Defying the ongoing AI investment frenzy, Taiwan’s biotech sector saw a wave of regulatory milestones in the third quarter, with more than seven companies announcing positive progress across eight drug programs. Among them, PharmaEssentia’s Ropeginterferon alfa-2b (Ropeg) gained approval for an additional indication—essential thrombocythemia (ET)—potentially making Taiwan the first country in the world to approve this new use. Meanwhile, Foresee Pharmaceuticals’ three-month formulation of CAMCEVI for prostate cancer has received U.S. FDA approval for commercialization, paving the way for significant business growth.

Gongwin-KY’s new drug for canine malignant melanoma is expected to receive approval from Taiwan’s FDA in the second half of the year, marking its first entry into the emerging pet oncology market. In addition, its lung cancer drug Proximan, already launched in China, has successfully passed both national medical insurance and commercial insurance reviews under the “dual catalog” framework. If the upcoming expert evaluations, pricing negotiations, and listing processes proceed smoothly, the product could soon be included in China’s national reimbursement system—an achievement that would dramatically accelerate sales growth and revenue expansion.

Preliminary data show that HCmed Innovations, Gongwin-KY, Foresee Pharmaceuticals, Panion & BF Biotech Inc., TSH Biopharm, Orient Pharma, and PharmaEssentia have all recently secured or filed new drug applications this quarter. Analysts noted that the concentration of these approvals spans diverse therapeutic areas including oncology, nephrology, prostate cancer, and smoking cessation—collectively setting the stage for stronger revenue performance and deeper international market expansion.

Among the regulatory highlights, HCmed Innovations’ respiratory-triggered nebulizer AdheResp has received U.S. FDA 510(k) clearance, becoming the first FDA-approved device of its kind worldwide. It is currently the only production-ready advanced nebulization system capable of supporting pharmaceutical partners in clinical trials and is poised to compete in the growing mRNA and antibody drug delivery markets.

Panion & BF Biotech is advancing its new indication for iron-deficiency anemia in adult patients with chronic kidney disease. The company has submitted its PBF-1681 Tablet new drug application to Taiwan’s TFDA, following the global success of its kidney disease drug Nephoxil.

Orient Pharma has leveraged its proprietary multi-layer release technology platform to develop a generic version of tofacitinib using the OROS osmotic-controlled release system. The drug, indicated for rheumatoid arthritis, is a direct challenge to Pfizer’s original patent, which is valid until 2034. After a successful patent challenge, Orient Pharma may be able to launch its product in the U.S. as early as June 2026.

Meanwhile, Chuang Yi Biotech, a subsidiary of TSH Biopharm, obtained TFDA approval for VA23, a generic version of varenicline, making it Taiwan’s first approved smoking cessation generic. The drug will help fill supply gaps left by the original manufacturer and further promote smoking cessation treatments domestically.

Resource: 利多助威 7大生技強將報捷