In recent months, as Hong Kong’s biotech and innovative drug market has cooled, even major business development deals have failed to energize investors. Market attention has returned to what truly drives long-term value for pharmaceutical companies: revenue stability, clinical differentiation, and commercial execution.
Henlius Biopharmaceutical has emerged as a beneficiary of this shift. Since the start of the year, its share price has climbed more than 200%, at one point surging nearly 500% from its lowest to highest level.
Unlike peers that began with first-in-class or best-in-class ambitions, Henlius, founded in 2010, started with a focus on developing biosimilars: lower-cost versions of blockbuster biologics. Its portfolio covers oncology and autoimmune diseases, including rituximab, already approved for marketing. While biosimilars typically have limited revenue potential per product, they offer faster commercialization cycles and stable cash flow, which Henlius reinvests into higher-risk, higher-return innovative drug pipelines.
By balancing reliable income with disciplined R&D risk-taking, Henlius became one of the first Chinese drugmakers to achieve consistent profitability.
In the first half of this year, the company reported RMB 2.8 billion (USD 392 million) in total revenue and RMB 390 million (USD 54.6 million) in net profit. While China remains its main market, Henlius’s interim report showed that overseas product profits rose 200% year-on-year. The company expects robust international growth through 2026.
With its biosimilar portfolio now maturing, Henlius is increasingly focused on innovative drugs—an essential path, it says, to breaking through the growth ceiling faced by maturing pharmaceutical firms.
Henlius’s innovation strategy centers on clinical differentiation, targeting indications where patient needs remain unmet.
Its flagship PD-1 inhibitor serplulimab is being tested for perioperative treatment of gastric cancer, an area where both Keytruda and Opdivo previously failed. The company announced that its Phase 3 trial reached its primary endpoint, marking a potential milestone for immunotherapy in early-stage gastric cancer.
At the China Healthcare Decision-makers Conference, Henlius executive director and CEO Zhu Jun told 36Kr that the company’s global strategy rests on challenging assumptions. “The worst mistake in developing innovative drugs is relying too heavily on past experience,” he said. “Experience should guide you, not limit you.”
Among Henlius’s marketed products, serplulimab stands out. In 2024, it generated RMB 1.31 billion (USD 184 million) in global sales, more than 20% of total revenue, with over 90% derived from China.
Serplulimab entered a crowded field where eight PD-1 inhibitors had already been approved domestically. Its success stems from its indication strategy. It became the world’s first PD-1 drug approved for first-line treatment of small cell lung cancer (SCLC), achieving a median overall survival of 17.2 months, a new benchmark for SCLC immunotherapy.
Henlius estimates global peak sales could reach USD 5 billion, supported by indication expansion and overseas market entry.
Serplulimab’s first international approvals came from Southeast Asian countries, followed by European Union authorization in early 2024. The company used the same approach for its lymphoma treatment rituximab, which debuted in Southeast Asia and Latin America before expanding further abroad.
While emerging markets are price-sensitive, Zhu said limited competition creates opportunities for brand building. “In India, serplulimab is currently the only PD-1 therapy approved for small cell lung cancer,” he noted. “It’s one of our fastest-growing markets, and we expect sales there to surpass China’s next year.”
This stepwise global rollout also allows Henlius to refine its international development capabilities across clinical design, regulatory strategy, and manufacturing. The company is now preparing for the US market, where its first filing will again target small cell lung cancer. A bridging study has completed enrollment, with a regulatory submission expected next year.
Additional target indications include perioperative gastric cancer and colorectal cancer, which are areas where Keytruda has yet to establish success.
In gastric cancer, surgery remains the main treatment, but recurrence rates are high. Perioperative therapy has become a key research area. Until recently, chemotherapy dominated this space, though it often caused severe side effects.
“Many patients fail to complete chemotherapy not because of disease progression, but because of toxicity,” Zhu said. “That insight led us to test serplulimab monotherapy after surgery.”
The move was unconventional as most benchmark PD-1 therapies combine with chemotherapy. After six years of development, Henlius announced in October that its Phase 3 registrational study met its primary endpoint of event-free survival. The independent data monitoring committee recommended early regulatory submission, indicating that immunotherapy alone could potentially replace adjuvant chemotherapy for some gastric cancer patients.
“We want to show that not all PD-1 assets are created equal,” Zhu said. “If you solve real clinical problems, the market will recognize it.”
Including serplulimab, Henlius has launched nine products worldwide, six approved in overseas markets. Its therapies now reach more than 900,000 patients across 60 countries and regions, including the US, EU, Australia, and Indonesia.
Reflecting on Henlius’s globalization experience, Zhu cautioned that overconfidence can be a risk. “In global regulatory discussions, experience can become a burden,” he said. “If you present a rational argument—based on patient needs, mechanism of action, and market impact—and have the courage to ask questions, regulators can often be convinced.”
This pragmatic approach is reflected in Henlius’s pipeline.
One promising candidate, HLX43, is a PD-L1 antibody-drug conjugate (ADC) designed to overcome the limits of existing PD-L1 inhibitors and ADCs, which often face narrow indications and high toxicity. “Most products use PD-L1 merely as a targeting mechanism,” Zhu said. “We designed HLX43 as an ADC with built-in immune modulation, addressing dependence on PD-L1 biomarker screening, limited scope, and hematologic toxicity.”
In trials, HLX43 achieved an objective response rate of 46.7% in patients with EGFR wild-type non-squamous non-small cell lung cancer (NSCLC)—a population representing over 100,000 patients in the US. Following the results, several US principal investigators expressed interest in joining international trials, Zhu said.
Another key candidate, HLX22, targets HER2-positive advanced gastric cancer in combination with trastuzumab and chemotherapy. The global Phase 3 trial, backed by nearly USD 200 million in investment, is underway and positioned to compete directly with Keytruda.
Most HER2-positive advanced gastric cancer patients are inoperable, and current regimens offer only eight to ten months of progression-free survival (PFS). Under the HLX22 combination, Henlius has observed some patients maintaining disease control for up to two years.
“If patients can live longer with stable disease, the commercial potential expands dramatically,” Zhu said.
KrASIA Connection features translated and adapted content that was originally published by 36Kr. This article was written by Hu Xiangyun for 36Kr.