Keymed completed Phase 2 trial of CM512, a TSLP x IL-13 bispecific antibody for chronic sinusitis
Today, Keymed Biosciences announced that its Phase 2 clinical trial of long-acting TSLP x IL-13 bispecific antibody CM512 for the treatment of chronic sinusitis with nasal polyps (CRSwNP) has met all study endpoints.
The results showed that CM512 had a rapid onset of action in the treatment of chronic sinusitis with nasal polyps. By the fourth week of administration, it could rapidly shrink nasal polyps, significantly improve nasal congestion, and promote the recovery of olfactory function.
One injection of CM512 can maintain efficacy for six months. The nasal polyp score (NPS) at 24 weeks showed a significantly better change from baseline than the control group, while also significantly reducing overall sinus inflammation.
All dose groups of CM512 demonstrated good safety and tolerability, with an extremely low incidence of anti-addictive antibodies (ADA). The incidence of treatment-related adverse events (TEAEs) was comparable to that in the placebo group, and no serious adverse events occurred in the CM512 group.
There are approximately 38 million patients with chronic sinusitis and nasal polyps in China. This is a chronic inflammatory disease primarily characterized by type 2 inflammation. Its core feature is the high degree of proliferation and edema of the nasal and sinus mucosa under long-term inflammatory stimulation, eventually forming polyp-like growths that obstruct the nasal cavity. The main symptoms include persistent nasal congestion, decreased or lost sense of smell, purulent nasal discharge, and facial swelling and pain. These persistent symptoms can severely impact patients’ sleep, daily work, and quality of life.
However, currently used drugs and surgical procedures have limitations in efficacy and high recurrence rates. Some patients experience persistent symptom control after hormone or surgical treatment, with polyps repeatedly growing. There is an urgent clinical need for more effective, longer-lasting, and conveniently administered treatment options.
In recent years, biologics targeting the type 2 inflammatory pathway have brought new hope for treatment.
CM512 is the world’s first IgG-like long-acting TSLP x IL-13 dual blocker independently developed by Keymed. It can simultaneously target TSLP and IL-13, inhibit the initiation of the inflammatory cascade response in the early stage, effectively reduce Th2 cell differentiation and the release of cytokines such as IL-13, and directly inhibit pathological symptoms driven by IL-13, thereby more effectively treating type 2 inflammation-related diseases.
In July 2026, CM512 was included in the Breakthrough Therapy List by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration for the treatment of chronic sinusitis with nasal polyps.
The results of this Phase 2 clinical trial further validate its best-in-class therapeutic potential for chronic sinusitis with nasal polyps.
Keymed Biosciences plans to launch a Phase 3 clinical trial of CM512 for the treatment of chronic sinusitis with nasal polyps, and has specified a dosage regimen of 300 mg every six months (Q24W).
Keymed is also advancing several Phase 2 clinical trials of CM512 for moderate to severe asthma, moderate to severe chronic obstructive pulmonary disease (COPD), moderate to severe atopic dermatitis in adults, and chronic spontaneous urticaria.
Source: Keymed Biosciences | Top image: Getty Images
