---
title: "Dongcheng Biochem: Sodium Fluoride [18F] Injection has passed the drug marketing authorization application"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/241958703.md"
description: "Dongcheng Biochem's wholly-owned subsidiary AndiKe recently received approval from the National Medical Products Administration, and the Sodium Fluoride [18F] Injection has passed the drug market authorization application, obtaining a drug registration certificate. This drug is a PET radiopharmaceutical that can effectively diagnose bone metastatic lesions, enhancing the company's product line and market competitiveness. Due to the particularity of the pharmaceutical industry, there is uncertainty in sales performance"
datetime: "2025-05-27T08:12:03.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/241958703.md)
  - [en](https://longbridge.com/en/news/241958703.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/241958703.md)
generator: "portal-rs"
---

# Dongcheng Biochem: Sodium Fluoride [18F] Injection has passed the drug marketing authorization application

According to the Zhitong Finance APP, Dongcheng Biochem (002675.SZ) announced that its wholly-owned subsidiary Nanjing Jiangyuan Andike Positron Research and Development Co., Ltd. (hereinafter referred to as "Andike") has received the Drug Registration Certificate for Sodium Fluoride \[18F\] Injection approved and issued by the National Medical Products Administration (hereinafter referred to as "NMPA"). Sodium Fluoride \[18F\] Injection has passed the drug marketing authorization application and can be produced and sold.

Sodium Fluoride \[18F\] Injection is a radioactive imaging agent for positron emission tomography (PET), used to identify areas of osteogenic activity changes in bone imaging. The fluoride \[18F\] ions in Sodium Fluoride \[18F\] Injection can exchange with hydroxyl groups in the hydroxyapatite crystals of bones, forming fluorinated hydroxyapatite, which is chemically adsorbed to bone tissue. The uptake of fluoride \[18F\] ions by bones depends on local blood flow and osteogenic activity, thus preferentially depositing in bone tissues with high turnover rates and active remodeling, showing high accumulation in both osteoblastic and osteolytic bone metastases. In completed clinical trials, Sodium Fluoride \[18F\] Injection has demonstrated excellent diagnostic efficacy and good safety, enabling earlier and more sensitive detection of bone metastatic lesions, providing more treatment strategies for clinical patients.

The approval of the Drug Registration Certificate for Sodium Fluoride \[18F\] Injection by the NMPA will further enrich the company's product line and enhance the market competitiveness of the company's products. Due to the particularity of the pharmaceutical industry, the sales of drugs are easily affected by national policies, changes in the market environment, and other factors, leading to significant uncertainty in specific sales situations

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---
> **Disclaimer: This article is for reference only and does not constitute any investment advice.**