Hansi Aitai-B(03378.HK) announces 2025 annual results, with R&D expenses increasing by 19.7% year-on-year

Gelonghui, March 27 | Hansai Aitai-B (03378.HK) announced its annual results for 2025, with the group’s other income and gains increasing by 115.6% from approximately RMB 7.7 million in 2024 to approximately RMB 16.6 million during the reporting period, primarily due to changes in the assessment of receivable contingent consideration leading to fair value changes. The loss for the year increased from approximately RMB 116.9 million in 2024 to approximately RMB 131.5 million during the reporting period. The group’s R&D costs increased by 19.7% from approximately RMB 74.7 million in 2024 to approximately RMB 89.4 million during the reporting period, mainly due to increased investment in pipeline R&D in 2025, which led to higher technical service expenses.

2025 is an important year for the company’s pipeline clinical breakthroughs and the realization of the technical platform’s value. The company has made progress in core product clinical development, pipeline team construction, technical platform iteration, and global clinical layout, with key milestones as follows:

Core product clinical data stands out: The flagship product HX009 (PD-1/SIRPα dual-functional fusion protein) has achieved clinically meaningful preliminary efficacy data in EBV+ non-Hodgkin lymphoma, melanoma, and other indications with unmet clinical needs, validating the clinical value of the dual-target mechanism and laying the foundation for subsequent key clinical development;

Continuous improvement of the pipeline team: Three core candidate drugs have progressed to clinical stages (HX009, HX301 reaching Phase IIa, HX044 reaching Phase I), and the first FIC ADC product HX111 has received NMPA IND approval, marking a key move for the company in the ADC field, forming a dual-track pipeline pattern led by bispecific antibodies and breakthroughs in ADCs;

Global clinical layout implemented: HX044 has achieved simultaneous enrollment at dual centers in China and Australia, completing patient enrollment of 8 cases across 3 centers in Australia and 18 cases across 4 centers in China, further enhancing international clinical research and registration communication capabilities;

Verification of technical platform value: The VersatiBody™ platform successfully produced two clinical-stage dual-functional antibodies, HX009 and HX044, while also completing the preclinical molecular design of multiple ADCs and bispecific antibodies, fully validating the platform’s molecular design efficiency and drugability optimization capabilities;

Accelerated layout of combination therapies: Clinical approvals and enrollments for combination therapies of multiple products including HX009, HX301, and HX044 have been granted, targeting difficult-to-treat indications such as cholangiocarcinoma, glioblastoma, and ICI-resistant solid tumors, opening up subsequent commercialization market space for the products.