New Stocks News | Junshi Biosciences Files to List on HKEX, Committed to Innovative Cell Therapy and Drug Development for Solid Tumors.

According to the disclosure by the Hong Kong Stock Exchange on December 10th, Shanghai Jinyu Bio-Technology Co., Ltd. (referred to as Jinyu Bio) has submitted an application for listing on the main board of the Hong Kong Stock Exchange, with CITIC SEC as its exclusive sponsor. The prospectus shows that Jinyu Bio is a biotechnology company dedicated to innovative cell therapy and drug development for solid tumors. It focuses on developing immunocell therapy that is safer, more effective, more accessible, and more affordable, without being limited by any fixed molecular targets, covering the most common or difficult-to-treat solid tumors. According to Frost & Sullivan data, the company's core product GC101 is the world's first tumor-infiltrating lymphocyte (TIL) therapy that does not require high-intensity chemotherapy or IL-2 administration, and is expected to become the first approved TIL therapy in China. TIL cell therapy, administered once, can bring curative effects to some late-stage cancer patients. Clinical data shows that TIL therapy also brings long-term benefits to patients with a variety of solid tumors, including late-stage melanoma, non-small cell lung cancer, breast cancer, bile duct cancer, cervical cancer, endometrial cancer, head and neck squamous cell carcinoma, gastrointestinal tumors, and other types of solid tumors. In terms of advantages and disadvantages, TIL therapy is a personalized therapy, with its core advantage being breakthrough efficacy, while its disadvantages include complex manufacturing processes, complicated clinical protocols, resulting in high overall costs, low accessibility, and limiting its widespread application. In order to make the high clinical value of TIL therapy available to a larger number of patients, the company has innovated from the production end to the clinical end, simplifying the manufacturing processes and clinical protocols while maintaining curative opportunities for TIL therapy, significantly improving the safety, accessibility, and affordability of TIL cell therapy. The company's core product GC101 is the world's first TIL cell new drug that does not require high-intensity cleansing and IL-2 injection. Phase I clinical trials for various types of advanced metastatic solid tumors that have failed standard treatment have shown objective response rates for GC101 in melanoma, non-small cell lung cancer, cervical cancer, and other types of solid tumors. Among them, for 10 cases of late-stage metastatic melanoma patients who failed standard treatment (median of 3.5 previous lines of treatment, 100% failed PD-1 antibody treatment), the objective response rate was 30%, and the median progression-free survival was 5.5 months. For 12 cases of late-stage metastatic non-small cell lung cancer patients who failed standard treatment (median of 3 previous lines of treatment), at a median follow-up of 13.0 months, GC101 showed an objective response rate of 41.7%, and the median duration of response has not yet been reached; the 12-month overall survival rate was 66.7%, with the median survival period not yet reached. Currently, clinical trials are underway for GC101 to treat melanoma, with a pivotal Phase II clinical trial expected to be submitted for Biologics License Application (BLA) in 2026; the clinical pipeline for GC101 to treat non-small cell lung cancer is currently in Phase Ib clinical trials; combination therapy and post-operative adjuvant therapy for multiple indications have also been laid out. Financial information Revenue For the fiscal years ending June 30 in 2023, 2024, and the six months ending June 30, 2025, the company recorded revenues of 6.812 million yuan, 3.372 million yuan, and 6.83 million yuan, respectively. Yearly/periodic losses For the fiscal years ending June 30 in 2023, 2024, and the six months ending June 30, 2025, the company recorded yearly/periodic losses of 94.391 million yuan, 164 million yuan, and 97.58 million yuan, respectively. Industry overview Tumor drug market size In recent years, the global tumor drug market has experienced strong growth. By 2024, the market size had increased to $253.3 billion, with a compound annual growth rate of 13.9% from 2020 to 2024. It is expected that by 2030, the market size will further expand to $452.5 billion, with a compound annual growth rate of 10.2% from 2024 to 2030, reaching $702.7 billion by 2035, with a compound annual growth rate of 9.2% from 2030 to 2035. By 2024, the size of the tumor drug market in China reached 258.2 billion yuan, with a compound annual growth rate of 6.9% from 2020 to 2024. In the next few years, this market is expected to accelerate growth, reaching 527.3 billion yuan by 2030, with a compound annual growth rate of 12.6% from 2024 to 2030, and further expanding to 1.042 trillion yuan by 2035, with a compound annual growth rate of 14.6% from 2030 to 2035. Overview of tumor immunotherapy Tumor immunotherapy is roughly divided into three categories: immune checkpoint inhibitors (ICI) therapy, cancer vaccines, and adoptive cell immunotherapy (T-cell therapy). Among them, the growth of tumor immunotherapy is particularly rapid, accounting for 11.3% of the global tumor drug market in 2024. It is expected that this field will continue to exhibit strong growth, with the proportion reaching 47.5% by 2035. TIL therapy market size By 2024, the global TIL therapy market size reached $104 million and is expected to grow significantly in the coming years. It is projected that by 2030, the market size will increase to $1.692 billion, and by 2035, it will further reach $4.501 billion, with a compound annual growth rate of 59.3% from 2024 to 2028, and 21.6% from 2030 to 2035. China's first TIL therapy is expected to enter the commercial market around 2027, with the market size projected to reach $200 million by 2030. In China, the TIL therapy market is expected to grow rapidly, with a market size of 1.077 billion yuan by 2035, with a compound annual growth rate of 40.0% from 2024 to 2030, surpassing the growth rate of the global market during the same period. Supported by various factors in clinical, technological, regulatory, and funding aspects, the TIL therapy market is expected to expand rapidly in the next few years. Trends at both macro and industry levels are driving the widespread application and accelerated development of TIL therapy. In addition, TIL therapy has also shown good results in other areas, such as late-stage melanoma, non-small cell lung cancer, breast cancer, gastrointestinal tumors, and other types of solid tumors. Board of Directors Information The company's board of directors consists of 9 directors, including 4 executive directors, 2 non-executive directors, and 3 independent non-executive directors. Directors serve a term of 3 years and can be re-elected for consecutive terms. Equity structure As of December 5, 2025, Shanghai Ruilai and Shanghai Qunbo are controlled by Dr. Jin, and under the Securities and Futures Ordinance, Dr. Jin is considered to have equity in the holdings of these two entities. Dr. Jin collectively holds a 34.5% stake. In addition, Katex Capital, Yuanhe Origin, and Mr. Huang Shizhuan hold 9.13%, 13.81%, and 5.3% of the shares, respectively. Fuer Capital and Sanfu Entrepreneurship collectively hold a 5.23% stake. Intermediary Team Exclusive Sponsor: CITIC SEC (Hong Kong) Limited Company Legal Counsel: Davis Polk & Wardwell for Hong Kong and U.S. law; JT&N for Chinese law Legal Counsel for the Exclusive Sponsor: Sullivan & Cromwell LLP (Hong Kong) for Hong Kong and U.S. law; King & Wood Mallesons for Chinese law Auditors and Reporting Accountants: Ernst & Young Industry Consultant: Frost & Sullivan Consulting Company, Shanghai Branch Compliance Consultant: FIRST SHANGHAI Finance Co., Ltd.