On December 10, Shanghai Junsai Biotechnology Co., Ltd. (hereinafter referred to as "Junsai Biotechnology") submitted a listing application to the Hong Kong Stock Exchange.
According to its prospectus, Junsai Bio is a biotechnology company dedicated to the development of innovative cell therapies and drugs for solid tumors. Its core product, GC101, is expected to become the first approved tumor-infiltrating lymphocyte (TIL) therapy. In 2023, 2024, and the first half of 2025, the company projected net losses of RMB 94 million, RMB 164 million, and RMB 98 million, respectively.
The core product GC101 undergoes important testing.
According to its prospectus, Junsai Bio focuses on the huge unmet clinical needs in the treatment of solid tumors and is developing the next generation of pan-solid tumor immunotherapy.
According to the company, its core product GC101 is currently undergoing a pivotal Phase II clinical trial for the treatment of melanoma, with a Biologics License Application (BLA) expected to be submitted in 2026. The clinical pipeline for GC101 in the treatment of non-small cell lung cancer is currently in Phase Ib clinical trials. In addition, the company has also established a presence in early-line combination therapy for multiple indications and postoperative adjuvant therapy.
Regarding production, the company stated that it has taken the lead in establishing a complete TIL industrialization production base in China, employing high-standard production equipment and relying on an intelligent and digital management platform to ensure the large-scale preparation and reliable delivery of TIL cell products. In addition, as the leading drafting organization, the company participated in the formulation of the first TIL group standard, "Guidelines for the Preparation and Quality Control of Tumor Infiltrating Lymphocyte (TIL) Preparations".
According to the prospectus, Junsai Bio intends to use the funds raised from this offering primarily for: advancing the clinical development of its TIL product pipeline; upgrading the company's technology platform; strengthening production management and manufacturing capabilities; working capital and other general corporate purposes.
Continued losses
According to the prospectus, the company's net profit was approximately -94 million yuan, -164 million yuan, and -98 million yuan in 2023, 2024, and the first half of 2025, respectively. The company anticipates continued losses in the short term, as stated in the prospectus.
In its prospectus, JunSai Bio stated that the company's business, financial condition, and prospects largely depend on the successful development, regulatory approval, and commercialization of its product candidates. Any failure or delay could have a material adverse effect on the company.
In terms of R&D, the company's R&D costs were RMB 57.62 million, RMB 90.99 million, and RMB 52.801 million in 2023, 2024, and the first half of 2025, respectively. "Due to plans to expand the indications for our core products and continue to advance their clinical development, while also pushing more pipeline candidates into clinical trials and conducting additional preclinical studies, we expect to continue to invest heavily in R&D," the company stated.
The company further stated: "Due to the numerous risks and uncertainties surrounding the regulatory approval and commercialization of TIL therapies, it is impossible to predict the specific timing or magnitude of increased expenses, nor when or whether profitability will be achieved or maintained. If additional research or clinical trials are required, the company's expenses may exceed expectations. Even if the candidate product is approved, significant costs associated with commercialization are expected, including specialized infrastructure and logistics systems for patient-specific therapies."