Tong Yang Launches Taiwan's First Locally Developed Third-Generation EGFR-TKI Lung Cancer Drug, Covered by National Health Insurance in August

Taiwan's biopharmaceutical industry has reached a significant milestone. Tong Yang (4105-TW) announced that its domestically developed lung cancer targeted therapy, Aumolertinib, will be included in the National Health Insurance (NHI) reimbursement program starting August 2024. This marks not only a new treatment option for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), but also a historic achievement as Taiwan's first locally manufactured third-generation EGFR-TKI oral drug entering clinical use.

Tong Yang emphasized that this achievement reflects the tangible results of its recent efforts to upgrade manufacturing processes and strengthen local production capabilities. It also represents a major advancement in Taiwan's self-reliance in pharmaceuticals and supply chain resilience.

According to the Ministry of Health and Welfare's 2025 (Minguo Year 114) report on the top ten causes of death, malignant tumors remain the leading cause of death in Taiwan, with lung cancer treatment being a critical public health issue. Currently, treatments for advanced NSCLC with EGFR gene mutations are primarily imported. To enhance local supply resilience and drug accessibility, Tong Yang, following recommendations from clinical physicians, initiated the development and manufacturing of Aumolertinib, aiming to provide locally produced treatment options for patients and healthcare providers.

General Manager Hou Jing-Lan stated that Tong Yang focused on the lung cancer treatment needs of the Taiwanese population and invested one year in process development at its Liudui plant in Keelung. The company established an integrated production line covering mixing, granulation, tablet pressing, and packaging, dedicated exclusively to manufacturing Aumolertinib, a third-generation EGFR-TKI oral targeted therapy for lung cancer.

Additionally, to support local clinical research and accumulate domestic clinical data, Tong Yang launched four local clinical trials, enrolling nearly 400 patients. This demonstrates not only Tong Yang’s capability in local manufacturing of targeted therapies but also its commitment to strengthening pharmaceutical resilience and addressing clinical needs.

Hou Jing-Lan noted that Taiwan diagnoses over 4,000 new lung cancer patients annually with EGFR gene mutations, making long-term treatment and medication a key clinical care issue. With Aumolertinib now covered by NHI, it benefits both physicians and patients and signifies the formal clinical application of Taiwan’s first domestically developed third-generation EGFR-TKI lung cancer drug. This further highlights the multi-faceted value of domestic innovation in healthcare resilience, drug accessibility, and biotech industry development.

In alignment with the 'Healthy Taiwan' policy goal of reducing cancer mortality, Tong Yang has prioritized clinical needs and product development strategies, focusing on four key areas: 'lung cancer,' 'hematological tumors,' 'breast, gynecological, and upper gastrointestinal cancers,' and 'head and neck and colorectal cancers.'

Aumolertinib represents a major milestone in pharmaceutical technology and product portfolio expansion, following the successful launch of Pemetrexed, a domestically produced chemotherapy generic drug compatible with immunotherapy. This marks Tong Yang’s strategic expansion from chemotherapy into precision medicine within its lung cancer product line.

Hou Jing-Lan emphasized that Aumolertinib’s inclusion in NHI reimbursement completes Tong Yang’s milestone in end-to-end development, manufacturing, and market deployment of Taiwan’s first domestically developed third-generation EGFR-TKI targeted therapy. Supported by steadily growing overseas sales of complex generics, Tong Yang will continue to increase its focus on proprietary new drugs and high-barrier-to-entry pharmaceuticals. By integrating AI-driven digital management strategies to enhance operational efficiency and aiming to launch two new products annually, the company plans to sustain business momentum and expand its global footprint.