Pediatric generic drugs are about to become a new hot spot.-Zhejiang Jianfeng Pharmaceutical Co., Ltd.

Pediatric generic drugs are about to become a new hot spot.

Release time:

2017-06-02

A few days before Children's Day, CFDA released the official draft of "Technical Guidelines for Extrapolation of Adult Drug Use Data to Pediatric Population", which is undoubtedly a major benefit for pediatric drug research and development, especially for pediatric generic drugs. Although the current data shows that pediatric drug projects are rarely launched, with the support and promotion of policies, generic pediatric drugs will become a new hot spot in the future.

Pediatric project "most"

Since 2016, according to the statistics of clinical registration numbers, there are 55 registration numbers related to children's indications, of which levetiracetam tablets, tenofovir disoproxil fumarate tablets, montelukast sodium granules, polyethylene glycol recombinant human growth hormone injection, recombinant human growth hormone injection and 13-valent pneumococcal conjugate vaccine are the top five products with registration numbers. It can be seen that chemical generics and biological products are the main product categories in pediatric drug clinical trials.

In terms of indications, the number of clinical registration numbers of pediatric drugs involved in anti-infection, especially anti-viral infections, is the largest. There are two main types: one is tenofovir disoproxil fumarate 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, Haemophilus influenzae type B conjugate vaccine, Sabin strain polio inactivated vaccine (Vero cells), 13-valent pneumococcal polysaccharide conjugate vaccine and enterovirus 71 inactivated vaccine (human diploid cells).

Epilepsy is the second most clinical registration number of pediatric drug indications, respectively, levetiracetam tablets, lamotrigine tablets and setipentanol dry suspension.

Respiratory products are also clinical hotspots, such as montelukast sodium granules, a special drug for children with asthma, ambroxol hydrochloride solution for inhalation for the treatment of mucus disease of lower respiratory tract infection, and dimethorphan phosphate syrup for the treatment of cough caused by respiratory tract infection in children. Pediatric Chinese patent medicine is also often the main focus of this Junior College, such as pediatric lung cough syrup.

From the perspective of the choice of indications, companies prefer indications with greater market potential. At present, there are few projects in China for ADHD and autism where epidemiological cases are increasing.

Which generic drugs will accelerate the market?

Although there are children with registered indications, there are many products whose minimum age for clinical trial entry is over 18 years old.

Including tenofovir disoproxil fumarate tablets declared by Chongqing Pharmaceutical Friends Pharmaceutical, Sichuan Haisco Pharmaceutical and Sichuan Kelun Pharmaceutical respectively, montelukast sodium granules declared by Jiangsu Zhengda Fenghai Pharmaceutical, Jiangsu Wangao Pharmaceutical and Changchun Haiyue Pharmaceutical respectively, levetiracetam tablets declared by Zhejiang Prokangyu Pharmaceutical, Beijing Sihuan Pharmaceutical, Zhejiang Huahai Pharmaceutical, Huarun Seko Pharmaceutical and Alabindol Pharmaceutical respectively, and enovale and enovalide tablets declared by Anhui Tenobin, pancreatin enteric-coated capsule 25000 of Abbott Trade (Shanghai), stipiroxol dry suspension of Shijiazhuang Four Drugs, cefuroxime axetil tablets of Zhuhai Federal Pharmaceutical, oseltamivir phosphate granules of Yichang East Sunshine Changjiang Pharmaceutical, lamotrigine tablets of Zhejiang Huahai Pharmaceutical, lamivudine tablets of Shijiazhuang Longze Pharmaceutical, and recombinant human growth hormone injection of Anhui Anke Biological. 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 and prognosis of disease progression in countries or regions, there are no racial differences, provided that there are already Chinese adult data and indications for foreign pediatric population have been approved, there are no significant differences in clinical pharmacology (pharmacokinetics, pharmacodynamics) and therapeutics (medical practice, safety and effectiveness data), and foreign pediatric population drug clinical trial data can be used. This means that chemical generic drug products that have been listed abroad with children's indications only need to complete the human bioequivalence test to obtain pediatric indications.

In the short term, the number of pediatric indications and the number of domestic listed manufacturers is small, the market potential of the product is expected to increase the number of clear declarations of the rules.

The main direction of the launched project?

For Chinese patent medicines, biological products, especially vaccines, and chemical drugs that are not listed in China, it is still necessary to initiate clinical trials for children. Such trials are generally clinical trials above Phase II.

As shown in Table 1, the vaccine is mainly launched in the Center for Disease Control and Prevention. The most popular disease prevention and control centers are Henan Provincial Center for Disease Control and Prevention and Jiangsu Provincial Center for Disease Control and Prevention.

Table 1 List of institutions initiating pediatric clinical trials after 2016

Clinical Research Institutions	Clinical Trials (number)
Beijing Children's Hospital Affiliated to Capital Medical University	Taizhou Fudan Zhangjiang Pharmaceutical's T0004 Phase IV Clinical, Jilin Sihuan Pharmaceutical's Ambroxol Hydrochloride Solution for Inhalation Phase III Clinical, Yunnan Longhai Natural Plant Pharmaceutical's Ambroxol Hydrochloride Solution for Inhalation Phase III Clinical, Pfizer's Pregabalin 20 mg/mL Oral Liquid Phase III Clinical, Sanofi's Teriflunomide Phase III Clinical, Changchun Jinsai Pharmaceutical's Polyethylene Glycol Recombinant Human Growth Hormone Injection Phase II Clinical, Recombinant Human Growth Hormone Injection Phase III Clinical (Recombinant Human Growth Hormone Injection)
Henan Provincial Center for Disease Control and Prevention	Phase III clinical trials of live attenuated varicella vaccine from Kexing (Dalian), Phase III clinical trials of group ACYW135 meningococcal conjugate vaccine from Tianjin Kangshino, Phase I and Phase II clinical trials of 13-valent pneumococcal conjugate vaccine from Lanzhou Institute of Biological Products, Phase III clinical trials of 13-valent pneumococcal polysaccharide conjugate vaccine from Yuxi Watson, phase II and III clinical trials of Sabin strain inactivated polio vaccine (Vero cells) from Beijing Tiantan Biology (7 items)
Jiangsu Provincial Center for Disease Control and Prevention	Luo Yi (Wuxi) Biology's Haemophilus influenzae Type B Conjunction Vaccine Phase III Clinical, Beijing Minhai Biology's 13-valent Pneumococcal Conjunction Vaccine Phase III Clinical, Chengdu Olin Biology's Group A Group C Meningococcal Conjunction Vaccine Phase III Clinical, Beijing Kexing's Sabin Strain Inactivated Poliomyelitis Vaccine (Vero Cell)(4 Items)
The First Hospital of Jilin University	Yunnan Longhai Natural Plant Pharmaceutical's Ambroxol Hydrochloride Solution for Inhalation, Changchun Kinsey Pharmaceutical's Polyethylene Glycol Recombinant Human Growth Hormone Injection Phase II Clinical, Pfizer's Pregabalin 20 mg/mL Oral Liquid Phase III Clinical, Sanofi's Teriflunomide Phase III Clinical (4 items)
Jiangxi Provincial Children's Hospital	Phase III Clinical of Ambroxol Hydrochloride Solution for Inhalation of Jilin Sihuan Pharmaceutical, Phase II Clinical of Ambroxol Hydrochloride Solution for Inhalation of Yunnan Longhai Natural Plant Pharmaceutical, Phase II Clinical of Polyethylene Glycol Recombinant Human Growth Hormone Injection of Changchun Jinsai Pharmaceutical, Phase III Clinical of Guizhou Bailing Dimethorphan Phosphate Syrup (4 items)
Children's Hospital of Zhejiang University School of Medicine	Phase III Clinical of Ambroxol Hydrochloride Solution for Inhalation of Jilin Sihuan Pharmaceutical, Phase II Clinical of Polyethylene Glycol Recombinant Human Growth Hormone Injection of Changchun Jinsai Pharmaceutical, Phase III Clinical of Recombinant Human Growth Hormone Injection, Phase III Clinical of Guizhou Bailing Dimethorphan Phosphate Syrup (4 items)
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine	Phase III Clinical of Ambroxol Hydrochloride Solution for Inhalation of Jilin Sihuan Pharmaceutical, Phase III Clinical of Ambroxol Hydrochloride Solution for Inhalation of Yunnan Longhai Natural Plant Pharmaceutical, and Phase III Clinical of Guizhou Bailing Diphthanol Phosphate Syrup (3 items)
Shanghai Children's Hospital	Jilin Sihuan Pharmaceutical's Ambroxol Hydrochloride Solution for Inhalation Phase III Clinical, Changchun Jinsai Pharmaceutical's Polyethylene Glycol Recombinant Human Growth Hormone Injection Phase II Clinical, Recombinant Human Growth Hormone Injection Phase III Clinical (3 items)
Second Affiliated Hospital of Wenzhou Medical University (Affiliated Yuying Children's Hospital)	Jiangsu Kefeiping's Tibipenem Ester Granules Phase III Clinical, Yunnan Longhai Natural Plant Pharmaceutical's Ambroxol Hydrochloride Solution for Inhalation, Guizhou Bailing's Dimethylphenane Phosphate Syrup Phase III Clinical (3 items)
Shengjing Hospital of China Medical University	Phase III Clinical of Ambroxol Hydrochloride Solution for Inhalation of Jilin Sihuan Pharmaceutical, Phase III Clinical of Ambroxol Hydrochloride Solution for Inhalation of Yunnan Longhai Natural Plant Pharmaceutical, and Phase III Clinical of Guizhou Bailing Diphthanol Phosphate Syrup (3 items)
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Changchun Jinsai Pharmaceutical's polyethylene glycol recombinant human growth hormone injection phase II clinical, Guizhou Bailing's dimethorphan phosphate syrup phase III clinical, Sanofi's teriflunomide phase III clinical (3 items)
Children's Hospital of Shanxi Province	Ambroxol Hydrochloride Solution for Inhalation of Yunnan Longhai Natural Plant Pharmaceutical, Polyethylene Glycol Recombinant Human Growth Hormone Injection Phase II Clinical of Changchun Kinsey Pharmaceutical, and Dimethylorphan Phosphate Syrup Phase III Clinical of Guizhou Bailing (3 items)
Kaifeng Xiangfu District Center for Disease Control and Prevention	Phase III clinical trial of live attenuated varicella vaccine of Kexing (Dalian) and phase III clinical trial of group ACYW135 meningococcal conjugate vaccine of Tianjin Kangshino (2 items)
The Third Hospital of Nanchang	Phase III Clinical of Ambroxol Hydrochloride Solution for Inhalation of Jilin Sihuan Pharmaceutical and Phase III Clinical of Dimethylalkane Phosphate Syrup of Guizhou Bailing (2 items)
The First Affiliated Hospital of Xiamen University
The Second Affiliated Hospital of Kunming Medical University
The First Affiliated Hospital of Nanjing Medical University	Changchun Jinsai Pharmaceutical's polyethylene glycol recombinant human growth hormone injection phase II clinical, recombinant human growth hormone injection phase III clinical (2)
Hubei Provincial Hospital of Traditional Chinese Medicine	Phase IV Clinical of Xiaoer Huanglong Granules of Chongqing Xian Pharmaceutical and Phase III Clinical of Xiaoer Xuanfei Zhike Syrup of Qingdao Haichuan Innovative Biological Natural Medicine Research Center (2 items)
Children's Hospital of Fudan University	Changchun Jinsai Pharmaceutical's polyethylene glycol recombinant human growth hormone injection phase II clinical, Sanofi's teriflunomide phase III clinical (2 items)
West China Hospital of Sichuan University	Pfizer's Pregabalin 20 mg/mL Oral Solution Phase III Clinical, Sanofi's Teriflunomide Phase III Clinical (2 items)
The First Affiliated Hospital of Chongqing Medical University
The First Hospital of Shanxi Medical University
Tangdu Hospital of the Fourth Military Medical University
The Third Affiliated Hospital of Sun Yat-sen University
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Changchun Jinsai Pharmaceutical's polyethylene glycol recombinant human growth hormone injection phase II clinical, recombinant human growth hormone injection phase III clinical (2)
changge city center for disease control and prevention	Phase II and III clinical trials of Sabin strain inactivated polio vaccine (Vero cells) from Beijing Tiantan Biology (2 items)
Neihuang County Center for Disease Control and Prevention
Hunan Children's Hospital	Phase II Clinical of Polyethylene Glycol Recombinant Human Growth Hormone Injection of Changchun Jinsai Pharmaceutical (1 item)
Henan Wenxian Center for Disease Control and Prevention	The 13-valent pneumococcal conjugate vaccine phase I and phase II clinical (2 items) of Lanzhou Institute of Biological Products
Jiangsu Provincial Hospital of Traditional Chinese Medicine	Phase II and Phase III Clinical Studies of Xiaoer Xuanfei Zhike Syrup in Qingdao Haichuan Innovative Biological Natural Medicine Research Center (2 items)
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region
Affiliated Hospital of Nanjing University of Chinese Medicine
Henan Puyang County Center for Disease Control and Prevention	Phase II clinical study of 13-valent pneumococcal conjugate vaccine in Lanzhou Institute of Biological Products (1 item)
Chaoyang District Center for Disease Control and Prevention of Beijing Municipality	Phase III Clinical of 13-valent Pneumococcal Polysaccharide Conjunction Vaccine of Yuxi Watson Bio (1 item)
Hebei Provincial Center for Disease Control and Prevention
Shanxi Provincial Center for Disease Control and Prevention
Lianshui County Center for Disease Control and Prevention	Phase III Clinical Study of Group A and Group C Meningococcal Conjunction Vaccine of Chengdu Oulin Biology (1 item)
Pizhou Center for Disease Control and Prevention	Sabin strain inactivated polio vaccine (Vero cells) from Beijing Kexing (1 item)
Biyang County Center for Disease Control and Prevention	Phase III Clinical of Live Attenuated Varicella Vaccine in Kexing (Dalian) (1 item)
Xiangcheng County Center for Disease Control and Prevention
Affiliated Hospital of Yanbian University	Guizhou Bailing's dimethorphanol phosphate syrup phase III clinical (1 item)
Shenzhen Children's Hospital
Changde First People's Hospital
Huashan Hospital	Pfizer's Pregabalin 20 mg/mL Oral Solution Phase III Clinical (1 item)
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Teriflunomide Phase III in Sanofi (1)
Peking University First Hospital
The Second Hospital of Hebei Medical University
The Second Xiangya Hospital of Central South University
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine	Pediatric Huanglong Granules Phase IV Clinical (1 item) of Chongqing Shier Pharmaceutical
Huanggang Central Hospital
The Second People's Hospital of Yibin
The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Kaifeng Traditional Chinese Medicine Hospital
Hangzhou Seventh People's Hospital
Luoyang Second Traditional Chinese Medicine Hospital
Luohe Central Hospital
Shenyang Children's Hospital

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