Shanghai Longyao Biotech Secures Nearly RMB 100 Million in Series A Funding to Advance CD20-OX40 CAR-T into Phase II Clinical Trials

On December 8, China Biotech Services Holdings Limited (08037) announced that its subsidiary, Shanghai Longyao Biological Technology Co., LTD. ("Longyao Bio"), has completed the first round of financing of nearly RMB 100 million, with a pre-investment valuation of approximately RMB 800 million. This round of financing was led by Yixing Environmental Science Park Industrial Development Equity Investment Partnership (Limited Partnership), and the controlling shareholder, China Biotech Services, continued to increase its investment. The funds from this round of financing will mainly be used for Phase II clinical trials of the CD20-OX40 CAR-T product and clinical research of other solid tumor pipeline products, as well as the construction of a new GMP cell production laboratory in Yixing.

Shanghai Longyao Biological Technology Co., LTD. was established in 2013 and is dedicated to the research and development of tumor immunotherapy cell technologies and products. As a high-tech enterprise recognized by the state, it focuses on R&D and product development. The company has developed a pipeline of multiple tumor immunotherapy cell products, covering areas such as hematological tumors and solid tumors.

On January 21, 2021, Longyao Biotechnology received the approval notice from the National Medical Products Administration for the clinical trial of Shanghai Longyao's cell injection named LY007 ('LY007 Cell Injection'), registered as a Class I new drug. This is the first and only CAR-T product targeting the CD20 antigen to receive clinical trial approval in China, primarily intended for treating relapsed or refractory CD20-positive B-cell non-Hodgkin lymphoma (B-NHL).

Since patients with relapsed or refractory B-NHL treated with CD19 CAR-T still experience non-response and recurrence, CD20 CAR-T, which optimizes the immune response of B cells, is an excellent alternative. LY007 from Shanghai Longyao Biological Technology Co., LTD utilizes a lentiviral vector for genetic modification and incorporates a unique design independently developed by Longyao Biological Technology. This design introduces an independent costimulatory signal receptor, OX40, into the CAR structure, thereby forming a novel CAR-T construct.

This novel structure not only enhances the cytotoxic ability of CAR-T cells but also reduces the expression of exhaustion molecules on the cell surface, better maintaining the functionality of CAR-T cells within the tumor's immunosuppressive microenvironment, with the potential to prevent tumor recurrence.

LY007, with its differentiated target, novel structural design, and excellent clinical performance, has garnered the favor of Academician Saijuan Chen from the National Center for Translational Medicine at Shanghai Ruijin Hospital, Professor Weili Zhao, Vice President of Ruijin Hospital and Deputy Chairperson of the Lymphoma Society of the Chinese Medical Association, and Professor Jianyong Li, Director of the Hematology Department at Jiangsu Provincial People's Hospital and Deputy Chairperson of the Integrated Hematology Professional Committee of the Chinese Medical Doctor Association since the initiation of its Phase I clinical trial. These experts jointly participated in the product’s Phase I clinical trial. To date, a total of 9 subjects (9/12) across three dosing groups have completed the reinfusion at Ruijin Hospital and Jiangsu Provincial People's Hospital, demonstrating good safety and efficacy. The CAR-T therapy targeting this specific antigen is currently among the leading clinical progress in China.

Moreover, based on the positive outlook for the international commercial development of the CD20-targeted CAR-T and OX40 patented technology platforms, AstraZeneca (China) signed a strategic cooperation agreement with China Biotech Services Holdings Limited this October. Both parties will collaborate on immune cell therapy in Yixing City to facilitate the innovative achievements of Shanghai Longyao Biological Technology Co., LTD.'s projects being implemented in Yixing. AstraZeneca will provide comprehensive guidance and support in areas such as project design and fund investment, which will help accelerate the pre-market commercial operations and post-market sales expansion of Shanghai Longyao’s products.

At the same time, the strategic cooperation with AstraZeneca also lays a commercial foundation for the future overseas development of the CD20-OX40 CAR-T patent. As a global leading pharmaceutical company, AstraZeneca's CGT cell therapy R&D and production base products are available in major economies around the world. Once the patent licensing cooperation begins, it will surely accelerate the clinical trials and approval process of this product in various countries. With the first-mover advantage, as well as good safety and efficacy, Shanghai Longyao Biological Technology Co., LTD. can leverage AstraZeneca's global R&D platform and sales network to achieve an earlier overseas listing, providing treatment to more patients worldwide sooner.

About Yixing Huanke Park Industrial Development Equity Investment Partnership (Limited Partnership)

Established on September 22, 2021, with a registered capital of 2.5 billion RMB, its general partner is the state-owned enterprise Yixing Jiayi Private Equity Fund Management Co., Ltd., and its limited partners are the state-owned holding companies Yixing Environmental Industry Co., Ltd. and Wuxi Xinyuan Investment Co., Ltd.