【FSMP】 11 FSMPs Approved in China in the Second Quarter of 2024 – Bringing the Total to 192 - Regulatory News - Food & Food Contact Materials

Updated on July 4, 2024

According to the information from the Special Food Division of the State Administration for Market Regulation (SAMR), the number of foods for special medical purposes (FSMP) approved in China has reached 192 by July 1, 2024. In the second quarter of 2024, 11 domestic FSMPs have been approved, including three nutritionally complete products, six nutritionally incomplete products, and two infant formula for special medical purposes. Details are given in the table below:

Table 1. FSMPs approved in the second quarter of 2024

S.N.	Applicant	Product name	Dosage form	Certificate number	Valid until
1	Fresenius Kabi Huarui Pharmaceutical Co., Ltd.	德瑞清® liquid formula for special medical purposes	Liquid	国食注字TY20240017	2029.4.1
2	JIANGSU DAISY FSMP CO., LTD	冬泽益全nutritionally complete food for special medical purposes	Liquid	国食注字TY20240018	2029.4.1
3	JIANGSU DAISY FSMP CO., LTD	冬泽力亮protein formula for special medical purposes	Liquid	国食注字TY20240019	2029.4.1
4	JIANGSU DAISY FSMP CO., LTD	冬泽益能fat formula for special medical purposes	Powder	国食注字TY20240020	2029.4.1
5	Shandong Ruoyao FSMP Co. LTD	若宁thickening components for special medical purposes	Powder	国食注字TY20240021	2029.4.1
6	Nestlé Health Sciences (China) Co., Ltd.	佰态能nutritionally complete food for special medical purposes	Liquid	国食注字TY20240022	2029.5.16
7	Du’erbote Yili Dairy Co. LTD	托菲儿早护preterm/low birth weight infant formula for special medical purposes	Powder	国食注字TY20240023	2029.5.16
8	Du’erbote Yili Dairy Co. LTD	托菲儿早护preterm/low birth weight infant formula for special medical purposes	Powder	国食注字TY20240024	2029.5.16
9	Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd.	海维甘® nutritionally complete food for special medical purposes	Liquid	国食注字TY20240025	2029.5.16
10	Guizhou Jinjiu Biotech Co., Ltd	金康宜® electrolyte formula for special medical purposes	Liquid	国食注字TY20240026	2029.5.16
11	Guizhou Jinjiu Biotech Co., Ltd	玖康益® carbohydrate formula for special medical purposes	Liquid	国食注字TY20240027	2029.5.16

FSMP registration and approval status

As of July 1, 2024, a total of 192 FSMPs have obtained approval (with five having applied for cancellation). Of these, 159 are domestically produced and 33 are imported. Notably, among the approved products, the majority (141) are in powdered form, with the remaining 51 being liquid products.

China,Food,FSMP,Registration,Analysis,Medical,Special

Figure. 1 Distribution of domestic and imported FSMP

Figure. 2 Distribution of FSMP product forms

Analysis of previously registered FSMP types

Since the first infant formula for special medical purposes was successfully registered in 2017, the pathway for FSMP registration has officially opened. As shown in Figure 3, registrations for infant formula for special medical purposes experienced a strong start but later declined, with most registrations occurring in 2018 and 2019. Registrations for nutritionally incomplete formulas, on the other hand, were mainly concentrated in 2021 and 2023.

In 2022, the total number of registrations was relatively low, but the registered product types increased, including the first specific nutritionally complete formula.

In 2023, the first thickening component was introduced, with registrations primarily focusing on nutritionally complete and incomplete products, which together accounted for 87% of the total. Compared to the registration volume in 2022, 2023 showed explosive growth. In the first and second quarters of 2024, 17 and 11 new products were added respectively, indicating a strong momentum for approvals in 2024. Additionally, three specific nutritionally complete foods and one amino acid metabolism disorder formula have been included in the priority review and approval process.

The trend of registered types of FSMP over the years is shown in the figure below:

Figure. 3 FSMP registrations over the years

Distribution of approved product types

In terms of product types, as shown in the figure below, there are 56 infant formulas for special medical purposes, making up 29% of the total. These include five extensively hydrolyzed protein or amino acid formulas, 11 partially hydrolyzed protein formulas, 15 lactose-free or low-lactose formulas, one amino acid metabolism disorder formula, 19 preterm/low birth weight infant formulas, and five nutrition supplements. 76 are nutritionally incomplete foods, including 22 protein components, two fat components, 19 carbohydrate components, 24 electrolyte formulas, three thickening components, four liquid formulas, and two amino acid metabolism disorder formulas (for individuals over one year old), accounting for 40% of the total. The remaining 59 are nutritionally complete foods, accounting for 31% of the total. These include ten nutritionally complete foods designed for children aged 1-10 and 49 for individuals aged 10 and above. There is only one specific nutritionally complete food: Su Yisu oncology nutritionally complete food for special medical purposes.

Note: For detailed information on the names, applicants, registration numbers, and validity period of the 192 products, please click here to check out the latest list of registered FSMP products (approval information is subject to updates on the official website).

Figure. 4 Distribution of product types

Figure. 5 Registration volume of various products

Details are as follows:

Table 2. FSMP product types and approval status

Category/type			Number of approval	Product/Company	Target population
Infant formula for special medical purpose	Extensively hydrolyzed milk protein formula or amino acid-based formula food		5	Neocate / SHS	0-12 months
				ALFARE/ NESTLE
				Althera/NESTLE
				ALFAMINO/ NESTLE
				Pepti Junior/Nutricia
	Partially hydrolyzed milk protein formula food		11	Eleva Care / ABBOTT	0-12 months
				Similac / ABBOTT
				EnfaGentlease/MEAD JOHNSON
				优博敏佳/ SYNUTRA
				舒力乐/ HANGZHOU BEINGMATE
				Similac / ABBOTT
				特爱敏佳/ Qingdao Shengtong
				启赋®敏适/Nestle
				宜品怡贝/ Yeeper Dairy
				爱他美亲熠/ Nutricia
				恬适康敏/Shijiazhuang Junlebao Diary Group
	Lactose free formula or low lactose formula food		15	Beingmate / HANGZHOU BEINGMAT	0-12 months
				Enfagrow / MEAD JOHNSON
				安儿宁能恩/ Nestle
				爱思诺赋儿嘉/ Maeil Dairies
				力诺康宁/Tianjin Aumix
				优博瑞安/ SYNUTRA
				葆安素/Yeeper Dairy
				稚舒/ Ausnutria Dairy (China)
				蓓舒消/ Heilongjiang Feihe
				安尼尔/ Wissun International
				爱优诺优安力/ AusNuotore
				特爱瑞安/ Qingdao Shengtong
				嘉复褓/Zhangjiang kelubao
				能盾/ Wissun International
				怡安消/Shijiazhuang Junlebao Diary Group
	Amino acid metabolism disorder formula food		1	Periflex /SHS	0-12 months
	Premature or low birth weight infant formula food		17	Similac Neo/ABBOTT	0-12 months
				Similac Gro/ABBOTT
				早瑞能恩/NESTLE
				Enfapro/ MEAD JOHNSON
				优博安能/ SYNUTRA
				Similac/ ABBOTT
				Nutricia/ MILUPA
				早启能恩/ Nestle
				爱思诺晨而慧/ Maeil Dairies
				贝新尔/ HANGZHOU BEINGMATE
				Wyeth® ULTIMA® 蔼而嘉/Wyeth
				甄而蔼/ Yeeper Dairy
				爱优诺优健力/ AusNuotore
				特爱安能/ Qingdao Shengtong
				溙敏康/ Zhangjiang Kelubao
				蓓舒维/Heilongjiang Feihe
				蓓舒焕/Heilongjiang Feihe
				托菲儿早护/Du'erbote Yili Dairy Co. LTD
				托菲儿早优/Du'erbote Yili Dairy Co. LTD
	Infant nutrition supplement		5	Similac HMFortifi/ ABBOTT	0-12 months
				优博启能/ SYNUTRA
				昔倍护/ HANGZHOU BEINGMATE
				特爱启能/ Qingdao Shengtong
				嘉璐佰/Zhejiang Kelubao
FSMP for people over the age of 12 months	Nutritionally complete foods		56	Pediasure / ABBOTT	1-10 years old or above 10
				佳膳佳立畅/Nestle
				小佰太能/Nestle
				伊利®欣活®/Yili
				ENSURE COMPLETE®/Abbott
				NUTREN JUNIOR /Nestle
				NUTREN® OPTIMUM /Nestle
				优博启瑞/ SYNUTRA
				力存优太®/Nantong Richen
				麦孚畅清®/Jilin Maifu
				爱优诺优益力/ AusNuotore
				爱优诺优康力/ AusNuotore
				唯卡能®/Harbin Ballansat
				君蓓全/GUANGDONG JUNJOY
				希瑞臻/ SUZHOU HENGRUI JIANKANG
				唯源素®/YABAO
				希瑞怡®/ SUZHOU HENGRUI JIANKANG
				麦孚康全®/ Jilin Maifu
				拜妥优/KWINS HESLTH
				麦孚乐贝®/ Jilin Maifu
				特爱启瑞/Qingdao Shengtong
				冬泽全太/ DAISY FSMP
				力存全衡素®/Nantong Richen
				麦速®/ Jilin Maifu
				康素得臻膳/ Ausnutria Dairy
				康素得舒膳/ Ausnutria Dairy
				唯源全®/ YABAO
				海维舒®/ Jiangsu Zhengda Fenghai
				海维安®/ Jiangsu Zhengda Fenghai
				卡乐全/ Shandong Ruoyao
				润能®/ HAISCO PHARMACEUTICAL
				立佳营®/XI'AN LI BANG
				安能®/ HAISCO PHARMACEUTICAL
				麦孚乐宝®/ Jilin Maifu
				立佳泰/ XI'AN LI BANG
				佳安素/ AusNuotore
				江中初元/ Jiangzhong Pharmaceutical
				拜优能/KWINS HEALTH
				辰盈/Cisen Pharmaceutical
				伊盈佳®/Haizheng Sulikang
				能荃力益嘉/NUTRICIA （Wuxi）
				特宜元/SUNMYAN
				小拜妥优/KWINS HEALTH
				恒益启元/Wuxi Hengyi
				恒益卓元/Wuxi Hengyi
				小佳膳汇立能/Nestle(China)
				冬泽全素®/ DAISY FSMP
				益诺安/ Yeeper Dairy
				雅培®全安素®/ Abbott (Jiaxing)
				他普荟/Zhejiang kelubao
				德瑞怡®/ Fresenius Kabi
				德瑞太®/ Fresenius Kabi
				倍舒然/Heilongjiang Feihe
				博佳健®/Jilin Boya
				小佳太®/ Nantong Richen
				怡贯®/Linyi Shansong
				冬泽益全/JIANGSU DAISY FSMP CO., LTD
				佰态能/Nestlé
				海维甘®/Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd.
	Specific nutritionally complete foods	Tumor	1	速熠素/ Nestle	Above 10 years old
	Nutritionally incomplete foods	Electrolyte formula	23	君蓓乐维/Guangdong Junyue	Above 10 years old
				冬泽畅康/ DAISY FSMP
				乐赋/ SUZHOU HENGRUI JIANKANG
				特颐欣/ YICHANG HUMANWELL
葆畅佳/ CSPC Zhongnuo Yaoye
诺葆素®/Heibei Aisheng
西泓源®/Jiangshu Xihong
循康®/ HAISCO PHARMACEUTICAL
循畅®/ HAISCO PHARMACEUTICAL
辰乐维®/ Cisen Pharmaceutical
益护宁/ Zhejiang Yiyuansu
伊衡佳®/Zhejiang haizheng sulikang
艾诺利/Tibet DUOXIN
麦孚乐舒®/Jilin Maifu
金康宜®/Guizhou Jinjiu Biotech Co., Ltd
乐棠/ SUZHOU HENGRUI JIANKANG				Above 18 years old
枢能/ YICHANG HUMANWELL
若新/ Shandong Ruoyao
拜瑞恬/ KWINS HEALTH
恬能®/ Jiangsu Zhengda Fenghai				10-14 years old
贝耶/ Shandong Ruoyao				10-14 years old
乐潼/ SUZHOU HENGRUI JIANKANG				1-10 years old
君蓓乐维/GUANGDONG JUNJOY				Above 1 year old
Nutrient components		43	伊能佳®/ Haizheng Sulikang	Above 10 years old
			泉克/ Tibet DUOXIN
			普柔汀®/Guanzhou EnterNutr
			浦索®/ Jilin Maifu
			诺葆平®/ Hebei Aisheng
			葆棠华/ CSPC Zhongnuo Yaoye
			益安喜®/Zhejiang Yiyuansu
			西沁®/Jiangsu Xihong
			冬泽定/ DAISY FSMP
			蓝沛/Qingdao Languo
			诺葆安®/ Hebei Aisheng
			唯源泰®/ Yabao Pharmaceutical
			爱优诺优达力/ AusNuotore
			立如箐®/XI'AN LI BANG
			初元安本®/Jiangzhong Pharmaceutical
			嘉膳能/ KWINS HEALTH
			若益/ Shandong Ruoyao
			恒益清元/ Wuxi Hengyi
			爱优诺赋力素/ AusNuotore
			唯卡素®/ Harbin Ballansat
			海能博/ Hangzhou New Quxing
			科惠研/ Nanjing Jade Crane Ming
			冬泽力太/ DAISY FSMP
			若速/ Shandong Ruoyao
			力优宜®/ Nantong Richen
			采衡/Guangdong Yuewei
			伊畅佳®/ Haizheng Sulikang
			恒益舒棠/Wuxi Hengyi
			咪素®/Shandong Lihao
			艾诺佳/Tibet DUOXIN
			君蓓清/Guangdong Junjoy
			冬泽力亮/JIANGSU DAISY FSMP CO., LTD
			君蓓安/ GUANGDONG JUNJOY	Above 18 years old
			富安/Hainan DonglianChangfu
			素乾®/ Jiangsu Zhengda Fenghai
			若和®/Shandong Ruoyao
			冬泽速棠/ DAISY FSMP	Above 1 year old
			欣饴元/ Cisen Pharmaceutical
			冬泽力安/ DAISY FSMP
			冬泽予棠DAISY FSMP
			麦孚卡能®/Jilin Maifu
	冬泽益能/JIANGSU DAISY FSMP CO., LTD
	玖康益®/Guizhou Jinjiu Biotech Co., Ltd
Thickening components	3	麦孚顺宝® Jilin Maifu	Above 10 years old
		诺葆畅®/ Hebei Aisheng
		若宁/Shandong Ruoyao FSMP Co. LTD
Liquid formula	4	诺葆舒® /Heibei Aisheng	Above 10 years old
		术和®/ Jilin Maifu
		艾诺优/Tibet DUOXIN
		德瑞清®/Fresenius Kabi Huarui Pharmaceutical Co., Ltd.
Amino acid metabolism disorder formula	2	Periflex Ad./SHS	Above 10 years old
Amino acid metabolism disorder formula	2	Periflex®/SHS	1-10 years old

Analysis of applicants

In terms of applicants, a total of 53 companies have obtained FSMP registration certificates. Among them, 45 are domestic companies. Nestlé continues to lead with the highest number of approved products in China, totaling 16 products, followed by Jiangsu Daisy Dairy Co., LTD, and Jilin Maifu.

Nestlé, Abbott, and Nutricia, as global FSMP industry leaders, have secured approvals in both the infant and non-infant FSMP categories. In contrast, domestic companies tend to have a more singular focus. For example, domestic pharmaceutical companies mainly focus on non-infant FSMP, while domestic dairy companies primarily focus on infant FSMP. Only a few nutrition companies in the domestic market are involved in both sectors. In terms of registered companies and product numbers, the number of domestic registered companies and products has been steadily increasing, far surpassing foreign enterprises and taking a dominant position. Currently, FSMP registration is primarily concentrated among dairy, nutrition & health, and pharmaceutical companies.

Details are given in the following chart.

Figure. 6 Number of FSMP approved by companies

For more information on FSMP registration in China, please click here to know about our FSMP registration service.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

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