Shares of KEYMED BIO-B (02162) surged more than 9% during the trading session. At the time of writing, the stock was up 6.69% to HK$86.15, with a turnover of HK$468 million.

The upward movement follows news that the company's TSLP/IL-13 dual-specific antibody, CM512, is being considered for designation as a breakthrough therapy for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). The Phase II clinical study for CM512 in this indication has already completed patient enrollment.

Beyond CRSwNP, the company is advancing clinical studies for CM512 across several other conditions, including atopic dermatitis, asthma, chronic obstructive pulmonary disease (COPD), and chronic spontaneous urticaria, indicating a broad development strategy.

Should CM512 receive the breakthrough therapy designation, it is expected to significantly accelerate the subsequent review and approval process, shortening the overall timeline to market.

Analysts have highlighted that KEYMED BIO-B has multiple drug candidates approaching critical data readouts and regulatory submission milestones in the second half of the year. CMG901 is anticipated to release pivotal data for later-line gastric cancer and may concurrently advance its application with the U.S. FDA. The Phase II data readout for CM512 in CRSwNP is also highly anticipated. Furthermore, CM336 is planned for submission of a Biologics License Application (BLA) in China. The sales growth of spogibart, benefiting from its inclusion in the national reimbursement drug list, is expected to continue.