Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced results from its Phase Ib clinical study of the novel anti-TMPRSS6 monoclonal antibody (R&D code: 9MW3011) in patients with polycythemia vera (PV) at the 2026 European Hematology Association (EHA) Annual Congress held in Stockholm, Sweden, from June 11–14.

The study results indicate that 9MW3011 demonstrated favorable safety and tolerability and showed potential to prolong time free from cytoreductive therapy in PV patients, thereby suggesting a potential improvement in quality of life.

The study (NCT06752746) was designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of 9MW3011 in relapsed/refractory PV patients, and to preliminarily explore its efficacy.

A total of 25 participants were enrolled. The results showed a favorable safety and tolerability profile. The most common adverse reactions were laboratory test abnormalities (Grade 1–2). No deaths or serious adverse reactions were reported. The adverse reactions rate was consistent across dose groups (150 mg Q4W, 150 mg Q2W, 300 mg Q4W), with no dose-dependent trend observed, and no new clinical safety risk signals were identified.

Preliminary efficacy was evaluated based on cytoreductive-therapy-free (CTF) status (i.e., no need for cytoreductive interventions such as hydroxyurea or interferon‑α) in terms of duration and rates. Results showed that the median CTF duration increased with dose, reaching 120, 139, and 197 days in the 150 mg Q4W, 150 mg Q2W, and 300 mg Q4W groups, respectively. Rates of participants remaining CTF were 43%, 57%, and 83% in the 150 mg Q4W, 150 mg Q2W, and 300 mg Q4W groups, respectively. An increasing trend was observed with higher drug exposure of 9MW3011. These findings indicate that 9MW3011 demonstrated favorable safety and tolerability in Chinese patients with PV and showed potential to prolong time free from cytoreductive therapy, thereby reducing cytoreductive treatment-related adverse reactions and suggesting a potential improvement in quality of life.

9MW3011 is the first anti-TMPRSS6 monoclonal antibody developed by a Chinese company to enter clinical trials. It has received Fast Track designation and Orphan Drug Designation from the FDA, offering the potential to bring more treatment options for PV patients.

About 9MW3011

9MW3011 is a novel anti-TMPRSS6 monoclonal antibody independently developed by Mabwell’s innovation center in San Diego, USA. By specifically binding to the target, it upregulates hepcidin expression in hepatocytes, inhibits iron absorption and release, reduces serum iron levels, and thereby regulates iron homeostasis. Indications under development include multiple rare diseases worldwide, such as β‑thalassemia and polycythemia vera, which are associated with iron homeostasis. Currently, no mature or effective large‑molecule therapeutic drugs are available for these indications. 9MW3011 has received Fast Track designation and Orphan Drug Designation from the FDA.

Previously, Mabwell granted DISC MEDICINE, INC. (NASDAQ: IRON) exclusive rights to develop, manufacture, commercialize, and otherwise develop 9MW3011 in all territories except Greater China and Southeast Asia. Mabwell is eligible to receive up to $412.5 million in upfront and milestone payments, as well as royalties on net sales after product launch.