Hengrui Pharmaceutical's omega-3 fish oil three-chamber bag injection for parenteral nutrition support was approved for clinical trials

Recently, Hengrui Pharmaceutical and its subsidiary Fujian Shengdi Pharmaceutical Co., Ltd. received the "Drug Clinical Trial Approval Notice" approved and issued by the National Medical Products Administration, approving the company's omega-3 fish oil medium and long chain fat emulsion/amino acid (16)/glucose (30%) injection to carry out clinical trials for adult patients with moderate to severe catabolism who cannot be carried out orally or enteral nutrition is insufficient, insufficient or contraindicated, to provide energy in the form of parenteral nutrition, Essential fatty acids (including omega-3 and omega-6 fatty acids), amino acids, electrolytes, and fluids.

Total parenteral nutrition refers to the supply of all the nutrients needed by the patient from outside the gastrointestinal tract so that the patient can maintain good nutritional status even after severe trauma or complex surgery that cannot be ingested and absorbed. At present, there are two kinds of total parenteral nutrition solution commonly used in clinical practice: artificial configuration of "total nutrient solution" nutrient solution (also known as total nutrient mixture TNA, Total Nutrient Admixture) and three-cavity bag nutrient solution. The three-chamber bag refers to a soft bag filled with fat emulsion, amino acids and glucose, separated into three relatively independent chambers, and the three liquids can be quickly mixed into parenteral nutrition mixture by squeezing when used. Foreign studies have shown that three-cavity bags are cheaper than multi-bottle tandem and hospital preparation of TNA, and the safety of sterilization production is more and more guaranteed [1], which is more and more valued in clinical practice.

Omega-3 fish oil medium and long chain fat emulsion/amino acid (16)/glucose (30%) injection is packaged in three-chamber bags, and three separate pockets contain omega-3 fish oil medium and long chain fat emulsion solution, compound amino acid (16) solution and compound glucose solution (30%). The original omega-3 fish oil medium and long chain fat emulsion/amino acid (16)/glucose (30%) injection was launched in many European countries in 2010, and at present, no similar products have been approved for marketing in China.

At present, there is no omega-3 fish oil fat emulsion component in the three-cavity bag products marketed in China, and the "Guidelines for Perioperative Nutritional Support in Adults" recommends that the use of omega-3 unsaturated fatty acids in parenteral nutrition can improve clinical outcomes in patients with severe surgical disease (level of evidence: medium; Highly recommended), the addition of fish oil to parenteral nutrition has been shown to benefit patients in terms of reduced infection morbidity and shorter hospital stay [2]. Based on this clinical approval, Hengrui Pharmaceutical will carry out clinical trials of the product for parenteral nutrition support to evaluate the effectiveness and safety of the drug.