Shanghai Henlius Biotech, Inc. Announces First Patient Dosed in HLX701 Phase 1b/2 Clinical Study for Advanced Colorectal Cancer

Key Highlights

• First patient dosed: Shanghai Henlius Biotech, Inc. has announced that the first patient has been dosed in its phase 1b/2 clinical study of HLX701 (recombinant human SIRPα–IgG4 Fc fusion protein injection) in combination with cetuximab and chemotherapy for advanced colorectal cancer.
• Trial location: The study is taking place in Mainland China, excluding Hong Kong, Macau, and Taiwan.
• Phase 1b/2 design: The clinical trial is structured in three stages, focusing on safety, dose determination, and efficacy in combination with standard chemotherapy regimens (FOLFOX/FOLFIRI) and cetuximab.
• Potential market impact: No SIRPα-Fc fusion protein targeting CD47 has been approved for marketing globally, suggesting HLX701 could be a first-in-class product if successful.
• Important warning: The company notes that it cannot guarantee successful development and commercialization of HLX701, and advises shareholders to exercise caution.

Clinical Trial Details

1. Stage 1: Safety run-in using a 3+3 dose-escalation approach across four dose levels (5 mg/kg to 18 mg/kg). Patients receive weekly intravenous HLX701 with cetuximab and chemotherapy. The primary endpoint is the proportion of dose-limiting toxicities (DLTs), along with secondary endpoints including safety (adverse events), efficacy (objective response rate [ORR], disease control rate [DCR]), pharmacokinetics (PK), and immunogenicity.
2. Stage 2: Expansion to three dose groups (8 mg/kg to 18 mg/kg), administered weekly. The main objectives are to determine the recommended Phase II dose (RP2D), ORR, and progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR). Secondary endpoints include safety, overall survival (OS), efficacy (investigator-assessed ORR and PFS), PK, immunogenicity, and biomarker-efficacy associations.
3. Stage 3: Randomized, double-blind, multi-center comparison of HLX701 or placebo with cetuximab and chemotherapy. The primary endpoints are ORR and PFS (BICR-assessed), with secondary endpoints similar to Stage 2.

About HLX701

HLX701 is a SIRPα-Fc fusion protein licensed from FBD Biologics Limited. Henlius holds exclusive rights to develop, manufacture, and commercialize HLX701 in China (excluding Taiwan), Southeast Asia, Middle East, and North Africa. HLX701 is engineered by fusing the IgV domain of human SIRPα with the Fc region of human IgG4. The mechanism involves binding to CD47 on tumor cells, blocking CD47-mediated anti-phagocytic signaling, thereby promoting macrophage phagocytosis and enhancing anti-tumor activity.

Preclinical studies indicate synergistic efficacy when HLX701 is combined with chemotherapy, immune checkpoint inhibitors, EGFR inhibitors, anti-angiogenesis drugs, and other targeted therapies. This suggests potential for HLX701 to enhance both innate and adaptive immune responses when used alongside standard treatments.

The investigational new drug (IND) application for this phase 1b/2 trial was approved by China’s National Medical Products Administration (NMPA) in January 2026.

Market Condition and Shareholder Considerations

As of this announcement, no SIRPα-Fc fusion protein targeting CD47 has been approved globally. If HLX701 proves successful in clinical trials and receives regulatory approval, it could be a first-to-market product with significant commercial potential. This development may be price-sensitive, as the progress of HLX701 represents a major milestone and could affect share values due to its potential to address a significant unmet medical need in advanced colorectal cancer.

However, Henlius explicitly warns shareholders that successful development and commercialization are not guaranteed, and investors should exercise caution in trading company shares.

Corporate Governance

The current board consists of Chairman Wenjie Zhang, Executive Director Dr. Jun Zhu, multiple non-executive directors, and several independent non-executive directors, reflecting strong governance and oversight.

Conclusion

The initiation of dosing for the first patient in this clinical trial marks a significant step forward for Shanghai Henlius Biotech, Inc. HLX701 has the potential to become a pioneering therapy for advanced colorectal cancer. The progress of this study and subsequent results will be closely watched by investors and could move the share price given the global unmet need and lack of approved products in this class.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Clinical trials are subject to numerous risks and uncertainties, and there is no assurance that HLX701 will be successfully developed or commercialized. Investors should consider these risks and consult with their financial advisors before making investment decisions.

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