Taiwan Biosimilar and CDMO Companies
As of October 22, 2026, this table includes biosimilar or biologics CDMO products and services at 10 Taiwan companies. [1] [2] [3] [4] [5] [6] [7] [8] [9] [10]
HERWENDA and NYPOZI have the stated regional authorizations, and the FYB206 U.S. filing is accepted for review; the selected Mycenax, Locus Cell, TFBS and Bora rows identify customer-manufacturing or service roles. [1] [2] [3] [4] [5] [6] [7] [8] [9] [10]
| Company | Ticker | Product / pipeline | Indication | Latest verified stage | Stage source and date | Most recent catalyst |
|---|---|---|---|---|---|---|
| EirGenix Company source | 6589 | EG12014 / HERWENDA (trastuzumab biosimilar) Product source | HER2-positive breast cancer and metastatic gastric cancer | EU marketing authorization granted November 15, 2023 | 2026-08-18 Stage source marketing authorisation valid | — |
| GlycoNex Company source | 4168 | SPD8 (denosumab biosimilar) | Osteoporosis; cancer-related skeletal events | Phase 3 complete in Japan; unblinded June 11, 2026 | 2026-10-22 Stage source Phase 3 complete in Japan | The company pipeline records Japanese Phase 3 unblinding on June 11, 2026, with the primary endpoint met. 2026-06-11 Source unblinded on June 11, 2026 |
| Formosa Pharmaceuticals Company source | 6838 | TSY-110 / EG12043 (biosimilar ADC) | HER2-positive metastatic and early-stage breast cancer | European CTA submitted | 2026-08-28 Stage source Clinical Trial Application (CTA) | — |
| Mycenax Company source | 4726 | SCD Eylea biosimilar (CDMO customer project; code undisclosed) | Not disclosed in this announcement | Commercial production stage per company; Mycenax is manufacturing partner | 2025-06-30 Stage source commercial production stage | — |
| Tanvex BioPharma Company source | 6541 | NYPOZI (filgrastim-txid; U.S. subsidiary product) | Chemotherapy-induced neutropenia in cancer patients | FDA approved in the United States | 2024-08-19 Stage source (FDA) approved NYPOZI | — |
| Medigen Vaccine Biologics Company source | 6547 | Palivizumab / anti-RSV biosimilar | Prevention of RSV infection | Pilot controlled human infection model study ongoing; numbered phase unspecified | 2026-10-22 Stage source 先導人體感染控制模型試驗 | — |
| TFBS Bioscience Company source | 6939 | AAV gene therapy CDMO services for OGTP | Gene therapy development support; specific customer-product indication undisclosed | CDMO collaboration agreement with ONODERA GT Pharma signed | 2026-10-14 Stage source 與日本ONODERA GT Pharma（OGTP）簽署合作協議 | — |
| Locus Cell Company source | 6891 | Elate Ocular (Cambium Bio customer project) | Moderate-to-severe dry eye / immune-related ocular surface disease | Manufacturing for customer’s international Phase 3 trial | 2026-08-25 Stage source 樂迦承接 Cambium 三期臨床試驗的製造需求 | — |
| Lotus Pharmaceutical Company source | 1795 | FYB206 (pembrolizumab biosimilar; commercialization partner in parts of APAC) | Oncology; filing indications not individually listed in this release | U.S. BLA accepted for review; Lotus rights are in parts of APAC, not the U.S. | 2026-10-13 Stage source accepted for review | — |
| Bora Pharmaceuticals Company source | 6472 | Bora Pharmaceuticals biologics CDMO services | Service offering; individual customer indications undisclosed | Services include biologics and sterile injectables, from formulation through clinical and commercial manufacturing and packaging | 2026-10-22 Stage source 生物製劑與無菌注射劑 | — |
Scope and public-document limits
Coverage is not exhaustive. Undisclosed customer-project codes and indications remain unfilled; commercial production does not establish approval in other jurisdictions.