AstraZeneca Announces Two New Drug Indications Approved in China

Mar 10, 2025 14:23 CST Updated 14:23

AstraZeneca

Biopharmaceutical Manufacturer

On March 10, the NMPA website announced that AstraZeneca's two new drugs for new indications were approved for marketing in China: 1)Durvalumab, SpeculationFor neoadjuvant/adjuvant treatment of resectable Stage II and III non-small cell lung cancer (NSCLC) Patient;2）Benralizumab,SpeculationUsed forAdditional Maintenance Treatment for Eosinophilic Asthma in Children Aged 6-11。

Durvalumab

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.In China, durvalumab has previously been approved for 3 indications, respectively:

In December 2019, it was approved for marketing by the NMPA for the first time, for the treatment of patients with unresectable, stage III NSCLC whose disease has not progressed after concurrent chemoradiotherapy based on platinum drugs.
In July 2021, it was approved by the NMPA in combination with etoposide and carboplatin or cisplatin as a first-line treatment regimen for adult patients with extensive-stage small cell lung cancer.
In November 2023, it was again approved by the NMPA for first-line treatment in adult patients with locally advanced or metastatic biliary tract cancer in combination with gemcitabine and cisplatin, which also expanded the indications of durvalumab from the field of lung cancer to gastrointestinal tumors.

According to the Insight database, AstraZeneca has launched a double-blind, placebo-controlled, international multicenter Phase 3 clinical trial in China (CTR20200932), aimed to evaluate the neoadjuvant/adjuvant treatment of durvalumab for resectable stage II and IIINSCLC Efficacy and safety of patients.

At the 2023 American Association for Cancer Research (AACR) At the annual meeting, AstraZeneca announced the positive results of the Phase III clinical study AEGEAN. The trial data showed that compared with neoadjuvant chemotherapy alone, the combination of durvalumab and chemotherapy as neoadjuvant treatment before surgery and as adjuvant monotherapy after surgery for resectable early-stage (IIA-IIIB) NSCLC patients demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS):

In the pre-specified interim analysis of EFS, patients who received neoadjuvant therapy before surgery and adjuvant therapy after surgery based on durvalumab,The risk of recurrence, progression events, or death was reduced by 32%.；
In the final analysis of pCR,The pCR rate for patients receiving neoadjuvant therapy with durvalumab combined with chemotherapy before surgery was 17.2%., while the pCR rate of patients treated with neoadjuvant chemotherapy alone was 4.3%.

Overview of Phase III Clinical Trial AEGEAN

Screenshot source: Insight Database official website

Currently, durvalumab has been approved in multiple countries for the treatment of various types of lung cancer. Additionally, durvalumab has also been approved in several countries in combination with chemotherapy for locally advanced or metastatic biliary tract cancer, in combination with tremelimumab for unresectable hepatocellular carcinoma. In Japan and the EU, durvalumab has also been approved as a monotherapy for unresectable hepatocellular carcinoma. In a few countries, durvalumab has also been approved for the treatment of previously treated advanced bladder cancer.

Since its first approval in May 2017, more than 220,000 patients have been treated with durvalumab. According to the Insight database, since its approval in 2027, the sales of durvalumab have continued to rise with the increasing number of indications.

Durvalumab Annual Sales

Screenshot from: Insight Database Official Website

According to publicly available information from AstraZeneca, as part of its overall R&D program, durvalumab is being explored as a monotherapy or in combination with other anti-cancer drugs for the treatment of small cell lung cancer, non-small cell lung cancer, bladder cancer, breast cancer, various gastrointestinal tumors, and other solid tumors.

Benralizumab

Benralizumab is a humanized anti-IL-5Rα monoclonal antibody,Previously approved by the NMPA in August 2024 for use in adults and adolescents aged 12 years and above with severe eosinophilic asthma.（SEA）Maintenance treatment.

In April 2024, AstraZeneca announced an open-label, multi-country, non-randomized, parallel-groupPhase III TATE Clinical Results. This study aims to evaluate the pharmacokinetics, pharmacodynamics, and long-term safety of Benralizumab in children with severe eosinophilic asthma.The primary endpoint includes the maximum blood drug peak.Concentration (C max ), Clearance, Half-life(t 1/2 )And blood eosinophil count.

The study results showed that the 10 mg/<35 kg group and the 30 mg/≥35 kg groupFlatAverage C max MinuteDon'tFor 1901.2 and 3118.7 ng/mL. Overall eosinophilClearance rate: 0.257，Average Half-Life（t 1/2）For 14.5 Days. Almost complete depletion of blood eosinophils was observed in all dose/body weight groups.

In terms of safety,BenralizumabSafety and tolerability were consistent with the known characteristics of the drug.

Screenshot source: Insight database

Benralizumab has previously received multiple FDA approvals:

Add-on maintenance treatment for patients 12 years and older with severe eosinophilic asthma(November 2017)；
Add-on maintenance treatment for severe asthma patients aged 6 to 11 with eosinophilic phenotype(April 2024)；
For Adult Eosinophilic Granulomatosis with Polyangiitis(September 2024)。

Since its approval, the sales of Benralizumab have maintained steady growth, entering 2021.$10 billionRow, global sales reach in 2024$16.89 billion, an increase of 8.76% over the same period last year.

Screenshot source: Insight database

Insight database shows that, apart from Benralizumab, China has also approvedGSKMepolizumab andRegeneron/SanofiDupilumab, Two Targeted Biologics, Used for the Treatment of Eosinophilic Asthma.

Screenshot source: Insight database

New Chinese-produced with the same indicationsThere are 6 drugs in development, most of which target IL.5Monoclonal or bispecific antibodies.The fastest progress isHengrui SHR-1703 and3SBio SSGJ-610 has currently entered Phase III clinical trials.

Screenshot source: Insight database

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