8846威尼斯(中国百科)有限公司

CStone will showcase clinical advancements from its Pipeline 2.0 at one of the premier global oncology conferences, the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Germany (October 17-21). Key presentations include the latest first-in-human Phase Ia data for the novel PD-1/VEGF/CTLA-4 trispecific antibody CS2009, and the global multicenter Phase Ib study design for its ROR1-targeting antibody-drug conjugate (ADC) CS5001.

• CS2009, a potential first-in-class/best-in-class PD-1/VEGF/CTLA-4 trispecific antibody, is currently being evaluated in global multicenter Phase I dose escalation and expansion studies. Patient enrollment is actively proceeding in Australia and China, with planned expansion to the United States (U.S.) for Phase II recruitment. The ESMO presentation marks the first disclosure of clinical data for CS2009 and represents among the earliest clinical reports globally for a PD-1/VEGF/CTLA-4 trispecific antibody.
• CS5001 is the first ROR1 ADC known to demonstrate clinical antitumor activity in both lymphomas and solid tumors and positioned among the top two globally in clinical development. CS5001 continues to advance through Phase Ib dose expansion. CStone’s ESMO update will detail the design of its ongoing multiregional study across the U.S., Australia, and China.

CStone’s ESMO Data Disclosure Schedule:

Title: CS2009, a novel PD-1/VEGF/CTLA-4 trispecific antibody, in patients with advanced solid tumors: an open-label, multicenter, phase I first-in-human study

Category: Investigational immunotherapy

Presentation Type: Poster

Presentation Number: 1545P

Title: A phase Ib trial of CS5001 (ROR1-ADC) as a single agent and in combination with systemic therapies in patients with advanced solid tumours and lymphomas

Category: Haematological malignancies

Presentation Type: ePoster

Presentation Number: 1316eTiP

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

CS2009 is a novel trispecific antibody targeting PD-1, VEGFA, and CTLA-4 to achieve multidimensional antitumor effects through synergistic mechanisms. It is independently developed by CStone from molecular inception, with the potential to be first- or best-in-class. Its differentiated molecular design combines these validated targets, preferentially invigorating exhausted tumor infiltrating lymphocytes (TILs) while demonstrating VEGF neutralization comparable to existing anti-VEGF antibodies. CS2009 covers a wide range of cancers, including but not limited to non-small cell lung cancer, hepatocellular carcinoma, gastric adenocarcinoma, endometrial cancer, ovarian cancer, renal cell carcinoma, cervical cancer and etc.

About CS5001 （ROR1 ADC）

CS5001 is a clinical-stage antibody-drug conjugate ("ADC") targeting ROR1 (receptor tyrosine kinase-like orphan receptor 1). CS5001 has been uniquely designed with proprietary tumor-cleavable linker and pyrrolobenzodiazepine ("PBD") prodrug. The use of the linker plus PBD prodrug effectively helps address the toxicity associated with traditional PBD payloads, leading to a better safety profile. CS5001 has demonstrated complete tumor suppression in several preclinical cancer models and demonstrated favorable serum half-life and pharmacokinetic characteristics. CS5001 is a promising candidate drug with precision treatment potential in both hematologic tumors and malignant solid tumors. Additionally, CS5001 utilizes site-specific conjugation for a precise drug antibody ratio of which enables homogeneous production and large-scale manufacturing.

In October 2020, CStone signed a licensing agreement with LigaChem Biosciences, Inc. (LCB) for the development and commercialization of CS5001 which was originally generated by collaboration of LCB and ABL Bio, both South Korea-based leading biotech companies. Under the agreement, CStone obtains the exclusive global right to develop and commercialize CS5001 outside the Republic of Korea.

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 (NDAs) 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 www.cstonepharma.com.

IR contact: ir@cstonepharma.com

PR contact: pr@cstonepharma.com

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