Breakthrough! 6 Innovative Drug Candidates from CSPC Pharmaceutical Group Selected for Presentation at Top International Academic Conferences

SYH2053-Primary Hypercholesterolemia or Mixed Dyslipidemia-IIPhase Study: Oral Presentation(Oral Presentation)

• Abstract Title:Efficacy and safety of SYH2053 in patients with primary hypercholesterolemia or mixed dyslipidemia: a phase II, multicenter, randomized, double-blind, placebo- and active-controlled trial (Abstract #84626)

• Report Number:3102

• Report Time:31 August 2026, 12:00 - 13:00

August 28–31, 2026: The 2026 European Society of Cardiology Congress (ESC) will be held in Munich, Germany. This congress is one of the largest and most influential international academic gatherings in the field of cardiovascular medicine worldwide.

SYH2053 is a dual-strand small interfering RNA (siRNA) drug targeting PCSK9, independently developed by CSPC Pharmaceutical Group. The drug achieves liver-targeted delivery through conjugation with N-acetylgalactosamine (GalNAc) and employs an optimized full-sequence chemical modification strategy to achieve sustained gene silencing. Previous preclinical and Phase I clinical trials have demonstrated that SYH2053 exhibits favorable safety profiles and lipid-lowering activity, highlighting its significant potential for clinical development.

This study is a multicenter, randomized, double-blind, placebo- and active-controlled Phase II clinical trial led by Professor Tang Yida from Peking University Third Hospital. It aims to evaluate the efficacy and safety of different doses of SYH2053 injection in Chinese participants with primary hypercholesterolemia or mixed dyslipidemia on top of background therapy. The study results demonstrate that SYH2053 exhibits favorable efficacy and safety profiles in this population.

This research has been successfully selected for an oral presentation at the 2026 ESC Congress, marking international authoritative recognition by the cardiovascular community of the clinical value of SYH2053 in lipid management. Furthermore, SYH2053 is the first domestically developed innovative PCSK9 siRNA drug to enter Phase III clinical trials. Currently, three Phase III clinical trials of this product are being actively advanced, holding promise for enriching clinical treatment options in this disease area and benefiting more patients in the near future.

SYS6010Combined with Enlunsubai Monoclonal Antibody-I/IIPhase Study: Oral Presentation (Oral Presentation）

• Abstract Title:Phase II study of SYS6010 plus Enlonstobart in actionable genomic alteration (AGA)-negative advanced non-small cell lung cancer (aNSCLC)

• Abstract No.:2262

September 12–15, 2026: The IASLC World Conference on Lung Cancer (WCLC) will be held in Seoul, South Korea. It is the world’s largest and most authoritative professional academic conference dedicated to lung cancer and thoracic malignancies.

SYS6010 is an antibody-drug conjugate (ADC) independently developed by CSPC, targeting the epidermal growth factor receptor (EGFR). It comprises a humanized anti-EGFR monoclonal antibody linked via a cleavable linker to a topoisomerase I inhibitor payload. This product specifically binds to EGFR receptors on the surface of tumor cells and, upon internalization, releases the cytotoxic payload intracellularly, thereby exerting antitumor effects. EGFR is highly expressed in various solid tumors, offering broad development prospects. Currently, CSPC has strategically positioned this product across multiple solid tumor indications.

This study is a multicenter Phase I/II clinical trial (ChiCTR2400089402) led by Professor Zhou Caicun from Shanghai East Hospital, designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of SYS6010 in combination with enlanrubart injection (a PD-1 inhibitor), with or without chemotherapy, in patients with advanced non-small cell lung cancer (NSCLC) harboring wild-type EGFR and ALK, as well as other advanced solid tumors. This report presents the results of a randomized controlled study comparing two dosing regimens of SYS6010 combined with enlanrubart injection in patients with driver gene-negative advanced NSCLC who have not previously received systemic therapy. Meanwhile, a Phase III clinical trial (NCT07633873) comparing SYS6010 plus enlanrubart versus tislelizumab plus chemotherapy as first-line treatment for PD-L1-positive advanced or metastatic NSCLC is also ongoing.

The successful selection of this research for an oral presentation at the WCLC marks a high level of global recognition for the innovative development of SYS6010 in combination with enaralimab injection for lung cancer. CSPC will leverage this opportunity to continue advancing the clinical development of SYS6010 combination therapy in advanced non-small cell lung cancer (NSCLC) and other solid tumors, actively exploring additional patient populations who may benefit, thereby providing more innovative treatment options for cancer patients worldwide.

TG103(IdaglutideαInjection) Treatment2Type Diabetes-IIIPhase Study: Brief Oral Presentation(Short Oral Presentation)

• Abstract Title:Efficacy and safety of TG103 versus Dulaglutide as an add-on to Metformin in patients with type 2 diabetes: a randomized phase III trial

• Report No.:836

• Report Time:30 September 2026, 11:45 - 12:45

From September 28 to October 2, 2026, the 62nd European Association for the Study of Diabetes Annual Meeting (2026 EASD) will be held in Milan, Italy. As one of the largest and most authoritative professional academic conferences on diabetes and metabolic diseases in Europe and globally, it serves as a key barometer platform driving advances in global scientific research and clinical practice in diabetes.

TG103 is a recombinant human glucagon-like peptide-1 (hGLP-1) Fc fusion protein injection independently developed by CSPC, administered only once weekly. This product selectively binds to and activates the GLP-1 receptor, promoting insulin secretion and inhibiting glucagon release in a glucose concentration-dependent manner, thereby steadily lowering blood glucose levels. Meanwhile, it suppresses appetite, reduces food intake, exerts weight-regulating effects, and improves cardiovascular and metabolism-related indicators.

This study is a randomized, open-label, dulaglutide-controlled, multicenter Phase III clinical trial led by Professor Ji Linong from Peking University People’s Hospital, aiming to evaluate the efficacy and safety of different doses of TG103 injection in combination with metformin in subjects with type 2 diabetes who have inadequate glycemic control on metformin monotherapy. This report will present the primary results of the study.

This research has been selected for a short oral presentation at the 2026 EASD, marking its high recognition by international peers for its innovation and scientific value in the field of diabetes. In addition, the marketing application for TG103 for the indication of diabetes has been accepted by the CDE. Based on its advantages in efficacy and safety, this product has significant clinical application value and is expected to become a new treatment option for type 2 diabetes.

Nectin-4 ADC SYS6002Monotherapy for Advanced Cervical CancerIPhase Study: Rapid Oral Presentation (Rapid Oral Presentation）

• Abstract Title:First-in-human study of SYS6002 in pretreated advanced cervical cancer

• Report Number:584

• Report Time:2 October 2026, 10:30 - 11:30

The Annual Meeting of the International Gynecologic Cancer Society (IGCS) is one of the most influential academic conferences in the field of gynecologic oncology worldwide, having become a key international platform for experts and scholars to share the latest research data and discuss clinical diagnosis and treatment strategies.

The SYS6002-001 study is a nationwide, multicenter Phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of SYS6002 in patients with advanced solid tumors. The abstract of data from the advanced cervical cancer cohort of this study has been accepted for presentation at the 2026 IGCS Annual Meeting and will be delivered as a Rapid Oral Presentation on October 2, 2026, in Montreal, Canada.

SYS6002 is a next-generation antibody-drug conjugate (ADC) targeting Nectin-4. By employing enzyme-catalyzed site-specific antibody conjugation technology, this drug selectively delivers the potent mitotic inhibitor MMAE to cancer cells expressing Nectin-4. Its stable linker design not only facilitates the delivery of high concentrations of MMAE to tumors but also reduces toxicity by minimizing systemic exposure to the toxin. In the Phase I first-in-human clinical study (ChiCTR2200066256), SYS6002 monotherapy demonstrated favorable safety and preliminary efficacy in patients with advanced cervical cancer. Currently, a pivotal Phase III clinical study (NCT07230626) evaluating SYS6002 monotherapy for recurrent or metastatic cervical cancer after platinum-based and immunotherapy is ongoing.

CM326Monoclonal Antibody Therapy-Severe AsthmaIIPhase Study: Poster (Poster）

• Abstract Title:Efficacy and safety of CM326, a humanized anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody, in moderate-to-severe asthma: a phase II randomized, double-blind, placebo-controlled trial

• Poster Number:58254

• Display Time:6 September 2026, 8:00 AM - 9:30 AM

From September 5 to 9, 2026, the European Respiratory Society International Congress 2026 (2026 ERS) will be held in Barcelona, Spain. It is one of the largest and most academically authoritative international conferences in the field of respiratory medicine worldwide.

CM326 is a recombinant humanized IgG1 monoclonal antibody injection targeting thymic stromal lymphopoietin (TSLP), developed by Keymed Biosciences Inc. and further developed and commercialized by CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. CM326 exhibits high affinity for TSLP, potentially enabling more potent inhibition of the upstream inflammatory cascade at its source, suppressing downstream signal transduction and pathway activation, effectively inhibiting the progression of airway inflammation, and achieving superior clinical and biological remission outcomes.

This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial (NCT05774340) led by Professor Qu Jieming and Professor Tang Wei from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, aimed at evaluating the efficacy and safety of CM326 in patients with moderate-to-severe asthma who have inadequate asthma control. This report presents the efficacy and safety data of two CM326 dosing regimens versus placebo in participants with moderate-to-severe asthma enrolled in this trial. Furthermore, Phase III clinical trials of CM326 for the treatment of moderate-to-severe asthma and chronic rhinosinusitis with nasal polyps are currently being rapidly advanced.

This research achievement was successfully selected for the poster session at ERS 2026, marking high global recognition of CM326 monoclonal antibody in the innovative R&D field for moderate-to-severe asthma within respiratory medicine.

HB1801+Enlunsubai Injection Combined with Cisplatin and Concurrent Radiotherapy for the Treatment of Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma-IIPhase Study: Poster (Poster）

• Abstract Title:Efficacy and safety of albumin-bound Docetaxel plus Enlonstobart versus Paclitaxel, combined with Cisplatin and concurrent radiotherapy in patients with locally advanced unresectable esophageal squamous carcinoma: results from a randomized phase II study

• Poster Number:2253

• Display Time:27 September 2026, 3:00 PM - 4:00 PM

September 26–30, 2026: The 68th Annual Meeting of the American Society for Radiation Oncology (2026 ASTRO) will be held in Boston, USA. As one of the largest and most prestigious academic conferences in the global field of radiation oncology, it serves as a key platform for unveiling core achievements in innovative radio-oncology pharmaceuticals.

HB1801 is one of the representative drugs independently developed by CSPC Pharmaceutical Group’s nanomedicine technology platform. It encapsulates docetaxel within human serum albumin. As it does not contain Tween-80 or ethanol, it offers the following advantages compared to docetaxel injection: (1) Safety: No corticosteroid premedication is required, allowing for rapid administration at high concentrations, thereby enhancing safety and patient compliance; (2) Efficacy: It has demonstrated significant efficacy in multiple preclinical tumor models and several early-stage clinical studies, enabling higher dosing in clinical practice to further improve therapeutic outcomes. Enlunsubai Monoclonal Antibody Injection is a humanized anti-PD-1 IgG4 monoclonal antibody with the potential to treat malignant tumors in various human organs and tissues. This product was previously approved for the treatment of patients with recurrent or metastatic cervical cancer who are PD-L1 positive (CPS ≥ 1) and have experienced failure after platinum-based chemotherapy. Currently, multiple clinical trials targeting other tumor types are actively underway.

This randomized, open-label, multicenter, controlled Phase Ib/II clinical trial was led by Professor Yu Jinming from Shandong Cancer Hospital and Professor Pang Qingsong from Tianjin Medical University Cancer Institute and Hospital. The study aimed to evaluate the efficacy and safety of albumin-bound docetaxel for injection combined with envafolimab injection and cisplatin, administered concurrently with radiotherapy, versus paclitaxel combined with cisplatin and concurrent radiotherapy in patients with locally advanced unresectable esophageal squamous cell carcinoma. This conference will present the latest results from the Phase II portion of the trial. The selection of these findings for poster presentation at ASTRO 2026 underscores their significant academic value and full recognition by global experts in the field of radiation oncology.