It's time for China's innovative drugs to redefine standards.

On September 13th, at the first Presidential Symposium of the 2026 World Lung Cancer Conference (WCLC), Hanson Pharmaceuticals' independently developed Rui Kang Li Fu Tuo Ta monoclonal antibody (HS-20093) was presented in the form of the latest breakthrough abstract (LBA) and gave an oral report. The expert for the report is Professor Wang Jie from the Cancer Hospital of the Chinese Academy of Medical Sciences.

Professor Wang Jie reports on ARTEMIS-008 research at the WCLC 2026 Chair Forum session

The reviewed interim analysis results showed that Rui Kang Li Fu Tuo Ta monoclonal antibody achieved the primary endpoint of overall survival (OS) in phase III clinical trials. This means that B7-H3 targeted ADC is a major breakthrough in later research for the first time.

After the report ended, the on-site discussion was exceptionally lively, lasting about 30 minutes, far exceeding the usual session time. At the WCLC Chairman's Forum, a global top academic stage, this enthusiasm also made this Chinese original research B7-H3 ADC the focus of the first day.

01. First B7-H3 ADC phase III OS positive

This release presents the interim analysis results of the Phase III ARTEMIS-008 study of Rui Kang Li Fu Tuo Ta monoclonal antibody against recurrent small cell lung cancer (SCLC). This phase III study enrolled a total of 461 patients who were randomly assigned 1:1 to receive treatment with either Rui Kang Li Fu Tuo Ta monoclonal antibody or the standard chemotherapy drug Topotecan.

As of June 6, 2026 (median follow-up of 12.2 months), Rui Kang Li Fu Tuo Ta monoclonal antibody has demonstrated comprehensive and robust efficacy advantages in second-line SCLC treatment.

The median OS was 18.5 months vs. 10.3 months (HR=0.46; 95% CI: 0.35-0.62; p<0.001), with a 54% reduction in mortality risk; The 12-month OS rate was 64.5% vs. 43.3%, breaking the current record for the longest OS for second-line treatment of small cell lung cancer. Consistent OS benefit trends were observed in all preset subgroups, regardless of platinum resistance/sensitivity, presence of brain metastases, prior PD - (L) 1 inhibitor treatment, or limited/extensive phase.

The progression free survival (PFS) was also significantly improved: the median PFS was 7.2 months vs. 3.0 months (HR=0.33; 95% CI: 0.25-0.42). In terms of tumor response indicators, the ORR was 58.3% vs. 12.6%, the DCR was 90.4% vs. 60.2%, and the median duration of response was 6.9 months vs. 5.6 months.

In terms of safety, Ruikang Lifututamab has more advantages than Topotecan: the incidence of treatment-related adverse events (TRAEs) of grade ≥ 3 is 60.9% vs. 78.2%; The difference in the incidence of platelet count decline between grade 3 and above was particularly significant (13.9% vs. 59.7%). Lethal hematological events only occurred in the Topotecan group; The discontinuation or death caused by TRAEs was comparable between the two groups. Interstitial lung disease (ILD) events are generally consistent with past safety characteristics, with most being grades 1-2, which can be relieved after symptomatic treatment, and no grade 4 or fatal ILD events have been reported.

Based on this result, ARTEMIS-008 became the first positive study in the world to confirm the OS benefit of B7-H3 targeted ADC in a randomized controlled phase III clinical trial. Rui Kang Li Fu Tuo Ta monoclonal antibody is also the world's first and currently the only B7-H3 targeted ADC proven to have statistically significant survival benefits in multiple tumor species.

02. China's original research and development, accelerating globalization development

Rui Kang Li Fu Tuo Ta monoclonal antibody is a targeted B7-H3 ADC independently developed by Hansen Pharmaceuticals. It is covalently linked to a topoisomerase I inhibitor (TOP1i) payload through a cleavable tetrapeptide linker by a fully human anti-B7-H3 monoclonal antibody.

At present, the clinical development of Rui Kang Li Fu Tuo Ta monoclonal antibody for osteosarcoma, small cell lung cancer, and non-small cell lung cancer in China has entered phase III, and multiple PoC concept validation clinical studies for indications such as head and neck cancer, prostate cancer, esophageal squamous cell carcinoma, and colorectal cancer are underway.

In terms of global development, in December 2023, Hanson Pharmaceuticals granted GSK an exclusive license for the development, production, and commercialization of this product worldwide (excluding mainland China, Hong Kong, Macau, and Taiwan). GSK is accelerating the Phase I and III clinical trials of this product overseas. The collaborative development model between China and foreign countries has enabled this Chinese original ADC to be embedded into the global registration and clinical system from the early research stage.

Regulatory and academic progress is also accelerating.

In August 2026, Rui Kang Li Fu Tuo Ta monoclonal antibody is scheduled to be included in the CDE priority review, with indications for small cell lung cancer that has failed platinum based treatment; On September 2, 2026, its marketing authorization application (BLA) was accepted by the National Medical Products Administration (NMPA) of China and included in the priority review and approval process.

This product has obtained 13 regulatory qualifications in China, the United States, Japan, and Europe, covering breakthrough therapy certification, priority review qualification, and orphan drug qualification.

At the academic level, its clinical achievements have been showcased at top international academic conferences such as ESMO and AACR with extremely high standards, including Proffered Paper Presentation and Clinical Trials Plenary Session. In March 2026, the team led by Wang Jie and Duan Jianchun from the Cancer Hospital of the Chinese Academy of Medical Sciences published a research paper on ARTEMIS-001 phase 1a/b in the journal Cancer Cell under Cell Press, presenting for the first time the Phase I clinical data of this product in patients with advanced lung cancer.

03. Hansen's innovation strategy enters the period of realization

Behind the breakthrough of WCLC this time is Hansen Pharmaceutical's continued investment in innovative research and development strategy.

In the first half of 2026, Hansen Pharmaceutical's revenue was approximately 8.304 billion yuan, a year-on-year increase of approximately 11.7%; Profit of approximately 4.258 billion yuan, a year-on-year increase of approximately 35.8%; The revenue from innovative drugs is about 7.092 billion yuan, accounting for 85.4% of the total revenue, setting a new historical high. R&D expenses amounted to approximately 1.739 billion yuan, a year-on-year increase of 20.7%, accounting for approximately 20.9% of total revenue.

Currently, Hanson Pharmaceuticals is advancing over 70 clinical trials of innovative drugs, including more than 40 candidate innovative drugs. Several heavyweight pipelines, represented by Ruikang Lifututamab, are accelerating into the critical stage of registration, and the company's innovative research and development strategy has entered a new cycle of mutual verification between performance resilience and pipeline fulfillment.

From the WCLC Chair Forum LBA report, to ARTEMIS-008 breaking the second-line SCLC survival record, to BLA being accepted and included in priority review, every step of Ruikang Lifututamab is rewriting the global coordinates of China's original B7-H3 ADC.

The latest data released this time is a benchmark footnote for China's original research and innovation and Sino foreign collaborative globalization development. With the acceleration of the registration process, this B7-H3 ADC is expected to benefit patients worldwide more quickly, and Hansen Pharmaceuticals is also expected to stand at the forefront of the world's top research and development team.