Hope to say goodbye to the downturn! Paediatric generic drugs will become a new hotspot

Recently, CFDA released the official draft of "technical guidelines for extrapolation of adult drug use data to pediatric population", which is undoubtedly a great benefit to pediatric drug research and development, especially paediatric generic drug research and development Although the current data shows that there are few paediatric drug projects launched, with the support and promotion of policies, paediatric generic drugs will become a new hot spot in the future The author analyzes the pediatric project approval since 2016, in order to find out the existing problems and future space of the pediatric project Since 2016, according to the statistics of clinical registration numbers, there are 55 registration numbers related to children's indications, Among them, levetiracetam tablets, tenofovir dipivoxil fumarate tablets, montelukast sodium granules, pegylated recombinant human growth hormone injection, recombinant human growth hormone injection and 13 valent pneumococcal conjugate vaccine are the top five registered products It can be seen that chemical generic drugs and biological products are the main product categories in clinical trials of pediatric drugs From the perspective of indications, anti infection, especially anti-virus infection, involves the largest number of pediatric drug clinical registration numbers There are two main categories: one is tenofovir fumarate dipivoxil tablets and lamivudine tablets, which are used to fight HIV-1 infection and treat chronic hepatitis B; the other is vaccines, such as 13 valent pneumococcal conjugate vaccine, B-type Haemophilus influenzae conjugate vaccine, Sabin strain poliomyelitis inactivated vaccine (Vero cell), 13 valent pneumococcal polysaccharide conjugate vaccine and enterovirus 71 Inactivated vaccine (human diploid cells) Epilepsy is the second indication of pediatric drugs with the second most clinical registration number, which are levetiracetam tablets, lamotrigine tablets and stivalol dry suspension Respiratory products are also clinical hot spots, such as montelukast sodium granules, a special drug for children's asthma, ambroxol hydrochloride solution for the treatment of mucositis caused by lower respiratory tract infection, and dimethylphenorphine phosphate syrup for the treatment of cough caused by children's respiratory tract infection Pediatric Chinese patent medicine is often the main focus of this specialty, such as children Xuanfei cough syrup From the perspective of the selection of indications, enterprises prefer the indications with greater market potential At present, there are few projects in China for the increasing number of ADHD and autism cases Which generic drugs will speed up the market? Although there are children with the registered indications, there are many products with the minimum age of 18 years or above in clinical trials
Including tenofovir dipivoxil fumarate tablets declared by Chongqing Yaoyou Pharmaceutical Co., Ltd., Sichuan haicisco Pharmaceutical Co., Ltd and Sichuan Kelun Pharmaceutical Co., Ltd., mengruist sodium granules declared by Jiangsu zhengdafenghai Pharmaceutical Co., Ltd., Jiangsu wangao Pharmaceutical Co., Ltd and Changchun Haiyue Pharmaceutical Co., Ltd., Zhejiang puluokangyu Pharmaceutical Co., Ltd., Beijing Sihuan pharmaceutical Co., Ltd., Zhejiang Huahai Pharmaceutical Co., Ltd., China Resources SECCO Pharmaceutical Co., Ltd and alabindu Pharmaceutical Co., Ltd., respectively Zuoxiracetam tablets declared, enterapine tenofovir tablets of Anhui Baker biopharmaceutical, pancreatin enteric coated capsules 25000 of Abbott Trading (Shanghai), stivalol dry suspension of Shijiazhuang No.4 pharmaceutical, cefuroxime ester tablets of Zhuhai United pharmaceutical, oseltamivir phosphate granules of Yichang East Sunshine Changjiang pharmaceutical, lamotrigine tablets of Zhejiang Huahai pharmaceutical, Shijiazhuang Longze pharmaceutical Lamivudine tablet, a recombinant human growth hormone injection of Anhui Anke biology Co., Ltd These products are mainly chemical generic drugs
However, according to the official draft of "technical guidelines for extrapolation of adult drug use data to pediatric population" released in May 2017, if there are no differences in disease epidemiology, etiology, pathogenesis, disease progression and prognosis between countries or regions, no racial differences, no clinical pharmacology (drug metabolism) and other differences, when there are existing Chinese adult data and the indications of overseas pediatric population have been approved Significant differences in dynamics, pharmacodynamics) and therapeutics (medical practice, safety and effectiveness data) can be used as clinical trial data of foreign pediatric population This means that the chemical generic products with children's indications have been listed abroad, and only the bioequivalence test of human needs to be completed to obtain pediatric indications In the short term, the number of paediatric indications and domestic listed manufacturers is small, and products with great market potential are expected to increase the number of clear declaration of the rules What is the main direction of the started project? For Chinese patent medicine, biological products, especially vaccines and unlisted chemical drugs in China, clinical trials for children still need to be started, which are generally over phase II clinical trials As shown in Table 1, the vaccine is mainly launched in the Centers for Disease Control and prevention The most popular centers for Disease Control and prevention of the manufacturers are the Centers for Disease Control and prevention of Henan Province and the Centers for Disease Control and prevention of Jiangsu Province Table 1 list of institutions that launched pediatric clinical trials after 2016 clinical trials of clinical research institutions (number) Beijing Children's Hospital Affiliated to Capital Medical University T0004 phase IV clinical of Zhangjiang Pharmaceutical Co., Ltd in Fudan, Taizhou, phase III clinical of ambroxol hydrochloride solution for inhalation of Jilin Sihuan Pharmaceutical Co., Ltd., ambroxol hydrochloride solution for inhalation of natural plant Pharmaceutical Co., Ltd in Longhai, Yunnan, 20mg / ml of pregabalin of Pfizer Phase III clinical of oral liquid, phase III clinical of trifluramine of Sanofi, phase II clinical of polyethylene glycol recombinant human growth hormone injection and phase III clinical of recombinant human growth hormone injection of Changchun Jinsai Pharmaceutical (7 items) Henan Provincial Center for Disease Control and Prevention Kexing (Dalian) live attenuated varicella vaccine phase III clinical, Tianjin kangxino acyw135 group meningococcal conjugate vaccine phase III clinical, Lanzhou Institute of biological products 13 valent pneumococcal conjugate vaccine phase I and phase II clinical, Yuxi Watson 13 valent pneumococcal polysaccharide conjugate vaccine phase III clinical, Beijing Tiantan Biological Sabin strain polio inactivated vaccine (Vero Cell) phase II and phase III clinical (7 items) phase III clinical of Haemophilus influenzae b conjugate vaccine of Luoyi (Wuxi) biology, phase III clinical of 13 valent pneumococcal conjugate vaccine of Beijing minhai biology, group a C of Chengdu Olin biology Group meningococcal combined vaccine phase III clinical, Sabin strain polio inactivated vaccine (Vero cell) of Beijing Kexing (4 items) First Hospital of Jilin University Ambroxol hydrochloride solution for inhalation, pegylated recombinant human growth hormone injection phase II, pregabalin 20mg / ml oral liquid phase III, telifloxamide phase III of Sanofi (4 items) Jiangxi Children's Hospital Phase III clinical application of ambroxol hydrochloride solution for inhalation of Jilin Sihuan Pharmaceutical Co., Ltd., phase II clinical application of ambroxol hydrochloride solution for inhalation of Yunnan Longhai natural plant Pharmaceutical Co., Ltd., phase II clinical application of polyethylene glycol recombinant human growth hormone injection of Changchun kinsai Pharmaceutical Co., Ltd., and phase III clinical application of diphenyl phosphate syrup of Guizhou bailing (4 items) The third stage clinical application of ambroxol hydrochloride solution for inhalation in Jilin 4th Ring Pharmaceutical Co., Ltd., Affiliated Children's Hospital of Zhejiang University Medical College, the second stage clinical application of polyethylene glycol recombinant human growth hormone injection, the third stage clinical application of recombinant human growth hormone injection, and the third stage clinical application of dimethylphenorphine phosphate syrup in Guizhou bailing (4 items) Phase III clinical application of ambroxol hydrochloride solution for inhalation in Jilin Sihuan Pharmaceutical Co., Ltd., Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University Medical College, phase III clinical application of ambroxol hydrochloride solution for inhalation in Yunnan Longhai natural plant Pharmaceutical Co., Ltd., and phase III clinical application of diphenkephalan phosphate syrup from Guizhou bailing (3 items) The third phase of ambroxol hydrochloride solution for inhalation of Jilin Sihuan pharmaceutical, Shanghai Children's Hospital, the second phase of polyethylene glycol recombinant human growth hormone injection and the third phase of recombinant human growth hormone injection of Changchun Jinsai Pharmaceutical (3 items) The second hospital affiliated to Wenzhou Medical University (Yuying children's Hospital Affiliated to Wenzhou Medical University) Jiangsu kefeiping's taibienan ester granule phase III clinical, Yunnan Longhai natural plant pharmaceutical industry's inhalative ambroxol hydrochloride solution, Guizhou bailing's dimethylphenorphine phosphate syrup phase III clinical (3 items) Phase III clinical application of ambroxol hydrochloride solution for inhalation in Jilin 4th Ring Pharmaceutical Co., Ltd., Shengjing Hospital Affiliated to China Medical University, phase III clinical application of ambroxol hydrochloride solution for inhalation in Yunnan Longhai natural plant Pharmaceutical Co., Ltd., and phase III clinical application of dimethylphenorphine phosphate syrup from Guizhou bailing (3 items) Phase II clinical application of pegylated recombinant human growth hormone injection of Changchun kinsai Pharmaceutical Co., Ltd., Xinhua Hospital Affiliated to Shanghai Jiaotong University Medical College, phase III clinical application of trimethyl enkephaline phosphate syrup of Guizhou bailing, phase III clinical application of treflomide of Sanofi (3 items) Shanxi children's Hospital Ambroxol hydrochloride solution for inhalation in Longhai natural plant pharmaceutical industry of Yunnan Province, pegylated recombinant human growth hormone injection phase II clinical application of Changchun Jinsai pharmaceutical industry, and diphenkephaline phosphate syrup phase III clinical application of Guizhou bailing (3 items) disease prevention and control center of Xiangfu District, Kaifeng City Kexing (Dalian) live attenuated varicella vaccine phase III clinical, Tianjin kangxinuo group acyw135 meningococcal conjugate vaccine phase III clinical (2 items) Nanchang Third Hospital The third stage clinical application of ambroxol hydrochloride solution for inhalation of Jilin Sihuan Pharmaceutical Co., Ltd and the third stage clinical application of dimethylphenorphine phosphate syrup of Guizhou bailing (2 items) the Second Affiliated Hospital of Kunming Medical University, the First Affiliated Hospital of Xiamen University Phase Ⅱ clinical application of pegylated recombinant human growth hormone injection and phase Ⅲ clinical application of recombinant human growth hormone injection in Changchun Jinsai Pharmaceutical Co., Ltd., the First Affiliated Hospital of Nanjing Medical University (2 items)