Analysis of 19 Approved Preterm/Low Birth Weight Infant Formulas for Special Medical Purposes

As of now, China has officially approved 19 preterm/low birth weight infant formulas for special medical purposes. CIRS Group will provide a detailed analysis of the energy density, macronutrient energy supply ratio, and ingredient sources of these products.

Approval status

The 19 products consist of 11 domestic formulas and 8 imported ones from 14 companies. Among these, Abbott has 3 formulas approved, while Nestlé, Yili, and Feihe each have 2. Of the 19 products, 17 are powdered products and 2 are liquid, with all domestic formulas being powdered.

Table 1 19 approved preterm/low birth weight infant formulas for special medical purposes

S.N.	Applicant	Product name	Dosage form	Registration number
1	ABBOTT	Xi Kang Bao Bei Chu (喜康宝贝初)	Liquid	国食注字TY20185003
2	ABBOTT	Xi Kang Bao Bei Yu (喜康宝贝育)	Liquid	国食注字TY20185004
3	NESTLE	Zao Neng Rui En (早瑞能恩)	Powder	国食注字TY20185006
4	Mead Johnson	An Ying Bao (安婴宝)	Powder	国食注字TY20185008
5	Synutra International Inc	You Bo An Neng (优博安能)	Powder	国食注字TY20180005
6	ABBOTT	ABBOTT Xi Kang Bao (雅培喜康宝)	Powder	国食注字TY20185009
7	Milupa	Niu Quan Xing (纽荃星)	Powder	国食注字TY20185010
8	NESTLE	Zao Qi Neng En (早启能恩)	Powder	国食注字TY20195001
9	Hangzhou BEINMATE	Bei Xin Er (贝新尔)	Powder	国食注字TY20190004
10	Maeil Dairies Co., Ltd	Ai Si Nuo Chen Er Hui (爱思诺晨而慧)	Powder	国食注字TY20195008
11	Wyeth	Hui Shi®Bo Zhen® (惠氏®铂臻®)	Powder	国食注字TY20195011
12	Beian Yeeper Dairy	Zhen Er Ai (甄而蔼)	Powder	国食注字TY20210003
13	AusNuotore	AusNuotore You Jian Li (优键力)	Powder	国食注字TY20220009
14	Qingdao Shengtong	Te Ai An Neng (特爱安能)	Powder	国食注字TY20230025
15	Zhejiang Kelubao	Tai Min Kang (溙敏康)	Powder	国食注字TY20230053
16	Heilongjiang Feihe	Bei Shu Wei (蓓舒维)	Powder	国食注字TY20240002
17	Heilongjiang Feihe	Bei Shu Huan (蓓舒焕)	Powder	国食注字TY20240003
18	Du’erbote Yili Dairy Co. LTD	Tuo Fei Er Zao Hu (托菲儿早护)	Powder	国食注字TY20240023
19	Du’erbote Yili Dairy Co. LTD	Tuo Fei Er Zao Hu (托菲儿早护)	Powder	国食注字TY20240024

Formula characteristics

According to the Recommendations on Feeding Preterm/Low Birth Weight Infants by the Neonatology Group of the Chinese Medical Association’s Pediatrics Society, preterm/low birth weight infants are defined as newborns with a gestational age of less than 37 weeks and a birth weight of less than 2,500 g. These infants differ significantly from full-term infants in terms of physiological conditions, nutritional needs, and ability to digest and absorb nutrients. To support their catch-up growth, the levels of energy, protein, and certain vitamins and minerals in their formula are significantly higher than those in formulas designed for full-term infants.

Table 2 Energy density and energy supply ratios of nutrients

S.N.	Product name	Energy density kcal/mL	Energy supply ratio of protein	Energy supply ratio of fat	Energy supply ratio of total carbohydrate	Energy supply ratio of linoleic acid	Energy supply ratio of α-linolenic acid
1	Xi Kang Bao Bei Chu (喜康宝贝初)	0.68	12%	46%	42%	7.7%	0.6%
2	Xi Kang Bao Bei Yu (喜康宝贝育)	0.81	12%	46%	42%	7.6%	0.6%
3	Zao Neng Rui En (早瑞能恩)	0.80	12%	46%	42%	6.8%	0.8%
4	An Ying Bao (安婴宝)	0.75	11%	47%	42%	8.9%	0.8%
5	You Bo An Neng (优博安能)	0.81	13%	45%	43%	7.7%	0.9%
6	ABBOTT Xi Kang Bao (雅培喜康宝)	0.74	11%	49%	40%	6.4%	0.7%
7	Niu Quan Xing (纽荃星)	1.00	11%	48%	40%	7.5%	0.6%
8	Zao Qi Neng En (早启能恩)	0.74	11%	46%	43%	5.2%	0.7%
9	Bei Xin Er (贝新尔)	0.75	11%	48%	41%	5.8%	0.6%
10	Ai Si Nuo Chen Er Hui (爱思诺晨而慧)	0.71	12%	45%	42%	7.5%	0.7%
11	Hui Shi®Bo Zhen® (惠氏®铂臻®)	0.73	11%	48%	42%	5.9%	0.6%
12	Zhen Er Ai (甄而蔼)	0.81	12%	48%	40%	6.0%	0.7%
13	AusNuotore You Jian Li (优键力)	0.80	12%	47%	40%	8.1%	0.8%
14	Te Ai An Neng (特爱安能)	0.81	13%	45%	43%	7.7%	0.9%
15	Tai Min Kang (溙敏康)	0.74	13%	49%	37%	6.2%	0.7
16	Bei Shu Wei (蓓舒维)	0.81	12%	46%	42%	6.9%	0.7%
17	Bei Shu Huan (蓓舒焕)	0.73	11%	47%	41%	5.9%	0.6%
18	Tuo Fei Er Zao Hu (托菲儿早护)	0.82	12%	45%	43%	6.1%	0.7%
19	Tuo Fei Er Zao Hu (托菲儿早护)	0.74	11%	46%	43%	5.7%	0.7%

1) Energy density

According to GB 25596 and its related guidelines, the energy content of preterm and low birth weight infants formulas should be within 250 kJ to 465 kJ per 100 mL, as specified in Standard 4.4, which is equivalent to 0.6 kcal to 1.1 kcal per mL. As shown in the table, the energy density of the 19 approved formulas ranges from 0.68 kcal/mL to 1.00 kcal/mL, with most products centered around 0.8 kcal/mL.

2) Protein

Protein intake is essential for the optimal growth and development of preterm infants. Randomized controlled trials have demonstrated that insufficient protein intake can lead to long-term consequences, including potential cognitive decline. *

* Reference: ESPGHAN Committee on Nutrition. Enteral nutrient supply for preterm infants: commentary from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2010 Jan;50(1):85-91.

According to GB 25596 and its guidelines, the protein content in such formulas should not fall below the minimum value specified in Standard 4.4, while the upper limit can be adjusted as necessary. This approach aligns with the recommendations from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition’s guidelines on enteral nutrition for preterm and low birth weight infants, which emphasize that while exceeding the required protein intake shows no adverse effects, inadequate protein intake can hinder growth.

The protein content in such formulas ranges from 0.45 g to 0.98 g per 100 kJ, which is equivalent to a protein energy ratio of 7.7% to 16.7%. As shown in Table 2, the 19 approved formulas have a protein energy ratio ranging from 11% to 13%. This represents an appropriate increase compared to the protein energy ratios of other infant formulas for special medical purposes, which range from 7.7% to 11.9%.

GB 25596 does not specify particular types of protein sources, but due to the specific needs of the target population, formulas generally prioritize high-quality milk proteins. Among the 19 approved products, the primary protein sources are predominantly a combination of whey protein powder and milk powder, with some also incorporating casein or hydrolyzed milk protein. Notably, demineralized whey powder and skim milk powder are the most commonly used ingredients.

Table 3 Ingredient sources of protein

S.N.	Ingredient source	Frequency
1	Demineralized whey powder	13
2	skim milk powder	12
3	Whey protein powder	9
4	Concentrated whey protein powder	8
5	casein	4
6	Whole milk powder	3
7	Hydrolyzed whey protein powder	3
8	Skimmed pasteurized milk	1
9	Whey	1

3) Fat

The AAP (American Academy of Pediatrics) research report recommends that such formulas should provide approximately 40% of their energy from fat to ensure sufficient total energy intake to support growth and optimize the utilization of dietary protein.

According to GB 25596 and its guidelines, the fat content in such formulas should range from 1.05 g to 1.90 g per 100 kJ, which is equivalent to a fat energy ratio of 38.6% to 70.3%. As shown in Table 2, the fat energy ratio in the 19 approved formulas ranges from 45% to 49%, with most products centered around 46%. Only two products have a fat energy ratio of 49%.

GB 25596 stipulates that such formulas should include easily digestible medium-chain fats as part of the fat source, with medium-chain fats comprising no more than 40% of the total fat content. Among the 19 approved products, the fat sources are primarily a combination of medium-chain triglycerides (MCTs), which enhance fat absorption, and various vegetable oils. A few products also include palm (kernel) oil, (low erucic acid) rapeseed oil, and 1,3-dioleic acid-2-palmitic acid triglyceride. Sunflower oil and soybean oil are the most commonly used vegetable oils, both offering a high absorption rate of up to 96% and being rich in linoleic acid, an essential fatty acid. MCTs are preferred because they are absorbed more rapidly in the intestines compared to long-chain triglycerides (LCTs), serving as an immediate energy source.

Table 4 Ingredient sources of fat

S.N.	Ingredient source	Frequency
1	Sunflower seed oil	18
2	MCTs	17
3	Soybean oil	14
4	Coconut oil	13
5	Low-erucic acid rapeseed oil	6
6	Palm oil	5
7	1,3-dioleic acid-2-palmitic acid triglyceride	3
8	Rapeseed oil	3
9	Palm kernel oil	1

4) Carbohydrates

Carbohydrates are the primary source of energy. The AAP research report recommends that approximately 50% of the energy in infant formulas should come from carbohydrates, typically derived from lactose or nutritionally equivalent disaccharides, oligosaccharides, or polysaccharides. GB 25596 and its guidelines state that in preterm and low birth weight infant formulas with increased energy content, the higher fat content may reduce the carbohydrate content. As a result, there is no minimum limit required for carbohydrates in these formulas.

According to GB 25596, the carbohydrate content should range from 2.2 g to 3.3 g per 100 kJ, which corresponds to an energy ratio of 37.4% to 56.1%. Among the 19 approved products, the carbohydrate energy ratio ranges from 37% to 43%. For formulas with a higher fat energy ratio, the carbohydrate energy ratio is appropriately reduced.

It is stipulated in GB 25596 that, except for specific cases such as lactose intolerance, the preferred carbohydrates should be lactose and/or glucose polymers. Only pre-gelatinized starch is permitted in infant formulas for special medical purposes, while fructose is not allowed. Among the approved products, carbohydrates primarily derive from lactose, maltodextrin, and glucose syrup.

Table 5 Ingredient sources of carbohydrates

S.N.	Raw material source	Frequency
1	Lactose	13
2	Maltodextrin	11
3	Glucose syrup (solid)	6
4	Starch sugar (solid)	3
5	Solid corn syrup	3

According to GB 25596 and its guidelines, the upper limits for energy, protein, and certain vitamins and minerals in formulas for preterm and low birth weight infants can be adjusted based on practical considerations. The above information represents CIRS Group's statistical analysis of energy density, macronutrient energy ratios, and ingredient sources, aimed at supporting companies in their formula development efforts.

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