Keymed Biosciences, Inc.

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. SOURCE Keymed Biosciences WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CHENGDU, China, April 25, 2025 /PRNewswire/ -- Keymed Biosciences Inc. (HKEX: 02162) ("Keymed" or the "Company") today announced CM518D1, a CDH17-targeted antibody-drug conjugate (ADC) developed by Keymed, received Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), and is currently undergoing Phase I/II clinical trials in China for the treatment of solid tumors. This milestone marks another breakthrough in Keymed's ADC drug development, further strengthening its innovative therapeutic pipeline in oncology. CM518D1: a novel ADC drug targeting CDH17 CDH17 (Cadherin-17), a member of the cadherin superfamily, is an emerging therapeutic target in gastrointestinal cancers. Studies indicate that CDH17 is highly expressed in multiple gastrointestinal cancers including colorectal cancer, gastric cancer, pancreatic cancer, esophageal cancer, and plays a critical role in tumor invasion and metastasis. CM518D1 delivers cytotoxic payloads precisely to tumor cells by a CDH17-specific monoclonal antibody, which combines the specificity of antibodies and the potent cytotoxicity of chemotherapeutics. Preclinical studies demonstrated that CM518D1 exhibits strong direct cytotoxic activity, potent bystander killing effect and excellent plasma stability. CM518D1 exhibits remarkable anti-tumor efficacy in multiple solid tumor xenograft models and a favorable safety profile and wide therapeutic window in toxicological evaluations. Clinical development: providing a potential treatment regimen for gastrointestinal cancers Keymed is currently conducting Phase I/II clinical trials in China to evaluate the safety, tolerability, and preliminary efficacy of CM518D1 in patients with advanced solid tumors. Future studies aim to provide a more precise, effective, and safe therapeutic option for patients worldwide with gastrointestinal cancers. Keymed's ADC platform: a next-generation of proprietary ADC program for innovative drug development Keymed's proprietary ADC platform has capabilities for developing next-generation ADCs with novel payloads (e.g., diverse mechanisms of action), hydrophilic linkers (optimized for stability and drug release) and engineered antibodies (enhanced binding and pharmacokinetics). To meet the demands of next-generation ADC development and clinical research, Keymed has established GMP-compliant facilities for linker-payload and ADC drug substance production. This infrastructure positions Keymed at the forefront of ADC therapeutic development, helping to address unmet medical needs for patients worldwide. 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. SOURCE Keymed Biosciences WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CHENGDU, China, April 24, 2025 /PRNewswire/ -- Keymed Biosciences Inc. (HKEX: 02162) ("Keymed" or the "Company") recently announced CM518D1, a CDH17-targeted antibody-drug conjugate (ADC) developed by Keymed, received Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), and is currently undergoing Phase I/II clinical trials in China for the treatment of solid tumors. This milestone marks another breakthrough in Keymed's ADC drug development, further strengthening its innovative therapeutic pipeline in oncology. CM518D1: a novel ADC drug targeting CDH17 CDH17 (Cadherin-17), a member of the cadherin superfamily, is an emerging therapeutic target in gastrointestinal cancers. Studies indicate that CDH17 is highly expressed in multiple gastrointestinal cancers including colorectal cancer, gastric cancer, pancreatic cancer, esophageal cancer, and plays a critical role in tumor invasion and metastasis. CM518D1 delivers cytotoxic payloads precisely to tumor cells by a CDH17-specific monoclonal antibody, which combines the specificity of antibodies and the potent cytotoxicity of chemotherapeutics. Preclinical studies demonstrated that CM518D1 exhibits strong direct cytotoxic activity, potent bystander killing effect and excellent plasma stability. CM518D1 exhibits remarkable anti-tumor efficacy in multiple solid tumor xenograft models and a favorable safety profile and wide therapeutic window in toxicological evaluations. Clinical development: providing a potential treatment regimen for gastrointestinal cancers Keymed is currently conducting Phase I/II clinical trials in China to evaluate the safety, tolerability, and preliminary efficacy of CM518D1 in patients with advanced solid tumors. Future studies aim to provide a more precise, effective, and safe therapeutic option for patients worldwide with gastrointestinal cancers. Keymed's ADC platform: a next-generation of proprietary ADC program for innovative drug development Keymed's proprietary ADC platform has capabilities for developing next-generation ADCs with novel payloads (e.g., diverse mechanisms of action), hydrophilic linkers (optimized for stability and drug release) and engineered antibodies (enhanced binding and pharmacokinetics). To meet the demands of next-generation ADC development and clinical research, Keymed has established GMP-compliant facilities for linker-payload and ADC drug substance production. This infrastructure positions Keymed at the forefront of ADC therapeutic development, helping to address unmet medical needs for patients worldwide. 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. SOURCE Keymed Biosciences WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED