【FSMP】 14 Approvals in Q3 of 2024 – Analysis of 206 Registered FSMP Formulas in China - Regulatory News - Food & Food Contact Materials

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.	豐白protein formula for special medical purpose	Powder	國食注字TY20240028	2029.7.1
Tecang Pharmaceutical Group Co.	速勁carbohydrate formula for special medical purpose	Powder	國食注字TY20240029	2029.7.1
Tecang Pharmaceutical Group Co.	益立佳protein formula for special medical purpose	Liquid	國食注字TY20240030	2029.7.1
Jiangsu Zhengda Fenghai Pharmaceutical Co.	冬澤力順thickening components for special medical purpose	Powder	國食注字TY20240031	2029.7.1
Jiangsu Dongze Special Medical Food Co.	愛優諾優貝素®infant nutrition supplement for special medical purpose	Powder	國食注字TY20240032	2029.8.28
Aiyunuo Nutritional Products Co.	海樂泰®nutritionally complete food for special medical purpose	Liquid	國食注字TY20240033	2029.8.28
Jiangsu Zhengda Fenghai Pharmaceutical Co.	卓倍全®nutritionally complete food for special medical purpose	Powder	國食注字TY20240034	2029.8.28
Heilongjiang Feihe Dairy Co.	倍舒和nutritionally complete food for special medical purpose	Powder	國食注字TY20240035	2029.8.28
Heilongjiang Feihe Dairy Co.	石藥諾寧nutritionally complete food for special medical purpose	Powder	國食注字TY20240036	2029.8.28
Shijiazhuang Junlebao Taihang Dairy Co.	恬適優康preterm/low birth weight infant formula for special medical purpose	Powder	國食注字TY20240037	2029.8.28
Shijiazhuang Junlebao Taihang Dairy Co.	述暢®protein formula for special medical purpose	Powder	國食注字TY20240038	2029.8.28
Jiangxi Renzhichu Dairy Nutrition Co.	卡素益®protein formula for special medical purpose	Powder	國食注字TY20240039	2029.8.28
Shaanxi Qinlong Tianrun Dairy Co.	佰美樂nutritionally complete food for special medical purpose	Powder	國食注字TY20240040	2029.8.28
Nanjing Hemeile Biotechnology Co.	石藥諾力nutritionally complete food for special medical purpose	Powder	國食注字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	紐康特/SHS Nutricia	0-12 months
				藹兒舒/NESTLE
				肽敏舒/NESTLE
				恩敏舒/NESTLE
				紐太特/Nutricia
	Partially hydrolyzed milk protein formula food		11	Abbott親護/Abbott	0-12 months
				菁摯呵護/Abbott
				親舒/MEAD JOHNSON B.V.
				優博敏佳/SYNUTRA
				超啟能恩/NESTLE
				舒力樂/HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION
				特愛敏佳/Qingdao Shengtong Nutrition Food
				啟賦®敏適/NESTLE
				宜品怡貝/Beian Yeeper Dairy
				愛他美親熠/Nutricia
				恬適康敏/Shijiazhuang Junlebao Taihang Diary Group
	Lactose-free or low-lactose formula food		15	貝因美/HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION	0-12 months
				安兒寶/MEAD JOHNSON B.V.
				安兒寧能恩/NESTLE
				愛思諾賦兒嘉/Maeil Dairies
				力諾康寧/Tianjin Aumix Dairy
				優博瑞安/SYNUTRA
				葆安素/Beian Yeeper Dairy
				稚舒/Ausnutria Dairy (China)Ausnutria Dairy (China)
				蓓舒消/Heilongjiang Feihe Dairy
				安尼爾/Wissun International Nutrition
				愛優諾優安力/AusNuotore Nutritional Products
				特愛瑞安/Qingdao Shengtong Nutrition Food
				嘉復褓/Zhejiang Kelubao Food
				能盾/Wissun International Nutrition
				怡安消/Shijiazhuang Junlebao Taihang Diary Group
	Amino acid metabolism disorder formula food		1	紐貝瑞/ SHS Nutricia	0-12 months
	Premature or low birth weight infant formula food		20	喜康寶貝初/Abbott	0-12 months
				喜康寶貝育/Abbott
				早瑞能恩/NESTLE
				安嬰寶/MEAD JOHNSON B.V.
				優博安能/SYNUTRA
				Abbott喜康寶/Abbott
				紐荃星/Milupa
				早啟能恩/NESTLE
				愛思諾晨而慧/Maeil Dairies
				貝新爾/HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION
				惠氏®鉑臻®藹而嘉/Wyeth
				甄而藹/Beian Yeeper Dairy
				愛優諾優鍵力/AusNuotore
				特愛安能/Qingdao Shengtong Nutrition Food
				溙敏康/Zhejiang Kelubao Food Co., Ltd.
				蓓舒維/Heilongjiang Feihe Dairy
				蓓舒煥/Heilongjiang Feihe Dairy
				托菲兒早護/Du’erbote Yili Dairy Co. LTD
				托菲兒早優/Du’erbote Yili Dairy Co. LTD
				恬適優康/Shijiazhuang Junlebao Taihang Diary Group
	Infant nutrition supplement		6	喜康寶貝添/Abbott	0-12 months
				優博啟能/SYNUTRA
				昔倍護/HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION
				特愛啟能/Qingdao Shengtong Nutrition Food
				嘉璐佰/Zhejiang Kelubao Food Co., Ltd.
				愛優諾優貝素®/Jiangsu Dongze Special Medical Food Co.
FSMPs	Nutritionally complete foods		65	小安素/Abbott	1-10 years or older
				佳膳佳立暢/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
				佳膳悠選/NESTLE
				優博啟瑞/SYNUTRA
				力存優太®/Nantong Richen Bioengineering Co. LTD
				麥孚暢清®/Maifu Nutrition
				愛優諾優益力/Jiangsu Dongze Special Medical Food Co.
				愛優諾優康力/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
				麥孚康全®/Maifu Nutrition
				拜妥優/KWINS HEALTHY Pharmaceutical Jiangsu Co., LTD
				麥孚樂貝®/Maifu Nutrition
				特愛啟瑞/Qingdao Shengtong Nutrition Food
				冬澤全太/JIANGSU DAISY FSMP CO., LTD
				力存全衡素®/Nantong Richen Bioengineering Co. LTD
				麥速®/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
				海維舒®/Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd.
				卡樂全/Shandong Ruoyao FSMP Co. LTD
				海維安®/Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd.
				潤能®/Liaoning Haisco Pharmaceutical Co., Ltd.
				立佳營®/Xi'an Libang Clinical Nutrition Co., Ltd.
				安能®/Liaoning Haisco Pharmaceutical Co., Ltd.
				麥孚樂寶®/Maifu Nutrition
				立佳泰/Xi'an Libang Clinical Nutrition Co., Ltd.
				佳安素/ AusNuotore
				江中初元/Jiangzhong Pharmaceutical Co., Ltd.
				拜優能/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.
				小拜妥優/KWINS HEALTHY Pharmaceutical Jiangsu Co., LTD
				恒益啟元/Wuxi Hengyi Health Technology Co., Ltd.
				恒益卓元/Wuxi Hengyi Health Technology Co., Ltd.
				小佳膳匯立能/NESTLE（China）
				冬澤全素®/JIANGSU DAISY FSMP CO., LTD
				益諾安/Beian Yeeper Dairy Co., Ltd
				Abbott®全安素®/Abbott (Jiaxing)
				他普薈/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
				怡貫®/Linyi Shansong Pharmaceutical Co., Ltd.
				冬澤益全/JIANGSU DAISY FSMP CO., LTD
				佰態能/NESTLE
				海維甘®/Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd.
				海樂泰®/Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd.
				卓倍全®/Heilongjiang Feihe Dairy
				倍舒和/Heilongjiang Feihe Dairy
				石藥諾寧/Heilongjiang Feihe Dairy Co.
				佰美樂/Nanjing Hemeile Biotechnology Co.
石藥諾力/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	君蓓樂維/GUANGDONG JUNJOY MEDICAL NUTRITION CO., LTD	1 year older
			冬澤暢加/JIANGSU DAISY FSMP CO., LTD	1 year older
			樂賦/SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD	10 years older
			卡捷®/Maifu Nutrition
			特頤欣/YICHANG HUMANWELL FSMP Co. LTD
			葆暢佳/Heilongjiang Feihe Dairy Co.
			冬澤暢康/JIANGSU DAISY FSMP CO., LTD
			諾葆素®/Hebei Aisheng Technology Co., Ltd
			西泓源®/Jiangsu Xihong Biological Medicine Co. LTD
			循康®/Liaoning Haisco Pharmaceutical Co., Ltd.
			循暢®/Liaoning Haisco Pharmaceutical Co., Ltd.
			辰樂維®/Cisen Pharmaceutical Co., Ltd
			益護寧/Zhejiang Yiyuanyu Nutrition Technology Co., Ltd.
			伊衡佳®/Zhejiang Hisun Sulikang Biotechnology Co., Ltd.
			艾諾利/Tibet DUOXIN HEALTH CO., LTD.
			麥孚樂舒®/Maifu Nutrition
			金康宜®/Guizhou Jinjiu Biotech Co., Ltd
			樂棠/SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD	18 years and older
			樞能/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
			貝耶/Shandong Ruoyao FSMP Co. LTD	10-14 years
			樂潼/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
			諾葆平®/Hebei Aisheng Technology Co., Ltd
			葆棠華/Heilongjiang Feihe Dairy Co.
			益安喜®/Zhejiang Yiyuanyu Nutrition Technology Co., Ltd.
			西沁®/Jiangsu Xihong Biological Medicine Co. LTD
			冬澤定/JIANGSU DAISY FSMP CO., LTD
			藍沛/Qingdao Lanpei Nutrition health Technology Co., LTD
			諾葆安®/Hebei Aisheng Technology Co., Ltd
			唯源泰®/YABAO Pharmaceutical Group Co., L
			愛優諾優達力/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.
			愛優諾賦力素/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.
			冬澤力太/JIANGSU DAISY FSMP CO., LTD
			若速/Shandong Ruoyao FSMP Co. LTD
			力優宜®/Nantong Richen Bioengineering Co. LTD
			采衡/Guangdong Yue Microbiology Technology Co., Ltd.
			伊暢佳®/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.
			艾諾佳/Tibet DUOXIN HEALTH CO., LTD.
			君蓓清/GUANGDONG JUNJOY MEDICAL NUTRITION CO., LTD
			冬澤力亮/JIANGSU DAISY FSMP CO., LTD
			豐白/Tecang Pharmaceutical Group Co.
			速勁/Tecang Pharmaceutical Group Co.
			益立佳/Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd.豐海
			述暢®/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
冬澤速棠/JIANGSU DAISY FSMP CO., LTD			1 year older
欣飴元/Cisen Pharmaceutical Co., Ltd
冬澤力安/JIANGSU DAISY FSMP CO., LTD
冬澤予棠/JIANGSU DAISY FSMP CO., LTD
麥孚卡能®/Maifu Nutrition
冬澤益能/JIANGSU DAISY FSMP CO., LTD
玖康益®/Guizhou Jinjiu Biotech Co., Ltd
Thickening components	4	麥孚順寶®/Maifu Nutrition	10 years older
		諾葆暢®/Hebei Aisheng Technology Co., Ltd
		若寧/Shandong Ruoyao FSMP Co. LTD
		冬澤力順/JIANGSU DAISY FSMP CO., LTD
Liquid components	4	諾葆舒®Hebei Aisheng Technology Co., Ltd	10 years older
		術和®Maifu Nutrition
		艾諾優/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	紐貝臻/SHS	10 years older
	2	紐貝福 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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