share_log

福森药业(01652.HK):“复合磷酸氢钾注射液”上市许可申请获得受理

Forson Pharmaceutical (01652.HK): Application for marketing license for “Compound Potassium Hydrogen Phosphate Injection” was accepted

Gelonghui Finance ·  Apr 23 07:02

Gelonghui, April 23 | Forson Pharmaceutical (01652.HK) announced that the compound potassium hydrogen phosphate injection developed by Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd., a wholly-owned subsidiary of the Group, has submitted a marketing application to the China National Drug Administration and has been accepted for the treatment of the following diseases: as a phosphorus supplement in complete parenteral nutritional therapy; it can also be used for hypophosphatemia caused by certain diseases.

Phosphorus is involved in sugar phosphorylation in sugar metabolism, making up phospholipids in membrane components, and is an important component of RNA, DNA, and many coenzymes in cells. Phosphorus is also involved in energy storage, conversion, and regulation of body fluid buffering functions. Potassium hydrogen phosphate compound injection is a phosphorus supplement: used to treat hypophosphatemia via intravenous infusion when oral or enteral supplementation is not possible, insufficient, or contraindicated; for parenteral nutrition for adults and pediatric patients when oral or enteral nutrition is impossible, inadequate, or contraindicated.

Hypophosphatemia is usually asymptomatic and is present in as many as 5% of patients. It is more common in alcohol abuse, diabetic ketoacidosis, or sepsis, with a frequency of up to 80%. Hypophosphatemia can occur in people of all ages and genders. Mild cases are asymptomatic, and severe cases can lead to serious clinical consequences.

This product is medical insurance class B, a national-based drug type. It has characteristics such as high safety, fast absorption, double supplementation with phosphorus and potassium, and consensus on multiple guidelines. The compound potassium hydrogen phosphate injection developed by our company is declared according to the 3 types of chemicals. The prescription is basically the same as the original reference preparation, and the quality of the product is strictly controlled to ensure that its quality is superior to or consistent with the original developed product to ensure the safety of patients. Furthermore, non-clinical safety studies were carried out in accordance with regulatory requirements, and the results showed that the specific safety of this product was consistent with the reference formulation. Compound potassium hydrogen phosphate injections provide a very favorable risk-benefit ratio in treating hypophosphatemia and parenteral nutrition requiring phosphorus supplementation, and improving laboratory test results and clinical symptoms in adults and children.

Compound potassium hydrogen phosphate injection is another important product of the Group, further enriching the Group's product pipeline in the field of nutritional supplement treatment. Once launched, the product will provide more treatment options for adults and children with hypophosphatemia and parenteral nutrition.

Disclaimer: This content is for informational and educational purposes only and does not constitute a recommendation or endorsement of any specific investment or investment strategy. Read more
    Write a comment