In a significant stride towards advancing cancer treatment, Zai Lab Limited (HKEX: 9688))) has proudly announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation for investigational repotrectinib. This innovative therapy aims to revolutionize the treatment of patients battling advanced solid tumors with an NTRK gene fusion who have shown progression following treatment with TRK tyrosine kinase inhibitors (TKIs). The grant of Breakthrough Therapy Designation for repotrectinib is rooted in compelling data obtained from both global and Chinese patients enrolled in the Phase 1/2 TRIDENT-1 study.

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Paving the Path for a Potential First-in-Class Treatment

Zai Lab's President and Head of Global Oncology Research and Development, Rafael G. Amado, M.D., expressed his excitement about this remarkable achievement. This is the fourth Breakthrough Therapy Designation that repotrectinib has secured in China, underscoring its potential as a pioneering treatment for NTRK-positive, TKI-pretreated solid tumors in the country. NTRK, an oncogenic driver in around 0.5 percent of patients grappling with diverse advanced solid tumors, represents a critical medical challenge. Currently, there are no approved targeted therapies available for NTRK-positive, TKI-pretreated advanced solid tumor patients, making the urgency of this breakthrough all the more apparent.

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Addressing Unmet Medical Needs through Regulatory Collaboration

Dr. Amado further emphasized the importance of collaboration with Chinese regulatory authorities to promptly bring this transformative medicine to patients in need. The Breakthrough Therapy Designation review policy, purpose-built to streamline the development and review of novel medicines for life-threatening diseases, plays a pivotal role in expediting the drug development process. Repotrectinib's designation underscores its potential to revolutionize the landscape of advanced solid tumor treatment, offering hope to patients facing dire circumstances.

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A Year of Remarkable Milestones for Zai Lab

This latest announcement comes on the heels of Zai Lab's recent accomplishments. In June 2023, the company revealed that the NMPA had accepted its New Drug Application (NDA) for repotrectinib. The application is aimed at treating adult patients dealing with locally advanced or metastatic ROS1-positive NSCLC. The NMPA's decision to grant priority review in May 2023 showcases the growing recognition of the potential impact of this novel therapy.

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Shaping the Future of Cancer Treatment

As Zai Lab's repotrectinib continues to garner attention for its potential to transform the lives of cancer patients, it becomes clear that breakthroughs like these are driving the future of cancer treatment. With the Breakthrough Therapy Designation backing its development, repotrectinib stands as a beacon of hope for those whose options were once limited. As the journey towards making this treatment accessible to patients unfolds, the collaboration between Zai Lab and regulatory authorities shines a light on the immense potential of medical innovation in the face of unmet needs.