Progene Biopharma Secures Over €20 Million Upfront in Landmark Out-Licensing Deal with CellPoint B.V. for PRG-1801 CAR-T Therapy in Europe and the U.S.

Beijing time, April 1, 2022,Shenzhen Pregene Biopharma Co., Ltd. and European CellPoint B.V. Announce Major Licensing Collaboration! Based on the clinical value prospects, key regulatory, sales milestones, and other commercialization value 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 more than 10% commercial sales royalties. As part of the transaction, Pregene will provide a supply of lentiviral vectors. WinX Capital (VCBeat) 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.

This licensing collaboration is Pregene's fourth outbound drug licensing deal, following the authorizations granted 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).This is another milestone in the global layout of its core products, once again fully demonstrating Pregene's innovative R&D capabilities and commercialization abilities on a global scale.

According to the agreement, CellPoint B.V. will obtain the European and American rights for Pregene's self-developed PRG-1801 (a chimeric antigen receptor T-cell injection targeting BCMA) for hematological tumor indications, and will be responsible for the clinical development and commercialization of the product in these regions. Pregene will act as the exclusive lentiviral vector supplier, providing core raw materials—lentiviral vectors—for the production of this product in Europe and America.

This product’s main business model is based on the rapid development and delivery of PRG-1801 through the Point-of-Care (POC) platform. The POC platform, using a decentralized approach, can overcome the limitations of traditional cell product manufacturing models. This decentralized delivery method effectively addresses numerous bottlenecks that restrict the commercialization of CAR-T products, such as production, transportation, quality control, time constraints, and clinical supply limitations. Compared to the traditional centralized production model, the POC platform will significantly expand the deliverable regions for cell therapies, 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 is being commercialized in a more innovative manner. We are delighted 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 features a highly efficient production process with significant cost advantages, while its manufacturing process and quality control system ensure repeatability and stability, fully supporting the global industrialization and commercialization of the project. Clinical research results of PRG-1801 have demonstrated favorable safety and efficacy, and the subsequent clinical trials in China and internationally, along with industrialization and commercialization efforts, are rapidly advancing.

Pregene is deeply engaged in the innovation of cell and gene therapy drugs. It has a biopharmaceutical R&D and industrialization team with strong academic backgrounds and rich practical experience. The company has established a comprehensive platform for the R&D and industrialization of cell and gene therapy drugs. Its shareholders include well-known investment institutions such as the National SME Development Fund, Guoke Jiahe Fund, Haier Medical, Huabang Health, and CITIC Securities. Pregene participated in drafting the "Key Considerations for CAR-T Cell Quality Control Testing Research and Non-Clinical Evaluation" published by the National Institutes for Food and Drug Control (NIFDC) in June 2018, and as an expert group member, has participated multiple times in the formulation and revision of relevant regulations.

Pregene's product pipeline includes CAR-T, TCR-T, CAR-NK, stem cell drugs, etc., with indications covering multiple fields such as hematological tumors, solid tumors, infectious diseases, autoimmune diseases, and age-related degenerative diseases. It is the only leading innovative drug company that achieves full coverage of immune cell drugs and stem cell drugs, with a wide range and large market. Looking ahead, Pregene will take the development of affordable biologic innovative drugs for patients as its mission, guided by clinical needs. It will further strengthen original research and development, expand into more product pipelines with high clinical value, build a comprehensive international patent barrier, maintain and expand its leading advantage in the industry, seize the commanding heights of world biopharmaceutical technology, and become one of the top international new biopharmaceutical companies.

CellPoint B.V., headquartered in Amsterdam, Netherlands, is committed to providing affordable and rapidly deliverable CAR-T therapies for all patients in need. CellPoint B.V. has obtained exclusive rights in Europe and the United States through a strategic partnership with Lonza to establish a fully enclosed automated cell production platform. By utilizing full automation, closed systems, flexible personalized configurations, and an online-monitored QC and QA system, CellPoint B.V. can achieve end-to-end demand matching at every stage of immune cell cultivation, including CAR-T therapy. This enhances the efficiency, reliability, and stability of cell culture, improves the quality of the final product, reduces clinical usage costs and risks, and accelerates the transition from process development to GMP commercial production.

WinX Capital is a leading investment bank in China's healthcare sector. The founding team includes five global finance Ph.D. holders from Tsinghua University's PBC School of Finance, and the frontline team has an average of over 10 years of experience in management, investment, and mergers & acquisitions, with a cumulative M&A amount exceeding 30 billion yuan. Headquartered in Beijing and Shanghai, it covers more than 3,000 active investment institutions and industry groups. In 2020 and 2021, WinX Capital was consecutively ranked among the "WISE2020/2021 Top 5 Most Growth-Oriented New Investment Banks in China" by 36Kr, "Top 4 Most Active Financial Advisors in Healthcare for 2021" by First Sounding, and "Top 4 Best Financial Advisor Institutions in Healthcare for 2020" and "Top 2 Best Financial Advisor Institutions in Healthcare for 2021" by Qiming Technology & New Sound Venture Services.