GNTbm announced that its domestically developed anti-breast cancer novel drug Kepida, which has been under development in Taiwan for a decade, has been approved for reimbursement by Taiwan’s National Health Insurance, with coverage taking effect on December 1.

Kepida is a patented novel drug licensed and developed by GNTbm over the past 10 years in Taiwan. Manufactured in collaboration with leading Taiwanese active pharmaceutical ingredient and formulation manufacturers, the drug was tested in a five-year pivotal Phase III clinical trial enrolling patients with advanced breast cancer across eight medical centers in Taiwan. In 2013, it received approval from the Taiwan Food and Drug Administration (TFDA) and was granted marketing authorization for the breast cancer indication.

GNTbm stated that Kepida is a domestically developed, oral, epigenetic-regulating novel drug that introduces an entirely new mechanism of action among global anti-breast cancer therapies. Its uniqueness lies in its ability to modulate the expression of multiple genes through epigenetic regulation in a multi-target manner, thereby enhancing sensitivity to endocrine therapy and overcoming resistance that commonly arises from prior endocrine treatments.

In addition, studies have shown that through its distinctive epigenetic regulatory mechanism, Kepida can effectively overcome dual resistance induced by long-term use of first-line CDK4/6 inhibitor–based combination endocrine therapy.

Beyond the development of Kepida for breast cancer and the expansion of its indications to include relapsed or refractory peripheral T-cell lymphoma, GNTbm has accelerated the advancement of its proprietary oncology pipeline. These globally promising novel drugs were presented at the 2025 ASCO and ESMO congresses, including the next-generation novel compound GNTbm-38, which features potent epigenetic regulation and immune activation, as well as GNTbm-TKI, a highly potent immune-activating multi-target kinase inhibitor.

With Kepida now covered by National Health Insurance, GNTbm noted that its R&D team will further accelerate the global development of these two proprietary new drugs to benefit more patients with advanced cancers. Both GNTbm-38 and GNTbm-TKI are core tumor immunotherapy agents with strong immune-activating properties and distinct mechanisms of action.

Resource: 華上生醫乳癌新藥獲健保給付 12月1日生效