Taiwan Improved New Drug and 505(b)(2) Companies
As of October 23, 2026, this table includes 505(b)(2) products or planned programs at 5 Taiwan companies, including formerly listed Taiwan Liposome and Genovate. [1] [2] [3] [4] [5] [6] [7]
ONIVYDE and three-month CAMCEVI have U.S. approvals; TLC599 is in Phase 3 development, PMR has a terminated Phase 3 trial and a completed Phase 1 bioequivalence trial, and APP13002 is IND-enabling. [1] [2] [3] [4] [5] [6] [7]
| Company | Ticker | Product / pipeline | Indication | Latest verified stage | Stage source and date | Most recent catalyst |
|---|---|---|---|---|---|---|
| Taiwan Liposome (delisted in 2021) Company source | 4152 | TLC599 (extended-release liposomal dexamethasone sodium phosphate; planned 505(b)(2)) Product source | Pain associated with osteoarthritis of the knee | Phase 3 development; EXCELLENCE (NCT04123561) registered as Completed | 2024-10-08 Stage source COMPLETED | — |
| PharmaEngine Company source | 4162 | ONIVYDE (PEP02; irinotecan liposome; 505(b)(2)) Product source | First-line metastatic pancreatic adenocarcinoma in combination with oxaliplatin, fluorouracil and leucovorin | Initial U.S. approval in October 2015; first-line combination regimen approved in February 2024 | 2024-02-13 Stage source On February 13, 2024 | — |
| Foresee Pharmaceuticals Company source | 6576 | CAMCEVI ETM 21 mg (leuprolide, three-month formulation) | Advanced prostate cancer | U.S. 505(b)(2) approval in August 2025 | 2026-05-19 Stage source 獲美國FDA授予505(b)(2)新藥藥證 | — |
| Genovate Biotechnology (delisted in July 2026) Company source | 4130 | PMR (once-daily extended-release cilostazol; planned 505(b)(2)) Product source | Intermittent claudication | Phase 3 GBL14-001 (NCT06886620): Terminated (ended February 2017); Phase 1 bioequivalence GBL23-001 (NCT06167265): Completed | 2025-03-20 Stage source TERMINATED | — |
| Formosa Pharmaceuticals Company source | 6838 | APP13002 (ophthalmic antibiotic reformulation; planned 505(b)(2) pathway) | Potential development uses: anterior ocular infections and disorders, including conjunctivitis, keratitis, blepharitis and meibomian gland dysfunction | Preclinical; IND-enabling | 2026-10-23 Stage source in IND-enablement stages | — |
Scope and public-document limits
This is a source-verified selection rather than an industry census. Stages retain their individual source dates; undisclosed names, indications and event dates are not filled in.