---
title: "3D MEDICINES: The application for the launch of Envida® as a first-line drug for biliary tract cancer has been accepted by the National Medical Products Administration"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/272088008.md"
description: "3D MEDICINES announced that its new drug Envita® (Envafolimab injection) has been accepted for listing by the National Medical Products Administration (NMPA). This drug, in combination with gemcitabine and oxaliplatin (GEMOX) regimen, is intended for first-line treatment of unresectable or metastatic biliary tract cancer. The acceptance is based on the results of the Phase III clinical trial (KN035-CN-005), aimed at evaluating its efficacy and safety"
datetime: "2026-01-09T14:07:05.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/272088008.md)
  - [en](https://longbridge.com/en/news/272088008.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/272088008.md)
---

> Supported Languages: [简体中文](https://longbridge.com/zh-CN/news/272088008.md) | [繁體中文](https://longbridge.com/zh-HK/news/272088008.md)


# 3D MEDICINES: The application for the launch of Envida® as a first-line drug for biliary tract cancer has been accepted by the National Medical Products Administration

According to the Zhitong Finance APP, 3D MEDICINES (01244) announced that the National Medical Products Administration (NMPA) has officially accepted the company's new drug application (NDA) for the commercialized product Envita® (generic name: Envafolimab injection, original research code: KN035) in combination with Gemcitabine and Oxaliplatin (GEMOX) for first-line treatment of unresectable or metastatic biliary tract cancer (BTC). This acceptance is based on the clinical research results of the Phase III clinical trial (KN035-CN-005), which is a randomized, parallel-controlled, multi-center Phase III clinical trial designed for Chinese patients with advanced first-line biliary tract cancer, aimed at evaluating the efficacy and safety of Envita® (KN035) in combination with the GEMOX regimen compared to the GEMOX regimen alone

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