Jan 3, 2025, Simcere Zaiming, an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group (2096.HK) announce that SIM0505, a CDH6 Antibody-Drug Conjugate independently developed by the company has received a Clinical Trial Approval in advanced solid tumors issued by the China National Medical Products Administration (NMPA) of China. Just days ago, on December 28, 2024, the Investigational New Drug (IND) application of SIM0505 was approved by the U.S. Food and Drug Administration (FDA).
CDH6 (cadherin-6 or K-cadherin) is a single-pass membrane protein involved in cell-cell adhesion, organ development, and epithelial-mesenchymal transition. The expression of CDH6 is extremely low in normal tissues, but high in a variety of tumors. It has the potential to become an important target for the treatment of advanced tumors.
SIM0505 is the an ADC candidate developed by Simcere Zaiming’s proprietary technology platform that enters clinical stage. It is consisted of an anti-CDH6 monoclonal antibody and proprietary camptothecin derivative toxin payloads, conjugated by a cleavable linker. By combining the tumor-specific targeting antibody and the highly potent small molecule toxin, SIM0505 demonstrates specific tumor killing activities and reduced toxicities compared to traditional chemotherapies. SIM0505 will be investigated in a globally multi-center clinical study to treat varies of malignant tumors such as ovarian cancer and renal cancer.
About Simcere Zaiming
Simcere Zaiming, an oncology-centric biopharmaceutical subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096), was established in 2023. The company is dedicated to developing groundbreaking therapies to meet the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several products in China, including COSELA®, Enweida®，Endostar®, and Enlituo®. The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners in cancer therapeutics. For media inquiries, please contact: pr@zaiming.com.