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.
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 |
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 |
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