SYS6010 / CSPC Pharma - LARVOL DELTA

Phase II Study of SYS6010 Plus Enlonstobart in Actionable Genomic Alteration (AGA)-Negative Advanced Non-Small Cell Lung Cancer (Ansclc) (IASLC-WCLC 2026) - P1/2 | "The confirmed ORR at the data cutoff remains immature, as some responses remain pending confirmation. Phase III regimen selection contingent on further data."

Metastases • P2 data • Interstitial Lung Disease • Leukopenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • Thrombocytopenia • PD-L1

PT2.02. Metastatic NSCLC – Immunotherapy (IASLC-WCLC 2026) - "Additional presentations highlight innovative combination and next-generation approaches, including the PD-1/VEGF/CTLA-4 trispecific antibody HC010, tislelizumab plus SYS6010, the LIBRA platform study, the ROSETTA Lung-202 phase 3 trial of pumitamig versus pembrolizumab, and the ResQ1010 and ResQ201A trials evaluating nogapendekin alfa inbakicept and NAI-based regimens. Together with a randomized non-inferiority trial of denosumab dosing in bone metastases, these presentations offer a comprehensive view of the evolving therapeutic landscape and unmet needs in metastatic NSCLC immunotherapy."

IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • BRAF • CTLA4 • KEAP1 • KRAS • PD-1 • RET • STK11

A Phase Ib Study of Tislelizumab Plus SYS6010 in Immunotherapy-Pretreated Locally Advanced or Metastatic NSCLC (IASLC-WCLC 2026) - "The primary objective is to evaluate the safety of the combination therapy, with primary endpoints including the incidence, severity, and type of adverse events (AEs) according to NCI-CTCAE v6.0 criteria. Secondary objectives include assessing efficacy (objective response rate [ORR], disease control rate [DCR], duration of response [DOR], progression-free survival [PFS], overall survival [OS]) and exploring the association of potential predictive or prognostic biomarkers (e.g., EGFR and PD-L1 expression levels) with response to study treatment."

IO biomarker • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

First-in-human study of SYS6010, a novel EGFR targeting antibody drug conjugate (ADC) for patients with advanced solid tumors (AACR 2025) - "SYS6010 demonstrated a tolerable safety profile with promising efficacy in patients with advanced solid tumors, particularly in nsq-NSCLC subjects with EGFR TKI resistance or EGFR wild type."

ADC • Clinical • First-in-human • IO biomarker • Metastases • P1 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

SYS6010, epidermal growth factor receptor-targeting antibody-drug conjugate for advanced non-small cell lung cancer: A phase 1 trial. (PubMed, Cancer Cell) - P1 | "Median progression-free survival and overall survival were 7.6 and 19.4 months, respectively, in EGFR-mutant NSCLC treated with EGFR TKIs and platinum chemotherapy. Overall, SYS6010 shows a manageable safety profile and encouraging antitumor activity in previously treated, advanced NSCLC."

Journal • P1 data • Hematological Disorders • Leukopenia • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thrombocytopenia • EGFR

CSPC Pharmaceutical Group Limited…is pleased to announce that SYS6010…has recently been granted another Breakthrough Therapy Designation by the…NMPA of the People’s Republic of China, for the proposed indication of…R/M HNSCC in patients who have failed prior immunotherapy and platinum-based chemotherapy (HKEXnews) - "Currently, a pivotal Phase III clinical trial of the Product as a monotherapy for the treatment of R/M HNSCC following failure of immunotherapy and platinum-based chemotherapy is underway."

Breakthrough therapy • Squamous Cell Carcinoma of Head and Neck

Phase II trial of SYS6010, an EGFR antibody-drug conjugate (ADC) in patients with advanced esophageal squamous cell carcinoma (ESCC). (ASCO 2026) - P1, P1/2 | "SYS6010 demonstrated a manageable safety profile and promising antitumor activity, supporting further development in patients with advanced ESCC, especially TOPOi-naïve patients. A phase 3 study is planned to compare SYS6010 with standard of care (SOC) in patients with TOPOi-naïve ESCC."

ADC • Clinical • Metastases • P2 data • Esophageal Squamous Cell Carcinoma • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Squamous Cell Carcinoma • Thrombocytopenia

Phase I/II clinical trial data of SYS6010 in combination with Enlonstobart for the treatment of systemic treatment-naive, actionable genomic alteration-negative advanced nsclc orally presented at the 2026 world conference on lung cancer (WCLC) (CSPC Press Release) - "In terms of safety, the safety profile of both dosing regimens of SYS6010 in combination with Enlonstobart was generally manageable. The incidences of Grade 3 and above treatment-related adverse events were 51.6% (Arm 1) and 52.5% (Arm 2), respectively, while the incidences of treatment-related adverse events leading to treatment discontinuation were 9.7% (Arm 1) and 8.2% (Arm 2), respectively. In terms of efficacy, both regimens demonstrated preliminary efficacy in the study population. Among them, the benefits were more prominent in patients with non-squamous cell carcinoma and high expression of programmed death-ligand 1 ('PD-L1'), and efficacy was observed in both squamous and non-squamous cell carcinoma patients with high PD-L1 expression."

P1/2 data • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer

SYS6010 granted Breakthrough Therapy Designation by NMPA in China for the treatment of patients with actionable genomic alteration-negative non-squamous non-small cell lung cancer (CSPC Press Release) - "Currently, a randomised, open-label, multicentre Phase III clinical trial is underway to evaluate the Product as a monotherapy for the treatment of actionable genomic alteration-negative locally advanced or metastatic non-squamous NSCLC that has failed standard treatment."

Breakthrough therapy • Lung Non-Squamous Non-Small Cell Cancer

CSPC Pharmaceutical Group (01093.HK): SYS6010's Phase III clinical trial for EGFR-mutant locally advanced or metastatic NSCLC that has failed EGFR TKI therapy has met its pre-specified primary endpoint. [Google translation] (Sohu.com) - "The study data showed that the product's PFS was significantly better than existing treatment regimens, with statistically significant and clinically meaningful efficacy differences, and the overall safety profile of the product was good."

P3 data • Non Small Cell Lung Cancer

SYS6010 vs Investigator's Choice of Monotherapy in Patients With Recurrent or Metastatic HNSCC (clinicaltrials.gov) - P3 | N=340 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

Monotherapy • New P3 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

EGFR-targeting ADCs: From oncogene addiction to antigen-guided drug delivery. (PubMed, Cancer Cell) - "report a first-in-human phase 1 study of SYS6010, an epidermal growth factor receptor (EGFR)-targeting antibody-drug conjugate, in advanced solid tumors. The study highlights how EGFR-directed therapy moves beyond kinase inhibition toward antigen-guided cytotoxic delivery in non-small cell lung cancer."

First-in-human • Journal • CNS Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Psychiatry • Solid Tumor

A Phase Ib Study of Tislelizumab Plus SYS6010 in Immunotherapy-Pretreated Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - P1 | N=21 | Not yet recruiting | Sponsor: Sichuan University

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ROS1

SPC Pharmaceutical Group Limited…is pleased to announce that the Phase III clinical study (Protocol No.: SYS6010–022 (SYNSTAR-04)) of SYS6010 in combination with enlonstobart for the treatment of driver-gene negative…NSCLC developed by the Group officially initiated in China, with the enrolment of the first subject expected to be completed in July 2026 (HKEXnews) - "SYS6010–022 (SYNSTAR-04) is a randomised, open-label, multi-centre, Phase III clinical study designed to evaluate the efficacy and safety of SYS6010 in combination with enlonstobart versus immunotherapy plus platinum-based chemotherapy in subjects with driver gene-negative and programmed cell death ligand-1 (PD-L1)-positive locally advanced or metastatic NSCLC."

Trial status • Non Small Cell Lung Cancer

A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=102 | Recruiting | Sponsor: Conjupro Biotherapeutics, Inc.

New P1 trial • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • KRAS

A Study of SYS6010 Plus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy in Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P3 | N=570 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

SYS6010 combined with SYH2051 in advanced solid tumors: Results from a phase Ib/II trial. (ASCO 2026) - P=N/A | "The combination of SYS6010 and SYH2051 showed acceptable safety and tolerability in patients with advanced solid tumors. Promising antitumor activity was observed in patients with advanced GC, particularly among those receiving the regimen as ≥3rd-line therapy."

Metastases • P1/2 data • Colon Cancer • Colorectal Cancer • Gastric Cancer • Leukopenia • Neutropenia • Oncology • Rectal Cancer • Solid Tumor • Thrombocytopenia

Preliminary safety and efficacy of SYS6010 combined with enlonstobart in patients with recurrent or metastatic esophageal cancer: Results from a phase I/II study. (ASCO 2026) - P1/2 | "This study demonstrates that the combination therapy of SYS6010 and Enlonstobart has the potential to represent a novel and effective treatment option for patients with R/M EC. The promising clinical activity, together with a manageable safety profile, supports further clinical development of this regimen."

Clinical • Metastases • P1/2 data • Esophageal Cancer • Leukopenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology

SYS6010 Combined With Enlonstobart Versus Immunotherapy+ Platinum-based Chemotherapy for Patients With PD-L1-Positive Locally Advanced or Metastatic NSCLC（SYNSTAR 04） (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P3 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

CSPC PHARMA…announced that its self-developed SYS 6010 (an EGFR-targeting humanized monoclonal antibody-drug conjugate) has recently been included again by the National Medical Products Administration in the Breakthrough Therapy Designation list. (iis.aastocks.com) - "The proposed indication is monotherapy for patients with locally advanced or metastatic esophageal squamous cell carcinoma who have previously failed platinum-containing chemotherapy and immunotherapy."

Breakthrough therapy • Esophageal Squamous Cell Carcinoma

SYNSTAR-02: A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - P3 | N=680 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. | N=450 ➔ 680 | Initiation date: Mar 2026 ➔ Jun 2026

Enrollment change • Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A first-in-human study result of a novel EGFR-targeted antibody drug conjugate (ADC) in patients with advanced nasopharyngeal carcinoma (NPC) (SYS6010-001-NPC) (AACR 2026) - P1 | "SYS6010 demonstrated encouraging antitumor activity and manageable safety profile in advanced NPC patients, supporting further pivotal clinical development."

ADC • Clinical • First-in-human • IO biomarker • Metastases • P1 data • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

CPO301-US-101: A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=132 | Recruiting | Sponsor: Conjupro Biotherapeutics, Inc. | Trial completion date: Dec 2025 ➔ Aug 2027 | Trial primary completion date: Jun 2025 ➔ May 2027

Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • KRAS

SYNSTAR03: SYS6010 Versus Docetaxel for Previously Treated EGFR Wild-type NSCLC: Phase Ⅲ (clinicaltrials.gov) - P3 | N=686 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

SYS6090 Combination Therapy in Advanced Lung Cancer (clinicaltrials.gov) - P1/2 | N=596 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

New P1/2 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor