KEYMED BIO-B (02162) surged over 5% during intraday trading. As of press time, the stock was up 4.58% to HK$75.4, with turnover reaching HK$87.53 million.

On the news front, according to global clinical trial registry websites, KEYMED BIO-B's CM336 launched its first Phase III study on September 18. This drug represents the company's first dual-antibody therapy to advance to Phase III stage.

The newly initiated Phase III study is a randomized, open-label, multicenter clinical trial (n=280) designed to evaluate the efficacy and safety of CM336 monotherapy compared to investigator's choice of standard treatment in patients with relapsed or refractory multiple myeloma (R/R MM) who have previously received at least second-line therapy. The study's primary endpoint is progression-free survival (PFS).

Previously, CM336 completed a Phase I/II study targeting R/R MM. In the dose escalation cohorts, 23 patients were evaluable for efficacy. Results showed that at a median follow-up of 12.1 months, the objective response rates (ORR) for the ≤5mg group, 20-40mg group, and 80-160mg group were 17%, 71%, and 80% respectively. The proportions of patients achieving stringent complete response or complete response were 17%, 71%, and 60% respectively.