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Updated on October 15, 2024

According to the information released by the Department of Special Food of the State Administration of Market Supervision, as of September 30, 2024, the number of domestic and foreign special medical foods successfully registered in China has reached 206.

14 new special medical foods were added in the third quarter of 2024, all of which are domestically manufactured products, including six full nutritional products, six non-full nutritional products, and two special medical infant products, and the details of the new products are listed in the table below:

Table 1: List of new special medical foods added in the third quarter

Applicant	Product name	Dosage form	Certificate number	Expiry date
Tecang Pharmaceutical Group Co.	丰白protein formula for special medical purpose	Powder	国食注字TY20240028	2029.7.1
Tecang Pharmaceutical Group Co.	速劲carbohydrate formula for special medical purpose	Powder	国食注字TY20240029	2029.7.1
Tecang Pharmaceutical Group Co.	益立佳protein formula for special medical purpose	Liquid	国食注字TY20240030	2029.7.1
Jiangsu Zhengda Fenghai Pharmaceutical Co.	冬泽力顺thickening components for special medical purpose	Powder	国食注字TY20240031	2029.7.1
Jiangsu Dongze Special Medical Food Co.	爱优诺优贝素®infant nutrition supplement for special medical purpose	Powder	国食注字TY20240032	2029.8.28
Aiyunuo Nutritional Products Co.	海乐泰®nutritionally complete food for special medical purpose	Liquid	国食注字TY20240033	2029.8.28
Jiangsu Zhengda Fenghai Pharmaceutical Co.	卓倍全®nutritionally complete food for special medical purpose	Powder	国食注字TY20240034	2029.8.28
Heilongjiang Feihe Dairy Co.	倍舒和nutritionally complete food for special medical purpose	Powder	国食注字TY20240035	2029.8.28
Heilongjiang Feihe Dairy Co.	石药诺宁nutritionally complete food for special medical purpose	Powder	国食注字TY20240036	2029.8.28
Shijiazhuang Junlebao Taihang Dairy Co.	恬适优康preterm/low birth weight infant formula for special medical purpose	Powder	国食注字TY20240037	2029.8.28
Shijiazhuang Junlebao Taihang Dairy Co.	述畅®protein formula for special medical purpose	Powder	国食注字TY20240038	2029.8.28
Jiangxi Renzhichu Dairy Nutrition Co.	卡素益®protein formula for special medical purpose	Powder	国食注字TY20240039	2029.8.28
Shaanxi Qinlong Tianrun Dairy Co.	佰美乐nutritionally complete food for special medical purpose	Powder	国食注字TY20240040	2029.8.28
Nanjing Hemeile Biotechnology Co.	石药诺力nutritionally complete food for special medical purpose	Powder	国食注字TY20240041	2029.8.28

FSMPs Registration Approval Status

As of September 30, 2024, a total of 206 registrations of foods for special medical purposes (FSMPs) have been approved (of which five have applied for cancelation). With 174 domestically produced and 32 imported, and the number of domestically produced products registered has far exceeded that of imported products. Among the 206 approved products, 153 products are powdered, and the remaining 53 are liquid.

1. Analysis of FSMP registration types in the past years

Since the successful registration of the first special medical infant formula product in 2017, the door of special medical food registration has been officially opened. As can be seen from Figure 3, Infant FSMPs show a trend of high start and low finish, and their registration is mainly concentrated in 2018 and 2019, while the registration of nutritionally complete food is concentrated in 2021 and 2023. In 2022, the total number of registrations was less, but the types of registered products increased, and the first nutritionally complete food was registered. The first thickening component was registered in 2023, and the types of registrations were mainly concentrated in nutritionally complete and nutritionally incomplete food, which accounted for 87% of the total. Compared with the number of registrations in 2022, 2023 has shown explosive growth. 42 new products have been approved in the first three quarters of 2024, which shows that the momentum of product approval in 2024 is strong, and there are already three nutritionally complete foods and one amino acid metabolism disordered formula that have been announced for inclusion in the priority review and approval process.

The trend of types of FSMP registrations over the years is shown in the chart below:

Figure 3. FSMP registrations over the years

2. Distribution of approved product types

From the perspective of product type, as shown in the figure below, 58 of the approved products are infant FSMPs, accounting for 28% of the total, including five milk protein deeply hydrolyzed formulas or amino acid formulas, 11 milk protein partially hydrolyzed formulas, 15 lactose-free or low-lactose formulas, one amino acid metabolism disordered formula, 20 preterm/low-birth-weight infant formulas, and six nutritional supplements; 82 were non-complete FSMPs, including 26 protein components, two fat components, 20 carbohydrate components, 24 electrolyte formulas, four thickening components, four fluid formulas, and two formulas for impaired metabolism of amino acids (one year and older), representing 40% of the total; 65 were complete food formulas, representing 32% of the total, including 11 complete food formulas (1-10 years) and 54 complete food formulas (over 10 years old); only one specific complete food, namely Tacteasy Special Medical Use Tumor complete Food.

Note: For detailed information on the specific names, registered companies, registration numbers, and expiration dates of the 206 products, please click on List of Registered Formulas for Special Medical Purposes (information on approvals is subject to the release of the official website).

Figure 4: Distribution of product types

Figure 5. Product Registrations by Category

Specific product registration information is listed below:

Table 2: Types of FSMPs and Corresponding Approvals

*Newly registered products in the third quarter are shown in red.

Category			Number of approvals	Brand/Company	Population
Infant Formula for Special Medical Purposes	Extensively hydrolyzed milk protein or amino acid-based formula		5	纽康特/SHS Nutricia	0-12 months
				蔼儿舒/NESTLE
				肽敏舒/NESTLE
				恩敏舒/NESTLE
				纽太特/Nutricia
	Partially hydrolyzed milk protein formula food		11	Abbott亲护/Abbott	0-12 months
				菁挚呵护/Abbott
				亲舒/MEAD JOHNSON B.V.
				优博敏佳/SYNUTRA
				超启能恩/NESTLE
				舒力乐/HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION
				特爱敏佳/Qingdao Shengtong Nutrition Food
				启赋®敏适/NESTLE
				宜品怡贝/Beian Yeeper Dairy
				爱他美亲熠/Nutricia
				恬适康敏/Shijiazhuang Junlebao Taihang Diary Group
	Lactose-free or low-lactose formula food		15	贝因美/HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION	0-12 months
				安儿宝/MEAD JOHNSON B.V.
				安儿宁能恩/NESTLE
				爱思诺赋儿嘉/Maeil Dairies
				力诺康宁/Tianjin Aumix Dairy
				优博瑞安/SYNUTRA
				葆安素/Beian Yeeper Dairy
				稚舒/Ausnutria Dairy (China)Ausnutria Dairy (China)
				蓓舒消/Heilongjiang Feihe Dairy
				安尼尔/Wissun International Nutrition
				爱优诺优安力/AusNuotore Nutritional Products
				特爱瑞安/Qingdao Shengtong Nutrition Food
				嘉复褓/Zhejiang Kelubao Food
				能盾/Wissun International Nutrition
				怡安消/Shijiazhuang Junlebao Taihang Diary Group
	Amino acid metabolism disorder formula food		1	纽贝瑞/ SHS Nutricia	0-12 months
	Premature or low birth weight infant formula food		20	喜康宝贝初/Abbott	0-12 months
				喜康宝贝育/Abbott
				早瑞能恩/NESTLE
				安婴宝/MEAD JOHNSON B.V.
				优博安能/SYNUTRA
				Abbott喜康宝/Abbott
				纽荃星/Milupa
				早启能恩/NESTLE
				爱思诺晨而慧/Maeil Dairies
				贝新尔/HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION
				惠氏®铂臻®蔼而嘉/Wyeth
				甄而蔼/Beian Yeeper Dairy
				爱优诺优键力/AusNuotore
				特爱安能/Qingdao Shengtong Nutrition Food
				溙敏康/Zhejiang Kelubao Food Co., Ltd.
				蓓舒维/Heilongjiang Feihe Dairy
				蓓舒焕/Heilongjiang Feihe Dairy
				托菲儿早护/Du’erbote Yili Dairy Co. LTD
				托菲儿早优/Du’erbote Yili Dairy Co. LTD
				恬适优康/Shijiazhuang Junlebao Taihang Diary Group
	Infant nutrition supplement		6	喜康宝贝添/Abbott	0-12 months
				优博启能/SYNUTRA
				昔倍护/HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION
				特爱启能/Qingdao Shengtong Nutrition Food
				嘉璐佰/Zhejiang Kelubao Food Co., Ltd.
				爱优诺优贝素®/Jiangsu Dongze Special Medical Food Co.
FSMPs	Nutritionally complete foods		65	小安素/Abbott	1-10 years or older
				佳膳佳立畅/NESTLE
				小佰太能/NESTLE
				Du’erbote Yili Dairy Co. LTD®欣活®/Du’erbote Yili Dairy Co. LTD
				全安素®/Abbott
				小佳膳/NESTLE
				佳膳悠选/NESTLE
				优博启瑞/SYNUTRA
				力存优太®/Nantong Richen Bioengineering Co. LTD
				麦孚畅清®/Maifu Nutrition
				爱优诺优益力/Jiangsu Dongze Special Medical Food Co.
				爱优诺优康力/Jiangsu Dongze Special Medical Food Co.
				唯卡能®/Harbin Ballansat Clinical Nutrition Co., Ltd
				君蓓全/GUANGDONG JUNJOY MEDICAL NUTRITION CO., LTD
				希瑞臻/SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD
				唯源素®/YABAO Pharmaceutical Group Co., L
				希瑞怡®/SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD
				麦孚康全®/Maifu Nutrition
				拜妥优/KWINS HEALTHY Pharmaceutical Jiangsu Co., LTD
				麦孚乐贝®/Maifu Nutrition
				特爱启瑞/Qingdao Shengtong Nutrition Food
				冬泽全太/JIANGSU DAISY FSMP CO., LTD
				力存全衡素®/Nantong Richen Bioengineering Co. LTD
				麦速®/Maifu Nutrition
				康素得臻膳/Ausnutria Dairy (China) Co., Ltd
				康素得舒膳/Ausnutria Dairy (China) Co., Ltd
				唯源全®/YABAO Pharmaceutical Group Co., L
				海维舒®/Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd.
				卡乐全/Shandong Ruoyao FSMP Co. LTD
				海维安®/Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd.
				润能®/Liaoning Haisco Pharmaceutical Co., Ltd.
				立佳营®/Xi'an Libang Clinical Nutrition Co., Ltd.
				安能®/Liaoning Haisco Pharmaceutical Co., Ltd.
				麦孚乐宝®/Maifu Nutrition
				立佳泰/Xi'an Libang Clinical Nutrition Co., Ltd.
				佳安素/ AusNuotore
				江中初元/Jiangzhong Pharmaceutical Co., Ltd.
				拜优能/KWINS HEALTHY Pharmaceutical Jiangsu Co., LTD
				辰盈/Cisen Pharmaceutical Co., Ltd
				伊盈佳®/Zhejiang Hisun Sulikang Biotechnology Co., Ltd.
				能荃力益嘉/Nutricia Pharmaceuticals (Wuxi) Co., Ltd.
				特宜元/Hunan Shengmingyuan FSMP Biotechnology Co., Ltd.
				小拜妥优/KWINS HEALTHY Pharmaceutical Jiangsu Co., LTD
				恒益启元/Wuxi Hengyi Health Technology Co., Ltd.
				恒益卓元/Wuxi Hengyi Health Technology Co., Ltd.
				小佳膳汇立能/NESTLE（China）
				冬泽全素®/JIANGSU DAISY FSMP CO., LTD
				益诺安/Beian Yeeper Dairy Co., Ltd
				Abbott®全安素®/Abbott (Jiaxing)
				他普荟/Zhejiang Kelubao Food Co., Ltd.
				德瑞怡®/Fresenius Kabi Huarui Pharmaceutical Co., Ltd.
				德瑞太®/Fresenius Kabi Huarui Pharmaceutical Co., Ltd.
				倍舒然/Heilongjiang Feihe Dairy
				博佳健®/Jilin Boya Nutraceuticals Co., Ltd.
				小佳太®/Nantong Richen Bioengineering Co. LTD
				怡贯®/Linyi Shansong Pharmaceutical Co., Ltd.
				冬泽益全/JIANGSU DAISY FSMP CO., LTD
				佰态能/NESTLE
				海维甘®/Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd.
				海乐泰®/Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd.
				卓倍全®/Heilongjiang Feihe Dairy
				倍舒和/Heilongjiang Feihe Dairy
				石药诺宁/Heilongjiang Feihe Dairy Co.
				佰美乐/Nanjing Hemeile Biotechnology Co.
石药诺力/Heilongjiang Feihe Dairy Co.
Specific nutritionally complete foods	Tumor complete nutrition	1	速熠素/NESTLE	10 years older
Non Specific nutritionally complete foods	Electrolyte formula	24	君蓓乐维/GUANGDONG JUNJOY MEDICAL NUTRITION CO., LTD	1 year older
			冬泽畅加/JIANGSU DAISY FSMP CO., LTD	1 year older
			乐赋/SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD	10 years older
			卡捷®/Maifu Nutrition
			特颐欣/YICHANG HUMANWELL FSMP Co. LTD
			葆畅佳/Heilongjiang Feihe Dairy Co.
			冬泽畅康/JIANGSU DAISY FSMP CO., LTD
			诺葆素®/Hebei Aisheng Technology Co., Ltd
			西泓源®/Jiangsu Xihong Biological Medicine Co. LTD
			循康®/Liaoning Haisco Pharmaceutical Co., Ltd.
			循畅®/Liaoning Haisco Pharmaceutical Co., Ltd.
			辰乐维®/Cisen Pharmaceutical Co., Ltd
			益护宁/Zhejiang Yiyuanyu Nutrition Technology Co., Ltd.
			伊衡佳®/Zhejiang Hisun Sulikang Biotechnology Co., Ltd.
			艾诺利/Tibet DUOXIN HEALTH CO., LTD.
			麦孚乐舒®/Maifu Nutrition
			金康宜®/Guizhou Jinjiu Biotech Co., Ltd
			乐棠/SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD	18 years and older
			枢能/YICHANG HUMANWELL FSMP Co. LTD
			若新/Shandong Ruoyao FSMP Co. LTD
			拜瑞恬/KWINS HEALTHY Pharmaceutical Jiangsu Co., LTD
			恬能®/Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd.	10-14 years
			贝耶/Shandong Ruoyao FSMP Co. LTD	10-14 years
			乐潼/SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD	1-10 years
	Nutrient component	48	伊能佳®/Zhejiang Hisun Sulikang Biotechnology Co., Ltd.	10 years older
			泉克/Tibet DUOXIN HEALTH CO., LTD.
			普柔汀®/Guangzhou EnterNutr
			浦索®/Maifu Nutrition
			诺葆平®/Hebei Aisheng Technology Co., Ltd
			葆棠华/Heilongjiang Feihe Dairy Co.
			益安喜®/Zhejiang Yiyuanyu Nutrition Technology Co., Ltd.
			西沁®/Jiangsu Xihong Biological Medicine Co. LTD
			冬泽定/JIANGSU DAISY FSMP CO., LTD
			蓝沛/Qingdao Lanpei Nutrition health Technology Co., LTD
			诺葆安®/Hebei Aisheng Technology Co., Ltd
			唯源泰®/YABAO Pharmaceutical Group Co., L
			爱优诺优达力/AusNuotore
			立如箐®/Xi'an Libang Clinical Nutrition Co., Ltd.
			初元安本®/Jiangzhong Pharmaceutical Co., Ltd.
			嘉膳能/KWINS HEALTHY Pharmaceutical Jiangsu Co., LTD
			若益/Shandong Ruoyao FSMP Co. LTD
			恒益清元/Wuxi Hengyi Health Technology Co., Ltd.
			爱优诺赋力素/AusNuotore
			唯卡素®/Harbin Ballansat Clinical Nutrition Co., Ltd
			海能博/Hangzhou Nuquxing Biotechnology Co., Ltd.D
			科惠研/Nanjing Yuheming Medical Nutrition Technology Co., Ltd.
			冬泽力太/JIANGSU DAISY FSMP CO., LTD
			若速/Shandong Ruoyao FSMP Co. LTD
			力优宜®/Nantong Richen Bioengineering Co. LTD
			采衡/Guangdong Yue Microbiology Technology Co., Ltd.
			伊畅佳®/Zhejiang Hisun Sulikang Biotechnology Co., Ltd.
			恒益舒棠/Wuxi Hengyi Health Technology Co., Ltd.
			咪素®/Shandong Lihao Food for Special Medical Purpose Co., Ltd.
			艾诺佳/Tibet DUOXIN HEALTH CO., LTD.
			君蓓清/GUANGDONG JUNJOY MEDICAL NUTRITION CO., LTD
			冬泽力亮/JIANGSU DAISY FSMP CO., LTD
			丰白/Tecang Pharmaceutical Group Co.
			速劲/Tecang Pharmaceutical Group Co.
			益立佳/Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd.丰海
			述畅®/Shijiazhuang Junlebao Taihang Dairy Co.
			卡素益®/Jiangxi Renzhichu Dairy Nutrition Co.
			君蓓安/GUANGDONG JUNJOY MEDICAL NUTRITION CO., LTD	18 years older
			富安特/Hainan DonglianChangfu Pharmaceutical Co., Ltd
			素乾®/Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd.
若和®/Shandong Ruoyao FSMP Co. LTD
冬泽速棠/JIANGSU DAISY FSMP CO., LTD			1 year older
欣饴元/Cisen Pharmaceutical Co., Ltd
冬泽力安/JIANGSU DAISY FSMP CO., LTD
冬泽予棠/JIANGSU DAISY FSMP CO., LTD
麦孚卡能®/Maifu Nutrition
冬泽益能/JIANGSU DAISY FSMP CO., LTD
玖康益®/Guizhou Jinjiu Biotech Co., Ltd
Thickening components	4	麦孚顺宝®/Maifu Nutrition	10 years older
		诺葆畅®/Hebei Aisheng Technology Co., Ltd
		若宁/Shandong Ruoyao FSMP Co. LTD
		冬泽力顺/JIANGSU DAISY FSMP CO., LTD
Liquid components	4	诺葆舒®Hebei Aisheng Technology Co., Ltd	10 years older
		术和®Maifu Nutrition
		艾诺优/Tibet DUOXIN HEALTH CO., LTD.
		德瑞清®/Fresenius Kabi Huarui Pharmaceutical Co., Ltd.
Amino acid metabolism disorder formula food (above 1 year old)	2	纽贝臻/SHS	10 years older
	2	纽贝福 Periflex®/SHS	1-10 years

3. Analysis of declared enterprises

According to enterprises, a total of 58 enterprises have obtained the registration of FSMPs, and the number of domestic enterprises that have obtained the certificate of registration has reached 50. With a total of 15 products, Nestle is still the enterprise with the largest number of approved products in China, followed by JIANGSU DAISY FSMP CO., LTD and Maifu Nutrition. Nestle, Abbott and Nutricia, as the world's leading FSMPs companies, they have products approved in both the non-infant FSMPs and infant FSMPs sectors.

On the other hand, there is a product homogenization phenomenon among domestic enterprises, such as domestic pharmaceutical enterprises mainly focusing on non-infant FSMPs, domestic dairy enterprises mainly focusing on infant FSMPs, and only some nutrition enterprises are involved in both infant FSMPs and non-infant FSMPs. From the point of view of the number of registered enterprises and products, the number of registered domestic enterprises and products continues to increase and far exceeds the number of foreign enterprises and occupies a dominant position. At present, the registration of FSMPs is mainly concentrated in dairy, nutrition and health, pharmaceutical and other enterprises.

The specific situation of the number of products approved by each enterprise is shown in the following chart:

Figure 6. Number of Approved FSMPs by Enterprise

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