HANSIZHUANG,the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of small cell lung cancer (SCLC), has achieved another milestone. It is poised to usher in a new era of chemotherapy-free treatment for gastric cancer.

As one of Fosun’s innovative drugs, HANSIZHUANG was initially designated by its research and development (R&D) code “HLX10”. Does this code hold a special significance? What do the R&D codes represent?

Uncovering the significance behind these codes may offer us a glimpse into Fosun’s blueprint for biopharmaceutical innovation.

Making history through “independent R&D”

As an independently developed innovative drug, HANSIZHUANG marks a significant milestone in Fosun’s journey of pharmaceutical innovation.

It is the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of SCLC, and its successful launch not only demonstrates Henlius’ robust R&D capabilities but also establishes HLX10 as a milestone in the company’s R&D history.

Since its launch over three years ago, HANSIZHUANG has been approved in the European Union (EU), the United Kingdom, Indonesia, and other markets. It has also been granted orphan drug designation (ODD) by both the United States (U.S.) Food and Drug Administration (FDA) and the European Commission (EC).

Wang Qunbin, Co-Chairman of Fosun International, said, “As a Chinese company, we are very proud. This approval marks the successful entry of Chinese innovative drugs into the world’s most stringent pharmaceutical regulatory market.”

HANSIZHUANG has recently achieved another significant R&D breakthrough. It became the world-first regimen aiming to replace adjuvant chemotherapy with mono-immunotherapy in the perioperative treatment of gastric cancer. This milestone marks a promising step toward a new era of chemotherapy-free treatment for gastric cancer.

In addition to HANSIZHUANG, Henlius’ marketed products include HANLIKANG (HLX01), which is primarily indicated for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis. As Henlius’ first product, the launch of HANLIKANG not onlyfilled the gap in China’s biosimilar market but also represented a notable achievement in China’s biopharmaceutical industry.

As Henlius’ second product, HANQUYOU (HLX02) is China’s first independently developed trastuzumab biosimilar. Its launch has expanded treatment options for patients worldwide with HER2-positive breast and gastric cancer.

Today, HANQUYOU, a China-developed monoclonal antibody biosimilar drug, has been approved in China, Europe, and the U.S. With marketing approvals in over 50 countries and regions, and out-licensing covering over 100 countries globally, it stands as a leading example of China’s biopharmaceuticals going global.

The potential of the HLX pipeline

In addition to marketed drugs, several drugs under development within the “HLX” family have also gained industry interest.

Among these, HLX43 is particularly noteworthy.

As an innovative PD-L1-targeting antibody-drug conjugate (ADC), HLX43 offers dual benefits of immunotherapy and targeted ADC treatment, significantly reducing the side effects of cancer therapies. The broad tumor targeting nature of PD-L1 enables PD-L1 ADCs to address various indications including non-small cell lung cancer, esophageal squamous cell carcinoma, hepatocellular carcinoma, cervical cancer, nasopharyngeal carcinoma, and head and neck squamous cell carcinoma.Its wide tumor coverage positions HLX43 as a promising broad-spectrum anticancer drug.

Gastric cancer is one of the three most prevalent cancers globally, with HER2 positivity occurring in approximately 15% to 20% of patients. HLX22 is a novel epitopeanti-HER2 monoclonal antibody. It is also the first gastric cancer anti-HER2 therapy to receive ODD in both the EU and the U.S. Currently, HLX22’s Phase III clinical trials have been approved by regulatory authorities in China, the U.S., Japan, Australia, Germany, and South Korea, and the first patient has already been dosed globally.

Differentiated blueprint for biopharmaceutical innovation

While “HLX” might appear as an abbreviation for Henlius,this seemingly mysterious code also reflects the breadth and complexity of Henlius’ R&D efforts.

At present, Henlius has 9 products approved for marketing worldwide, and 4 marketing applications under review by the National Medical Products Administration (NMPA) in China, the U.S. FDA and the European Medicines Agency (EMA) in the EU, respectively. Meanwhile, over 30 clinical trials are underway for 19 pipeline products globally.

Henlius’ pipeline ranges from drugs for well-established targets such as HLX14, a denosumab biosimilar, to next-generation innovative molecules and biopharmaceutical platforms that are cultivating a new wave of innovative drugs such as HLX43.

Henlius’ preclinical pipeline focuses on oncology, driven by patient needs and clinical value. Centered on antibody technology, it explores novel targets and mechanisms across modalities including monoclonal antibodies, multi-specific antibodies, ADCs, fusion proteins, and small molecules. With a differentiated strategy, Henlius aims to continuously develop blockbuster products and indications.

China’s innovative drug industry is undergoing significant transformation.

Wang Qunbin said, “For Fosun, we will continue to pursue original innovation, focus on addressing unmet clinical needs, and collaborate with global partners to advance healthcare development together.”

Reflecting Fosun’s commitment to an “innovation-driven” strategy, the “HLX” designation signifies more than just the R&D process of a drug. It charts a course toward addressing clinical needs, forming the backbone of the company’s innovation strategy and illustrating the progression of Chinese pharmaceutical innovation from “following behind”, to “running alongside”, and ultimately “leading the race”.