Anbenitamab

Alphamab Oncology (HKEX: 9966) revealed that anbenitamab (KN026), a bispecific anti-HER2 antibody, met its primary endpoint in the Phase III Neo-Healer trial evaluating neoadjuvant treatment of early or locally advanced HER2-positive breast cancer, with the company describing the total pathological complete response (tpCR) result as both statistically and clinically significant versus the current standard of care. Neo-Healer (KN026-004) is a randomized, open-label, multicenter Phase III study planned to enroll approximately 520 patients with early or locally advanced HER2+ breast cancer, assigned 1:1 to receive KN026 plus albumin-bound docetaxel (HB1801) ± carboplatin or trastuzumab plus pertuzumab plus docetaxel ± carboplatin, with total pathological complete response assessed by a blinded independent review committee as the primary endpoint. No numerical tpCR rates, confidence intervals, or p-values were disclosed. The announcement stated only that KN026 in combination with HB1801 ± carboplatin “significantly improved” tpCR compared with the standard regimen, with full data to be presented at an international conference. The absence of quantitative results limits any assessment of effect size at this stage. Safety data were not reported. Alphamab’s HER2 bispecific engineering Anbenitamab is engineered using Alphamab’s CRIB (Charge Repulsion Induced Bispecific) platform and binds two non-overlapping epitopes on HER2 simultaneously, blocking downstream signaling while enhancing antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity, and receptor downregulation. The design effectively consolidates the biological roles of trastuzumab and pertuzumab — which target distinct HER2 epitopes — into a single molecule. The experimental arm also replaces standard docetaxel with HB1801, CSPC Group’s albumin-bound docetaxel formulation, which encapsulates the active drug in human serum albumin, eliminating the polysorbate 80 and ethanol solvents associated with hypersensitivity reactions and premedication requirements. Competitive context The neoadjuvant HER2+ breast cancer setting is one where the limitations of current therapy are quantifiable. Trastuzumab plus pertuzumab combined with chemotherapy — the THP/TCbHP regimen — achieves tpCR in roughly half of patients with early or locally advanced disease. Patients who do not achieve tpCR face a materially worse prognosis and are typically escalated to adjuvant ado-trastuzumab emtansine (T-DM1). A bispecific antibody that raises the tpCR ceiling would, in principle, reduce downstream escalation requirements, though the Neo-Healer data needed to substantiate that argument have not yet been released. The competitive framing matters here. The trial’s active comparator is trastuzumab plus pertuzumab plus docetaxel — which is itself the globally established standard and the benchmark against which Roche’s Phesgo, the fixed-dose subcutaneous co-formulation of both antibodies, has positioned its convenience advantage. KN026 is not competing on route of administration but on mechanistic consolidation and, if the data support it, on efficacy magnitude. The absolute tpCR improvement will need to be evaluated carefully when full results are published. KN026’s regulatory trajectory is more advanced in gastric cancer than in breast cancer. The China National Medical Products Administration accepted a new drug application for KN026 in combination with chemotherapy for second-line or above HER2+ gastric or gastroesophageal junction cancer in September 2025, and that application remains under review. The US FDA has granted KN026 orphan drug designation for HER2+ or HER2-low gastric cancer. The NMPA also granted breakthrough therapy designation for the same gastric cancer indication. None of these designations extend to breast cancer, where KN026 remains investigational. The breast cancer program is structured as a multi-indication effort. Alongside Neo-Healer, Alphamab and its partner JMT-Bio — a subsidiary of CSPC Pharmaceutical Group (HKEX: 1093), which holds exclusive mainland China development and commercialization rights for KN026 in breast and gastric cancer — are running registrational trials in first-line HER2+ breast cancer and in the adjuvant HER2+ breast cancer setting. A Phase III adjuvant study (NCT07441460) is listed on AllSci as not yet recruiting. The partnership structure is relevant to the commercial picture. JMT-Bio’s rights cover mainland China; Alphamab retains rights elsewhere. The primary near-term market for Neo-Healer data, if regulatory submissions follow, would be China, where HER2+ breast cancer accounts for approximately 20%-30% of breast cancer cases and where roughly 75% of patients present at early or locally advanced stage — the exact population Neo-Healer enrolled. Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Suzhou, China, October 28, 2025 - Alphamab Oncology (stock code: 9966.HK) announced that the biparatopic HER2-targeting antibody-drug conjugate (ADC) JSKN003 has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (PROC), not restricted by HER2 expression. This marks another accelerated review recognition for JSKN003 from an internationally authoritative regulatory agency, following two previous Breakthrough Therapy Designations from the National Medical Products Administration (NMPA) for both PROC and colorectal cancer (CRC) and an Orphan Drug Designation from the FDA for gastric cancer/gastroesophageal junction cancer (GC/GEJ) this year. As a significant milestone in its global development progress, this achievement fully validates the drug's substantial clinical potential and market prospects. Ovarian cancer (OC) is one of the most common malignant tumors of the female reproductive system. Most patients are diagnosed at an advanced stage, and the disease is characterized by a high recurrence rate and significant treatment challenges. The standard treatment regimens recommended by authoritative guidelines both domestically and internationally include surgery combined with platinum-based chemotherapy and targeted therapy maintenance. However, about 80% of OC cases recur, and eventually progress to PROC, leaving patients with limited effective treatment options and poor prognosis. The U.S. National Comprehensive Cancer Network (NCCN) recommended single-agent non-platinum chemotherapy with or without bevacizumab as preferred regimens for PROC. However, these non-platinum chemotherapies demonstrate limited efficacy, with the objective response rate (ORR) of only 10% to 15%, a median progression-free survival (mPFS) of only 3 to 4 months, and a median overall survival (OS) of approximately 12 months, highlighting an urgent need for new treatment options. The grant of FTD is based on the promising clinical data of JSKN003. The Company has presented a pooled analysis of the phase I clinical study in Australia (JSKN003-101, NCT05494918) and the phase I/II clinical study in China (JSKN003-102, NCT05744427) at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO). As of February 28, 2025, 46 patients with PROC, including 21 patients (45.7%) with HER2 IHC 0 and 18 patients (39.1%) with HER2 IHC 1+, 2+, 3+, were enrolled. Among all 46 patients, the ORR was 63.0%, the median PFS was 7.7 months. In patients with HER2 IHC 1+, 2+ and 3+, the ORR was 72.2%, the median PFS was 9.4 months. JSKN003 demonstrated robust PFS improvement in PROC, and the efficacy was observed across different HER2 expression subgroups. The Phase III clinical study of JSKN003 for PROC is currently underway in China, while a Phase II study has been approved to initiate in the U.S. The granting of FTD by the FDA will further accelerate the clinical development and regulatory review process of JSKN003, offering new hope to global patients with PROC who face limited treatment options. About JSKN003 JSKN003 is developed by site-specific conjugation to the Fc glycans of anbenitamab, resulting in a homogeneous and stable ADC with a DAR of 4. JSKN003 binds to two HER2 epitopes on tumor cells and release topoisomerase I inhibitors through cellular endocytosis, exerting anti-tumor effects. Compared to similar ADCs, JSKN003 demonstrates better serum stability, reduced hematological toxicity, and stronger tumor inhibition and bystander effect, resulting in significantly wider therapeutic window. Multiple registrational studies of JSKN003 are ongoing, including trials in HER2-positive breast cancer (BC), all-comer platinum-resistant ovarian cancer (PROC), HER2-low BC, and HER2-positive colorectal cancer (CRC). JSKN003 has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for gastric cancer (GC) and gastroesophageal junction cancer (GEJ); It has been granted two Breakthrough Therapy Designations by the National Medical Products Administration (NMPA) for platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer and HER2-positive advanced CRC that has failed prior oxaliplatin, fluorouracil, and irinotecan therapy. In September 2024, the Company entered a licensing agreement with JMT-Bio Technology Co., Ltd. (“JMT-Bio”), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (“CSPC”) (stock code: 1093.HK). JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for tumor-related indications in mainland China (excluding Hong Kong, Macau or Taiwan). Alphamab retains exclusive production rights for JSKN003. About Alphamab Oncology Alphamab Oncology is an innovative biopharmaceutical company focused on oncology. On December 12, 2019, the Company was successfully listed on the Main Board of the Hong Kong Stock Exchange (Stock Code: 9966.HK). Leveraging proprietary platforms-including single-domain antibodies, bispecific antibodies, glycan-specific conjugation, linker-payloads, dual-payload ADCs, and high-concentration subcutaneous formulations-the Company has built a differentiated and globally competitive pipeline, covering cutting-edge candidates in ADCs, bispecific antibodies, and single-domain antibodies. One product has received market approval: Envafolimab (KN035, brand name: 恩维达 ® ), the world's first subcutaneously injected PD-(L)1 inhibitor, offering greater convenience and accessibility in cancer treatment. The NMPA has accepted the new drug application for KN026 (Anbenitamab Injection), a HER2 bispecific antibody, for second-line or later HER2-positive gastric cancer. Four bispecific ADC candidates have entered clinical stages, and next-generation ADC pipelines—such as dual-payload ADCs—are advancing rapidly. The Company has established strategic partnerships with organizations including CSPC, ArriVent, and Glenmark, covering both product development and technology platforms. Our overarching mission is to make cancer manageable and curable by addressing unmet clinical needs in oncology. Alphamab Oncology is continuously dedicated to the development of effective, safe, and globally competitive anti-tumor drugs, delivering China-innovated cancer therapies to benefit patients worldwide. Alphamab Oncology Forward-Looking Statements This press release contains statements related to our future business，financial performance and future events involving Alphamab Oncology that may constitute forward-looking statements. These statements include projections and estimates and relevant assumptions, statements regarding plans and expectations and statements regarding future activities, operations and performance. These statements may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," or words of similar meaning. Such statements are based on the certain assumptions of Alphamab Oncology’s management and business operations, which are subject to various risks and uncertainties, including but not limited to political, economic, legal and business environment. The actual results, performance or achievements of Alphamab Oncology may (negatively or positively) vary materially from those described explicitly or implicitly in the relevant forward-looking statements. Unless otherwise required by applicable laws, Alphamab Oncology does not undertake obligation to publicly update any forward-looking statement nor liability for the failure to materialize such forward-looking statements, whether because of new information, future events or otherwise. Pharmaceutical Information Statements Alphamab Oncology does not recommend the clinical use of any already approved or under-development drugs/indications. Any information contained in this press release should not be regarded as any drug application, promotion or advertisement. Source: Alphamab Oncology