---
title: "Dongcheng Biochem's subsidiary has received the drug clinical trial approval notice"
type: "News"
locale: "zh-HK"
url: "https://longbridge.com/zh-HK/news/254091421.md"
description: "Dongcheng Biochem's subsidiary LNC PHARMA PTE. LTD. has received FDA approval to conduct Phase I clinical trials for the 225Ac-LNC1011 injection. The FDA has completed the safety review of the drug and believes that clinical research for prostate cancer can continue. After receiving approval, the drug still needs to complete clinical trials and pass FDA review before it can be marketed in the United States"
datetime: "2025-08-22T03:54:03.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/254091421.md)
  - [en](https://longbridge.com/en/news/254091421.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/254091421.md)
---

> 支持的語言: [简体中文](https://longbridge.com/zh-CN/news/254091421.md) | [English](https://longbridge.com/en/news/254091421.md)


# Dongcheng Biochem's subsidiary has received the drug clinical trial approval notice

According to the Zhitong Finance APP, Dongcheng Biochem (002675.SZ) announced that on August 22, 2025, its subsidiary LNC PHARMA PTE. LTD. (referred to as "LNC Pharma") received a Study May Proceed Letter (SMP) approved and issued by the U.S. Food and Drug Administration (FDA) regarding the clinical trial approval for the 225Ac-LNC1011 injection, and will soon commence Phase I clinical trials.

The FDA has completed the safety review of the application for the 225Ac-LNC1011 injection and believes that the proposed clinical research for prostate cancer can proceed. According to the relevant laws and regulations for drug registration in the United States, after obtaining the SMP, the 225Ac-LNC1011 injection must conduct clinical trials and be reviewed and approved by the FDA before it can be marketed and sold in the United States

### 相關股票

- [Dongcheng Biochem (002675.CN)](https://longbridge.com/zh-HK/quote/002675.CN.md)

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