On Dec 30, 2020, the National Health Commission (NHC) announced the list of second batch of encouraged generic drugs, including 19 drugs in which patents are about to expire in 2021 and 2022. The list is selected collectively by the National Health Commission (NHC), Ministry of Science and Technology (MOST), Ministry of Industry and Information Technology (MIIT), National Healthcare Security Administration (NHSA), China National Intellectual Property Administration (CNIPA), and National Medical Products Administration (NMPA). NHC is openly circulating for comments for the list from industries until Jan 7, 2021.

 

Specific information about the drugs is as follows:

 

List of Second Batch of Suggested Generic Drugs

 

SN	Drug Name	Dosage Form	Strength
1	Arformoterol	Inhalation Solutions	2ml:15μg
2	Fluticasone Furoate and Vilanterol Trifenatate	Powder for Inhalation	0.1mg Fluticasone, 25μg Vilanterol
3	Fluticasone Furoate, Umeclidinium Bromide and Vilanterol Trifenatate	Powder for Inhalation	0.1mg Fluticasone, 62.5μg Umeclidinium Bromide, 25μg Vilanterol; 0.2mg Fluticasone, 62.5μg Umeclidinium Bromide, 25μg Vilanterol
4	Clevidipine	Emulsions for Injection	50ml:25mg, 100ml:50mg
5	Obeticholic Acid	Tablets	5mg
6	Plecanatide	Tablets	3mg
7	Mirabegron	Sustained-release Tablets	25mg, 50mg
8	Elagolix	Tablets	150mg, 200mg
9	Eliglustat	Capsules	84mg
10	Macimorelin	Oral Solutions	120ml:60mg
11	Eslicarbazepine	Tablets	200mg, 400mg
12	Perampanel	Tablets	2mg, 4mg
		Oral Suspensions	0.5mg/ml
13	Brivaracetam	Tablets	10mg, 25mg, 50mg
		Oral Solutions	10mg/ml
		Injections	5ml:50mg
14	Desvenlafaxine	Sustained-release Tablets	25mg, 50mg, 100mg
15	Tasimelteon	Capsules	20mg
16	Tapentadol	Sustained-release Tablets	50mg, 100mg
17	Brimonidine Tartrate and Timolol Maleate	Eye Drops	0.2% Brimonidine Tartrate, 0.5% Timolol Maleate
18	Cabazitaxel	Injections	1.5ml: 60mg
19	Olaparib	Tablets	150mg

 

 

Background Information:

The list of First Batch of Encouraged Generic Drugs was issued for the first time on June 20, 2019 and it was later officially published on September 17, 2019. The first batch included 33 drugs. Besides some domestic drugs whose patents had already expired or were close to expiration, the list also included, as recognized by the Chinese officials, those that were in short clinical supply and those with insufficient market competition. The indications of the drugs covered Behcet’s disease, tuberous sclerosis, myasthenia gravis and etc. In the official announcement, it was indicated that the government encouraged relevant enterprises in the industry to develop and produce the drugs in the list. In turn, the government would provide assistance in areas like clinical trials and technical research, and also grant priority status during the review and approval procedure.