– Encouraging efficacy and a positive safety profile were observed in a Phase 1 study and Investigator Initiated Trial of KL003 for beta thalassemia patients –

– KL003 manufacturing costs are substantially lower than those of currently approved gene therapies –

– A pivotal Phase 2 beta thalassemia study for KL003 is anticipated to commence in 2025 –

HANGZHOU, China, Nov. 25, 2024 — Kanglin Biotechnology (Hangzhou) Co., Ltd., a pioneering biotech firm developing next-generation gene therapies, today announced the successful closing of a $20 million Series A financing round. These funds will support the clinical advancement of KL003, the company’s lead candidate for treating beta thalassemia and sickle cell disease. Further funding will explore the potential of additional therapeutic indications within their pipeline.

“Our leading gene therapy has the potential to provide a one-time cure for patients with beta thalassemia and sickle cell disease. We believe our treatment can significantly improve the lives of patients suffering from these debilitating diseases,” stated Dr. Haoquan Wu, CEO and Founder of Kanglin Biotechnology. “In our trial, KL003 demonstrated 100% efficacy in 17 patients, leading to considerably faster transfusion independence and engraftment. We are confident that KL003’s clinical profile distinguishes it from other therapies in its class and eagerly anticipate initiating our pivotal Phase 2 study next year. Moreover, the substantial reduction in manufacturing costs may address the high cost of currently available gene therapies, thereby broadening access to this vital treatment for those who need it most.”

KL003 is a lentiviral vector gene therapy delivering a functional ß-globin gene for the single-administration treatment of beta thalassemia and sickle cell disease. KL003 cell infusion has recently received Pediatric Rare Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA). In January 2024, the clinical trial application for KL003 cell injection was approved by China’s Center for Drug Evaluation (CDE) for the treatment of transfusion-dependent beta thalassemia.

About Kanglin Biotechnology (Hangzhou) Co., Ltd

Kanglin Biotech is a Chinese company focused on the research, development, and commercialization of first-in-class and best-in-class gene therapy drugs primarily targeting diseases with a significant impact on human health, including beta thalassemia, AIDS, hemophilia, and Parkinson’s disease.

Investor Contact:

Kiki Patel, PharmD
Gilmartin Group, Principal
Kiki@gilmartinir.com