Formosa Pharmaceuticals
Formosa Pharmaceuticals is a Taiwan-based clinical-stage biopharmaceutical company (TWSE: 6838) that develops ophthalmology and oncology drugs using its proprietary APNT® nanoparticle platform, commercializing its FDA-approved lead product APP13007 through a global out-licensing model covering 60+ countries.
- Company typePublic
- Founded2011
- HeadquartersTaipei, Taiwan
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Formosa Pharmaceuticals does
Formosa Pharmaceuticals (TWSE: 6838) is a clinical-stage biopharmaceutical company headquartered in Taipei, Taiwan, founded in 2010/2011 with approximately 19 employees as of end-2024. The company applies a dual-platform "Double A" strategy spanning ophthalmology and oncology. Its proprietary APNT® (Active Pharmaceutical Nanoparticle Technology) platform — acquired from Activus Pharma (Japan) in 2019 — reduces water-insoluble APIs to sub-200nm particle sizes using GRAS-listed grinding media, enabling homogeneous nanosuspensions for topical ocular, oral, and inhalation administration without organic solvents or刺激性 additives. The lead asset APP13007 (clobetasol propionate ophthalmic suspension 0.05%) received FDA approval in March 2024 as the first new ophthalmic steroid approved by the FDA in over 15 years, followed by Health Canada approval in March 2026 and commercial launch in the US in September 2024.
The oncology pipeline includes TSY-110 (a Kadcyla biosimilar co-developed with EirGenix for HER2-positive breast cancer) and TSY-310 (a first-in-class bispecific ADC targeting EGFR/ROR1, in-licensed from Almac Discovery in May 2025 and presented at ASCO 2026). Additional APNT-platform candidates include APP13002 (antibiotic 505(b)(2) formulation) and earlier-stage TSY-120, TSY-210, and MPT0E028 programs.
Formosa operates a capital-efficient, asset-light out-licensing business model, signing exclusive territorial licensing agreements with regional pharmaceutical majors (Harrow for the US, China Grand Pharma for Greater China, Samil for Korea/Vietnam, Arrotex for Australia/NZ, Cipla for 11 emerging markets, Adalvo for 39 European countries plus Brazil, among others) covering 60+ countries. The company receives upfront payments, regulatory and sales milestones, and royalties on net sales while retaining contract manufacturing responsibilities through Pharmasutics (Taoyuan, Taiwan). The company listed on the TWSE in August 2024 and has received multiple Taiwan biotech innovation awards (Taipei Biotech Awards, Taiwan BIO Awards) in 2022-2024.
Formosa Pharmaceuticals firmographics
Firmographics- Name
- Formosa Pharmaceuticals
- Legal name
- Formosa Pharmaceuticals, Inc.
- Website
- https://formosapharma.com
- Company type
- Public
- Founded year
- 2011
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Formosa Pharmaceuticals is a Taiwan-based clinical-stage biopharmaceutical company (TWSE: 6838) that develops ophthalmology and oncology drugs using its proprietary APNT® nanoparticle platform, commercializing its FDA-approved lead product APP13007 through a global out-licensing model covering 60+ countries.
- Ownership category
- akta.pro rank
Formosa Pharmaceuticals industry classification
Industry- Product category
- Ophthalmic Pharmaceuticals
- NAICS
- Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254), Biological Product (except Diagnostic) Manufacturing (325414)
- SIC
- Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836), Ophthalmic Goods (3851)
- akta.pro primary industry
- Ophthalmology Pharmaceuticals (HLAIAAAL)
- akta.pro secondary industries
- Ophthalmology Specialty Pharmaceuticals (HLAIACAK), Antibody-Drug Conjugates (ADCs) & Antibody Conjugates (HLAAAAAE)
Keywords
Where Formosa Pharmaceuticals is headquartered
LocationHeadquarters
- HQ city
- Taipei
- HQ country
- Taiwan
- HQ region
- Asia
Offices3 records
Markets served
Formosa Pharmaceuticals business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales
Revenue model
- Licensing Revenue (Upfront, Milestones, Royalties): Formosa receives upfront payments, regulatory milestones, sales milestones, and ongoing royalties based on net sales of licensed products (primarily APP13007) across global territories. Licensing agreements signed with partners in US (Harrow), China (China Grand Pharma), South Korea (Samil), Australia/New Zealand (Arrotex), EU/Brazil (Adalvo), Canada/Mexico (Apotex), and others.
- Contract Manufacturing Supply: Formosa manufactures and supplies finished APP13007 product to licensing partners (e.g., Eyenovia/Harrow in US). Taiwan FDA (TFDA) granted export permit for US shipments. Manufacturing carried out by contract partners including Baudax Bio (formerly SpecGx) for API supply and Pharmasutics (Taoyuan facility) for fill-finish.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Licensing deal terms include upfront payment, regulatory milestones, sales milestones, and royalties on net sales. |
Go-to-market motion2 records
Distribution channels14 records
Marketing channels6 records
Formosa Pharmaceuticals product offering
Product offeringCore offering
Formosa Pharmaceuticals is a clinical-to-commercial stage biopharmaceutical company that develops, manufactures, and out-licenses ophthalmology and oncology therapeutics built on two proprietary platforms: the APNT® nanoparticle formulation technology and a bispecific antibody-drug conjugate (ADC) platform. Its lead commercial product is APP13007 (clobetasol propionate ophthalmic suspension 0.05%), an FDA-approved corticosteroid nanosuspension for post-operative ocular inflammation and pain following cataract surgery. Pipeline assets include APP13002 (antibiotic ocular formulation), TSY-110 (Kadcyla biosimilar), TSY-120, TSY-310 (EGFR/ROR1 bispecific ADC), and TSY-210 (anti-infective program).
Product overview
Formosa Pharmaceuticals is a clinical-stage biopharmaceutical company with a dual focus strategy ("Double A" strategy) encompassing ADC (antibody-drug conjugate) and APNT (nanoparticle) platforms. The product portfolio includes: APP13007, an FDA-approved ophthalmic corticosteroid for post-surgical inflammation and pain; APP13002, an antibiotic formulation for infectious eye diseases; TSY-110, a Kadcyla biosimilar for HER2-positive breast cancer; and TSY-310, a first-in-class bispecific ADC targeting EGFR/ROR1 for solid tumors. All ophthalmic products are powered by the proprietary APNT nanoparticle technology platform, which enables enhanced drug delivery through improved dissolution and bioavailability.
Differentiator
Problem solved
Functional benefit
Brands
- APNT®: Active Pharmaceutical (ingredient) Nanoparticle Technology - proprietary nanoparticle formulation platform for enhancing dissolution and bioavailability of APIs
- APP13007
- TSY-110
- TSY-310
Products and services
- APP13007 (Clobetasol Propionate Ophthalmic Suspension 0.05%) FDA-approved topical corticosteroid nanosuspension derived from the proprietary APNT® nanoparticle formulation platform, delivered as a twice-daily dosing regimen for 14 days, indicated for the treatment of inflammation and pain following ocular surgery, particularly cataract surgery. Approved by FDA (March 2024) and Health Canada (March 2026). Phase 3 trials showed 80% of patients pain-free by day 4 and 60% achieving complete anterior chamber cell clearance (ACC=0) sustained from POD8 to POD15, with less than 2% adverse event rate.
- APP13002 Antibiotic 505(b)(2) formulation developed using the APNT® nanoparticle technology platform for infectious eye diseases, designed to enhance drug delivery for ocular infections.
- TSY-110 (ado-trastuzumab emtansine biosimilar) HER2-positive antibody-drug conjugate (ADC) biosimilar referencing Kadcyla® for treatment of metastatic HER2-positive breast cancer, developed using advanced antibody and bioconjugation technology through Taiwanese CDMO partners.
- TSY-310 (ALM-401) First-in-class bispecific antibody-drug conjugate targeting both EGFR and ROR1 for the treatment of solid tumors, including non-small cell lung cancer (NSCLC). Features enhanced internalization and bystander cytotoxicity to address limitations of traditional single-target therapies.
- TSY-120 ADC pipeline asset within Formosa Pharmaceuticals' antibody-drug conjugate pipeline.
- TSY-210 (抗感染研發專案 | Anti-Infective R&D Project) Anti-infective research and development program within Formosa Pharmaceuticals' pipeline, focused on infectious disease therapeutics.
Quantifiable outcome
- 80% of patients achieved complete pain relief within 4 days post-surgery (vs 50% with placebo); 60% achieved complete anterior chamber cell clearance (ACC=0) from POD8 sustained to POD15 (vs 4% placebo)
- +3 more outcomes
Companies that use Formosa Pharmaceuticals
Customer profileNamed customers2 records
Segments3 records
Ideal customer profiles3 records
Formosa Pharmaceuticals technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Formosa Pharmaceuticals partnerships and signals
Strategic signalPartnerships
21 partnerships are on record, tiered core.
- Samil Pharmaceutical Co., Ltd.coreExclusive licensing agreement for commercialization of APP13007 in Vietnam. Building on January 2026 South Korea license. Deal includes upfront payment, regulatory milestones, and royalties. Vietnam has 300,000 cataract surgeries annually with 5% growth; ophthalmic corticosteroid market valued at $4.26 million USD in 2024. Samil pursuing regulatory approval and launch preparations in both markets.
- Singapore Eye Research Institute (SERI)coreStrategic research collaboration announced April 30, 2026, to develop next-generation ophthalmic formulations for corneal and ocular surface diseases using Formosa's APNT® nanoparticle technology. Combines SERI's clinical research expertise (led by Associate Professor Yu-Chi Liu) with Formosa's drug delivery platform to enhance efficacy, bioavailability, and safety of topical ocular therapies.
- Arrotex Pharmaceuticals Pty Ltd.coreExclusive licensing agreement for commercialization of APP13007 in Australia and New Zealand. Deal includes upfront payments, regulatory milestones, sales milestones, and royalty considerations. Territory represents approximately 250,000 cataract surgeries annually. Arrotex fulfills 50% of Australia's total pharmaceutical volume and will leverage its national ophthalmology infrastructure.
- Samil Pharmaceutical Co., Ltd.coreExclusive licensing agreement for commercialization of APP13007 (clobetasol propionate ophthalmic suspension) in South Korea. Samil is a Korean pharmaceutical manufacturer (000520.KS) founded in 1947, specializing in ophthalmology, gastroenterology, and CNS. ~800,000 cataract surgeries annually in South Korea. Agreement includes upfront payment, sales milestones, and royalties. APP13007 is the first ophthalmic steroid to enter the Korean market since 2008.
- Rxilient Medical Pte. Ltd.coreExclusive licensing for major ASEAN markets: Singapore, Thailand, Indonesia, Philippines. Rxilient is a Singapore-based pharma company focused on emerging markets in Southeast Asia, Hong Kong, Macau, Taiwan, and MENA, with focus on ophthalmology, oncology, immunology, and internal medicine.
- Harrow, Inc.coreExclusive licensing agreement for US market commercialization of APP13007 (marketed as BYQLOVI™). Previously partnered with Eyenovia; rights transferred to Harrow in 2025. Harrow (NASDAQ: HROW) is a leading US ophthalmic pharmaceutical company. ~700,000 ophthalmic surgeries annually drive a ~USD 1.3 billion market.
- Adalvo LimitedcoreLicensing for 39 European countries plus Brazil. Adalvo is a leading European B2B pharmaceutical company with partnerships in 130+ countries. European markets include UK, France, Germany, Spain, Italy, and other EU member states.
- Almac DiscoverycoreIn-licensing of ALM-401 (renamed TSY-310), a first-in-class bispecific ADC targeting EGFR/ROR1 for treatment of solid tumors including NSCLC. This adds a novel bispecific ADC to Formosa's oncology pipeline alongside TSY-110 (Kadcyla biosimilar).
- Saval CorporationcoreExclusive licensing for Chile and 8 emerging Latin American markets: Bolivia, Costa Rica, Guatemala, El Salvador, Honduras, Paraguay, Peru, Panama. Saval (headquartered in Santiago, Chile) operates across 14 Latin American countries with 85+ years of history.
- Cipla LimitedcoreMulti-regional licensing for 11 emerging markets: India, Nepal, Sri Lanka, Bangladesh, Malaysia, Myanmar, Kenya, Nigeria, South Africa, Argentina, Colombia. Cipla is India's 3rd largest pharma company, #1 in South Africa prescription market, and #4 in US generics market.
- Medvisis Switzerland AGcoreExclusive licensing for Swiss market. Medvisis specializes in innovative medicines, rare disease treatments, and hospital pharmaceuticals, focusing on product registration and market access.
- DÁVI FarmacêuticacoreExclusive licensing for Portuguese market. DÁVI is a century-old company and major player in ophthalmology and ENT in Portugal. Partner of Pfizer for over 10 years (Xalacom, Xalatan). ~90,000 cataract surgeries annually in Portugal.
- Baudax Bio / SpecGx (Mallinckrodt)coreAPI (active pharmaceutical ingredient) supply for APP13007. Baudax Bio (formerly SpecGx, a subsidiary of Mallinckrodt) supplies clobetasol propionate API for the FDA-approved ophthalmic suspension.
- Apotex Inc.coreExclusive licensing for Canadian market. Apotex is Canada's largest pharmaceutical company. Expanded to include Mexico in 2025.
- Pharmasutics (Taoyuan) / Baudax GroupcoreContract fill-finish manufacturing for APP13007. Pharmasutics (景德製藥) in Taoyuan, part of Baudax Group, handles filling and packaging of the ophthalmic suspension for US export. TFDA export permit obtained September 2024; first shipment to US completed September 2024.
- AimMax Therapeutics, Inc.coreUS-based co-development partner for APP13007 clinical development. Joint NDA submission to FDA (May 2023), which was accepted July 2023 with PDUFA date of March 4, 2024. AimMax contributed to clinical trial design, regulatory strategy, and FDA interactions. FDA approval obtained March 2024. AimMax is based in Research Triangle Park, North Carolina.
- Tabuk Pharmaceuticals Manufacturing CompanycoreExclusive licensing for Middle East and North Africa (17 countries). Tabuk is a leading Saudi Arabian pharmaceutical company with manufacturing facilities in Saudi Arabia, Sudan, and Algeria, and 2,400+ employees.
- Cristália Produtos Químicos Farmacêuticos Ltda.coreExclusive licensing for Brazilian market. Cristália is a Brazilian pharmaceutical company.
- Eyenovia, Inc.coreDevelopment collaboration combining Formosa's APNT® nanoparticle formulation platform with Eyenovia's Optejet® microdose drug delivery technology (MAP™ - Microdose Array Print). Co-development of acute dry eye disease treatment using clobetasol ophthalmic suspension with Optejet device. Started August 2024 in the US.
- EirGenix Inc.coreCo-development alliance to develop TSY-0110 (EG12043 ado-trastuzumab emtansine biosimilar, Kadcyla®) for HER2-positive breast cancer. Taiwan's two major biopharma CDMOs provided antibody and bioconjugation technology.
- China Grand Pharmaceutical and Healthcare Holdings LimitedcoreExclusive licensing agreement for APP13007 in Mainland China, Hong Kong, and Macau. China Grand Pharma (HKEX: 00512) is one of China's largest ophthalmology companies with ~30 ophthalmic products covering prescription drugs, OTC, devices, and consumer health. NDA Phase 3 trial initiated in China Q4 2024.
Scale indicators10 records
Recent moves6 records
Expansion highlights6 records
Formosa Pharmaceuticals competitors and assessment
Company assessmentDirect peers
- Aldeyra Therapeutics: Aldeyra Therapeutics is a clinical-stage biotech developing novel treatments for ocular inflammatory diseases (dry eye, allergic conjunctivitis). Comparable as a small-cap ophthalmic-focused biotech with innovative therapeutics targeting post-operative and chronic ocular inflammation.
- Tarsus Pharmaceuticals: Tarsus Pharmaceuticals is a US biopharmaceutical company developing and commercializing novel therapeutics for eye diseases, including post-surgical and ocular surface conditions. Comparable as a small-cap specialty ophthalmic pharma with a recently commercialized product in similar therapeutic indications.
- Ocular Therapeutix: Ocular Therapeutix is a US-based biopharmaceutical company developing therapies for eye diseases using a proprietary hydrogel technology platform. Comparable as a small ophthalmic pharma commercializing innovative drug delivery-based products in the same therapeutic categories.
- Ocugen: Ocugen is a US-based biopharmaceutical company developing gene therapies and novel biologics for ophthalmic diseases. Comparable as a small-cap ophthalmic-focused biotech with a multi-platform strategy and global licensing ambitions.
- Kala Bio: Kala Bio is a clinical-stage biopharmaceutical company developing novel therapies for eye diseases using a proprietary mucus-penetrating particle technology platform. Comparable as a small ophthalmic biotech leveraging a differentiated drug delivery technology platform.
- Eyenovia: Eyenovia is a US ophthalmic therapeutics company that was Formosa's original US development partner for APP13007 (using its Optejet® microdose delivery platform). Comparable as a small-cap ophthalmic specialty pharma with innovative delivery approaches targeting the same prescriber base.
- Harrow Health: Harrow Health (NASDAQ: HROW) is a US specialty ophthalmic pharmaceutical company that is both Formosa's US commercial partner for APP13007 (BYQLOVI™) and a comparable specialty ophthalmic pharma focused on commercializing innovative therapies in the same end market.
- Nicox SA: Nicox is a European specialty ophthalmic pharmaceutical company developing therapeutics for ocular conditions including glaucoma and dry eye. Comparable as a small-to-mid cap specialty ophthalmic pharma with similar licensing-driven business model and end-market focus.
Emerging players
- Aurinia Pharmaceuticals: Aurinia Pharmaceuticals is a small-cap biopharma that has commercialized a specialty therapeutic (voclosporin) through global licensing deals with partners like Otsuka. Comparable business model of out-licensing a single approved asset to global commercial partners for milestone/royalty economics.
Regional players
- Samil Pharmaceutical: Samil Pharmaceutical (000520.KS) is a Korean pharmaceutical manufacturer that became Formosa's exclusive licensee for APP13007 in Korea and Vietnam. Comparable as a regional specialty pharma with ophthalmology focus, though primarily a partner rather than direct competitor.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
Formosa Pharmaceuticals social profiles
Digital presenceFormosa Pharmaceuticals financial estimates
Financial estimateRevenue estimate
Valuation estimate
Formosa Pharmaceuticals leadership team
Management profileNumber of profiles
Profiles10 records
Formosa Pharmaceuticals funding detail
Funding detailFunding overview
Funding rounds1 record
Investors11 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Formosa Pharmaceuticals M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Formosa Pharmaceuticals
What does Formosa Pharmaceuticals do?
Formosa Pharmaceuticals is a clinical-to-commercial stage biopharmaceutical company that develops, manufactures, and out-licenses ophthalmology and oncology therapeutics built on two proprietary platforms: the APNT® nanoparticle formulation technology and a bispecific antibody-drug conjugate (ADC) platform. Its lead commercial product is APP13007 (clobetasol propionate ophthalmic suspension 0.05%), an FDA-approved corticosteroid nanosuspension for post-operative ocular inflammation and pain following cataract surgery. Pipeline assets include APP13002 (antibiotic ocular formulation), TSY-110 (Kadcyla biosimilar), TSY-120, TSY-310 (EGFR/ROR1 bispecific ADC), and TSY-210 (anti-infective program).
Is Formosa Pharmaceuticals a public or private company?
Formosa Pharmaceuticals is a public company. It is classified as public and is currently operating.
When was Formosa Pharmaceuticals founded?
Formosa Pharmaceuticals was founded in 2011. It employs 11 to 50 people.
Where is Formosa Pharmaceuticals based?
Formosa Pharmaceuticals is headquartered in Taipei, Taiwan, in the Asia region.
How does Formosa Pharmaceuticals make money?
Two revenue lines are on record. Licensing Revenue (Upfront, Milestones, Royalties) is the primary driver. The others are contract Manufacturing Supply.
Who are Formosa Pharmaceuticals's main competitors?
Direct peers on record are Aldeyra Therapeutics, Tarsus Pharmaceuticals, Ocular Therapeutix, Ocugen, Kala Bio, Eyenovia, Harrow Health and Nicox SA. Aurinia Pharmaceuticals is listed as an emerging player. Samil Pharmaceutical is listed as a regional player.
Does Formosa Pharmaceuticals have an API?
No public API is recorded for Formosa Pharmaceuticals.
What industry is Formosa Pharmaceuticals in?
Formosa Pharmaceuticals's product category is Ophthalmic Pharmaceuticals. Its primary akta.pro industry code is HLAIAAAL, Ophthalmology Pharmaceuticals, with a secondary code of HLAIACAK, Ophthalmology Specialty Pharmaceuticals. Its NAICS code is 325412 and its SIC code is 2834.