Shanghai Henlius Biotech, Inc. Doses First Patient in Phase 1 HLX97 Clinical Trial for Advanced/Metastatic Solid Tumours in China
Key Highlights for Investors
- First Patient Dosed: Shanghai Henlius Biotech, Inc. (“Henlius” or “the Company”, Stock Code: 2696) has announced the dosing of the first patient in its phase 1 clinical study for HLX97, a KAT6A/B small molecule inhibitor, targeting advanced or metastatic solid tumours in mainland China (excluding Hong Kong, Macau, and Taiwan).
- Novel Target – KAT6A/B: HLX97 is a first-in-class, independently developed small molecule inhibitor of lysine acetyltransferase 6A/B (KAT6A/B), a promising target for combating resistance to endocrine therapy in cancers such as breast cancer.
- Clinical Trial Design: The trial is a multicenter, open-label, phase 1 study focused on evaluating safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity. The study is divided into two main parts:
- Part 1 (Dose-Escalation): Includes monotherapy dose escalation (Part 1A) and combination therapy with fulvestrant (Part 1B). Monotherapy will test five dose levels (1.0–15.0 mg daily, 28-day cycles). Combination therapy will assess 2–3 dose levels in patients with HR-positive, HER2-negative advanced/metastatic breast cancer.
- Part 2 (Dose-Expansion): Focuses on HR-positive, HER2-negative advanced/metastatic breast cancer, with two groups receiving HLX97 + fulvestrant and one group receiving fulvestrant monotherapy.
- Endpoints of the Study:
- Phase 1 Primary Endpoints: Incidence of dose-limiting toxicities (DLT) and determination of maximum tolerated dose (MTD) for both monotherapy and combination arms.
- Phase 2 Primary Endpoints: Objective response rate (ORR), progression-free survival (PFS) per RECIST v1.1, and the recommended phase 2 dose (RP2D) for HLX97 in combination with fulvestrant.
- Secondary Endpoints: Safety, PK, duration of response (DOR), disease control rate (DCR), overall survival (OS), and exploratory biomarker analyses.
- Mechanism and Rationale:
- KAT6A and KAT6B are acetyltransferases involved in modifying histones and other proteins, contributing to cancer development and resistance to existing therapies.
- Amplification and overexpression of KAT6A, particularly in breast cancer, is closely linked to resistance to endocrine therapy. Inhibition of KAT6 is thus a potential strategy to overcome this resistance.
- Non-clinical studies have demonstrated that HLX97 can inhibit KAT6A/B, with strong anti-tumour effects and a favourable safety profile.
- Regulatory Status: The investigational new drug (IND) application for HLX97 was approved by the National Medical Products Administration (NMPA) in March 2026.
- Market Opportunity: As of this announcement, there are no approved KAT6A/B small molecule inhibitors globally. This positions HLX97 as a potential first-in-class therapy if clinical development is successful.
Potential Share Price Sensitivities
- First-in-Class Potential: Given that there are no approved KAT6A/B inhibitors globally, successful development and commercialization of HLX97 could position Henlius as a leader in this novel therapeutic space. This is significant, as investors often respond positively to first-in-class development milestones, especially in major markets like China.
- Addressing Resistance in Major Cancers: HLX97 targets resistance mechanisms in hormone receptor-positive, HER2-negative breast cancer—a highly prevalent and challenging oncology segment. Progress in this area could expand Henlius’ portfolio and market share.
- Clinical Risks: As with all early stage clinical programs, there are significant risks. The company cautions that there is no guarantee HLX97 will be successfully developed or commercialized. Negative safety or efficacy data could adversely impact share value.
- Regulatory Progress: IND approval from the NMPA is a key milestone, clearing the path for clinical development in China—a major pharmaceutical market.
- Investor Caution: Shareholders and potential investors are advised to exercise caution, as the program remains in very early stages, and no product in this class has yet been commercialized.
Summary
Shanghai Henlius Biotech, Inc. has initiated a potentially market-moving clinical trial for HLX97, a novel KAT6A/B inhibitor, targeting advanced/metastatic solid tumours and breast cancer. With no approved therapies in this class globally, the successful progression of this trial could significantly enhance Henlius’ value proposition and competitive positioning in oncology. However, the inherent risks in early clinical development should be carefully considered by investors.
Disclaimer
The above summary is provided for informational purposes only and does not constitute investment advice. The development of HLX97 is subject to significant clinical, regulatory, and commercial risks. Investors are advised to exercise caution and undertake their own due diligence when considering investment decisions related to Shanghai Henlius Biotech, Inc.
