TaiMed Biologics announced on April 2 that it has received notification from its marketing partner, Wuzhou Drug International Trading, that its HIV drug Trogarzo has been approved for market authorization by the regulatory authorities in Macau. This marks the product’s official entry into the Asian market and positions it as TaiMed’s flagship drug in the region. The approval is also expected to facilitate future regulatory submissions in other Asian markets such as Hong Kong, Vietnam, and Sri Lanka.

TaiMed signed an exclusive marketing and distribution agreement with Wuzhou Drug in April 2024, granting the company exclusive rights to handle Trogarzo's regulatory applications, product promotion, and commercialization in Hong Kong and Macau.

James Chang, CEO of TaiMed Biologics, stated that Trogarzo continues to offer a critical treatment option for patients with multidrug-resistant (MDR) HIV. Through strategic partnerships, TaiMed is actively expanding its global reach to ensure that more patients in need can benefit from this life-saving therapy. Over the past year, the company has worked with new partners to extend Trogarzo’s availability beyond the United States into regions where treatment options have long been limited. The availability of Trogarzo in these markets represents a significant milestone in addressing unmet medical needs.

Chang emphasized that the regulatory approval in Macau is a key milestone for TaiMed, signifying the drug’s official entry into the Asian market and serving as a gateway for further expansion. It is expected to support regulatory filings in additional countries such as Hong Kong, Vietnam, and Sri Lanka, and potentially extend to other parts of Asia and regions with similar medical needs. This development is anticipated to enhance TaiMed’s international visibility and provide a positive boost to its overall operations.

Resource: 中裕愛滋病新藥Trogarzo 獲澳門主管機關核准上市