Cambridge, MA, Rotterdam, NL, Suzhou, CN — January 13, 2022

Harbour BioMed (“HBM”, HKEX: 02142) announced that, the Company has completed its first interim analysis of phase III clinical trial of tanfanercept (HBM9036), a new global innovative tumor necrosis factor (TNF) receptor-1 fragment-based drug for adult patients with moderate-to-severe dry eye disease (DED). The trial was planned to enroll 674 patients and to conduct two interim analyses over the course of the trial.

As of 28 December 2021, a total number of 187 patients have been evaluated for key efficacy endpoints assessment. The first interim analysis was performed according to trial protocol, and the interim data were reviewed by the Independent Data Monitoring Committee (the "IDMC"). As a result of its observed efficacy trend and favorable safety, the study was recommended by the IDMC to be continued according to the current protocol. As at the date of this announcement, the Company remains blinded to whether the participants involved in the trial received drug or placebo. Further announcement(s) regarding the details and developments of the phase III clinical trial will be made as and when appropriate.

About Tanfanercept (HBM9036)

Tanfanercept (HBM9036) is a modified 19 kDa TNF receptor 1 fragment originally developed by HanAll Biopharma as an ophthalmic solution with good eye permeability, strong TNF-α neutralizing activity, high stability, and minor side effects. Based on a licensing agreement, Harbour BioMed owns the exclusive rights for development and commercialization of Tanfanercept in mainland China, Taiwan, Hong Kong, and Macao.

About Dry Eye Disease (DED)

DED is a chronic, multifactorial ocular disease that can cause visual disturbance and long-term damage of the ocular surface, with a significant impact on quality of life. It currently affects 20-30% patients in China. The prevalence of this ocular disease is expected to grow significantly fueled by a growing aging population worldwide, excessive use of smartphones, and environmental changes. Artificial tears, which only provide temporary symptomatic relief, are still the most used treatment for DED in China, representing a large unmet need in the Chinese market.

About Harbour BioMed
Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners and select acquisitions.
 
The Company’s proprietary antibody technology platforms Harbour Mice^® generate fully human monoclonal antibodies in two heavy and two light chain (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE^®) are capable of delivering tumor killing effects unachievable by traditional combination therapies. Integrating Harbour Mice^® with single B cell cloning platform, our antibody discovery engine is highly unique and efficient for development of next generation therapeutic antibodies.