Several biotech companies are entering the final countdown for new drug approvals in 2025. PharmaEssentia has already announced in January that its blood cancer drug ET successfully completed Phase III clinical trials and will soon apply for regulatory approvals in multiple countries. Additionally, companies such as TAHO Pharmaceuticals, PANION & BF BIOTECH, and TaiGen Biopharmaceuticals are all preparing to submit new drug applications this year.

Oneness Biotech aims to obtain medical device approval for its diabetic foot ulcer treatment ON101 in April, covering five indications. Meanwhile, Foresee Pharmaceuticals is set to announce the approval of its second U.S. drug by the end of August.

TAHO Pharmaceuticals, which was recently listed on the emerging stock board, is developing TAH3311, an oral dissolvable anti-thrombosis drug, currently in Phase III clinical trials in the U.S.. According to Chairman Howard Lee, clinical data will be released in Q2, and if results are favorable, the company plans to apply for regulatory approval in the U.S. and EU in Q3, targeting a 2026 market launch in Europe and North America.

PANION & BF BIOTECH is advancing its nephrology drug Nephoxil, which is undergoing simultaneous applications for dual indications through its European licensing partner. The company aims to secure approvals for both hyperphosphatemia and iron deficiency anemia by Q3 this year, which could support higher insurance reimbursement pricing in the future.

TaiGen Biopharmaceuticals' antiviral flu drug TG-1000 (Pixavir marboxil) successfully completed Phase III trialslast year, yielding promising data. Through its Chinese partner, Joincare Pharmaceutical Group, a marketing authorization application has already been submitted to the National Medical Products Administration (NMPA) of China, with a potential approval expected later this year.

Resource: 生技股新藥利多 一波波