The asset has potential in treating non-small cell lung cancer patients with ALK/ROS1 fusion genes and resistance to multiple ALK mutations. Credit: JOURNEY STUDIO7/Shutterstock.

Simcere Zaiming has entered a collaboration deal with Shenzhen TargetRx to bring the third-generation anaplastic lymphoma kinase (ALK) inhibitor, TGRX-326, to the Chinese market.

Simcere Zaiming will hold exclusive commercial rights for TGRX-326 in Mainland China.

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These rights include marketing, strategy development and entitlement to related benefits from the asset.

TargetRx is entitled to receive an upfront payment of more than $20m and will also be compensated by Simcere Zaiming for promotional efforts.

TargetRx chairman Dr Yihan Wang stated: “TGRX-326 is a potentially best-in-class novel anti-tumour molecule independently developed by TargetRx.

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“It is a third-generation ALK inhibitor in late-stage clinical development which may bring a better option for patients. We believe that with the support of Simcere Zaiming, we will be able to bring this product quickly to the market.”

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TGRX-326 is a clinical-stage anti-tumour candidate,designed to inhibit both ALK and c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinases.

The asset is claimed to have potential in treating non-small cell lung cancer (NSCLC) patients with ALK/ROS1 fusion genes and resistance to multiple ALK mutations, including the G1202R mutation.

In its preclinical and Phase I clinical trial stages, TGRX-326 showed strong anti-tumour efficacy and a favourable safety profile.

The molecule penetrates the blood-brain barrier, crucial for treating NSCLC patients with brain metastases.

Simcere Zaiming chairman Dr Renhong Tang stated: “We are pleased to collaborate with TargetRx on novel dual-targeted therapy for lung cancer, a major malignancy that Simcere Zaiming strategically focuses on.

“This partnership will further enhance our innovative product portfolio. ALK/ROS1 fusion is a critical genetic mutation in non-small cell lung cancer. The advancement of targeted therapies has significantly improved survival rates for these patients. However, there remains a substantial need for new treatments with better efficacy and the ability to overcome drug resistance.”

In June 2024, the China National Medical Products Administration granted marketing approval for Simcere Zaiming’s Enlituo for metastatic colorectal cancer.