Twin blossoms bloom as Shengshi Taike's two Class 1 new drugs receive clinical approval.

Therefore, CGT-9475 shows promise as a next-generation ALK inhibitor, potentially serving as a后续 treatment for patients who have developed resistance to existing ALK inhibitors. Clinical Trial implied license. CXCR4 The antagonist CGT-1881 is indicated for hematopoietic stem cell mobilization in patients with non-Hodgkin lymphoma (NHL) or multiple myeloma (MM); meanwhile, CGT-9475, a next-generation ALK inhibitor, holds promise as a potential treatment option for patients who have developed resistance to existing ALK inhibitors.

CGT-1881 : Highly efficient and highly selective "stem cell mobilization"

CXCR4 It not only plays a critical role in tumors but 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 in human bone marrow. Therefore, traditional stem cell harvesting is a risky and complex procedure. Donors typically undergo a puncture surgery performed in a sterile operating room. While anesthesia can help alleviate some of the discomfort, the anesthetic itself carries significant risks. CXCR4 The antagonist works by blocking the interaction and signaling between SDF-1 and CXCR4, thereby eliminating the chemotactic attraction of bone marrow microenvironment-expressed SDF-1 toward hematopoietic stem/progenitor cells. This prevents their transendothelial migration and subsequent homing to the bone marrow niche, ultimately promoting the mobilization of these cells into peripheral blood circulation.

CGT-1881, currently under development by the company, is a next-generation CXCR4 antagonist that boasts high efficacy and selectivity. It is specifically designed to mobilize hematopoietic stem cells into the peripheral blood of patients with Non-Hodgkin Lymphoma (NHL) or Multiple Myeloma (MM), facilitating the collection and subsequent autologous transplantation of these cells. Compared to existing injectable medications on the market, CGT-1881 offers the convenience of oral administration, providing improved patient compliance and accessibility.

CGT-9475 : Quality Enhancement and Differentiated Development

Lung cancer is the leading cause of cancer-related deaths worldwide and also ranks as the number one killer among cancers in China. Based on biological characteristics, treatment options, and prognosis, lung cancer is classified into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), with NSCLC accounting for 80%–85% of cases. Among NSCLC patients, approximately 3% to 7% harbor an ALK gene mutation. ALK-positive advanced NSCLC patients typically have an average age of 52, and some already develop brain metastases at the time of initial diagnosis—a rate that continues to rise over time, posing a significant challenge to patient survival.

ALK Inhibitors offer significant advantages in clinical applications, but the use of ALK inhibitors inevitably leads to secondary resistance and challenges related to brain metastases. Meanwhile, the company’s investigational ALK inhibitor CGT-9475 is specifically designed to overcome drug resistance and address the critical issue of central nervous system metastasis. Conduct high-quality and differentiated development 。

CGT-9475 In preclinical studies, it demonstrated significant inhibitory effects against resistance mutations such as L1196M and RET in non-small cell lung cancer cell lines—mutations for which there are currently no available solutions. Meanwhile, The drug has demonstrated excellent blood-brain barrier penetration in preclinical studies, which will pave the way for NSCLC Brain metastasis patients find new hope. Therefore, CGT-9475 holds promise as a next-generation ALK inhibitor, potentially serving as a后续 treatment for patients who have developed resistance to existing ALK inhibitors.

Dr. Tong Wang, Chief Scientific Officer of Shengshi Taikang, stated: "I am delighted that CGT-1881 and CGT-9475 have been smoothly approved for clinical trials one after the other. Currently, these therapies target CXCR4 The antagonist Currently, no oral drugs targeting this specific pathway have been approved globally, presenting a vast market opportunity. The mechanism of action for this target is well-defined and has already demonstrated clinical efficacy, with promising potential across multiple therapeutic areas, including solid tumors and hematologic cancers. CGT-9475 addresses two major clinical challenges in NSCLC treatment—drug resistance and brain metastasis—offering the potential to become a next-generation ALK inhibitor. We remain hopeful that these two innovative therapies will advance swiftly through clinical trials, 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.