Member Profile
Formosa Pharmaceuticals, INC.
Formosa Pharmaceuticals (6838:TWO), founded in 2010 and based in Taipei, Taiwan, is a clinical stage biotechnology company with assets in ophthalmology, oncology, and anti-infectives. APP13007, our lead program for the treatment of inflammation and pain after ocular surgery, has been submitted to the US FDA and accepted for formal review, with anticipation to gain approval in 1H 2024. Formosa’s proprietary APNTTM nanoparticle formulation platform, from which APP13007 was developed, is available for licensing, CDMO services, or co-development. In the oncology space, we are developing TSY-0110, a biosimilar of Kadcyla®. TSY-0110 is an antibody-drug conjugate for the treatment of HER2+ metastatic or early breast cancer. We expect TSY-0110 will submit CTA application and start Phase 1 trials in EU in 2024.
Formosa Pharmaceuticals is backed by major shareholder, Formosa Laboratories (4746:TWSE), a GMP-certified producer and contract development and manufacturing provider of Active Pharmaceutical Ingredients.
Partnerships and co-development by program:
TSY-0110:
EirGenix, Inc.: antibody manufacturing and co-development.
APP13007:
AimMax Therapeutics: Co-development agreement
China Grand Pharmaceutical Healthcare & Holdings: Greater China licensing
MPT0E028:
Taipei Medical University: Co-development agreement
APNT:
Eyenovia, Inc.: Development Collaboration Agreement
Product Pipelines
Company Milestones
| 2010 | Formosa Pharmaceuticals founded |
| 2011 | Collaboration project MPT0E028 with Taipei Medical University in 2011 and initiated Phase I Trial (Taiwan) in 2015.床 |
| 2017 | Acquired Activus APNT formulation platform ADC projects partnered with EirGenix |
| 2019 | APP13007 IND is submitted to US FDA and Phase II studies are initiated in 2019 and completed in 2020. |
| 2021 | APP13007 initiates Phase III (US) Grand Pharmaceutical (China) enters license agreement with Formosa Pharmaceuticals for APP13007 |
| 2021 | Listing on emerging stock board (6838:TWO) |
| 2022 | March - Formosa Pharma Enters into Co-Development Agreement with EirGenix for TSY-0110. |
| 2022 | The enrollment of two Phase 3 Trials, CPN-301 and CPN-302, for APP13007 completed; Successful Top-Line Results reported for both trials. |
| 2023 | Executed Development Collaboration Agreement with Eyenovia. |
| 2023 | Submitted APP13007 NDA application and received the acceptance from the US FDA for formal review. |