CSPC Pharma to Present Eight Oncology Trial Updates, Including Two Late-Breaking Abstracts, at ESMO 2026

Bulletin Express
Oct 05

Hong Kong-based CSPC Pharmaceutical Group Limited (CSPC Pharma) announced it will disclose data from eight oncology clinical trials at the European Society for Medical Oncology (ESMO) Congress in Madrid on 23–27 October 2026. The slate comprises two Late-Breaking Abstracts (LBAs), one Proffered Paper, three Rapid Oral Presentations, three posters and one e-poster, spanning breast, gastric, lung, liver, colorectal, pancreatic cancers and perivascular epithelioid cell tumour (PEComa).

Key presentations:

1. HER2-positive advanced breast cancer – LBA15 • Phase III, multicentre, randomised, open-label study of Anbenitamab (Ennituo) plus albumin-bound docetaxel (HB1801) as first-line therapy. • Follows prior success of the same combination in neoadjuvant settings. • Positive data led China’s National Medical Products Administration (NMPA) in July 2026 to grant Breakthrough Therapy Designation (BTD) to both agents; HB1801 is the first modified chemotherapy formulation in China to receive BTD.

2. HER2-positive advanced gastric/gastro-oesophageal junction cancer – LBA80 • Updated overall survival results from a double-blind Phase III trial of Anbenitamab plus chemotherapy in post-first-line patients. • The regimen secured NMPA approval in May 2026 following earlier interim data presented at ESMO 2025.

Pipeline highlights:

• Anbenitamab (Ennituo): HER2 bispecific antibody that binds two non-overlapping HER2 epitopes, enhancing ADCC and CDC. Beyond the approved gastric indication, New Drug Applications for neoadjuvant and first-line HER2-positive breast cancer are under Priority Review; additional registration trials are under way in adjuvant breast cancer and first-line HER2-positive gastric cancer. The therapy also holds U.S. FDA Orphan Drug Designation for HER2-positive or HER2-low gastric cancer.

• Albumin-bound docetaxel (HB1801): Nanoparticle formulation eliminating polysorbate 80 and ethanol, enabling steroid-free, rapid administration. Phase III trials in breast and gastric cancers have met primary endpoints; first-line unresectable or metastatic HER2-positive breast cancer carries NMPA BTD.

Additional studies to be showcased:

• SYS6043 (B7-H3 ADC): Phase I/II Rapid Oral results in heavily pretreated solid tumours, including breast cancer. The agent, with a drug-to-antibody ratio of 6 and an effector-silencing Fc design, is progressing to pivotal Phase III trials in ovarian, breast and small-cell lung cancers.

• JMT108 (anti-PD-1/IL-15 bifunctional fusion protein): Phase I/II Rapid Oral data in liver and colorectal cancers demonstrate preliminary anti-tumour activity, supporting advancement into combination and pivotal studies.

• HB1901 (albumin-bound sirolimus): Poster on Phase Ib/III data in advanced PEComa, the first randomised controlled trial in this rare tumour type. HB1901 received NMPA BTD in February 2025.

• SYS6023 (HER3 ADC): Poster detailing Phase I/IIa safety and efficacy in advanced solid tumours; a Phase II combination study in breast cancer is in progress.

• Anbenitamab Repodatecan (JSKN003, HER2 ADC): Poster on Phase II combination therapy in first-line HER2-positive gastric cancer. The asset holds FDA Orphan Drug and Fast Track designations and dual NMPA BTDs.

• DAWN study (e-poster): Phase Ib/III trial of the ADOF regimen—albumin-bound docetaxel, oxaliplatin and 5-FU/leucovorin—versus FOLFOX in first-line HER2-low/negative, PD-L1 CPS ≥ 5 advanced gastric or gastro-oesophageal junction cancer.

Collectively, the forthcoming ESMO 2026 presentations underscore CSPC Pharma’s expanding oncology portfolio and its strategy to integrate proprietary biologics, antibody–drug conjugates and novel nanoparticle chemotherapies across multiple tumour types and treatment lines.

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