First in Taiwan! Taiwan Otsuka Successfully Develops and Manufactures Third-Generation EGFR-TKI Lung Cancer Targeted Drug, Covered by National Health Insurance in August

Taiwan's biopharmaceutical industry has reached a new milestone. Taiwan Otsuka's novel lung cancer targeted therapy, Aumolertinib, has been included in the National Health Insurance (NHI) reimbursement program this August. This not only provides a new treatment option for patients with locally advanced or metastatic non-small cell lung cancer but also represents a historic achievement as the first third-generation EGFR-TKI oral targeted drug developed and manufactured entirely by a local Taiwanese pharmaceutical company.

According to the Ministry of Health and Welfare's 2025 report on the top ten causes of death among Taiwanese citizens, malignant tumors remain the leading cause of death. Among these, lung cancer treatment continues to be one of the most critical public health issues. However, current treatments for advanced non-small cell lung cancer with EGFR gene mutations still rely heavily on imported medications.

Considering the need for local pharmaceutical resilience and improved drug accessibility, Taiwan Otsuka, upon recommendations from clinical physicians, initiated the development and manufacturing of Aumolertinib—a domestically produced targeted therapy for lung cancer—with the goal of providing locally accessible treatment options for both doctors and patients.

Hou Ching-Lan, CEO of Taiwan Otsuka, stated that the company has focused on the lung cancer treatment needs of the Taiwanese population and invested one year in process research and development at its Liudui plant. There, they established an integrated production line covering mixing, granulation, tablet compression, and packaging, dedicated exclusively to the manufacturing of Aumolertinib, the third-generation EGFR-TKI oral targeted lung cancer drug.

Additionally, to support local clinical research and accumulate domestic clinical data, Taiwan Otsuka has launched four clinical trials, enrolling nearly 400 patients in total.

Hou Ching-Lan emphasized, "The inclusion of our lung cancer targeted drug Aumolertinib in the NHI reimbursement program signifies that Taiwan Otsuka has achieved a major milestone—the complete journey from research and development, manufacturing, to market deployment—for Taiwan’s first domestically produced third-generation EGFR-TKI targeted therapy."

She further noted, "Approximately 4,000 new lung cancer patients with EGFR gene mutations are diagnosed annually in Taiwan, making long-term treatment and medication management a crucial aspect of clinical care. With Aumolertinib now covered by insurance, it benefits both medical professionals and patients alike, marking the official clinical application of a domestically developed third-generation EGFR-TKI lung cancer targeted drug. This achievement further demonstrates the multi-faceted value of domestic innovation in enhancing medical resilience, improving drug accessibility, and advancing Taiwan’s biotechnology industry."

In response to the government’s 'Healthy Taiwan' initiative aimed at reducing cancer mortality rates, Taiwan Otsuka has aligned its clinical focus and product development strategy around four key oncology areas: 'lung cancer,' 'hematological malignancies,' 'breast cancer, gynecological cancers, and upper gastrointestinal cancers,' and 'head and neck cancer and colorectal cancer.'

Among these, the domestically developed lung cancer targeted drug Aumolertinib stands as a significant technological and strategic advancement following Pemetrexed, a locally manufactured chemotherapy generic compatible with immunotherapy. This progression symbolizes Taiwan Otsuka’s expansion from conventional chemotherapy into the realm of precision medicine within its lung cancer portfolio.

Hou Ching-Lan added, "With Aumolertinib’s inclusion in NHI coverage, Taiwan Otsuka has completed the full cycle—from R&D to manufacturing and market rollout—for the country’s first domestically produced third-generation EGFR-TKI targeted drug. Supported by steadily growing overseas sales performance of complex generics, Taiwan Otsuka will continue to increase the proportion of self-developed innovative 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 will continuously expand its business momentum and global footprint."