Trungyu: AIDS New Drug Receives TFDA Approval Notification, Entering Final Stage for Taiwan Launch

(CNA, reporter He Xiuling, Taipei, July 6) Trungyu Pharmaceutical announced that its developed AIDS new drug, Trogarzo, has received an approval notification from the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare. Marketing partner Union Chemical will complete the drug license acquisition procedures according to regulations, marking the final stage for Trogarzo's launch in the Taiwan market.

Trungyu stated that Trogarzo received an Approval Letter from the TFDA in June this year, officially approving its Chinese and English names and indications. This latest approval notification from the TFDA signifies the completion of the drug license review process in Taiwan. Once Union Chemical completes the license acquisition and related launch preparations, promotion and sales in the Taiwan market can commence, offering a new treatment option for patients with multidrug-resistant HIV-1 infection in the country.

Trungyu mentioned that Trogarzo has already been approved for marketing by the US FDA, and Trungyu continues to promote new drug applications in other countries and regions to expand its global market presence.

Trungyu pointed out that it signed an exclusive licensing and sales cooperation agreement with Union Chemical for the Taiwan region in May 2024. Trungyu is responsible for drug supply, while Union Chemical handles the drug license application, market promotion, and commercial operations. Union Chemical has a deep understanding of the infectious disease and specialty drug market, possessing hospital channel access and marketing experience, which is expected to accelerate the introduction of Trogarzo into the Taiwan market, allowing eligible patients to access innovative treatment drugs as soon as possible.

Trungyu stated that Trogarzo has established a stable commercialization foundation and continues to contribute to Trungyu's revenue. Trungyu turned profitable in the first quarter of this year, demonstrating the operational results brought about by the Trogarzo commercialization strategy and global market layout.

Trungyu Pharmaceutical CEO Chang Jin-ming stated that receiving the TFDA approval notification for Trogarzo will help accelerate the market launch process in Taiwan. In the future, the company will continue to deepen its global HIV treatment product portfolio and accelerate the international market expansion of Trogarzo. (Editor: Chang Chun-mao) 1150706

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