Keymed Biosciences Announces the Latest Clinical Trial Results of CM336 Published in the New England Journal of Medicine

CHENGDU, China, June 12, 2025 /PRNewswire/ -- Keymed Biosciences Inc. (HKEX: 02162) today announced that Prof. Jun Shi's research team from the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences) has recently published a research report titled "BCMA-Targeted T-Cell Engager for Autoimmune Hemolytic Anemia after CD19 CAR T-Cell Therapy" in the New England Journal of Medicine (NEJM), which has reported for the first time globally the research data on a BCMA x CD3 bispecific antibody treatment for patients with refractory autoimmune hemolytic anemia (AIHA).

The study results showed that two patients experienced rapid disease improvement after the administration of CM336, achieving partial remission on days 13 and 19, respectively. Hemoglobin levels returned to normal on days 17 and 21, respectively, while reticulocyte counts, lactate dehydrogenase, and indirect bilirubin levels significantly decreased. Before receiving treatment with CM336, both patients had undergone multiple treatment regimens, including glucocorticoids, splenectomy, anti-CD20 antibodies, BTK inhibitors, and CD19 CAR-T cell therapies, but their disease eventually recurred or progressed to refractory status. The latest assessment results after 6 months post-starting CM336 showed that both patients remained in sustained remission without immunosuppressive therapies or transfusions. No cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or infection events occurred during the entire treatment and follow-up period.

The overall study showed that CM336 had demonstrated positive efficacy signals in treating patients with relapsed/refractory AIHA who had previously received multiple therapies, with rapid disease control and sustained remission lasting over half a year, while also exhibiting good safety profile, potentially making it an innovative treatment option for development in this disease.

About CM336
CM336 is a BCMA x CD3 bispecific antibody that can simultaneously target and identify and specifically bind both BCMA on the surface of target cells and the CD3 receptors on the surface of T cells to recruit immune T cells to the vicinity of the target cells, thereby inducing T-cell dependent cellular cytotoxicity (TDCC) to eliminate the target cells. As of the date of this announcement, the Phase II clinical study of CM336 for the treatment of primary light-chain amyloidosis has been approved by the Center for Drug Evaluation of the National Medical Products Administration and will commence clinical trials shortly.

About Keymed Biosciences
Keymed Biosciences Inc. (HKEX: 02162) is a biotech company focused on the urgent unmet clinical needs, and committed to providing high-quality, affordable, innovative therapies for patients in China and overseas. Keymed was founded by medical and scientific experts who have strong experience in the transformation of scientific and technological achievements to commercialization at home and abroad.