Shanghai Junce Biotechnology Co., Ltd. ("Junce Bio"), a company focused on developing innovative cell therapies and drugs for solid tumors, has officially submitted a listing application to the Hong Kong Stock Exchange, planning to list on the Biotech sector under Chapter 18A. Junce Bio has established a differentiated competitive advantage in the solid tumor treatment field with GC101, the world's first TIL therapy that does not require high-intensity lymphodepletion chemotherapy or IL-2 administration, and GC203, the world's first non-viral vector genetically modified TIL cell therapy. The latest clinical data shows that GC101 achieved an objective response rate of 41.7% in patients with metastatic advanced non-small cell lung cancer who failed standard therapy, and an ORR of 30% in patients with advanced melanoma, positioning it to potentially become China's first approved TIL therapy. Current data indicates that Junce Bio's GC101 is effective against various refractory advanced solid tumors. In 10 patients with metastatic advanced melanoma who failed standard therapy, the objective response rate was 30%, with a median progression-free survival of 5.5 months. In 12 patients with metastatic advanced non-small cell lung cancer who failed standard therapy, with a median follow-up of 13.0 months, GC101 demonstrated an objective response rate of 41.7%, while the median duration of response was not reached; the 12-month overall survival rate was 66.7%, and the median survival period has not yet been reached. Currently, the clinical trial of GC101 for treating melanoma is in a key Phase II trial, with a Biologics License Application expected to be submitted in 2026; the clinical pipeline for GC101 in non-small cell lung cancer is currently in Phase Ib. Furthermore, it has shown potential in various other malignancies including cervical cancer, cholangiocarcinoma, colorectal cancer, breast cancer, head and neck squamous cell carcinoma, sarcoma, and gallbladder cancer. According to the plan, GC101 is expected to submit a marketing application in 2026. If approved successfully, it would become the first TIL therapy launched in China. Besides GC101, Junce Bio has another key product, GC203, which is the world's first non-viral vector genetically modified TIL drug. This product has already received clinical trial approval and entered the subsequent development stage. The company's R&D expenditure was 57.62 million yuan in 2023, increased to 90.99 million yuan in 2024, and reached 52.80 million yuan in the first half of 2025, with R&D costs related to core products accounting for 46%.
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