The Registration Status of Protein Formulas for Special Medical Purposes in China

Currently, China has officially approved 24 protein formulas for special medical purposes designed for individuals over the age of one who require protein supplementation due to specific diseases or medical conditions.

All 24 products are domestically produced, involving 21 companies. Among them, Daisy FSMP has 3 products, Shandong Ruoyao has 2, and other companies such as Haizheng Sulikang, Guangzhou EnterNutr, and Jilin Mifu each have 1 product.

The products include 22 powdered formulas and 2 liquid formulas. Notably, Daisy FSMP’s Dongze Li Liang protein formula for special medical purposes - is the first liquid product of its kind in China.

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The product details are as follows:

24 approved protein formulas for special medical purposes

S.N.	Applicant	Product name	Dosage form	Registration No.
1	Haizheng Sulikang	Yi Neng Jia (伊能佳)	Powder	国食注字TY20200009
2	Guangzhou EnterNutr	Pu Rou Ting (普柔汀)	Powder	国食注字TY20200012
3	Maifu Nutrition	Pu Suo (浦索)	Powder	国食注字TY20200013
4	Hebei Aisheng	Nuo Bao Ping (诺葆平)	Powder	国食注字TY20210014
5	Hunan Jiudian Pharmaceutical	Dong Ze Ding (冬泽定)	Powder	国食注字TY20220002
6	YABAO	Wei Yuan Tai (唯源泰)	Powder	国食注字TY20230008
7	AusNuotore	AusNuotore You Da Li (爱优诺优达力)	Powder	国食注字TY20230018
8	XI'AN LI BANG	Li Ru Jing (立如箐)	Powder	国食注字TY20230019
9	Jiangzhong Pharmaceutical	Chu Yuan An Ben (初元安本)	Powder	国食注字TY20230027
10	KWINS HEALTH	Jia Shan Neng (嘉膳能)	Powder	国食注字TY20230033
11	Shandong Ruoyao	Ruo Yi (若益)	Powder	国食注字TY20230039
11	Shandong Ruoyao	Ruo Su (若速)	Powder	国食注字TY20230064
12	Wuxi Hengyi	Hengyi Qingyuan (恒益清元)	Powder	国食注字TY20230042
13	DAISY FSMP	Dong Ze Li An (冬泽力安)	Powder	国食注字TY20230045
		Dong Ze Li Tai (冬泽力太)	Powder	国食注字TY20230062
		Dong Ze Li Liang (冬泽力亮)	Liquid	国食注字TY20240019
14	Harbin Ballansat	Wei Ka Su (唯卡素)	Powder	国食注字TY20230056
15	Hangzhou Niuquxing	Hai Neng Bo (海能博)	Powder	国食注字TY20230057
16	Nanjing Yuheming	Ke Hui Yan (科惠研)	Powder	国食注字TY20230060
17	Nantong Richen	Li You Yi (力优宜)	Powder	国食注字TY20230065
18	Shandong Lihao	Mi Su (咪素)	Powder	国食注字TY20240007
19	GUANGDONG JUNJOY	Jun Bei Qing (君蓓清)	Powder	国食注字TY20240016
20	Shandong Tecompharma Ltd.	Feng Bai (丰白)	Powder	国食注字TY20240028
21	Jiangsu Zhengda Fenghai	Yi Li Jia (益立佳）	Liquid	国食注字TY20240030

The protein sources in the currently approved protein formulas mainly include milk proteins, plant proteins, and hydrolyzed proteins, with a protein content of approximately 80%.

Milk proteins: These include whey protein powder, concentrated whey protein powder, whey protein isolate, casein, calcium caseinate, and concentrated milk protein.
Plant proteins: Mainly soybean isolate protein.
Hydrolyzed proteins: These include hydrolyzed whey protein powder and soy peptides powder.
Dual protein sources: Combining two or more types of proteins can provide a complementary amino acid profile, thereby improving the nutritional value of the protein. 70% of the protein formulas products use a combination of milk protein and soybean isolate protein as their protein sources.

The ingredient composition is as follows:

Ingredient composition results

S.N.	Applicant	Product name	Ingredient composition
1	Haizheng Sulikang	Yi Neng Jia (伊能佳)	Whey protein powder, soybean isolate protein
2	Guangzhou EnterNutr	Pu Rou Ting (普柔汀)	Concentrated whey protein powder, soybean isolate protein, guar gum, mogroside
3	Maifu Nutrition	Pu Suo (浦索)	Whey protein isolate, calcium caseinate, edible essence, phospholipids, sucralose
4	Hebei Aisheng	Nuo Bao Ping (诺葆平)	Whey protein powder, soybean isolate protein, modified soybean phospholipids, silicon dioxide
5	Hunan Jiudian Pharmaceutical	Dong Ze Ding (冬泽定)	Hydrolyzed whey protein powder, soy peptides powder, edible essence, steviol glycoside, sucralose
6	YABAO	Wei Yuan Tai (唯源泰)	Calcium caseinate, concentrated whey protein powder, soybean isolate protein, silicon dioxide
7	AusNuotore	AusNuotore You Da Li (爱优诺优达力)	Concentrated milk protein, whey protein isolate, edible essence, silicon dioxide, sucralose
8	XI'AN LI BANG	Li Ru Jing (立如箐)	Concentrated whey protein powder, whey protein isolate, edible essence
9	Jiangzhong Pharmaceutical	Chu Yuan An Ben (初元安本)	Whey protein isolate, soybean isolate protein, sucralose
10	KWINS HEALTH	Jia Shan Neng (嘉膳能)	Hydrolyzed whey protein powder, soybean isolate protein, whey protein isolate, sucralose
11	Shandong Ruoyao	Ruo Yi (若益)	Concentrated whey protein powder, soybean isolate protein, guar gum, silicon dioxide
11	Shandong Ruoyao	Ruo Su (若速)	Hydrolyzed whey protein powder, soy peptides powder, citric acid, sucralose
12	Wuxi Hengyi	Hengyi Qingyuan (恒益清元)	Whey protein isolate, hydrolyzed whey protein powder
13	DAISY FSMP	Dong Ze Li An (冬泽力安)	Soybean isolate protein, whey protein isolate
		Dong Ze Li Tai (冬泽力太)	Soy peptides powder, hydrolyzed whey protein powder, food flavoring, steviol glycoside
		Dong Ze Li Liang (冬泽力亮)	Water, soy peptides powder, hydrolyzed whey protein powder, food flavoring, mogroside, steviol glycoside
14	Harbin Ballansat	Wei Ka Su (唯卡素)	Concentrated whey protein powder, soybean isolate protein, food flavoring
15	Hangzhou Niuquxing	Hai Neng Bo (海能博)	Concentrated whey protein powder, soybean isolate protein
16	Nanjing Yuheming	Ke Hui Yan (科惠研)	Concentrated whey protein powder, casein, phospholipids, mogroside, food flavoring
17	Nantong Richen	Li You Yi (力优宜)	Whey protein isolate, concentrated whey protein powder
18	Shandong Lihao	Mi Su (咪素)	Concentrated whey protein powder, soy protein isolate, Xanthan gum, Vanillin, silicon dioxide, sucralose
19	GUANGDONG JUNJOY	Jun Bei Qing (君蓓清)	Concentrated whey protein powder, soy protein isolate, silicon dioxide, food flavoring
20	Shandong Tecompharma Ltd.	Feng Bai (丰白)	—
21	Jiangsu Zhengda Fenghai	Yi Li Jia (益立佳）	—

Note: The two protein formulas approved this month (Feng Bai and Yi Li Jia) are not included in the above statistics because their label sample information is not available in the Special Food Information Query Platform.

Nutrient content statistics are as follows:

Nutrient content results

Nutrient	Unit	Content range
Energy	kJ/100g	1380~1664
Protein	g/100g	75~88
Fat	g/100g	0~6.1
Carbohydrate	g/100g	0.1~9
Sodium	mg/100g	100~1110
Potassium	mg/100g	471-486

When designing protein formulas, companies must comply with national food safety standards and thoroughly validate protein sources and other components. This ensures that the product design is well-founded and meets clinical needs.

For more information about the registration of FSMP in China, please click here to learn 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.

Further information

The Registration Status of Formulas for Fat Supplementation in China

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