NANJING,China,Sept. 2,2024 --On September 02,2024,Simcere Zaiming,an innovative oncology company under Simcere Pharmaceutical Group (2096.HK),announced a collaboration agreement with Shenzhen TargetRx Inc. The partnership focuses on the ALK/ROS1 dual receptor tyrosine kinase inhibitor TGRX-326,a clinical-stage anti-tumor candidate.

According to the terms of the agreement,Simcere Zaiming will acquire exclusive commercial rights to TGRX-326 in Mainland China. These rights encompass but are not limited to marketing promotion,strategy formulation and adjustment,and the right to obtain relevant benefits from TGRX-326. TargetRx will receive an initial payment exceeding $20 million. Additionally,TargetRx will compensate Simcere Zaiming for promotional services.

TGRX-326 is a third-generation anaplastic lymphoma kinase (ALK) inhibitor independently developed by TargetRx. It is a potent and highly selective small molecule inhibitor that targets ALK and c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinases (RTKs). This inhibitor holds significant therapeutic potential for ALK/ROS1 fusion gene-positive non-small cell lung cancer (NSCLC) patients,especially those with multiple ALK-resistant mutations,including G1202R.

In preclinical studies and a Phase 1 clinical trial,TGRX-326 demonstrated robust anti-tumor activity and a favorable safety profile. Moreover,the molecule effectively crosses the blood-brain barrier,exhibiting exceptional efficacy in NSCLC patients with brain metastases.

Dr. Renhong Tang,Chairman of Simcere Zaiming,said,"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. We look forward to working closely with TargetRx to provide Chinese lung cancer patients with more effective treatment options as soon as possible."

Dr. Yihan Wang,Chairman of TargetRx,"TGRX-326 is a potentially best-in-class novel anti-tumor molecule independently developed by TargetRx. 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. TargetRx aims to continuously deliver innovative therapies that will transform the lives of cancer patients."

About Simcere Zaiming

Simcere Zaiming,an oncology-centric biopharmaceutical subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096),was established in 2023. The company is dedicated to developing groundbreaking therapies to meet the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets,Simcere Zaiming has successfully launched several products in China,including COSELA®,Endostar®,Enweida®,and Enlituo®. The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D,manufacturing,and commercialization capabilities,complemented by strategic collaborations with leading partners in cancer therapeutics.

About TargetRx

TargetRx is a clinical stage,high-tech pharmaceutical R&D company focused on developing next-generation targeted therapies for cancer patients,particularly those who are resistant or refractory to current treatments. TargetRx has developed a series of cutting-edge and efficient small molecule drug discovery platforms,which combine innovative research and development capabilities for drug design,screening,evaluation and optimization. Since its establishment,TargetRx has been granted over 170 patents from authorities in China,the US,Europe,Japan and other regions. Several potential best-in-class compounds are at different stages of multi-national clinical trials.