Shenzhen Hemogen Therapeutic Co., Ltd. (hereinafter referred to as “Hemogen”) has achieved a significant milestone in its international clinical development. In collaboration with Siriraj Hospital, affiliated with Mahidol University, Hemogen’s clinical trial for Hemocel, a gene therapy targeting transfusion-dependent β-thalassemia, has received official clinical trial approval from the Thai Food and Drug Administration (Thai FDA).

In parallel, Hemogen has successfully completed the transfer and validation of its core manufacturing equipment to Thailand. The manufacture and clinical development of Hemocel will be carried out locally at Siriraj Hospital, supporting the implementation of gene therapy in the region.

This marks a key step forward in Hemogen’s internationalization strategy, providing strong momentum for market expansion in Southeast Asia and the advancement of the company’s global business presence.

High-standard 3Q Validation of Core Equipment

Hemogen’s fully Automated Cell Sorter (Celaxi-23), independently developed by BGI, has successfully completed the full Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation at the Siriraj hospital manufacturing site. The system demonstrated cell recovery rates exceeding 99%, establishing a solid foundation for future localized manufature and clinical application.

Figure 1: BGI Research Institute engineers assist Siriraj technicians in completing equipment transfer validation

ThaiFDA Grants Clinical Trial Approval

Backed by rigorous technical documentation and regulatory compliance, Hemogen has been granted official clinical trial approval by the Thai Food and Drug Administration (ThaiFDA). This approval signifies international recognition of the safety and efficacy of Hemocel, paving a critical path for accelerated market entry in Southeast Asia.

Figure2: ThaiFDA clinical trial approval notification for Hemocel (HGI-001 Injection) (original Thai version)

Parallel Progress in Reagent Material Export and Process Transfer Validation

The first batch of supporting consumables and reagents has been successfully exported to Hemogen’s Thai partner institutions. Going forward, essential reagents will be exported as needed based on clinical recruitment progress. In parallel, the company is conducting technology transfer and quality control validations to ensure the stability and consistency of localized manufacture, providing reliable for future large-scale supply.

Figure3: First batch of consumables and reagents arrives at Bangkok Airport, and is transported to Siriraj facilities.

Full Launch of Clinical Preparations

Hemogen has also reached preliminary collaborative intentions with other leading medical institutions in Thailand and is progressing through ethical reviews and patient recruitment , with all clinical preparations activities advancing in an orderly manner. .

· Showcasing Technological Strength: The ThaiFDA approval validates the international competitiveness and regulatory compliance of Hemogen’s product.

· Accelerating Market Expansion: Southeast Asia, one of the fastest-growing healthcare markets globally and a high-prevalence area for thalassemia. This strategic presence will significantly accelerate Hemogen’s reach across ASEAN markets.

· Enhancing Industrial Chain Synergy: The closed-loop process—from equipment validation and consumable&reagent export to localized manufacture, Hemogen demonstrates strong capabilities in cross-border resource integration and manufacture capacity deployment.

Currently, Hemogen is intensively preparing for the full implementation of clinical trials in Thailand and simultaneously advancing regulatory registration plans across Southeast Asian countries. Moving forward, the company will leverage its technological advantages and global team to deepen its presence in markets along the “Belt and Road” initiative, driving global health innovation.