How long can hydroxyethyl starch go on from the withdrawal from the EU to the revision of the "indication-prohibited" instruction in China?

On September 6, 2022, the China National Medical Products Administration(NMPA) issued an announcement on the revision of the instructions for hydroxyethyl starch injections (Document No.: No.72 in 2022), requiring all marketing authorization holder involved hydroxyethyl starch-related injections to revise the instructions in a unified manner to ensure the safety of public medication.


Hydroxyethyl starch is one of the three major artificial plasma substitutes. It is commonly used in the treatment of critically ill patients, shock patients and other patients with insufficient plasma volume. It occupies 70% of the market share in the field of plasma substitutes all year round. However, due to product attributes and safety issues, since listed, clinical academic experts and drug administrations in various countries have paid close attention, and various incidents have occurred frequently.


On May 24, 2022, the European Commission issued a legal decision prohibiting the sale of hydroxyethyl starch-related preparations in EU countries.


Conclusion: Hydroxyethyl starch is facing the severe situation of EU withdrawal from the market and Chinese contraindications covering indications. How long can Hydroxyethyl starch go on in the future? In the past 10 years, there is no new plasma replacement have been approved in China. In the future, the choice of plasma-substituting drugs for clinical and patients will be limited to gels and Dextran. The compound Dextran 40 injection produced by our company is a compound preparation combined with crystal gel, which can adjust the acid-base balance and keep the electrolyte stable while expanding the blood volume efficiently. Since listed, it has passed 14 times post-marketing drug re-evaluations, and its clinical efficacy has been highly recognized by clinical experts and patients in top hospitals in China. At the same time, with high-quality APIs and FDFs, the company has established long-term and stable supply relationships with many countries and won a good reputation in the industry. Compound Dextran 40 injection will become the preferred variety of blood volume expanders and will be brilliant in the field of plasma replacement!