On July 10, 2026, the 18th Suzhou International Elite Entrepreneurship Week and the 3rd Suzhou International Science and Technology Innovation Conference grandly opened. At the conference, the “2026 Suzhou Top Ten Industrial Scientific and Technological Achievements” were unveiled, showcasing breakthroughs in core technologies and high-quality innovation outcomes across the city’s strategic emerging industries. Anbenitamab Injection (brand name: 恩尼妥® , KN026), a HER2 bispecific antibody independently developed by Alphamab Oncology and co-developed with JMT-Bio Technology Co., Ltd., a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), was successfully selected. With its technological innovation, differentiated molecular design, and breakthrough clinical efficacy, it has become a benchmark achievement representing the high-end, independent, and international development of Suzhou’s biopharmaceutical industry.
Developed on Alphamab Oncology’s proprietary CRIB (Charge Repulsion Induced Bispecific) platform, Anbenitamab is a flagship innovative biologic with independent intellectual property rights, delivering mechanistic advancement and technological iteration in HER2-targeted therapy. Unlike single-target antibodies or monoclonal antibody combination regimens, Anbenitamab features a unique dual-epitope binding profile: it simultaneously binds to two non-overlapping epitopes of the HER2 receptor (domain IV and domain II). Through dual blockade of signaling pathways, induction of HER2 receptor clustering, and enhanced ADCC and CDC effects, the synergistic multi-mechanism action suppresses tumor cell proliferation and exerts superior anti-tumor activity. In May 2026, Anbenitamab obtained approval for marketing from the National Medical Products Administration of China (NMPA) through the priority review and approval pathway for combination with chemotherapy for the treatment of patients with locally advanced or metastatic HER2 positive gastric cancer/gastroesophageal junction cancer (GC/GEJ) who have previously received at least one trastuzumab-containing regimen. As the first domestically developed HER2 bispecific antibody approved for marketing in China, Anbenitamab has opened a new era in advanced gastric cancer treatment.
Clinical data strongly support the significant value of Anbenitamab: data from the pivotal Phase III study (KC-WISE) showed that Anbenitamab plus chemotherapy extended median overall survival to 20.9 months in second‑line patients with HER2‑positive gastric cancer, approximately twice that of chemotherapy; the objective response rate was 55.8%, roughly five times that of chemotherapy, substantially breaking through the current treatment ceiling. For indication expansion, two Phase III studies of Anbenitamab in neoadjuvant and first‑line treatment of breast cancer have both achieved robust positive results, rapidly extending the full treatment-cycle clinical development layout of HER2‑positive breast cancer. With its outstanding efficacy and safety profile, Anbenitamab has been granted two Breakthrough Therapy Designations by the NMPA (for gastric cancer and breast cancer) and an Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for gastric cancer.
This successful selection as one of “2026 Suzhou Top Ten Industrial Scientific and Technological Achievements” not only highly recognizes Anbenitamab as a front‑runner in HER2 bispecific antibodies, but also serves as an authoritative endorsement of Alphamab’s commitment to addressing clinical needs and pursuing original innovation. Biopharmaceuticals are a core pillar industry in Suzhou, and with a robust industrial ecosystem, a favorable business environment, and dedicated policy support, the city continues to nurture globally competitive original innovations. Anbenitamab stands as a typical example of the high‑quality development of Suzhou’s biopharmaceutical sector. Looking ahead, Alphamab will continue to develop safe, highly effective antitumor drugs with global competitive advantages, actively advancing next‑generation ADC drugs, combination therapies, subcutaneous formulations, and other cutting‑edge areas, delivering China-innovated cancer therapies to benefit patients worldwide.
About 恩尼妥® (Anbenitamab Injection)
恩尼妥® (Anbenitamab injection, KN026) is an anti-HER2 bispecific antibody independently developed by the Company using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). Anbenitamab can simultaneously bind two non-overlapping epitopes of HER2, resulting in HER2 signal blockade. Through antibody-induced receptor clustering, it enhances antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) effects while promoting the down-regulation of HER2 receptors on the cell surface.
In May 2026, 恩尼妥® obtained approval for marketing from the National Medical Products Administration of China (NMPA) through the priority review and approval pathway for combination with chemotherapy for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric cancer/gastroesophageal junction cancer (GC/GEJ) who have previously received at least one trastuzumab-containing regimen. Two Phase III clinical studies of neoadjuvant treatment for HER2-positive breast cancer and first-line treatment of HER2-positive breast cancer have reached the primary endpoints, and New Drug Application (NDA) will be submitted in the near future. Currently, multiple registrational clinical trials of Anbenitamab for indications such as adjuvant treatment of HER2-positive breast cancer and first-line treatment of HER2-positive GC/GEJ are ongoing.
Anbenitamab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of HER2-positive or low expressing GC; it has been granted two Breakthrough Therapy Designations by NMPA for the treatment of patients with HER2-positive GC/GEJ who have failed first-line standard treatment, and first-line treatment of patients with unresectable or metastatic HER2-positive breast cancer.
In August 2021, the Company entered an agreement with JMT-Bio Technology Co., Ltd. (JMT-Bio), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (CSPC) (stock code: 1093.HK), for the development and commercialization of KN026 in Mainland China. JMT-Bio was granted exclusive license rights of KN026 for the development and commercialization in the indications of BC and GC/GEJ in Mainland China (excluding Hong Kong, Macau and Taiwan).
About Alphamab Oncology
Alphamab Oncology (Stock Code: 9966.HK) is an innovative biopharmaceutical company focused on oncology. 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.
Two products have 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; and Anbenitamab (KN026, brand name: 恩尼妥®), the first domestically developed HER2 bispecific antibody approved for marketing in China, redefining the standard of treatment for second‑line HER2‑positive gastric cancer. Six bispecific ADC, dual-payload ADC candidates have entered clinical stages, and next-generation ADC pipelines 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, enabling patients to achieve long-term, high-quality survival and delivering China-innovated cancer therapies to benefit patients worldwide.
Alphamab Oncology Forward-Looking Statements
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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.
