is no granule type listing, and only one enterprise of wangao pharmaceutical has applied On March 26, the generic listing application of desloratadine oral solution declared by Enright pharmaceutical was accepted Desloratadine was jointly developed by Dainippon Sumitomo and Merck sharp Dohme (MSD) It was approved by EMA on January 15, 2001 and FDA on December 21, 2001 It is marketed in the UK by MSD (trade name: neoclarityn) It can be used to relieve the symptoms of seasonal allergic rhinitis and perennial (non seasonal) allergic rhinitis, as well as the itching and urticaria related to chronic idiopathic urticaria At present, domestic customized loratadine is mainly tablet, followed by syrup, capsule, dry suspension, etc There is no oral solution formulation In addition to Enright pharmaceutical, another enterprise has applied for the listing of generic drugs, which is Shandong lanuo Pharmaceutical Co., Ltd On March 27, the generic application of digarik acetate for injection was accepted Digarik acetate, originally researched by Huiling company, was approved by the U.S Food and Drug Administration (FDA) on December 24, 2008 under the trade name of firmagon It can be used to treat patients with advanced prostate cancer At present, there are only imported products in China, and the generic drug listing declaration and Shenzhen Jianxiang biopharmaceutical Co., Ltd apply for chemical drugs in 3 categories, which was accepted on September 19, 2018 On March 26, the generic drug listing application of alfatinib maleate declared by Zhengda Tianqing was accepted Afatinib maleate was developed by Boehringer Ingelheim and approved by the US Food and Drug Administration (FDA) on July 12, 2013 The product is named gilotrif The drug is used in the first-line treatment of metastatic non-small cell lung cancer (NSCLC), that is, when FDA approved clinical tests confirm the absence of exon 19 of tumor epidermal growth factor receptor (EGFR) or the substitution of exon 21 (L858R) for mutation At present, alfatinib maleate is only imported in China, with 16 acceptance numbers applying for generic drug listing, all of which are in accordance with four types of chemical drug applications, including 5 enterprises of Haosen, Yangzi River, Kelun, Qilu and Zhengda Tianqing Among them, 3 acceptance numbers of Haosen were first accepted on January 8, 2018, and cyhs1700433 has shown "issued", but there is no official approval information Now, five powerful enterprises have started to seize the market According to the database of China clinical trial of Yaozhi, in addition to the clinical information not disclosed by Kelun, the other four enterprises have completed the bioequivalence test It is worth noting that the group has also completed the bioequivalence test, but it has not yet applied for listing, only the earlier clinical acceptance number of the application according to the chemical medicine 3.1 Who is the first to look forward to In the new development of review and approval, 36 acceptance numbers have been updated in the processing status, including 2 for imported drugs, 2 for new drugs and 32 for generic drugs Among the generic drugs, 2 acceptance numbers refer to 2 kinds of drugs that were "approved" last week, and this week showed "issued" drugs, including Qilu's heavyweight drug wiggliptin tablets; 6 acceptance numbers 4 were "under approval" last week, and this week's approved drugs (for details, see the previous column [drug gajun] heavyweight! "Medicine king" meets the opponent, Novartis Sujin monoclonal antibody will come! Qilu chases hausen and starts to fight fiercely; xinlitai, Janssen, Lizhu McAb...) Note: the red color indicates that olaratumab injection, which was changed last week, was "under approval" and will be approved soon It is reported that in November 2018, CDE issued the notice of the first batch of clinically urgent overseas new drugs list, olaratumab was among them Next, Li can directly use the overseas clinical data to apply for listing in nmpa, which was accepted by CDE on December 10, 2018 It has been less than four months since it entered the approval process Olaratumab has been awarded the breakthrough drug qualification, fast track status, orphan drug status and priority review qualification in the US FDA for the treatment of advanced soft tissue sarcoma It was approved by the FDA on October 19, 2016, and can not be treated with radiotherapy or surgery when combined with doxorubicin, However, it is suitable for adult patients with soft tissue sarcoma (STS) with anthracycline drug therapy, trade name: lartruvo In addition, in February 2015, olamab was granted orphan status by EMA in the treatment of soft tissue sarcoma And obtained conditional listing license from EMA on November 9, 2016 It is reported that since lartruvo went public, its sales increased from US $9.4 million in 2016 to US $180 million in 2017, a nearly 18 fold increase After opening the Chinese market, lartruvo will have more considerable revenue Olamab is the first new drug for the initial treatment of STS that cannot be operated or treated with radiotherapy after doxorubicin was approved more than 40 years ago Olamab is also the only monoclonal antibody specifically binding to PDGFR - α In the past, the most commonly used treatment for such patients was adriamycin alone or in combination with other drugs The incidence rate of soft tissue sarcoma is about 1% of malignant tumors, about 2.63/10 million The prognosis is poor The patients in the late stage have a median survival of about one year and lack of effective treatment drugs Sts can occur in different parts of limbs, limbs, trunk, internal organs, head and neck, etc Data source: Yao Zhi data statement: This article only represents the author, not the position of Yao Zhi Com Welcome to exchange and supplement in the message area If you need to reprint, please be sure to indicate the author and source of the article.