Alphamab Oncology Achieves Major Milestone: KN026 Phase III Breast Cancer Results to be Presented in Prestigious ASCO LBA Oral Session

Key Highlights

• Phase III clinical results of KN026 for neoadjuvant treatment of HER2-positive breast cancer have been selected for the Late-Breaking Abstract (LBA) Oral Presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, one of the most significant forums in the global oncology industry.
• KN026, a HER2 bispecific antibody, demonstrated superior efficacy to the current standard-of-care (trastuzumab plus pertuzumab) in a head-to-head phase III trial—potentially establishing a new standard for neoadjuvant treatment in early and locally advanced HER2+ breast cancer.
• Safety profile of KN026 combination therapy was manageable, supporting its potential clinical adoption.
• The study was co-developed with Shanghai JMT-Bio Technology, a subsidiary of CSPC Pharmaceutical Group, and led by Professor Shao Zhimin of Fudan University Shanghai Cancer Center.

Detailed Report

Alphamab Oncology (9966.HK) has announced that its pivotal phase III clinical study (KN026-004) evaluating KN026, in combination with albumin-bound docetaxel (HB1801), as a neoadjuvant therapy for HER2-positive breast cancer, has been selected for oral presentation at the Late-Breaking Abstract (LBA) session during the 2026 ASCO Annual Meeting, to be held in Chicago from May 29 to June 2, 2026.

Clinical Significance

The LBA Oral Presentation is regarded as the most highly anticipated segment of the ASCO meeting, reserved for global clinical research of utmost clinical relevance and the greatest potential to change medical practice. Selection for this session underlines the international recognition of the clinical importance and innovation of KN026.

The KN026-004 trial is a randomized, controlled, open-label, multicenter phase III study comparing:

• KN026 + HB1801 ± carboplatin versus
• Trastuzumab + pertuzumab + docetaxel ± carboplatin (current standard of care, TCbHP)

as neoadjuvant treatment for early or locally advanced HER2+ breast cancer.

Results from the study:

• KN026 combination therapy resulted in a significant improvement in total pathological complete response (tpCR) rates compared to the standard regimen.
• This is the first time a HER2 bispecific antibody has outperformed the dual monoclonal antibody regimen (trastuzumab + pertuzumab) in a phase III head-to-head trial.
• The safety profile was manageable, supporting the clinical feasibility of the regimen.
• The data positions KN026 combination therapy as a potential new standard of care for the neoadjuvant treatment of early and locally advanced HER2+ breast cancer.

About KN026 (Anbenitamab)

KN026 is an anti-HER2 bispecific antibody, independently developed by Alphamab Oncology using its proprietary Fc-based heterodimer bispecific platform technology (CRIB). KN026 can simultaneously bind two distinct epitopes of HER2, enabling signal blockade, enhanced immune effects (ADCC and CDC), and downregulation of HER2 receptors.

KN026 has received Orphan Drug Designation from the US FDA for HER2+ or HER2-low gastric cancer, and Breakthrough Therapy Designation from the China NMPA as a second-line or above treatment for HER2+ gastric/gastroesophageal junction cancer. A New Drug Application (NDA) for KN026 in combination with chemotherapy was accepted by the NMPA in September 2025 and is under review.

Multiple registrational trials for KN026 are ongoing, covering first-line treatment for HER2+ gastric/gastroesophageal junction cancer, first-line and neoadjuvant/adjuvant treatment for HER2+ breast cancer.

In August 2021, Alphamab entered a licensing agreement with JMT-Bio, granting JMT-Bio exclusive development and commercialization rights for KN026 in breast and gastric cancer indications within Mainland China (excluding Hong Kong, Macau, and Taiwan).

About HB1801

HB1801 is a novel albumin-bound docetaxel formulation developed by CSPC Group’s nanomedicine platform. Unlike standard docetaxel formulations that use polysorbate 80 and ethanol (which can cause allergic reactions and other safety/compatibility issues), HB1801 encapsulates docetaxel in human serum albumin, offering:

• No need for hormone pretreatment
• Rapid, high-concentration administration with improved safety and patient compliance
• Better efficacy in preclinical tumor models and the potential for higher clinical dosing

Early-phase clinical studies indicate improved anti-tumor efficacy and safety compared to standard docetaxel injection. HB1801 is currently in pivotal phase III trials for breast and gastric cancers.

Company Background and Shareholder Information

Alphamab Oncology is a leading PRC-based biopharmaceutical company with a fully integrated technology platform focused on antibody-drug conjugates (ADC), bispecific antibodies, and multifunctional protein engineering. Its pipeline includes multiple phase III/pivotal stage assets, one approved product by the NMPA, and a robust set of antibody-based oncology therapies.

Potential Share Price Impact and Shareholder Considerations

• This announcement is highly price-sensitive. Selection for the LBA Oral Presentation at ASCO significantly elevates the global profile of Alphamab Oncology, validating the clinical potential and commercial value of KN026.
• Positive phase III data and the possibility of KN026 setting a new standard of care in HER2+ breast cancer could meaningfully boost investor confidence and share value, particularly if regulatory approvals and market adoption follow.
• Shareholders should be aware of the inherent risks: Alphamab notes that there is no guarantee KN026 will ultimately be approved or successfully commercialized. Investors should exercise caution.

Board and Governance

As of the announcement date (April 22, 2026), Alphamab’s Board comprises Dr. Xu Ting (Chairman & Executive Director), Ms. Liu Yang (Executive Director), Mr. Cho Man (Non-Executive Director), and three independent non-executive directors: Mr. Wu Dong, Ms. Wong Yan Ki Angel, and Dr. Gao Xiang.

Disclaimer: The above article is for informational purposes only and does not constitute investment advice. The development and commercialization of pharmaceutical products involve significant risks and uncertainties. Alphamab Oncology cannot guarantee successful development, regulatory approval, or marketing of KN026 or other pipeline products. Investors are advised to exercise caution and consult their professional advisors before making investment decisions.

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