Shengshi Taikang Completes First China-U.S. Dual-Reporting New Drug Project, Embarking on Its Overseas Journey

Today, Shengshi Taikе's independently developed The CXCR4 antagonist CGT-1881 has received approval from the U.S. Food and Drug Administration (FDA) to proceed into clinical trials. Hematopoietic stem cell mobilization for patients with blood cancer. This marks another significant achievement following the product's approval in June of this year by China's National Medical Products Administration (NMPA) for clinical trials—and it is Shengshi Taikang's first China-U.S. dual-regulatory new drug project 。

CXCR4 (chemokine receptor) as A Hot Target for Global R&D Not only does it play a critical role in tumors, but it is also closely linked to several immune diseases, genetic disorders, and viral illnesses. Currently, CXCR4 antagonists under development worldwide are being explored for clinical applications spanning areas such as acute lymphoblastic leukemia, acute myeloid leukemia, breast cancer, glioblastoma, hepatocellular carcinoma, and stem cell mobilization.

It is well known that stem cells reside within human bone marrow. As a result, traditional stem cell harvesting is a risky and complex procedure. Donors typically undergo a puncture procedure in a sterile operating room, and even the anesthesia itself carries significant risks. In contrast, CXCR4 antagonists work by blocking the interaction and signaling between SDF-1 and CXCR4, effectively depriving hematopoietic stem/progenitor cells of their chemotactic attraction to SDF-1, which is highly expressed in the bone marrow microenvironment. This prevents them from crossing the endothelial barrier and migrating into the bone marrow niche, ultimately enabling the mobilization of these cells into peripheral blood circulation.

The company's ongoing research CGT-1881 is a highly potent and highly selective next-generation CXCR4 antagonist. , used to mobilize hematopoietic stem cells into the peripheral blood of patients with blood cancer, enabling the collection and autologous transplantation of these cells. Compared to currently available injectable medications, CGT-1881 Oral administration offers greater convenience and accessibility in medication use.

Dr. Wang Tong, Chief Scientific Officer of Shengshi Taikang, stated: " We are thrilled that CGT-1881 has been approved for clinical trials in both China and the U.S. within less than a month, marking the company’s official launch of its global journey. Currently, no oral CXCR4 antagonists have been approved globally, presenting a vast market opportunity. The mechanism of action for this target is well understood and has already been clinically proven effective, with promising potential across multiple therapeutic areas, including solid tumors and hematologic cancers. We hope that both the U.S. and Chinese clinical trials for this drug can move forward swiftly, bringing much-needed relief to patients worldwide at the earliest possible date.

Founded in 2010 in Suzhou Industrial Park, Shengshi Taikang boasts a core team with decades of international experience spanning the entire lifecycle of pharmaceutical products. The company is dedicated to the research, development, and industrialization of innovative small-molecule drugs aimed at groundbreaking therapies. Leveraging an integrated drug R&D technology platform and a diversified business perspective, Shengshi Taikang has built a robust pipeline of cutting-edge drug candidates, targeting key therapeutic areas such as diabetes management, cancer treatment, and rare diseases.