Simcere Zaiming Inks Deal for Third-Generation ALK/ROS1 Inhibitor TGRX-326 with $20M Upfront Payment

On September 2, 2024, Simcere Zaiming, the oncology-focused innovative drug subsidiary of Simcere Pharmaceutical Group (2096.HK), announced that it had recently entered into a collaboration agreement with SHENZHENTARGETRX, INC. (“TargetRx”) regarding TGRX-326, a clinical-stage dual ALK/ROS1 receptor tyrosine kinase inhibitor candidate for the treatment of cancer.

Pursuant to the terms of the agreement, Simcere Zaiming will obtain exclusive commercialization rights for TGRX-326 in mainland China (including but not limited to the rights to promote TGRX-326, formulate and adjust related strategies, and receive benefits associated therewith). TARGETRX will receive an upfront payment of over USD 20 million and will pay promotion service fees to Simcere Zaiming.

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 of the dual receptor tyrosine kinases (RTKs) ALK and c-ROS oncogene 1 (ROS1). TGRX-326 holds significant potential therapeutic value for patients with non-small cell lung cancer (NSCLC) who are positive for ALK/ROS1 fusion genes or harbor various ALK resistance mutations, including G1202R. Preclinical studies and Phase I clinical trials have demonstrated favorable anti-tumor efficacy and safety profiles for TGRX-326. Furthermore, the molecule exhibits high blood-brain barrier permeability, yielding excellent therapeutic outcomes in NSCLC patients with brain metastases.

Dr. Tang Renhong, Chairman of Simcere Zaiming: “We are delighted to partner with SHENZHENTARGETRX, INC. on a novel dual-targeted inhibitor for lung cancer. Lung cancer is one of the key therapeutic areas strategically prioritized by Simcere Zaiming, and this collaboration will further strengthen our product portfolio in this field. ALK/ROS1 fusions represent critically important genetic mutations in non-small cell lung cancer (NSCLC). While precision targeted therapy has brought hope for prolonged survival to patients with these mutations, there remains an urgent unmet clinical need for new therapies that offer superior efficacy and safety profiles and can overcome drug resistance. We look forward to working hand in hand with SHENZHENTARGETRX, INC. to ensure that more effective treatments become available to lung cancer patients in China at the earliest possible date.”

Dr. Wang Yihan, Chairman of TargetRx: “TGRX-326 is a best-in-class novel anti-tumor molecule independently developed by TargetRx, filling the gap in domestically produced third-generation ALK inhibitors and bringing new hope to patients with ALK/ROS1-positive non-small cell lung cancer. We believe that with the support of Simcere Pharma, this product is poised to rapidly reach the market, benefiting a broad patient population. TargetRx will work hand in hand with its partners to continuously deliver innovative therapies, transforming cancer into a manageable chronic disease or even achieving clinical cures.”

Simcere Zaiming is a biopharmaceutical company under the Simcere Pharmaceutical Group, dedicated to the research and development, manufacturing, and commercialization of innovative oncology drugs. Operating independently since 2023, it is committed to addressing significant unmet clinical needs in the oncology field in China and globally through breakthrough therapeutic approaches. Zaiming focuses on building a high-value innovative R&D pipeline, with its launched product portfolio including Cosela.^®, Envista^®, Endostar^®, Enlituo^®Four innovative drugs are driving a trajectory of rapid revenue growth. Through collaborative innovation with global partners, Simcere is providing more effective therapeutic options for clinical practice, bringing renewed hope and vitality to more cancer patients.

SHENZHENTARGETRX, INC. is a high-tech pharmaceutical R&D company dedicated to the development of proprietary targeted anticancer drugs, committed to addressing the medical challenge of acquired drug resistance—an advanced form of cancer progression. The company has independently established a cutting-edge and efficient series of platforms for small-molecule drug development, adhering to source innovation and possessing comprehensive R&D capabilities in chemical drug design, screening, evaluation, and optimization. Since its inception, SHENZHENTARGETRX has been granted more than 170 patents in regions including China, the United States, Europe, and Japan, and is conducting multi-regional clinical trials for select drug candidates both in China and overseas.