EirGenix announced today that it has signed a supply agreement with Australian pharmaceutical company Clarity Pharmaceuticals, Ltd. for the active pharmaceutical ingredient (API) of its trastuzumab biosimilar, EG12014. The API will be used to advance Clarity’s novel radiopharmaceutical Cu-64/67 SAR-trastuzumab through clinical development and eventual commercialization. This collaboration will support Clarity’s expansion into the Australian and global markets.
Clarity has long been focused on radiopharmaceutical development and specializes in its proprietary copper-chelating technology, Sarcophagine (SAR technology). The company is advancing multiple theranostic clinical trials that utilize copper-64 for diagnostic imaging and copper-67 for targeted therapy. Cu-64/67 SAR-trastuzumab is an innovative radiopharmaceutical that combines EirGenix’s EG12014 API—already approved in the EU and Taiwan—with SAR technology. Preclinical data indicate that in HER2-positive mouse models, 67Cu-SAR-trastuzumab significantly reduces tumor size and extends survival compared to trastuzumab alone. Phase 1 clinical trials are currently planned for Australia and the United States.
Under this agreement, EirGenix will supply Clarity with EG12014 API throughout the product’s development and commercialization. EirGenix will receive milestone payments upon Clarity’s achievement of key research and development stages, as well as royalties on future product sales. This innovative therapeutic approach has the potential to capture significant market interest.
Trastuzumab is a targeted HER2 antibody used in the treatment of various cancers, including certain types of lung, gastric, and breast cancers. This novel theranostic radiopharmaceutical will initially focus on breast cancer and will be strategically integrated with Clarity’s broader product portfolio to strengthen its market position in this critical indication.
Clarity plans to conduct a Phase 1/2a study of 64/67Cu-SAR-trastuzumab in patients with HER2-positive breast cancer to address an urgent unmet medical need. This breast cancer subtype is characterized by high aggressiveness and poor prognosis. Despite advances in early-stage HER2-positive breast cancer treatment, up to 25% of patients experience recurrence within 10 years.
EirGenix’s EG12014 API has received manufacturing approval from major regulatory agencies worldwide, including the U.S. FDA. The company continues to expand commercial-scale production of this biosimilar to ensure a high-quality and stable supply of 67Cu-SAR-trastuzumab. Upon achieving full market approval, this collaboration aims to provide improved treatment options for both pediatric and adult cancer patients.
Breast cancer is the most commonly diagnosed cancer among women in the United States, with an estimated 319,750 invasive breast cancer cases projected in 2025, of which 316,950 will occur in women. It remains the second leading cause of cancer-related deaths among women, following lung cancer, with an estimated lifetime risk of 13%. Incidence rates have slightly increased in recent years, particularly among women under 50. Approximately 20% of breast cancers are HER2-positive, meaning they express high levels of the HER2 protein, leading to faster tumor growth. This innovative radiopharmaceutical therapy seeks to address the limitations of currently available treatments.
Beyond its focus on biosimilars, EirGenix is actively expanding into diversified markets. In addition to its collaboration with Clarity, the company is engaging in partnerships for the development of innovative therapeutics, extending the lifecycle of its existing and pipeline biosimilar products, and increasing API supply and production capacity. This flexible commercial strategy is expected to drive EirGenix’s continued diversification and create new market opportunities.
Resource: 台康生技與澳洲大廠 Clarity 簽訂EG12014原料供應合約
