Pregene Announces Exclusive Licensing Agreement with CellPoint B.V. for PRG-1801 CAR-T Therapy in Europe and the U.S.

Investment Circle (ID: pedaily2012) April 2nd News: Recently, Shenzhen Pregene Biopharma Co., Ltd. and European CellPoint B.V. announced a significant licensing partnership! Based on the clinical value prospects, key regulatory milestones, sales milestones, and other commercial values of the project, according to the agreement, Pregene will receive an upfront payment of over 20 million euros, subsequent milestone payments at corresponding stages, and royalties exceeding 10% from commercial sales. As part of the deal, Pregene will provide the supply of lentiviral vectors. WinXCapital (Mercury Capital) is serving as the financial advisor for this transaction for Pregene Biopharma and as the exclusive financial advisor for Pregene’s subsequent Series C financing round.

This licensing collaboration is Pregene's fourth outbound drug licensing deal, following the authorizations to Simcere Pharmaceutical Group (2096.HK), South Korea’s Biocast, and India’s multinational pharmaceutical company Dr. Reddy’s Laboratory (listed on the New York Stock Exchange). It also marks another milestone in the globalization strategy for its core products, once again fully demonstrating Pregene’s innovative R&D capabilities and commercialization strengths on a global scale.

According to the agreement, CellPoint B.V. will obtain the European and American rights for PRG-1801 (a chimeric antigen receptor T-cell injection targeting BCMA), developed independently by Pregene, for hematological tumor indications. CellPoint B.V. will also be responsible for the clinical development and commercialization of the product in the European and American regions. Pregene will act as the exclusive lentiviral vector supplier, providing the core raw material—lentiviral vector—for the production of this product in the European and American markets.

This product's main business model is based on the Point-of-Care (POC) platform for the rapid development and delivery of PRG-1801. The POC platform, leveraging a decentralized approach, can break through the constraints of traditional cell product manufacturing models. It effectively addresses numerous bottlenecks that restrict the commercialization of CAR-T products, such as production limitations, transportation restrictions, quality control challenges, time constraints, and clinical supply limitations. Compared to the traditional centralized production model, the POC platform will significantly expand the deliverable areas for cell-based therapeutics, improve delivery efficiency, reduce manufacturing costs and clinical treatment expenses, enabling fast and cost-effective commercial delivery without regional restrictions.

"The clinical study results of PRG-1801 demonstrate that the product has excellent clinical safety and efficacy. This collaboration signifies that the product has gained recognition in the international mainstream market and will be commercialized in a more innovative manner. We are thrilled to partner with CellPoint B.V. to fully realize the clinical and commercial value of this product," said Dr. Zhang Jishuai, CTO of Pregene. "We also look forward to the POC platform supporting this innovative product, benefiting more patients."

PRG-1801 is a CAR-T cell drug independently developed by Pregene that targets the BCMA antigen, incorporating a chimeric heavy chain variable domain with high affinity and high specificity. From drug discovery, preclinical research, pharmaceutical studies, clinical research, to commercial production, the entire process of PRG-1801 has been autonomously completed by the Pregene team. All research data, production processes, and quality control systems have been developed according to international standards. The project employs a highly efficient production process with significant cost advantages, ensuring repeatability and stability in both process and quality control systems, which sufficiently supports the global industrialization and commercialization of the project. Clinical research results of PRG-1801 have demonstrated good safety and efficacy, and subsequent clinical trials as well as industrialization and commercialization in China and globally are currently advancing rapidly.