Boteng Biologics and Kaidi Medical Deepen Strategic Collaboration to Advance Global Development of Cell Therapies

SuzhouJuly 4, 2023PR Newswire -- On June 30, 2023, Porton Biologics Ltd. (referred to as "Porton Biologics") and Nanjing Kaidi Biotechnology Co., Ltd. (referred to as "Kaidi Biotechnology") held a strategic cooperation signing ceremony to deepen the research, development, and production collaboration on cell therapy drugs, jointly promoting the development of new drugs in the Chinese, U.S., and global markets.

Porton Biologics Ltd. and Nanjing Kaidi Biotechnology Co., Ltd. Deepen Strategic Cooperation to Jointly Advance Global Development of Cell Therapy Drugs

In March this year, the clinical trial application (IND) for KD-025 Cell Injection, a solid tumor CAR-T project independently developed by Nanjing Kaidi Biotechnology Co., Ltd., was tacitly approved by the Center for Drug Evaluation (CDE) under the National Medical Products Administration. As the exclusive CDMO partner, Porton Biologics Ltd. provided CMC research and development services for the project, including process development, production of plasmids, viruses, and CAR-T cells, as well as support for the CMC section of the IND registration application.

Porton Biologics Ltd. has an end-to-end gene and cell therapy CDMO service platform, covering areas such as plasmids, cell therapy, gene therapy, oncolytic viruses, nucleic acid therapy, and live biotherapeutics. This signing will further strengthen the strategic cooperation between the two parties. Building on the existing collaboration, it will expand the U.S. IND application, clinical, and commercial production of cell therapy drugs, accelerating the drug's development process on a global scale.

Porton Biologics Ltd. and Nanjing Kaidi Biotechnology Co., Ltd. Deepen Strategic Cooperation to Jointly Advance Global Development of Cell Therapy Drugs

Dr. Dai Hongjiu, founder, executive president, and chairman of Nanjing Kaidi Biotechnology Co., Ltd., stated: "We are very pleased to comprehensively strengthen our strategic partnership with Porton Biologics Ltd. Kaidi Biotechnology has developed multiple new drug R&D pipelines for cell therapy, and this year, we also received approval for the first cell therapy product targeting NKG2DL in China. We believe that with the professional team and platform of Porton Biologics, we can help Kaidi Biotechnology achieve the IND application and commercialization process of cell therapy drugs in the United States and even globally."

Yan Yu, Deputy General Manager of the Marketing Department at Porton Biologics Ltd., stated: "We are very grateful for the trust and support from Nanjing Kaidi Biotechnology Co., Ltd. It is an honor to support Kaidi Medical’s CAR-T project for solid tumors in its IND application in China. Porton Biologics has a professional team and extensive project experience that can support international filings for gene and cell therapy drugs. We believe we can help Kaidi Medical achieve breakthroughs in new drug development globally, bringing effective medicines to benefit the public sooner."

AboutNanjing Kaidi Biotechnology Co., Ltd.

Kaidi Medical is a clinical-stage new drug development company dedicated to leveraging advanced synthetic biology technology platforms to develop novel cell therapies addressing unmet clinical needs for patients with solid tumors. Relying on its proprietary CAR library screening platform—KD-SmCAR™, and dual-targeting CAR development platform—KD-ScCAR™, Kaidi Medical has successfully developed multiple cell therapy pipelines targeting solid tumors, including next-generation autologous and allogeneic CAR-T/CAR-NK pipelines. To date, the company has filed over 30 CAR-related patent applications in China and the U.S., with 15 patents granted, including core pipeline patents such as KD-025 and KD-496, which were the first to be authorized in both China and the U.S. The development results of the KD-025 CAR-T product, targeting NKG2DL for indications such as liver cancer, colorectal cancer, and glioma, have been published in authoritative international journals on cancer immunotherapy, including *Journal for ImmunoTherapy of Cancer* and *Cancer Immunology Research*, as well as presented at the American Society of Clinical Oncology (ASCO) annual meeting. Earlier, the KD-025 CAR-T IIT clinical trial conducted at a well-known clinical center in China completed low-dose administration in several cases without significant toxic side effects, demonstrating the product’s safety and efficacy. Kaidi Medical became the first company in China to receive CDE clinical approval for an IND application for KD-025, a CAR-T cell injection targeting NKG2DL in solid tumors. The company is currently negotiating with multiple collaborators to initiate the Phase I registration clinical trial for KD-025. Meanwhile, the company's core product, KD-496, the world’s first novel dual-targeting CAR-T cell injection, has entered the IIT clinical stage. In addition, Kaidi Medical is advancing the development of next-generation allogeneic universal CAR-T/CAR-NK therapies, positioning itself to become a globally recognized leader in cell-based treatments for solid tumors in the near future. The company has built a 3,000-square-meter GMP cell therapy R&D and production center and completed nearly 100 million yuan in financing, with a Series B round currently underway. At the same time, the company is rapidly advancing the development and commercialization of synthetic biology products through strategic collaborations.

About Porton Biologics Ltd.

Porton Biologics Ltd. was founded in2018 Year12Month, based in Suzhou Industrial Park, with a listed company-Porton Pharmaceutical Technologies Inc. (Stock Code:300363) as the foundation, establishing an integrated platform for plasmids, viral vectors, and cell therapy products.CDMO Platform, providing from early research, investigator-initiated clinical trials, to new drug clinical trial applications (IND), registration of clinical trial samples and commercial production services to accelerate the drug research and development process.

Porton Biologics Ltd. focuses on gene and cell therapy, building on the successful experience of Porton Corporation, with a core team of world-class professionals, adhering to...“Customer First”The service tenet, with“Compliance, Professionalism, Focus, Open Collaboration”For the brand concept, continuing the strong legacy of its parent companyIPProtection and project management mechanisms, as well as a comprehensive quality management system, fully leverage the successful experience of the core team in advancing gene and cell therapy products from clinical trials to market launch, providing high-quality and efficient services to global customers and enabling innovative medicines to benefit the public sooner.