Member Profile

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:
EirGenix, Inc.: antibody manufacturing and co-development.
AimMax Therapeutics: Co-development agreement
China Grand Pharmaceutical Healthcare & Holdings: Greater China licensing
Taipei Medical University: Co-development agreement
Eyenovia, Inc.: Development Collaboration Agreement

Product Pipelines

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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.