TAIPEI, Taiwan, December 11, 2025－TaiGen Biopharmaceuticals Holdings Ltd. (“TaiGen”) announced today that it has received official notification from its partner, Joincare Pharmaceutical Group, that its novel influenza antiviral, Pixavir marboxil (TG-1000) oral capsules, has formally received New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA). The drug is indicated for the treatment of uncomplicated influenza A and B in adults and adolescents 12 years of age and older.

Pixavir marboxil was indigenously developed by TaiGen. Following the completion of Phase II clinical trials and preliminary verification of efficacy and safety, TaiGen entered into a licensing agreement with Joincare Pharmaceutical Group for development, manufacturing, and commercialization in mainland China, Hong Kong, and Macau. Joincare has since been responsible for Phase III clinical trials through to future commercial sales. This marketing approval signifies Pixavir marboxil’s formal entry into the vast Chinese influenza pharmaceutical market, providing a new treatment option with an excellent efficacy and safety profile.

A core advantage of Pixavir marboxil is its single-dose regimen. Unlike traditional influenza medications that require a five-day course with twice-daily dosing, this new drug precisely blocks the cap-snatching mechanism required for viral replication, providing sustained antiviral activity after just one dose. This mode of administration greatly improves treatment convenience and medication compliance, offering a more practical therapeutic choice for adolescents and patients groups who find it difficult to adhere to multiple-dose regimens.

Clinical data confirms Pixavir marboxil’s excellent efficacy and safety, with effective inhibition of both influenza A and B viruses. The median time to alleviation of all symptoms was shortened by 27 hours compared to placebo (P<0.0001), and time to fever resolution was accelerated by 24.6 hours (P<0.0001). Subgroup analysis revealed that in harder-to-treat influenza B patients, the median time to symptoms alleviation was significantly shortened by 31 hours (P<0.05). Furthermore, faster viral suppression and higher symptom alleviation rates were observed in adolescent patients. The rate of drug-related resistance mutations was extremely low, positioning the drug to overcome challenges faced by existing medications.

"Ths successful approval of Pixavir marboxil is attributed to the TaiGen team’s R&D capabilities and the highly efficient execution by our partner, Joincare," said Kuo-Lung Huang, Chairman of TaiGen. "The smooth review process demonstrates the regulatory authority’s high affirmation of our R&D results."

To prepare for the launch, Joincare has designated the Chinese brand name “Yi Li Kang” (壹立康) for Pixavir marboxil. The name implies recovery after just one dose, highlighting the convenience of the single-dose regimen and rapid recovery time. Joincare is currently finalizing pre-launch preparations and, upon completion, will officially launch sales to fully capture opportunities in the current flu season.

Regarding future market opportunities, Joincare revealed specific promotion strategies at a recent earnings call. Prior to inclusion in China’s National Reimbursement Drug List (NRDL), initial promotion of Pixavir marboxil will prioritize the out-of-pocket (self-pay) market outside hospitals. Strategically, this involves deepening physician and patient understanding of product characteristics through academic promotion and communication of clinical value. Simultaneously, Joincare aims to capture urgent demand during peak flu season by collaborating with large pharmacy chains and online platforms to expand sales channels. The goal is to rapidly increase product awareness and accessibility, laying a solid foundation for future volume growth.

This market approval implies that Pixavir marboxil, as a “blockbuster new drug,” formally enters this proven high-tier, high-efficiency therapeutic track, competing for a share of the multi-billion RMB influenza antiviral market.