Henlius’s gastric cancer drug meets phase 3 trial endpoint

SHANGHAI - Henlius Biotech, Inc. (2696.HK), a prominent biotechnology player with a market capitalization of $5.5 billion and impressive 250% return over the past year, announced Thursday that its anti-PD-1 monoclonal antibody HANSIZHUANG (serplulimab) has met the primary endpoint of Event-Free Survival in a phase 3 clinical trial for perioperative gastric cancer treatment. According to InvestingPro analysis, the company maintains robust gross profit margins of 76%, supporting its extensive R&D initiatives.

The ASTRUM-006 study evaluated HANSIZHUANG in combination with chemotherapy as neoadjuvant treatment, followed by HANSIZHUANG monotherapy in the adjuvant setting for early-stage gastric cancer patients.

According to the company, the drug combination significantly prolonged event-free survival and achieved more than three times higher pathological complete response rate compared to the placebo control arm. The Independent Data Monitoring Committee has recommended an early New Drug Application submission based on these results.

The trial represents what Henlius claims is the first regimen to replace adjuvant chemotherapy with immunotherapy monotherapy in the perioperative treatment of gastric cancer.

"This study is the first to confirm the feasibility of replacing adjuvant chemotherapy with mono-immunotherapy in the postoperative setting," said Professor Jiafu Ji from Beijing Cancer Hospital, a principal investigator of the study, according to the press release.

Gastric cancer ranks fifth globally in both incidence and mortality among all cancers, with approximately 969,000 new cases and 660,000 deaths worldwide in 2022, according to GLOBOCAN statistics cited in the announcement.

The company stated that HANSIZHUANG has already received approval in China for first-line treatment of esophageal squamous cell carcinoma in September 2023.

Henlius is developing additional treatments for gastrointestinal cancers, including a novel HER2 monoclonal antibody (HLX22) for HER2-positive advanced gastric cancer, currently in phase 3 trials. With strong financial health metrics and consistent revenue growth, the company appears well-positioned to advance its development pipeline. Get deeper insights into Henlius’s financial performance and growth potential with InvestingPro’s comprehensive analysis tools and expert recommendations.

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