May 8, 2025, marks the thirteenth "World Ovarian Cancer Day," with this year's theme being "Focus on Women's Health: Prevent and Combat Ovarian Cancer Scientifically." As a "silent killer" that poses a serious threat to women's health, ovarian cancer (OC) ranks as the third most common gynecologic malignancy in China and continues to show a rising incidence, with the highest mortality rate among all malignant gynecologic tumors.
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 platinum-resistant ovarian cancer (PROC), leaving patients with limited effective treatment options and poor prognosis. Non-platinum chemotherapy, with or without bevacizumab, is the standard treatment for PROC. Previous studies have shown that the objective response rate (ORR) of PROC treated with non-platinum chemotherapy is only 10% to 15%. The median progression-free survival (PFS) is only 3 to 4 months, and the median overall survival (OS) approximately 12 months, highlighting an urgent need for new treatment options.
JSKN003 is an anti-HER2 biparatopic ADC, which is developed inhouse with Alphamab’s proprietary Glycan-specific conjugation platform. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window. Data from two Phase I clinical studies of JSKN003 for the treatment of PROC presented at the 2024 European Society for Medical Oncology (ESMO) Congress indicated that JSKN003 monotherapy has a favorable tolerability and safety profile, with promising efficacy signals in patients with advanced PROC, and the efficacy was observed across patients with (IHC 1+/2+/3+) or without (IHC 0) HER2 expression, with or without prior bevacizumab and prior PARP inhibitor. In March 2025, JSKN003 was granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The designation is for the treatment of platinum-resistant recurrent epithelial ovarian cancer (PROC), primary peritoneal cancer, or fallopian tube cancer, not restricted to HER2 expression levels. The Phase III clinical study of JSKN003 for this indication (Study ID: JSKN003-306) is currently in the enrollment phase and the study is progressing smoothly.
On this World Ovarian Cancer Day, let us join hands in raising awareness for women's health and advancing the scientific treatment of ovarian cancer. We hope that JSKN003 will soon benefit more platinum-resistant ovarian cancer patients, safeguarding women's health and offering new hope.
About JSKN003
JSKN003 is a bispecific ADC developed based on KN026 using Alphamab’s proprietary glycan-specific conjugation platform. JSKN003 can bind HER2 on the surface of tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, thereby exerting anti-tumor effects. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window.
Results of multiple clinical studies at various stages of JSKN003 in China and Australia have demonstrated favorable safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with advanced solid tumors, especially in patients with platinum-resistant ovarian cancer (PROC), HER2-expressing breast cancer (BC), or high HER2-expressing solid tumors. JSKN003 was granted breakthrough therapy designation by CDE. The designation is for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. Three phase III clinical studies of JSKN003 for the treatment of HER2-low expressing BC, PROC, and HER2-positive BC as well as multiple exploratory phase II clinical studies are currenly undergoing smoothly.
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), pursuant to which, JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for the treatment of tumor-related indications (the “Field”) in mainland China (excluding Hong Kong, Macau or Taiwan) (the “Territory”) and become the sole marketing authorization holder for JSKN003 for the Field in the Territory. Alphamab retains the sole right to supply JSKN003.
About Alphamab Oncology
Alphamab Oncology is an innovative biopharmaceutical company focusing on oncology therapeutics. By leveraging its proprietary core technology platforms including single-domain antibodies, bispecific antibodies, glycan-specific conjugation, linker-payload, dual-payload antibody conjugation, and subcutaneous high concentration formulation for biologics, the Company has established a differentiated and globally competitive product portfolio, covering cutting-edge areas such as antibody-drug conjugates (ADCs), bispecific antibodies, and single-domain antibodies.
The Company has one product approved for marketing (Envafolimab, the world's first subcutaneously injectable PD-(L)1 inhibitor), which has made a significant breakthrough in the convenience and accessibility of cancer treatment. Additionally, the Company has multiple bispecific antibodies and bispecific ADCs in clinical stage, while rapidly advancing the preclinical pipeline prioritizing bispecific ADCs and dual-payload ADCs. Multiple strategic collaborations based on innovative products or technology platforms have been established with partners such as CSPC, ArriVent, and Glenmark.
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 to benefit patients.
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.
