Hengrui's $180M CTLA-4 Antibody SHR‑8068 Enters Late-Stage Lung Cancer Trial
Hengrui’s CTLA-4 antibody SHR‑8068, licensed from CStone in a 1.3B RMB deal, is now in Phase III trials for lung cancer, competing in a space dominated globally by ipilimumab and tremelimumab. Innovent’s IBI310 is under review.
Hengrui Pharma has officially launched a Phase III clinical trial of its anti-CTLA-4 monoclonal antibody SHR-8068 (CS1002), in combination with adebrelimab (anti-PD-L1) and platinum-based chemotherapy. The trial will compare this regimen with tislelizumab + chemo in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who are PD-L1 negative (TPS <1%).
Trial Highlights:
- Randomized, open-label, multicenter (China)
- Target enrollment: 460 patients
- Primary endpoints: Progression-Free Survival (PFS) and Overall Survival (OS) assessed via Blinded Independent Central Review (BICR)
SHR-8068 is a fully human anti-CTLA-4 antibody acquired from CStone Pharmaceuticals in a high-profile licensing deal valued at up to 1.3 billion RMB (~$180M USD). The drug is designed to enhance anti-tumor immune responses by blocking the CTLA-4 immune checkpoint.
Expanded Pipeline:
Hengrui is accelerating SHR-8068 development across multiple indications:
- Hepatocellular carcinoma (HCC) – Phase III
- Cholangiocarcinoma – Phase II
- Colorectal cancer – Phase II
Global CTLA-4 Landscape:
To date, only two CTLA-4 monoclonal antibodies have been approved globally:
- Ipilimumab (Yervoy, Bristol Myers Squibb) – Approved in 2011 by the FDA for metastatic melanoma and later for adjuvant treatment of Stage III melanoma.
- Tremelimumab (Imjudo, AstraZeneca) – Approved in the EU and US for hepatocellular carcinoma and other indications as part of combination immunotherapy regimens.
In China, Innovent Biologics’ IBI310, an ipilimumab biosimilar, is currently under NDA review. In early 2025, China’s NMPA accepted its application for use in combination with sintilimab as a neoadjuvant therapy for MSI-H/dMMR colon cancer and granted Priority Review.
With SHR-8068, Hengrui is positioning itself as a serious player in China’s next wave of immuno-oncology development, expanding beyond PD-1/PD-L1 inhibitors into more complex, combination-based checkpoint strategies.