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

Highlight: this month, the total number of drug audit centers accepted is 453 (excluding reexamination) In this month, 10 class 1 chemicals were applied for clinical trials of new drugs According to the latest statistics of drug intelligence database, in April 2018, CDE undertook 453 new drug registration applications with acceptance number (excluding reexamination, the same below) Fig 1 the total acceptance amount of CDE drugs in January April of 2018 decreased by 50.6% compared with that in March, including 345 chemical drugs, 25 traditional Chinese medicine, 76 biological products, 2 medical packaging materials, 3 medical auxiliary materials and 1 API Let's analyze the registration, acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products In April 2018, CDE undertook 345 new chemical registration applications with acceptance number Figure 2 the acceptance of CDE chemical drugs from January to April 2018 From the perspective of chemical drug declaration, in addition to adding an acceptance number to new drugs this month, supplement application, import, import re registration and imitation all decreased to varying degrees 1 Application of chemical medicine class 1 new drugs CDE accepted 29 acceptance numbers of chemical medicine class 1 new drugs this month, involving 10 varieties and 11 enterprises The figure below shows the newly undertaken class 1 new drugs in April Table I notes to newly undertaken new chemical drugs of category 1 in April 2018: 1 The queue number is up to May 2, 2018; 2 "*" is a special approved variety Tpn102 and its tablets developed by Shanghai Institute of medicine, Chinese Academy of sciences are new candidate antiepileptic drugs In vivo pharmacodynamics experiments showed that tpn102 had obvious therapeutic effect in the model of acute epilepsy induced by maximum electric shock, chemical induction and chronic electric kindling, and the effect was better than that of topiramate, which was a first-line antiepileptic drug, and had good therapeutic effect in the model of refractory epilepsy with ineffective topiramate Tpn102 has stable metabolic properties, high bioavailability (~ 100%), good blood-brain transmittance, no induction and inhibition of major CYP450 enzymes, and good pharmacokinetic properties Tpn102 has no Hg inhibition, hepatorenal cell toxicity and genetic toxicity Its main toxicity is enlarged pharmacological effect, showing good safety The clinical trial application was submitted to CFDA in December 2017, and has been undertaken by the drug Audit Center, waiting in line for audit This month, Zhengda Tianqing pharmaceutical group applied for tqa3526, the second innovative chemical medicine Figure 3 the application pattern of Zhengda Tianqing chemical in 2018 (up to May 2, 2018) the class 1 innovative drug max-40279-01 declared by Guangzhou Zaiji Pharmaceutical Technology Co., Ltd has entered the drug audit center The product is independently developed by repolarization medical researchers for the treatment of acute myeloid leukemia (AML) According to preclinical research data, max-40279 is a leading clinical trial product in the world, which can effectively overcome the drug resistance of bone marrow FGF pathway activation of drugs currently in clinical application through double strong inhibition of FLT3 and FGFR and high blood concentration of bone marrow drugs According to the information released by the company, its clinical product max-40279 has officially obtained the orphan drug qualification issued by the US Food and Drug Administration (FDA) Zsp1273 and its tablets are RNA polymerase inhibitors of influenza virus with clear mechanism and independent intellectual property rights jointly developed by Guangdong Zhongsheng Pharmaceutical Co., Ltd and Shanghai yaomingkant new drug development Co., Ltd The results of preclinical studies showed that zsp1273 had a strong in vitro broad-spectrum anti influenza A virus activity, and its inhibition ability to a variety of influenza A viruses was significantly better than that of oseltamivir, a compound with the same target and an enzyme inhibitor of neuraminidase; its in vivo efficacy test was also better than that of reference compound and oseltamivir with the same target to protect animals and reduce the titer of animal lung viruses; clinical Previous studies showed that zsp1273 had a strong inhibitory effect on oseltamivir resistant strains and highly pathogenic avian influenza The results also showed that the combination of zsp1273 and oseltamivir showed a strong synergistic effect, which could enhance the clinical anti influenza effect These results indicate that zsp1273 is of great clinical value (from its listing announcement) zsp1273 and tablet are the second category 1 innovative chemical drugs declared by Guangdong Zhongsheng Pharmaceutical Co., Ltd in 2018 In April, Sichuan Kelun Botai biomedical Co., Ltd declared a new innovative drug, kl280006 and injection Postoperative pain is the most common acute pain in clinic Opioids are recommended as an important part of postoperative analgesia, especially multimodal analgesia At present, the most commonly used opioids in clinic are central analgesics, which have many adverse reactions such as respiratory depression, restlessness, addiction, pruritus and constipation Kl280006 injection is a selective peripheral κ opioid receptor agonist with independent intellectual property rights developed by columbotel, which can achieve effective analgesia while avoiding the adverse reactions of central analgesic drugs, and is intended to be used for the treatment of acute pain (such as postoperative pain) Non clinical research data confirmed that kl280006 injection has a clear mechanism of action It has high affinity and high selectivity for peripheral kappa receptor, and it is not easy to penetrate the blood-brain barrier The analgesic effect has a good safety and tolerance, without adverse reactions such as heart, respiratory and central nervous system At present, there are no peripheral selective kappa receptor agonists approved for market in the world (source: announcement of listing) 2 Declaration of chemical medicine category 1 imported drugs this month 1 imported chemical medicine category 1 was undertaken Table II notes to newly undertaken imported chemical drugs of category 1 in April 2018: 1 The queue number is up to May 2, 2018; 2 "*" is a special approved variety Relugolix is a small molecule gonadotropin releasing hormone (GnRH) receptor antagonist, which is developed by myovant and Takeda This application is the first time Takeda has applied for import in China In April, CDE undertook 25 new applications for registration of traditional Chinese medicine, including 2 new drugs and 23 supplementary applications Fig 3 the acceptance of CDE traditional Chinese medicine from January to April in 2018, Shandong Academy of Pharmaceutical Sciences submitted two applications for listing five categories of traditional Chinese medicine new drugs, namely, side Calendula oral ulcer patch and total flavonoid extract of huangshusunflower III review of biological products in April CDE undertook 76 new biological product registration application acceptance numbers, 32 new drugs, 37 supplementary applications and 7 imports Figure 4 the acceptance of CDE biological products in January April, 2018 (4) the varieties declared according to the consistency evaluation this month, a total of 15 varieties were declared according to the requirements of the consistency evaluation Three new injection consistency evaluation varieties were added this month Table 4 data source of new undertaking consistency evaluation varieties in April 2018: Yaozhi registration and acceptance database