Three Chinese Innovative NSCLC Drugs Granted Breakthrough Therapy Designation on Same Day

Three Chinese pharmaceutical companies are advancing lung cancer treatments after their innovative drugs were designated for breakthrough therapy status by China's drug regulatory authority on the same day, signaling accelerated development in the country's oncology pipeline.

The Center for Drug Evaluation (CDE) under the National Medical Products Administration announced on September 7 that it has proposed including three domestic innovative drugs in the breakthrough therapy program. All three medications target non-small cell lung cancer (NSCLC), the most common form of lung cancer.

The regulatory move comes as lung cancer continues to pose a significant public health challenge in China. In 2024, approximately 1.176 million new lung cancer cases were diagnosed in the country, with NSCLC accounting for roughly 85% of all lung cancer cases. Among these NSCLC patients, approximately 40% to 50% carry EGFR mutations, making them candidates for targeted therapies.

AnRun Medical Technology (Suzhou) Co., Ltd. secured breakthrough therapy designation for AMX3009 maleate tablets, intended as a first-line treatment for patients with locally advanced or metastatic NSCLC harboring EGFR uncommon mutations, including G719X, S768I, E709X, and other PACC mutations, as well as the L861Q mutation. The drug is a self-developed irreversible EGFR/HER2 inhibitor that demonstrates significant inhibitory effects against EGFR lung cancer mutations, wild-type lung cancer, and HER2. Beyond NSCLC, the compound is also being developed for breast cancer and gastric cancer treatments.

CSPC Pharmaceutical Group Limited earned the designation for SYS6010, an antibody-drug conjugate (ADC) targeting EGFR. The drug is intended for patients with relapsed or metastatic driver gene-negative non-squamous NSCLC who have failed both immunotherapy and platinum-based chemotherapy. SYS6010 consists of a humanized anti-EGFR monoclonal antibody linked through a cleavable linker to a topoisomerase I inhibitor payload. The mechanism involves specific binding to EGFR receptors on tumor cell surfaces, followed by internalization and intracellular release of the cytotoxic payload to exert anti-tumor effects.

Multitude Therapeutics received breakthrough therapy status for AMT-116 injection, designed for patients with locally advanced or metastatic EGFR wild-type non-squamous NSCLC who have failed prior treatment with anti-PD-1/PD-L1 monoclonal antibodies and platinum-based chemotherapy. AMT-116 is a CD44v9-targeting ADC composed of a proprietary antibody with high binding affinity for CD44v9, a hydrolyzable linker, and a belotecan derivative payload. CD44v9 plays a crucial role in various biological signaling pathways and is particularly important for cancer stem cells. The target is a high-abundance cell membrane protein that is widely overexpressed in solid tumors but has limited expression in normal tissues. The drug's antibody-to-drug ratio is approximately 7 to 8.

The simultaneous breakthrough therapy designations for these three innovative drugs cover multiple clinical scenarios and are poised to reshape the treatment landscape for non-small cell lung cancer in China. As these medications accelerate through clinical trials and toward potential market approval, they are expected to expand the country's precision oncology treatment options, reduce barriers to patient access, and drive continued advancement in China's innovative cancer diagnosis and treatment capabilities.