On Aug. 23, 2023, China’s National Health Commission (NHC), Ministry of Science and Technology (MOST), Ministry of Industry and Information Technology (MIIT), and National Medical Products Administration (NMPA) jointly released the 4th List of Pediatric Drugs Encouraged for Development and Marketing Authorization.
The list contains 24 drugs, involving 30 strengths, 9 dosage forms, and covering multiple therapeutic areas such as nervous system diseases, gastrointestinal system, metabolic disorders, tumors, and immune disease.
No. | Name (CN) | Name (EN) | Dosage Form | Strength | |
1 | 伏索利肽 | Vosoritide | Injection | 1.2 mg | |
Injection | 0.56 mg | ||||
Injection | 0.4 mg | ||||
2 | 喷他脒 | Pentamidine | Powder for injection | 300 mg | |
3 | 硝唑沙奈 | Nitazoxanide | Suspension | 100 mg/5 ml | |
4 | 吉妥珠单抗/ 奥加吉妥珠单抗 | Gemtuzumab/ Gemtuzumab Ozogamicin | Injection | 4.5 mg | |
5 | 阿伏利尤单抗 | Anifrolumab | Injection | 2 ml: 0.3 g | |
6 | 波舒替尼 | Bosutinib | Tablet | 0.1 g | |
7 | 奈莫利珠 单抗 | Nemolizumab | Injection | 60 mg | |
8 | 贝洛度尤 单抗 | Bezlotoxumab | Injection | 1 ml: 25 mg | |
9 | 吉伏司瑞 | Givosiran | Injection | 0.189 g | |
10 | 加那索龙 | Ganaxolone | Suspension | 1 ml: 50 mg | |
11 | 雷美替安 | Ramelteon | Tablet | 8 mg | |
12 | 艾夫糖苷酶α | Avalglucosidase alfa | Injection | 0.1 g | |
13 | 培伐利酶 | Pegvaliase | Injection | 2.5 mg | |
Injection | 20 mg | ||||
14 | 替利珠单抗 | Teplizumab | Injection | 2 ml: 2 mg | |
15 | 苯丁酸 甘油酯 | Glycerol Phenylbutyrate | Oral solution | 1.1 g/ml | |
16 | 奥立扑酶α | Olipudase alfa | Injection | 20 mg | |
17 | 非诺多泮 | Fenoldopam | Injection | 10 mg/ml | |
18 | 培妥罗凝血素α | Turoctocog alfa pegol | Injection | 500 IU | |
Injection | 1000 IU | ||||
19 | 左甲状腺素钠 | Levothyroxine Sodium | Oral solution | 5 ml:0.15 mg | |
20 | 高血糖素 | Glucagon | Nasal powder | 3 mg | |
21 | 芬戈莫德 | Fingolimod | Orally disintegrating tablet | 0.25 mg | |
22 | 米诺环素 | Minocycline | Topical foam | 4% | |
23 | 哌甲酯 | Methylphenidate | Extended-release capsule | 5 mg | |
Extended-release capsule | 10 mg | ||||
Extended-release capsule | 60 mg | ||||
24 | 格列本脲 | Glibenclamide | Suspension | 1 ml: 0.6 mg |
Notes: WHO International Nonproprietary Names (INN) are adopted for the listed drugs.
Most of the listed drugs have not been approved in China. However, due to the unmet clinical needs, including the need for rare disease treatment, the drugs do have market potential in China.
The drugs’ dosage forms, including oral solutions and nasal sprays, are diversified as many as possible to meet the needs of pediatric patients of different age groups.
What About the Previous Three Lists of Encouraged Pediatric Drugs
Prior to the 4th list, China has rolled out three lists of encouraged pediatric drugs since 2016. Among the 105 drugs in the three lists, 23 drugs have been approved in China, including 6 for rare disease treatment.
Other approved drugs are for mental disorder, tumor, respiratory system, and gastrointestinal system. Here are some examples:
The first Midazolam Oromucosal Solution approved in China for acute convulsion in pediatric patients.
The first chloral hydrate preparation approved in China for sedation in pediatric patients.
The first Enalapril Maleate Oral Solution approved in China for hypertension treatment in pediatric patients.
Clobazam Tablets for the treatment of refractory and rare epilepsy in pediatric patients.
What Support Will China Offer to Pediatric Drug Companies
The Chinese authorities state they will take supportive measures for the listed pediatric drugs in terms of R&D, registration, manufacture, use, and reimbursement.
MOST will step up support for scientific researches on pediatric drugs.
MIIT will encourage the development of the projects on pediatric drug-related industries.
NHC will offer favorable measures for the scientific projects which focus on the R&D and marketing authorization of pediatric drugs. NHC will also prioritize the drugs when considering which drugs should be added to the National Essential Drug Catalog, a list deemed as the basis for determining the drugs to be purchased and used at healthcare institutions in China.
Likewise, National Healthcare Security Administration (NHSA) will add weight to the drugs when evaluating which drugs should be admitted into the National Reimbursement Drug List (NRDL), a list of drugs reimbursed by China’s basic healthcare insurance.
Though detailed measures have not come into shape, the list bodes well for companies that are interested in developing and marketing the listed pediatric drugs.
Contact BaiPharm if you’d like to know more about China’s drug regulations and policies.
