[Yao Kejun] Q2 is the first to see: 21 heavy new 3 kinds of generic drugs are coming! Hengrui, Zhengda Tianqing, Renfu, children's medicine, rare disease medicine first imitated

Highlights: 1 21 blockbuster 3 generic drugs Q2 may be approved, the first to be imitated in variety and dosage form; 2 Hengrui 3 potential to be imitated for the first time in the future, including the "Shatan" competition of 60 enterprises; 3 Zhengda Tianqing multiple myeloma drug pomadolamine capsule will be approved; 4 Nanjing xianshengdongyuan and Zhengda Tianqing qiliekai injection of bendamostin hydrochloride; 5 Mefalen or Lai for injection was the first drug for children with rare diseases; 6 Novartis sujinmab was officially approved, and the market of "king of medicine" Adamu mAb was under pressure; 7 Pemetrexed disodium for Qilu CO line injection was approved, and the conformity evaluation of overtaking was completed, and Sichuan Huiyu, selected in 4 + 7, met strong competitors; 8 Wutian rare disease drug was declared to be listed in China The first quarter of 2019 has been completed In the first quarter of 2019, CDE has accepted 2070 drug applications, an increase of 13.55% compared with the first quarter of 2018, including 256 applications for generic drugs, 196 for new drugs and 172 for imported drugs, excluding supplementary applications and reexamination In terms of approval, in the first quarter, there were 89 applications for production approval, 17 applications for import approval and 53 applications for clinical approval The approved production mainly includes generic drugs with 80 acceptance numbers, 62 of the old 6 categories and 18 of the new 4 categories It is worth mentioning that 5 of the new 3 categories have been approved, including temozolomide for injection of Jiangsu Hengrui medicine, lamivudine tenofovir tablets of Anhui Baker biology, lakoshamide tablets of Jiangxi Qingfeng pharmaceutical and zuelacetan sustained-release tablets of Shenzhen xinlitai pharmaceutical Three kinds of generic drugs (domestic applicants copy the drugs listed overseas but not listed in the original research drug) application as the primary source of the first generic varieties or dosage forms deserves attention Then in Q2, which three kinds of generic drugs will be approved? Q2 is the first to see the progress of the three categories of generic drugs currently included in the priority review After sorting out, 21 drugs shown in the figure below are expected to be approved in the second quarter of 2019 Note: blue is the first time that Hengrui 3, which has no approval for domestic generic drugs of the same variety or dosage form, has been registered according to the pharmaceutical intelligence In the second quarter, Hengrui has three varieties or will be approved, which are respectively esmketamine hydrochloride injection, ondansetron oral dissolution membrane and azilsartan tablets Esmketamine hydrochloride injection is suitable for the induction and implementation of general anesthesia in combination with sleeping pills, as a supplement to local anesthesia, children's anesthesia, and for anesthesia and analgesia in emergency care Ketamine hydrochloride was first developed by parkedavis in 1962 After Pfizer acquired the company, it continued to develop the right-handed resolution of ketamine, namely, esmketamine Currently, esmketamine hydrochloride has been listed in Australia, Germany, the Netherlands and other countries, with the trade name of ketanests ® At present, Jiangsu Hengrui, Shanxi Taiyuan Pharmaceutical Co., Ltd., Shandong Fangming Pharmaceutical Co., Ltd and other enterprises have been approved to produce ketamine raw materials and injection in China No other enterprises have declared or produced esmketamine injection As the first declaration, Hengrui has completed the review on January 30, 2019, and will enter the approval process, or will be approved in Q2 It is worth mentioning that on March 5 this year, the FDA approved the intranasal administration of esmketamine hydrochloride, a heavy-duty antidepressant developed by Johnson & Johnson, which has been awarded two breakthrough therapies by the US FDA, including the treatment of drug-resistant depression (November 2013) and severe depression (August 2016), which is at risk of suicide It is a nasal spray that is used in combination with oral antidepressants to treat refractory depression With the approval of FDA, ketamine has become the first antidepressant with new mechanism in the past 30 years Ondansetron is a selective 5-HT3 receptor antagonist, which can be used to prevent nausea and vomiting caused by hyperemetic chemotherapy, moderate emetic chemotherapy and repeated courses, radiotherapy and postoperative nausea and vomiting It is a new dosage form of antiemetic first developed by mono solrx LLC it was approved by FDA in July 2010 and marketed under the trade name of zuprenz In 2017, the global sales volume of ondansetron oral solution membrane was about US $9.78 million At present, ondansetron hydrochloride tablets, capsules, orally disintegrating tablets and injection are the main preparations on the market in China Compared with other dosage forms, ondansetron oral dissolution membrane has the advantages of convenient use, no need for water delivery, rapid dissolution on the tongue, suitable for children, elderly patients and patients with dysphagia, improved patients' compliance and portability, and compared with orally disintegrating tablets, no need to worry about choking or inhalation, and no easy vomiting According to pharmaceutical intelligence data, except Hengrui pharmaceutical, there is no application for generic drug listing In addition, Kelun pharmaceutical has submitted the clinical application of ondansetron oral instant membrane 3.1, which has been approved Azilsartan, a new generation of selective AT1 subtype of angiotension II receptor antagonists (ARBs) antihypertensive drug, was developed by Takeda Pharmaceutical Co., Ltd in Japan, and was approved in January 2012 At present, the drug has not been listed in the original research in China According to the clinical application acceptance number of class 3.1 new drugs, it has reached 105, involving 59 enterprises Except for one acceptance number of Fujian Haixi new drug creation Co., Ltd., the rest have been approved for clinical application Only Hengrui and Beijing Baiao Pharmaceutical Co., Ltd apply for listing Beijing Baiao Pharmaceutical Co., Ltd has not yet started the review, but Hengrui has already started, and it is included in the priority review A supplementary application was made on October 12, 2018, and it is expected to complete the review and approval in Q2 Zhengda Tianqing 4 potential is the first one that imitates Zhengda Tianqing 4 potential varieties or will be approved in Q2 It is pomadolamine capsule, polymyxin e-mesylate sodium for injection, azacytidine for injection and bendamoxetine hydrochloride for injection Pomadolamine capsule is used to treat multiple myeloma Pomadelamine was developed by celgene company, and approved by FDA on February 8, 2013, and then approved by EMA on August 5, 2013, and sold by new base company, under the trade name of pomalyst (USA) or innovid (Europe) In 2017, sales of new base reached US $1614 million Pamidramine is a kind of thalidomide analogues, which is an immunomodulator with antitumor activity In vitro, pamidramine inhibited the proliferation and induced apoptosis of hematopoietic tumor cells At present, there are 51 clinical acceptance numbers applied for according to class 3.1 new drugs in China, all of which have been approved Only two acceptance numbers of Zhengda Tianqing have been reported for production The review has been completed on March 6 and will enter the approval process Polymyxin e-mesylate sodium for injection is used for gastrointestinal infection, such as dysentery, enteritis, peritonitis, bacterial diarrhea, food poisoning diarrhea, etc At present, there is no listing in China The import application of Taiwan Toyo Pharmaceutical Industry Co., Ltd is under review and approval The application for class 3.1 new drug of Jiangsu aosaikang Pharmaceutical Co., Ltd has been approved clinically and has not been applied for listing Zhengda Tianqing's listing application has been reviewed and is about to enter the approval process Azacytidine for injection The drug is used to treat the following subtypes of Fab myelodysplastic syndrome (MSD): refractory anemia (RA) or refractory anemia with ring sideroblastic cells (RARs) (blood transfusion is required if neutropenia or thrombocytopenia is accompanied), refractory anemia with excess primitive cells (RAEB), refractory anemia with excess primitive cell transformation (RAEB-T) and chronic cell leukemia（ CMMoL) Azacytidine was developed by the new base It was first approved by the US Food and Drug Administration (FDA) on May 19, 2004, and then approved by the European Drug Administration (EMA) on December 17, 2008 It was approved by the Japanese pharmaceutical medical device integration Agency (PMDA) on January 21, 2011 It was listed and sold by the new base in the US under the trade name of vidaza Azacytidine is a kind of cytosine nucleoside analogue, which is an inhibitor of nucleoside metabolism It can promote DNA hypomethylation to achieve antitumor effect At present, there is only original research on the import of Xinji in China, and only Zhengda Tianqing and Sichuan Huiyu have applied for listing of generic drugs The application of Zhengda Tianqing has been reviewed, and the supplementary application was made on August 28, 2018 The review will be completed and the approval process will be entered It is worth mentioning that Sichuan Huiyu's acceptance No 2 is declared according to the new 4 categories, among which the acceptance No 1 cyhs1700181 was undertaken on August 11, 2017, has been reviewed and is expected to be approved in Q2 Bendamostine hydrochloride for injection is used to treat B-cell non-Hodgkin's lymphoma which develops slowly during or within six months after rituximab or rituximab regimen Bendamostin was first made in East Germany (the former German Democratic Republic) in 1963 by ozgovsky and Krebs In March 2008, cephalon was approved by the U.S Food and Drug Administration (FDA) to be sold in the United States for the treatment of chronic lymphocytic leukemia In October 2008, FDA further approved treanda At present, there are only imported drugs from cephalon Inc in China, with 6 generic drug application acceptance numbers, involving 4 enterprises including Zhengda Tianqing, Nanjing Xiansheng Dongyuan, Jianjin pharmaceutical and Sichuan Huiyu pharmaceutical In addition to Zhengda Tianqing, Nanjing Xiansheng Dongyuan has also been included in the priority review, and Nanjing Xiansheng Dongyuan has completed the review ahead of Zhengda Tianqing (Xiansheng Dongyuan: August 28, 2018; Zhengda Tianqing: March 29, 2019) At present, both enterprises will enter the final approval stage, who can get the approval first, and pay attention to the follow-up [yaokejun] column tracking! Alfentanil hydrochloride injection alfentanil hydrochloride injection is a powerful analgesic for anesthesia, which is suitable for short-term surgery Major foreign manufacturers include akorn, hospita, etc At present, the drug is not on the market in China According to the data of pharmaceutical intelligence, only Renfu and 2 enterprises of Jiangsu Enhua Pharmaceutical Co., Ltd apply for the new drug of class 3.1, which has been approved clinically, but not on the market temporarily The listing application of Renfu has started the review, and the supplementary application has been made on January 7, 2019, which is about to complete the review and enter the approval process Melphalan for injection is a Racemic Phenylalanine nitrogen mustard, which can be used for tumor It is the first choice for multiple myeloma in single chemotherapy and combined chemotherapy Developed by GlaxoSmithKline At present, there are only imported mephram tablets from Aspen Pharmaceutical Industry Ltd and imported mephram hydrochloride for injection from spectrum pharmaceuticals, Inc in China At present, the generic drug market application only has the meprolan for injection of Xi'an Libang pharmaceutical, which has been reviewed and will enter the approval process later Beijing Taide pharmaceutical injection of epoprost sodium epoprost sodium used in the treatment of pulmonary hypertension (PAH) to improve exercise ability Epoprostol (PGI2, PGx, prostacyclin) is a metabolite of arachidonic acid It is a naturally occurring prostaglandin with strong vasodilative activity and platelet aggregation inhibitory activity The most common side effects of this product for injection include dizziness, chin pain, headache, muscle or bone pain, nausea or vomiting Serious side effects include pulmonary effusion (pulmonary edema), increased risk of bleeding, etc In addition, when epoprost is used with diuretics, antihypertensives or other vasodilators, additional blood pressure reduction may occur At present, there is no import in China, and only 2 enterprises apply for generic drugs Among them, the clinical application for class 3.1 new drugs of Hainan Lingkang pharmaceutical has been completed