CARsgen Secures Key GPC3 CAR-T Patent at EPO, Bolstering IP Portfolio

SHANGHAI, July 13, 2025 – CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a leading biopharmaceutical company dedicated to the development of innovative CAR T-cell therapies for cancer, today announced a significant victory in intellectual property protection. The company successfully defended its European patent EP3445407, which specifically covers its groundbreaking GPC3-targeted CAR-T cell therapy, during opposition proceedings before the European Patent Office (EPO).

The favorable outcome stems from the formal withdrawal of an appeal by a U.S.-based biotechnology company on July 3, 2025. This company was the sole remaining appellant among the original two opponents challenging the EPO Opposition Division's earlier decision to maintain CARsgen's patent. The withdrawal effectively solidifies CARsgen's intellectual property rights in Europe for this critical therapeutic asset.

Strategic Importance of GPC3 CAR-T Technology

CARsgen's GPC3-targeted CAR-T cell therapy is a cornerstone of its oncology pipeline, particularly for treating hepatocellular carcinoma (HCC), a highly aggressive form of liver cancer with limited treatment options. Glypican-3 (GPC3) is a protein highly expressed in HCC cells but minimally in normal tissues, making it an ideal target for CAR-T cell therapy. This targeted approach aims to harness the patient's immune system to specifically identify and eliminate cancer cells, offering a potentially transformative treatment for patients.

The successful defense of this patent in Europe is crucial for CARsgen's global commercialization strategy. It provides a strong legal foundation for the company to develop, manufacture, and potentially market its GPC3 CAR-T therapy across key European markets without the threat of patent infringement challenges related to this specific intellectual property. This clarity in patent protection is vital for attracting partnerships, securing funding, and ultimately bringing this innovative therapy to patients in need.

Implications for the Biotechnology Sector and Investors

This development underscores the increasing importance of intellectual property in the highly competitive biotechnology and pharmaceutical sectors. Patent protection is a critical asset for biopharmaceutical companies, safeguarding their significant investments in research and development and providing a competitive edge. For CARsgen, this patent win not only validates its scientific innovation but also enhances its market position and long-term growth prospects.

Investors in the biotechnology space, particularly those following companies like CARsgen (GPC), should view this as a positive indicator. Strong patent portfolios reduce regulatory and competitive risks, which can translate into more stable revenue streams and higher valuations. The successful defense of a core patent like EP3445407 signals a robust intellectual property strategy and a commitment to protecting proprietary technologies.

Market Context and Future Outlook

The global market for CAR-T cell therapies is experiencing rapid growth, driven by their remarkable efficacy in treating various hematological malignancies and the expanding research into solid tumors. Liver cancer, specifically HCC, represents a significant unmet medical need, and a successful GPC3 CAR-T therapy could capture a substantial share of this market. CARsgen's progress in this area, now reinforced by patent security, positions it favorably within this evolving therapeutic landscape.

Looking ahead, CARsgen will likely continue to advance its GPC3 CAR-T program through clinical trials, aiming for regulatory approvals in major markets. The secured European patent provides a clear runway for these efforts in one of the world's largest pharmaceutical markets. This legal victory could also pave the way for potential licensing agreements or collaborations, further accelerating the development and commercialization of this promising therapy.

Investment Insights

For investors considering CARsgen (2171.HK) or the broader cell therapy sector, this patent defense is a de-risking event. It mitigates a significant legal overhang and strengthens the company's competitive moat. Key takeaways for investors include:

• Reduced IP Risk: The successful patent defense removes a potential barrier to market entry and commercialization in Europe.
• Enhanced Valuation: A stronger IP portfolio can lead to increased investor confidence and potentially higher valuations.
• Focus on Pipeline Execution: With patent concerns addressed, CARsgen can now fully concentrate on clinical development and regulatory submissions.
• Long-Term Growth Potential: The GPC3 CAR-T therapy targets a large unmet medical need, offering substantial long-term revenue potential if successful.

This development reinforces CARsgen's position as an innovator in the CAR-T space and highlights the critical role of intellectual property in the success of biopharmaceutical companies.