The Phase 3 trial is a randomized, controlled, open-label, multi-center study to evaluate the efficacy and safety of lemzoparlimab in combination with AZA versus AZA monotherapy as first-line therapy in subjects with higher-risk MDS. This is the first approved Phase 3 trial for anti-CD47 therapies in mainland China.

"We are excited to have dosed the first patient in the Phase 3 study for lemzoparlimab in higher-risk MDS, a disease with very limited treatment options. This milestone represents a significant step towards addressing the unmet medical needs of MDS patients and underscores our commitment to developing innovative therapies that could make a meaningful difference in their lives," said Dr. Andrew Zhu, President and Acting CEO of I-Mab. "We are hopeful that lemzoparlimab could become the first-to-market CD47-targeting therapy in China, providing a potentially new, safer, and effective treatment option for patients in need."

MDS is a type of hematologic malignancy that mainly affects older adults, causing dysplastic hematopoiesis, cytopenia(s), and risk of acute myeloid leukemia (AML) transformation. The incidence rate of MDS increases with age, especially among those aged 70 and above.

Hypomethylating agents (HMAs) and allogenic stem cell transplant (allo-HSCT) are the current standard of care for higher-risk MDS, but allo-HSCT can be limited by its associated morbidity. HMAs such as AZA and decitabine have been the primary therapies available for higher-risk MDS in mainland China in the past 15 years, but many patients experience leukemic transformation and long-term survival expectations remain discouraging.