China Securities Journal (Reporter Li Mengyang) – Recently, Henlius Biotech officially announced key updated data on its PD-L1 ADC (antibody-drug conjugate) HLX43 for the treatment of non-small cell lung cancer (NSCLC). This release integrates for the first time the results of the product's international multicenter Phase II clinical trial, further validating its global clinical value. Simultaneously, the company also announced the latest follow-up data from a Phase II dose-finding study of its independently developed recombinant anti-EGFR monoclonal antibody HLX07, in combination with the anti-PD-1 monoclonal antibody H, slulimab, for first-line treatment of EGFR-high expressing advanced or metastatic squamous non-small cell lung cancer (sqNSCLC).

　　"Currently, we invest most of our commercial revenue into the research and development of innovative pipeline products. The company is continuously advancing the development of core innovative products such as H-drug Hanseo and PD-L1 ADC HLX43," said Zhu Jun, Executive Director and CEO of Henlius Biotech, in an interview with China Securities Journal.In an interview with reporters, the company stated that, looking to the future, relying on its differentiated innovative R&D platform, globally integrated clinical development capabilities, and internationally leading supply chain system, Henlius will leverage its extensive pipeline of research and development projects to precisely target unmet clinical needs and strive for breakthroughs in multiple areas of lung cancer treatment.

　　Strengthening differentiated competitive advantages

　　When discussing the differentiated advantages of HLX43, Zhu Jun told reporters, "From the very beginning of the PD-L1 ADC project, we had a clear goal—to develop an ADC that combines broad-spectrum anti-tumor activity with immune function. This research direction is quite challenging. After unremitting efforts, we are pleased to say that we are gradually getting closer to this goal."

　　Specifically, Zhu Jun further explained that unlike many ADCs on the market that target driver gene mutations, HLX43 targets PD-L1, a pan-tumor target. Its antibody backbone uses HLX20, independently developed by Henlius Biotech, and incorporates an innovative linker-toxin combination from Yilian Biotech, possessing both intracellular and extracellular release mechanisms. It is the second PD-L1 ADC globally and the first in China to enter clinical development. "Overall, HLX43 possesses both the targeted killing effect of an ADC and the immunomodulatory function of a PD-L1/PD-1 immune checkpoint inhibitor (IO). This dual mechanism of action makes it a 'double-potential' ADC candidate molecule."

　　It is understood that HLX43 received clinical trial approvals from both the China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) in 2023. Currently, the company is fully committed to advancing the clinical development of HLX43, with over 400 patients enrolled globally, including over 170 patients with non-small cell lung cancer (NSCLC). Patient enrollment has been successfully progressing in multiple countries, including China, the United States, and Japan.

　　"The company is confident in the Phase III clinical trials of HLX43, and the specific dosage for the Phase III trials has already been determined. In the future, the company will launch at least eight Phase III clinical trials for HLX43, and all of these projects will focus on the treatment of lung cancer," Zhu Jun revealed. He added that the company will continue to leverage its core innovative pipeline, including HLX43, to amplify the differentiated therapeutic potential of its products, accelerate the release of their clinical value, and provide more groundbreaking treatment options for lung cancer patients worldwide.

　　It is worth mentioning that Henlius has continuously built and optimized globally competitive innovative R&D platforms, encompassing the proprietary ADC technology platform Hanjugator, the trispecific T-cell connector (TCellEngager, TCE) platform, the one-stop early-stage antibody drug development platform HAIClub, and the self-developed simulation computing platform HAIPBD. The improvement of these platforms has continuously enhanced the company's efficiency in translating innovative R&D into practical applications and the success rate of its projects.

　　Accelerate globalization

　　It is worth noting that China's current innovative drugsThe "license-out" transaction market remains active. According to data from PharmaCube, in the first three quarters of 2025, the number of Chinese innovative drug license-out transactions reached 103, exceeding the total number of transactions for the entire year of 2024; the total transaction amount reached US$92.03 billion.

　　"In recent years, it has become commonplace for multinational pharmaceutical companies (MNCs) to actively seek cooperation on high-quality innovative drug assets in China. The currently disclosed business development (BD) transactions represent only the tip of the iceberg; a large number of high-potential pharmaceutical assets in China remain to be explored," Zhu Jun believes. He argues that as more clinical data on Chinese innovative drugs is gradually disclosed, multinational pharmaceutical companies' trust and recognition of Chinese innovative drugs will continue to increase, thereby accelerating the pace of cooperation between the two parties. In the future, Chinese pharmaceutical companies are expected to obtain higher upfront payments and milestone payments in these collaborations.

　　According to Fosun Pharma's 2025 interim results announcement, the company achieved operating revenue of RMB 2.82 billion in the first half of 2025, a year-on-year increase of 2.7%; and net profit of RMB 390 million. The company stated that during the reporting period, overseas product profits increased by over 200% year-on-year, and BD contract cash inflows exceeded RMB 1 billion, a year-on-year increase of 280%. With the continued expansion of overseas commercial product sales, the company expects overseas product revenue and profits to achieve significant growth for the full year of 2025, and is expected to maintain a high growth rate in 2026.

　　"Thanks to more than a decade of steady development, Henlius has obtained approval for nine products to be launched globally and has successfully promoted six of its independently developed products to go global," Zhu Jun introduced.

　　Among them, the company's independently developed H drug, Hansz, is the world's first approved anti-PD-1 monoclonal antibody for first-line treatment of small cell lung cancer. It has been approved for marketing in nearly 40 countries and regions, including China, the United Kingdom, Germany, Singapore, and India.

　　On October 22, Henlius Biotech announced that its bridging clinical trial (ASTRIDE study) of H-drug Hansizine in previously untreated extensive-stage small cell lung cancer (ES-SCLC) patients in the United States has successfully enrolled all 200 patients required by the recruitment plan. This trial aims to compare the efficacy and safety of H-drug with atezolizumab (a PD-L1 immunosuppressant), the first-line standard treatment.

　　Regarding the aforementioned bridging clinical trial, Zhu Jun stated, "Our goal is to leverage our efficient execution capabilities to expedite the trial's progress towards its intended direction. This study, independently managed by Henlius's US team in terms of clinical operations and registration submissions, is being conducted simultaneously at over 100 US cancer centers, making it one of the largest ES-SCLC clinical trials in the US to date. We will fully commit to advancing subsequent work and strive to submit the biologics application to the FDA (US Food and Drug Administration) as soon as possible. "License application (BLA).

　　Looking ahead, Zhu Jun emphasized that the company will continue to solidify its long-term development strategy of "innovation + internationalization," continuously strengthen its differentiated competitive advantages through innovative research and development, and work with global partners to bring more high-quality, affordable biopharmaceuticals to patients worldwide.

https://finance.eastmoney.com/a/202511073558056221.html