CSPC and Qilu Secure Proposed Breakthrough Therapy Designations for Innovative Oncology Drugs

Two Chinese pharmaceutical companies, CSPC Pharmaceutical Group Limited and Qilu Pharmaceutical Co., Ltd., have each secured proposed Breakthrough Therapy designations for innovative oncology drugs from China's Center for Drug Evaluation (CDE), the regulatory body announced on August 24.

CSPC's SYS6010, an antibody-drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR), received the designation for treating patients with relapsed or metastatic head and neck squamous cell carcinoma who have failed immunotherapy and platinum-based chemotherapy. The drug, developed in-house by CSPC, consists of a humanized anti-EGFR monoclonal antibody linked to a topoisomerase I inhibitor payload through a cleavable linker. It works by binding to EGFR receptors on tumor cell surfaces, internalizing into the cell, and releasing cytotoxic payloads to exert anti-tumor effects.

SYS6010 has already obtained Breakthrough Therapy designations for two other indications: EGFR mutation-resistant non-small cell lung cancer and esophageal squamous cell carcinoma. CSPC is currently conducting multiple Phase 3 clinical trials for the drug across several solid tumor indications, including esophageal squamous cell carcinoma, first-line and second-line non-small cell lung cancer, and second-line and above breast cancer.

On the same day, Qilu Pharmaceutical's injectable QLC5508 also received proposed Breakthrough Therapy status for treating patients with advanced extrapulmonary neuroendocrine carcinoma who have failed first-line standard treatment. QLC5508 specifically binds to B7-H3 on tumor cell surfaces and delivers a potent topoisomerase inhibitor payload called SuperTopoi™ directly to tumors. According to the company, SuperTopoi™ is 5 to 10 times more potent than deruxtecan (DXd), a commonly used ADC payload.

QLC5508 has previously secured Breakthrough Therapy designations for three other indications: unresectable locally advanced or metastatic esophageal squamous cell carcinoma after failure of first-line platinum-based chemotherapy and immune checkpoint inhibitors; metastatic castration-resistant prostate cancer after failure of androgen receptor pathway inhibitors and taxane chemotherapy; and recurrent small cell lung cancer after failure of initial platinum-based treatment.

In addition to these two drugs, the CDE has proposed Breakthrough Therapy designations for other oncology treatments in recent days. On August 21, Pairei Bio's SS-001 ointment received the designation for treating hand-foot syndrome caused by chemotherapy drugs. On August 19, Johnson & Johnson's Bleximenib tablets were proposed for the designation to treat adult patients with relapsed or refractory acute myeloid leukemia carrying KMT2A rearrangement or NPM1 mutation.

The proposed Breakthrough Therapy designations for these multiple drugs are expected to accelerate the development process from clinical research to market approval, enabling innovative therapies to reach patients more quickly. As these breakthrough therapy drugs complete clinical development and successfully launch, they will continue to optimize the domestic oncology treatment landscape, providing more survival hope for patients with advanced, refractory, or multi-line treatment-resistant cancers, and promoting high-quality innovation and development of China's biopharmaceutical industry.