Science and Technology Innovation Board Daily, November 3 (Reporter Xu Hong) – “When the HLX43 project was first launched, not many people were optimistic about this direction. But drug development cannot follow the crowd; we must see what others cannot. Why do so many cancer patients still respond when they use PD-1 again after having previously used it? It was based on this observation that I pushed the team to follow up on this direction.”

During a media exchange on November 2, Dr. Zhu Jun, Executive Director and CEO of Henlius Biotech (02696.HK), reviewed the starting point of HLX43's research and development.

Today, this project, which started more as a "trial and error" experiment, is beginning to validate its initial scientific assumptions step by step as clinical research progresses.

HLX43 is an antibody-drug conjugate (ADC) that targets PD-L1. Its mechanism of action combines the dual functions of immune checkpoint inhibition and highly efficient cytotoxic killing. Therefore, theoretically, it has the potential to synergistically enhance the effects of "PD-1 inhibitor + ADC" .

As the world's first PD-L1 ADC to enter Phase II clinical trials, HLX43 is being studied by Henlius Biotech.It has undoubtedly secured an important place in the pipeline. Currently, the company is fully committed to advancing the clinical development of HLX43 , and its Phase I clinical study data has been presented at two major international academic conferences this year—the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and the World Congress of Lung Cancer (WCLC).

More than two months later, at the “2025 International Lung Cancer Frontier and Innovation Forum” held on November 2, Henlius Biotech updated key data on HLX43 in the field of non-small cell lung cancer (NSCLC) research.

　"Overall, the data shows a continuation of the trend presented at the WCLC conference: with an increase in the number of patients included, efficacy results remained stable, and some indicators were even more positive ," Dr. Zhu Jun summarized in response to a question from a reporter from the Science and Technology Innovation Board Daily. He further stated that as clinical research progresses, "our confidence in HLX43 is also constantly increasing."

Especially in the field of NSCLC treatment, HLX43 has shown the potential to cover a wide range of patients. This data update integrates data from two studies, HLX43-FIH101 and HLX43-NSCLC201, which included NSCLC patients treated with doses of 2.0 mg/kg and 2.5 mg/kg, respectively (a total of 174 patients).

Studies have shown that HLX43 has been observed to provide therapeutic signals in both squamous and non-squamous NSCLC, regardless of EGFR mutation status, presence of brain metastases, or PD-L1 expression levels .

　" These data provide crucial information for dose selection in Phase II and Phase III clinical trials , laying a solid foundation for subsequent large-scale clinical studies," Dr. Zhu Jun further revealed. Lung cancer will be the core focus of HLX43's development, with plans to advance at least eight Phase III clinical studies in this disease area in the future .

In addition to lung cancer, Henlius also plans to expand the clinical footprint of HLX43 to other cancer types, including cervical cancer, esophageal squamous cell carcinoma, and colorectal cancer. However, this broad range of indications also means that the company may need to simultaneously conduct approximately 15-16 large-scale Phase III clinical trials in the future , which will pose a challenge to the company's financial strength.

Therefore, promoting the clinical development of HLX43 through external licensing or joint development would be a very realistic and reasonable choice.

Dr. Zhu Jun did not deny this possibility . He mentioned that the company has two key considerations when choosing partners, especially that the other party must truly understand and agree with Henlius' long-term development blueprint for the product. He stated, "Given the current stage of HLX43, we are open to the possibility of 'co-development' ."

To date, Henlius has nine products approved for global launch, six of which are available overseas. In the first half of 2025, the company achieved revenue of RMB 2.8195 billion, a year-on-year increase of 2.7%, and net profit of RMB 390.1 million, basically flat compared to the same period last year.

As the world's first approved anti-PD-1 monoclonal antibody for first-line treatment of small cell lung cancer, H-drug Hanscept achieved sales revenue of nearly 600 million yuan in the first half of this year. Compared with the same period last year, the growth momentum has slowed down slightly. Its future performance will depend on the expansion of overseas markets and the approval of new indications .

In late July of this year, Henlius Biotech announced that it had completed the first batch of H-drug deliveries to the Indian market. As the first PD-1 monoclonal antibody approved in India for first-line treatment of extensive-stage small cell lung cancer, H-drug is expected to provide important immunotherapy for local lung cancer patients.Choice. It is reported that, to date, H-drug has received orders for 100,000 doses from the Indian market .

Regarding the expansion of new indications, Henlius Biotech is simultaneously conducting more than 10 clinical studies globally on immunotherapy combinations centered around its H drug, targeting globally prevalent cancers such as lung cancer and gastrointestinal tumors. Among these, the bridging trial for H drug in the United States has completed enrollment, and a BLA application is expected to be submitted in the first half of 2026. Meanwhile, its Phase III clinical trial of neoadjuvant/monoadjuvant chemotherapy for early-stage gastric cancer has met its primary endpoint and will be submitted for market approval ahead of schedule .

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