AstraZeneca Submits Seventh New Indication Application for Durvalumab in China

Feb 21, 2025 11:16 CST Updated 11:16

AstraZeneca

Biopharmaceutical Manufacturer

On February 21, the CDE website showed that AstraZenecaNew Indication Application for Durvalumab Injection Accepted for Review。According to the biologics registration classification standards, Category 3.1 refers to biologics that are produced overseas, already marketed overseas, and not yet marketed in China, for which an application for marketing authorization is submitted.

Insight database shows,This is the submission for marketing approval of Durvalumab in China.The 7th Indication。

Source: CDE Official Website

Durvalumab is a humanized PD-L1 monoclonal antibody that blocks the binding of PD-L1 to PD-1 and CD80, thereby interrupting tumor immune escape strategies and restoring suppressed immune responses.

Currently, the product hasApproved for 8 indications in the United States, including:

Unresectable, Stage III Non-Small Cell Lung Cancer Without Disease Progression After Chemoradiotherapy Based on Platinum Drugs（NSCLC）；
Combination of etoposide and carboplatin or cisplatin as first-line treatment for extensive-stage small cell lung cancer（ES-SCLC）；
In combination with gemcitabine and cisplatin, as first-line treatment for locally advanced or metastatic biliary tract cancer（BTC）；
Combined with Tremelimumab, First-line Treatment for Unresectable Hepatocellular Carcinoma (HCC) Adult patients;
In combination with tislelizumab and platinum-based chemotherapy, as first-line treatment for adult patients with metastatic NSCLC without sensitizing EGFR mutations or ALK gene mutations;
In combination with carboplatin and paclitaxel, as first-line treatment for dMMR primary advanced or recurrent endometrial cancer;
For neoadjuvant/adjuvant treatment of resectable NSCLC;
Limited-stage small cell lung cancer with no disease progression after receiving platinum-based chemotherapy and radiotherapy (LS-SCLC) 。

In the Chinese market, durvalumab alsoApproved for 3 indications, respectively:

Unresectable, Stage III NSCLC without disease progression after platinum-based chemotherapy and radiation therapy;
In combination with etoposide and carboplatin or cisplatin, as first-line treatment for ES-SCLC;
Combination of gemcitabine and cisplatin as first-line treatment for locally advanced or metastatic BTC.

AstraZeneca disclosed in its 2024 financial report that over the next two years, durvalumab will secure three new regulatory approvals for indications in China, including neoadjuvant/adjuvant treatment for NSCLC, LS-SCLC, and first-line treatment of NSCLC in combination with tremelimumab.

Source：AstraZeneca Earnings Report

According to AstraZeneca's previous press releases, the neoadjuvant/adjuvant treatment for NSCLC and the first-line combination therapy with Tremelimumab for NSCLC have both been submitted for marketing approval in China.

Since its launch, the sales of durvalumab have been growing rapidly. In 2024, its global sales reached $4.717 billion, making it one of the top three revenue-generating products in AstraZeneca's portfolio.

Source: Insight Database

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AstraZeneca Submits Seventh New Indication Application for Durvalumab in China

AstraZeneca

For neoadjuvant/adjuvant treatment of resectable NSCLC;