Henlius Biotech Achieves Breakthrough in Gastric Cancer Immunotherapy with Serplulimab Phase 3 Success
核心洞察
Henlius Biotech (搜索)'s PD-1 (搜索) inhibitor serplulimab achieved its primary endpoint in a Phase 3 trial for perioperative gastric cancer treatment, potentially becoming the first immunotherapy to replace adjuvant chemotherapy in this indication.
The company reported strong financial performance with RMB 2.8 billion in revenue and RMB 390 million in net profit for the first half of 2024, while overseas profits surged 200% year-over-year.
Serplulimab generated RMB 1.31 billion in global sales in 2024, representing over 20% of total revenue, with the company estimating peak sales potential of USD 5 billion globally.
Shanghai Henlius Biotech (搜索) has achieved a significant clinical milestone with its PD-1 (搜索) inhibitor serplulimab meeting the primary endpoint in a Phase 3 registrational study for perioperative gastric cancer treatment. The independent data monitoring committee recommended early regulatory submission, positioning serplulimab as a potential first-in-class immunotherapy monotherapy for this challenging indication.
Clinical Breakthrough in Gastric Cancer Treatment
The Phase 3 trial success represents a major advancement in gastric cancer care, where surgery remains the primary treatment but recurrence rates remain high. Unlike conventional approaches that combine PD-1 (搜索) therapies with chemotherapy, Henlius tested serplulimab as monotherapy after surgery, addressing a critical unmet medical need.
"Many patients fail to complete chemotherapy not because of disease progression, but because of toxicity," explained Henlius CEO Zhu Jun. "That insight led us to test serplulimab monotherapy after surgery." The unconventional approach developed over six years could potentially replace adjuvant chemotherapy for some gastric cancer patients, offering improved tolerability without compromising efficacy.
This achievement is particularly notable given that established PD-1 (搜索) inhibitors Keytruda and Opdivo previously failed in perioperative gastric cancer treatment, highlighting serplulimab's differentiated clinical profile.
Strong Commercial Performance Drives Growth
Henlius demonstrated robust financial performance in the first half of 2024, reporting RMB 2.8 billion (USD 392 million) in total revenue and RMB 390 million (USD 54.6 million) in net profit. The company's international expansion strategy showed significant momentum, with overseas product profits rising 200% year-over-year.
Serplulimab emerged as the company's flagship product, generating RMB 1.31 billion (USD 184 million) in global sales in 2024, representing more than 20% of total revenue. Over 90% of serplulimab sales currently derive from China, but international expansion is accelerating rapidly.
The drug's success stems from its indication strategy in small cell lung cancer (SCLC), where it became the world's first PD-1 (搜索) therapy approved for first-line treatment. Serplulimab achieved a median overall survival of 17.2 months in SCLC, establishing a new benchmark for immunotherapy in this indication.
Global Expansion Strategy Yields Results
Henlius has successfully launched nine products worldwide, with six approved in overseas markets. The company's therapies now reach more than 900,000 patients across 60 countries and regions, including the United States, European Union, Australia, and Indonesia.
The stepwise global rollout strategy has proven effective, with serplulimab receiving its first international approvals in Southeast Asian countries, followed by European Union authorization in early 2024. In India, serplulimab currently stands as the only PD-1 (搜索) therapy approved for small cell lung cancer, making it one of the company's fastest-growing markets.
"In India, serplulimab is currently the only PD-1 (搜索) therapy approved for small cell lung cancer," Zhu noted. "It's one of our fastest-growing markets, and we expect sales there to surpass China's next year."
The company is now preparing for US market entry, with its first filing targeting small cell lung cancer. A bridging study has completed enrollment, with regulatory submission expected next year.
Promising Pipeline Developments
Beyond serplulimab, Henlius is advancing several innovative candidates designed to address current treatment limitations. HLX43, a PD-L1 (搜索) antibody-drug conjugate (ADC), achieved a 46.7% objective response rate in patients with EGFR (搜索) wild-type non-squamous non-small cell lung cancer, representing a population of over 100,000 patients in the United States.
"Most products use PD-L1 (搜索) merely as a targeting mechanism," Zhu explained. "We designed HLX43 as an ADC with built-in immune modulation, addressing dependence on PD-L1 biomarker screening, limited scope, and hematologic toxicity."
Another key candidate, HLX22, targets HER2 (搜索)-positive advanced gastric cancer in combination with trastuzumab and chemotherapy. The global Phase 3 trial, backed by nearly USD 200 million in investment, is positioned to compete directly with Keytruda in a market where current regimens offer only eight to ten months of progression-free survival.
Market Recognition and Future Outlook
Henlius's strategic focus on clinical differentiation has translated into significant market recognition, with the company's share price climbing more than 200% since the start of the year. The stock has demonstrated remarkable momentum, with 1-year total shareholder return reaching 218.95%.
The company estimates serplulimab's global peak sales could reach USD 5 billion, supported by indication expansion and continued overseas market penetration. With robust international growth expected through 2026, Henlius expects to maintain its trajectory as one of the first Chinese drugmakers to achieve consistent profitability while advancing innovative therapies.
"We want to show that not all PD-1 (搜索) assets are created equal," Zhu emphasized. "If you solve real clinical problems, the market will recognize it."