AACR 2026 | HANSOH PHARMA PRESENTED RESULTS OF HS-10504 (A NOVEL, POTENT, HIGHLY SELECTIVE, FOURTH-GENERATION EGFR TKI) FROM A FIRST IN HUMAN PHASE 1 STUDY IN PATIENTS WITH ADVANCED NSCLC
- HS-10504 has demonstrated a promising anti-tumor activity in advanced NSCLC harboring EGFR C797S mutation with the ORR 52.9% and mPFS 9.6 months at the RP2D of 400 mg QD.
- Given its quick and durable response, HS-10504 is expected to provide a novel treatment option for these patients with poor prognostic and currently having no targeted treatment option.
SHANGHAI, April 22, 2026-Hansoh Pharmaceutical Group Co., Ltd. (“Hansoh Pharma,” 03692.HK) today announced that the encouraging results of HS-10504 for the treatment of advanced non-small cell lung cancer (NSCLC) post Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR TKI) therapy were presented in an oral session at AACR 2026 (April 17-22, San Diego, California).
HS-10504 is a novel, potent, highly selective, fourth-generation EGFR TKI under clinical development for NSCLC patients. At AACR 2026, the presented data was generated from HS-10504-101 (NCT06461156), which aimed to evaluate the safety, efficacy and pharmacokinetic (PK) profile of orally administered HS-10504. The leading principal investigator of this study is Professor Jianxing He (Department of Thoracic Surgery, Phase I Clinical Research Center, The First Affiliated Hospital of Guangzhou Medical University).
Study results showed:
● Promising Efficacy：In 34 efficacy-evaluable advanced NSCLC patients harboring EGFR C797S with or without T790M resistance mutations who received 400 mg once daily (QD), Objective Response Rate (ORR) was 52.9% and median Progression-Free Survival (PFS) was 9.6 months.
● Manageable safety profile: Overall, HS-10504 demonstrated a favorable and manageable safety profile, with most Treatment-Related Adverse Events (TRAEs) being Grade 1-2. The most common Grade ≥3 TRAEs were primarily hematological abnormalities, including decreased lymphocyte count and anemia, which were clinically manageable.
Details of the oral presentation are as follows:
◆ Presentation Title: The tolerability and efficacy of HS-10504 in patients with EGFR mutation-positive advanced NSCLC: Initial results from a first-in-human phase 1 study
◆ Session: Advances in Precision Oncology
◆ Date/Time: 4/21/2026 2:30:00 to 4:30:00 PM（ET）
◆ Presenting author: Prof. Zhanhong, Xie/ Department of Respiratory and Critical Care Medicine and Department of Oncology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China
About HS-10504
HS-10504 is an innovative drug independently developed by Hansoh Group with proprietary intellectual property rights, targeting EGFR-sensitive mutations and drug-resistant mutations. This compound specifically overcomes the steric hindrance effect caused by the serine residue at C797S on third-generation EGFR TKIs, as well as the steric hindrance effect induced by the T790M mutation on first- and second-generation TKIs.
About NSCLC
EGFR TKI had been widely used as first line treatment of EGFR-mutant advanced non-small cell lung cancer (NSCLC). After treatment with EGFR TKIs, most patients develop acquired resistance (AR)[1], leading to disease progression. The mechanism of resistance is complicated especially post third generation TKI. The C797S mutation is one of the main mechanisms leading to acquired resistance due to EGFR mutations. The EGFR C797S mutation accounts for approximately 7% of resistance mutations in the first-line treatment with osimertinib and approximately 14% of resistance mutations in the second-line treatment with osimertinib[2] and also reported in other third-generation EGFR TKIs (including aumolertinib and furmonertinib)[3].
References
1. Mok TS, Wu Y-L, Ahn M-J, et al; AURA3 Investigators. Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer. N Engl J Med. 2017 Feb 16;376(7):629-640.
2. Alessandro Leonetti, Sugandhi Sharma, Roberta Minari. et al. Resistance mechanisms to osimertinib in EGFR-mutated non-small cell lung cancer. British Journal of Cancer, 2019, 121: 725-737.
3. He J, Huang Z, Han L, Gong Y, Xie C. Mechanisms and management of 3rd‑generation EGFR‑TKI resistance in advanced non‑small cell lung cancer (Review). Int J Oncol. 2021;59(5):90.
Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative medicines that generate product sales in China, with the revenue from innovative medicines and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China, and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).
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