en.Wedoany.com Reported - On April 1, 2026, Alphamab Oncology announced that its self-developed HER2 bispecific antibody Enbetomab (KN026) combined with HB1801 has met the primary endpoint of total pathological complete response in a Phase III clinical study (KN026-004) for the neoadjuvant treatment of HER2-positive early or locally advanced breast cancer. Compared with the current standard treatment regimen, this combination therapy significantly improved the pathological response rate, demonstrating statistical and clinical significance.
The KN026-004 study is the world's first registrational study to demonstrate in a head-to-head trial that a HER2 bispecific antibody is superior to a combination of two monoclonal antibodies, bringing new progress to the field of neoadjuvant therapy for breast cancer. Detailed results will be announced at future international academic conferences, offering patients a more promising treatment option.
This randomized, controlled, multi-center Phase III study planned to enroll approximately 520 patients, who were allocated to the experimental or control group in a 1:1 ratio. The primary endpoint was assessed by an independent review committee. Clinical advantages include a shorter treatment course, utilizing a continuous 6-cycle regimen, allowing patients to undergo surgery approximately 6 weeks earlier, and being more simplified compared to other regimens. The bispecific antibody regimen avoids treatment gaps and drug switching. HB1801, as an albumin-bound docetaxel, does not require steroid premedication, potentially reducing toxicity. Enbetomab is a non-ADC drug, avoiding risks such as interstitial lung disease, and its safety profile is easier to manage.
In addition to the neoadjuvant study, the Phase III adjuvant study (KN026-007) was initiated in March 2026, planning to enroll approximately 1800 postoperative high-risk patients. The domestic drugs Enbetomab and HB1801 have cost advantages. If included in the national medical insurance in the future, they are expected to benefit more patients. Enbetomab is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes, enhancing immune effects. Its New Drug Application was accepted in September 2025 for the treatment of HER2-positive gastric cancer and has received FDA Orphan Drug designation and NMPA Breakthrough Therapy designation.
Alphamab Oncology focuses on the development of innovative oncology drugs, with a product pipeline including ADCs and bispecific antibodies. The company already has a subcutaneous PD-(L)1 inhibitor on the market and collaborates with institutions such as Sinopec Group to deliver effective therapies to patients worldwide.
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