June 16, 2025 | Boston, USA--Dr. Jason Yang, Chief Executive Officer, President of R&D, and Executive Director of CStone Pharmaceuticals, attended the BIO International Convention in Boston, USA. He also delivered a keynote speech titled “Beyond PD-(L)1/VEGF Bispecifics: Innovating Towards Definitive OS Benefits” at the BIO CHINA Global Forum.
BIO（BIO International Convention) is the world's largest and most influential gathering of the biotechnology industry. It attracts leading global biopharmaceutical companies, investors, and partners annually, with numerous partnering events held during the convention. This year's edition in Boston is expected to convene over 15,000 industry professionals to explore future growth opportunities in the sector.
Under the theme "Beyond PD-(L)1/VEGF Bispecifics: Innovating Towards Definitive OS Benefits", Dr. Yang shared CStone's latest achievements under its Innovative Pipeline 2.0 strategy and its future commercial potential with global industry peers. Dr. Yang comprehensively elaborated on CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody), detailing its scientific rationale, preclinical validation data, and robust clinical development plan with current progress.
CS2009 is a potential first-in-class/best-in-class PD-1/VEGF/CTLA-4 trispecific antibody independently developed by CStone, with its clinical advancement currently at the global forefront. It features balanced PD-1 and CTLA-4 affinity, multi-target synergistic effects, and potent immune checkpoint inhibitory (CPI) function. Its differentiated, innovative molecular design preferably targets the tumor microenvironment (TME) to suppress tumor growth and is expected to enhance efficacy while reducing systemic toxicity:
PD-(L)1/VEGF bispecific antibodies have already demonstrated favorable safety profiles and significantly improved progression-free survival (PFS). Dual checkpoint blockade of PD-1 and CTLA-4 has shown synergistic effects across multiple tumor types, including non-small cell lung cancer (NSCLC), improving overall survival (OS) and PFS benefits for patients. Addition of VEGFa inhibition is expected to further enhance the efficacy of this mechanism.
As a blockbuster candidate, CS2009 combines three clinically validated targets (PD-1, VEGFa, and CTLA-4) within a single antibody molecule. The synergistic mechanisms between these targets enable multi-dimensional anti-tumor activity. CS2009 is positioned to replace PD-(L)1 agents in the standard-of-care (SOC) across multiple tumor types, with potential benefits in PFS and OS. Furthermore, CS2009 holds potential application in tumor types traditionally unresponsive to PD-(L)1 therapy, including cold tumors and those with PD-L1 expression low or negative.
Dr. Jason Yang emphasized: "By integrating PD‑1, VEGF and CTLA‑4 mechanisms within a single molecule, CS2009 is poised to deliver greater clinical benefits compared to existing PD-(L)1-based therapies, PD-(L)1/VEGF bispecific antibodies and PD-(L)1/CTLA-4 bispecifics. In particular, existing clinical evidence demonstrates that the addition of CTLA-4 blockade significantly extends OS across multiple tumor types."
The global multicenter Phase I trial of CS2009 is currently underway in Australia and China, with expansion to the United States planned. The first patient was dosed in March 2025 and dose escalation is now progressing to higher levels. CS2009 demonstrates broad clinical potential across multiple solid tumors, including NSCLC, ovarian cancer, renal cell carcinoma, cervical cancer, hepatocellular carcinoma, gastric cancer, and other target indications. It holds significant potential to become a next-generation immuno-oncology backbone therapy.
Proprietary Pipeline Accelerates Growth Phase 2.0
Since its inception, CStone has been dedicated to addressing unmet medical needs for patients in China and globally. To date, the Company has successfully commercialized 4 innovative drugs with 16 NDA approvals across 9 indications.
In its Pipeline 2.0 innovation phase, CStone has strategically deployed a balanced portfolio of first-in-class and/or best-in-class antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies. CStone has established its proprietary ADC platform and built a differentiated Pipeline 2.0 comprising 11 novel assets, including ROR1 ADC, PD-1/VEGF/CTLA-4 trispecific antibody, EGFR/HER3 bispecific antibody and ADC, ITGB4 ADC, SSTR2-targeted assets, and autoimmune bispecifics.
Global Commercialization Momentum
CStone's core commercial product, sugemalimab, is the first China‑developed PD‑L1 antibody approved overseas and the first PD-L1 approved in Europe for first‑line Stage IV NSCLC all comers. New indication application has been submitted for stage III NSCLC in early 2025, expecting to become the SECOND PD-(L)1 approved in Europe for this indication.
Dr. Yang remarked, "Sugemalimab's dual usage in Stage III and IV NSCLC will further solidify its role as a cornerstone immunotherapy in lung cancer."
As CStone enters this new growth phase, the Company will ramp up R&D investment, leveraging innovative technologies and platforms to advance its product pipeline. For its commercialized products, CStone will collaborate closely with partners and maintain proactive regulatory engagement to expand additional approvals into additional regions, ultimately broadening patient accessibility and addressing global medical needs.
About BIO and BIO CHINA Global Forum
BIO （BIO International Convention）is one of the world's largest and most influential gathering of the biotechnology industry along with industry-leading companies, investors, and partnering meetings held around the world. The 2025 edition in Boston is anticipated to convene over 15,000 industry professionals to explore cutting-edge innovations and strategic collaborations in biopharma. With events now held in key locations such as Boston, San Diego, and Seoul, the BIOCHINA Global Forum fosters local technology and industry exchanges through forums and networking opportunities.
About CStone
CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies. Dedicated to addressing patients' unmet medical needs in China and globally, the Company has made significant strides since its inception. To date, the Company has successfully launched 4 innovative drugs and secured approvals for 16 new drug applications covering 9 indications. The company's pipeline is balanced by 16 promising candidates, featuring potentially first-in-class or best-in-class antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies and precision medicines. CStone also prides itself on a management team with comprehensive experiences and capabilities that span the entire drug development spectrum, from preclinical and translational research to clinical development, drug manufacturing, business development, and commercialization. For more information about CStone, please visit .
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