CSTONE PHARMA wrote a post · Feb 15 18:44

CS2009 (PD-1/VEGF/CTLA-4 tri-specific antibody) has been approved by the US FDA to commence Phase II clinical research

- CS2009 (PD-1/VEGF/CTLA-4 tri-specific antibody) for advanced solid tumorshas received approval from the US Food and Drug Administration (FDA) for a Phase II Investigational New Drug (IND) application, marking a significant step forward in the global development of this innovative immunotherapy.

– This Phase II global multicenter clinical trial is actively enrolling participants in Australia and China,comprising a total of 15 monotherapy/combination therapy cohorts and nine solid tumor indications, including but not limited to:

- Non-Small Cell Lung Cancer (NSCLC)

- Colorectal Cancer (CRC)

- Triple-Negative Breast Cancer (TNBC)

- Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

- Platinum-Resistant Ovarian Cancer (PROC)

– Preliminary data from the Phase I clinical study of CS2009 was presented at the 2025 European Society for Medical Oncology (ESMO) Annual Meeting,showing good safety and tolerability with encouraging anti-tumor activity.Further Phase I and Phase II clinical study results are expected to be released at this year's American Society of Clinical Oncology (ASCO) and ESMO conferences.

Suzhou, China, February 16, 2026 - CStone Pharmaceuticals (Stock Code: 2616.HK), an innovation-driven biopharmaceutical company focused on drug development for critical disease areas such as oncology, autoimmune disorders, and inflammation, today announced its core assetCS2009's IND application for a Phase II clinical trial in advanced solid tumors has been approved by the FDA.

Dr. Frank Jiang, CEO, President of R&D, and Executive Director of CStone Pharmaceuticals, stated: "We are very pleased to see CS2009'sglobal multicenter Phase II clinical trial advance efficiently and receive approval from the US FDA to proceed.This IND approval is based on proactive communication between CStone Pharmaceuticals and the US FDA, as well as the FDA’s full recognition of the key results from the dose escalation and dose expansion phases in the Phase I clinical trial, which demonstrated good safety and anti-tumor activity. During this meeting, both parties further confirmed the Phase II clinical trial protocol, including dose optimization strategies, dose expansion design, and other core elements. Currently, we are advancing the global clinical development program of CS2009, and we look forward to sharing more positive data and research progress in the near future."

About CS2009 (PD-1/VEGF/CTLA-4 Tri-Specific Antibody)

CS2009 is a novel tri-specific antibody independently developed by CStone Pharmaceuticals starting from molecular design, with first-in-class (FIC) / best-in-class (BIC) potential. It targets three clinically validated targets—PD-1, VEGFA, and CTLA-4—achieving multidimensional anti-tumor effects through synergistic action. Specifically, blocking PD-1 reverses T-cell exhaustion, blocking CTLA-4 promotes T-cell activation and proliferation, and blocking VEGFA inhibits tumor angiogenesis, thereby improving the tumor microenvironment (TME). In the TME, the dual blockade of PD-1 and CTLA-4 is significantly enhanced through cross-linking with VEGFA. Meanwhile, CS2009 preferentially binds to tumor-infiltrating T-cells positive for both PD-1 and CTLA-4, minimizing interference with the CTLA-4 regulatory pathway in peripheral T-cells.

The ongoing global multicenter Phase II clinical trial of CS2009 adopts a multi-cohort parallel expansion design, aiming to evaluate the efficacy, safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of CS2009 as monotherapy and in combination therapies. It encompasses 15 monotherapy/combination therapy research cohorts and nine solid tumor indications: NSCLC, CRC, TNBC, ES-SCLC, PROC, cervical cancer (CC), hepatocellular carcinoma (HCC), gastric cancer or gastroesophageal junction cancer (GC/GEJC), and esophageal squamous cell carcinoma (ESCC). The trial is currently actively enrolling patients in Australia and China and has received US IND approval.

About CStone Pharmaceuticals

CStone Pharmaceuticals (HKEX: 2616), founded at the end of 2015, is an innovation-driven biopharmaceutical company focused on drug research and development in key therapeutic areas such as oncology, autoimmune diseases, and inflammation, committed to addressing unmet medical needs of patients in China and globally. To date, the company has successfully launched four innovative drugs, received approval for 20 New Drug Applications (NDAs), and obtained nine indications. Its current R&D pipeline includes a balanced portfolio of 16 drug candidates, comprising potential first-in-class or best-in-class antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies, and precision medicines. Additionally, CStone Pharmaceuticals boasts a highly experienced management team that provides 'end-to-end' coverage across preclinical exploration, translational research, clinical development, manufacturing, business development, and commercial operations. For more information about CStone Pharmaceuticals, please visit: www.cstonepharma.com.

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