Simcere Zaiming and TargetRx agree on TGRX-326 rights

Simcere Zaiming has entered into a collaboration agreement with Shenzhen TargetRx to introduce the third-generation anaplastic lymphoma kinase (ALK) inhibitor, TGRX-326, into the Chinese market. Under this agreement, Simcere Zaiming will hold exclusive commercial rights for TGRX-326 in Mainland China. These rights encompass marketing, strategic development, and the entitlement to related benefits from the asset. In exchange, TargetRx will receive an upfront payment exceeding $20 million and will also be compensated for its promotional efforts by Simcere Zaiming.

TargetRx's chairman, Dr. Yihan Wang, highlighted the potential of TGRX-326, describing it as a promising novel anti-tumor molecule independently developed by TargetRx. He emphasized that it is a third-generation ALK inhibitor currently in late-stage clinical development, which could provide a better treatment option for patients. Dr. Wang expressed confidence that with Simcere Zaiming's support, the product can be rapidly brought to market.

TGRX-326 is a clinical-stage anti-tumor candidate specifically designed to inhibit ALK and c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinases. It is particularly promising for treating non-small cell lung cancer (NSCLC) patients who have ALK/ROS1 fusion genes and exhibit resistance to multiple ALK mutations, including the challenging G1202R mutation. During its preclinical and Phase I clinical trial stages, TGRX-326 demonstrated strong anti-tumor efficacy and a favorable safety profile. One of the significant advantages of this molecule is its ability to penetrate the blood-brain barrier, which is crucial for treating NSCLC patients with brain metastases.

Dr. Renhong Tang, the chairman of Simcere Zaiming, expressed satisfaction with the collaboration with TargetRx on this innovative dual-targeted therapy for lung cancer, a major area of focus for Simcere Zaiming. He pointed out that this partnership will enhance their innovative product portfolio. Dr. Tang emphasized that ALK/ROS1 fusion is a critical genetic mutation in NSCLC, and the advancement of targeted therapies has notably improved survival rates for these patients. However, there remains a significant need for new treatments that offer better efficacy and can overcome drug resistance.

In a related development, in June 2024, the China National Medical Products Administration granted marketing approval for another product from Simcere Zaiming, Enlituo, which is intended for the treatment of metastatic colorectal cancer.