BIODLINK-B Reports Annual Revenue of RMB 748 Million, Highlighting Strategic Shift to CDMO

Stock News
03/18

BIODLINK-B (01875) announced its annual results for the period ended December 31, 2025. The group recorded revenue of RMB 748 million, a decrease of 31.93% year-on-year. Research and development expenses amounted to RMB 85.675 million, an increase of 8.02% compared to the previous year. The loss attributable to company equity holders was approximately RMB 100 million, with a loss per share of RMB 0.14.

Revenue from product sales was RMB 488 million, a decline of 44% year-on-year, primarily attributed to intensified market competition. In contrast, revenue from the CDMO business reached RMB 235 million, representing a 13% increase.

A significant breakthrough was achieved in the international expansion of self-developed products. During the year, the company's proprietary product, Puxiting® (Bevacizumab Injection), successfully obtained marketing approvals in five countries, including Nigeria, Pakistan, Colombia, Indonesia, and Bolivia. Furthermore, the first overseas shipments to Colombia, Indonesia, and Nigeria were completed, marking a critical transition from "regulatory approval" to "commercial sales."

The strategic transition to a CDMO model has yielded significant results, establishing itself as a stable cornerstone for the company. Multiple new technology platforms were launched, strengthening front-end project acquisition and leading to a substantial increase in early-stage projects. A total of 60 new projects were added throughout the year, bringing the cumulative project count to 213, with ADC-related projects accounting for 68%. The company successfully secured one new Pre-BLA project, bringing the total number of such projects in hand to eight, which locks in potential future revenue. The value of signed but unfulfilled orders reached RMB 308 million, a 61% increase year-on-year.

The company successfully enabled the approval and launch in China of the world's first EGFR ADC drug, MeYouHeng® from Lepu Biopharma, establishing an industry milestone. This achievement fully demonstrates BIODLINK-B's robust capabilities in translating cutting-edge science into reliable products and providing full-cycle services within high-barrier complex drug fields like ADC, thereby building a solid competitive moat.

The company's high-standard quality management system has gained widespread recognition from the industry both domestically and internationally. It has successfully passed multiple on-site manufacturing inspections by regulatory authorities, GMP compliance checks from various countries, and GMP audits by clients and third-party consulting agencies. In 2025, the company underwent 37 various GMP inspections/audits with a 100% pass rate. These included six inspections by Chinese regulatory authorities and four audits by EU Qualified Persons. The company also obtained GMP certificates from countries such as Brazil, Argentina, and Thailand, as well as a registration approval letter from Syria. Additionally, the company has repeatedly assisted clients in passing inspections conducted by their overseas partners, including multinational pharmaceutical companies and institutions, successfully supporting clients in obtaining necessary authorizations and receiving high recognition.

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