[exclusive] analysis report on CDE drug review in June 2018

Attention: A kind of In this month, the total number of drug audit centers accepted is 651 (excluding reexamination) A kind of This month, the drug examination center of the state drug administration undertook a total of 2 applications for the listing of new chemical drugs of category I A kind of This month, 59 acceptance numbers declared according to the requirements of consistency evaluation were added, including 17 injection acceptance numbers According to the latest statistics of drug intelligence database, in June 2018, CDE undertook 651 new drug registration applications with acceptance number (excluding reexamination, the same below) Figure 1 the total acceptance amount of CDE drugs in January June 2018 continued to increase, 15.8% higher than that in May, including 538 chemical drugs, 53 traditional Chinese medicine, 43 biological products, 2 pharmaceutical packaging materials, 3 pharmaceutical excipients, 8 APIs, 3 in vitro diagnostic reagents and 1 combination of drugs and instruments Let's analyze the registration, acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products In June 2018, CDE undertook 538 new chemical registration applications with acceptance number This month, 47 acceptance numbers beginning with jth are added, which are found to be the acceptance numbers for one-time import application through small compilation Figure 2 acceptance of CDE chemical drugs from January to June 2018 from the perspective of chemical drug declaration, the number of newly increased acceptance numbers of new drugs in this month has decreased, and the number of supplementary applications, imports, import re registration and imitation has increased significantly 1 Application of chemical medicine class 1 new drugs CDE accepted 33 acceptance numbers of chemical medicine class 1 new drugs this month, involving 13 enterprises of 12 varieties The figure below shows the newly undertaken class 1 new drugs in June Table I notes to newly undertaken class 1 new chemical drugs in June 2018: 1 Queue No until July 9, 2018 The clinical trial application of class 1 Chemical d-0502 and d-0502 tablets declared by Yifang Biotechnology (Shanghai) Co., Ltd has been accepted by CDE According to the database of clinical trials, the drug is an anti breast cancer drug Currently, a phase I clinical trial will be conducted in the United States (in the state of non recruitment) Table II: relevant clinical trial data of d-0502: rmx1002 tablets declared by Hangzhou ruomaixiang Pharmaceutical Technology Co., Ltd were first undertaken by the drug Audit Center on March 30, 2017, and obtained the clinical approval document in November 2017 A clinical trial application was also submitted in May 2018 At present, only one phase 1 clinical trial is in progress (not yet recruited), and the registered indications are signs and symptoms for the treatment of osteoarthritis; relieve the persistent moderate to severe pain Table 3 rmx1002 related clinical trial data Shandong green leaf Pharmaceutical Co., Ltd submitted two clinical trial applications for class I chemical drugs - lpm570065 and ly03012 sustained release tablets this month According to the inquiry, lpm570065 is a prodrug of oral antidepressant demethylvenlafaxine (ODV), which is used for antidepressant treatment Ly03012 sustained release tablet is a new analgesic drug under research, which has been officially accepted by the State Food and Drug Administration and will enter phase I clinical trial Ly03012 is an oral small molecule compound As a new inhibitor of monoamine neurotransmitter transporter, ly03012 can enter the brain and inhibit presynaptic membrane 5-hydroxytryptamine transporter (SERT), noradrenaline transporter (net) and dopamine transporter, DAT) increased the concentration of noradrenaline, 5-hydroxytryptamine and dopamine in the synaptic space, and then played an analgesic role by enhancing the downward inhibition pathway of pain regulation In addition, ly03012 can also regulate the sleep wake of the body, which is different from the drugs in the same indication field that have been listed, and it can play an analgesic role without causing central inhibition related adverse reactions such as sedation and drowsiness (source of company news) kw-136 and capsule declared by Beijing Kaiyin Technology Co., Ltd is an NS5A inhibitor for the treatment of hepatitis C Kw-136 first submitted clinical trial application in 2015 At present, three clinical trials have been carried out in China Table 4: relevant clinical trial data of kw-136 Nanjing Shenghe Pharmaceutical Co., Ltd applied for a new class I chemical drug, sh1573, which was independently developed this month The indication was malignant hematoma In September 2017, another class I chemical shc014748m was declared by Nanjing Shenghe Its indication is also malignant hematoma In February this year, it has obtained the approval of clinical trial Zhejiang Essen Pharmaceutical Co., Ltd formally submitted the listing application of ivetinib maleate capsule to the State Drug Administration this month, which has been undertaken by the drug audit center and listed in the NDA sequence to wait for trial Ivetinib maleate capsule first submitted clinical trial application in August 2013, and applied for phase II / III clinical trial in 2016 Ivetinib maleate is an original national class 1.1 new drug independently developed by Essen Pharmaceutical Research Co., Ltd and the first third generation EGFR inhibitor to enter clinical research in China It has obtained the support of major national new drug development projects during the 12th Five Year Plan, and is mainly used to treat the first generation of EGFR targeted drug-resistant non-small cell lung cancer This month, Shanghai Pharmaceutical Group Co., Ltd reported the first category 1 Chemical drug of the year - sph4480 and sph4480 tablets This month, Jiangsu Enhua Pharmaceutical Co., Ltd submitted another application for clinical trial of class 1 Chemicals - d20140305-1 hydrochloride tablet, which is mainly used for the treatment of acute and chronic schizophrenia, as well as the treatment of obvious positive symptoms and obvious negative symptoms of other kinds of psychosis Rosa Sita capsule is the second class 1 listing application of chemical drugs undertaken by the drug examination center this month Rosastah is declared by fabergin (China) Pharmaceutical Technology Development Co., Ltd The listing application of losartan for the treatment of anemia in patients with dialysis dependent chronic kidney disease (dd-ckd) and patients with non dialysis dependent chronic kidney disease (ndd-ckd) was accepted by CDE on November 1, 2017, and was included in the priority review varieties by CDE on December 1, 2017, on the grounds that "it has obvious treatment advantages compared with the existing treatment methods" 2 Declaration of chemical medicine category 1 imported drugs 7 imported chemical medicine category 1 drugs were undertaken this month Table 5 notes to newly undertaken imported chemicals of category 1 in June 2018: 1 Queue No up to July 9, 2018 2 Evaluation of traditional Chinese medicine in June, CDE undertook 53 new applications for registration of traditional Chinese medicine, including 4 new drugs and 28 supplementary applications Figure 3 acceptance of CDE traditional Chinese medicine from January to June 2018 three review of biological products in June CDE undertook 43 new biological product registration application acceptance numbers, 12 new drugs, 26 supplementary applications and 4 imports Figure 4 acceptance of CDE biological products in January June 2018 4 Approval of new drugs in this month 6 Approval of new drugs in June 2018 5 Application and approval of varieties according to conformity evaluation 59 application acceptance numbers according to conformity evaluation requirements were added in this month, including 17 injection acceptance numbers By the end of June, there were 46 acceptance numbers in total, 29 varieties had passed the consistency The following is a compilation of the first drugs and enterprises that have passed the consistency evaluation Table 7 data source of the first pass of consistency evaluation varieties: drug intelligence registration and acceptance database