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PEC Investor Presentation 2026

May 14, 2026

52565_rns_2026-05-14_585fa037-b4ec-44dc-87a7-f08c631b254d.pdf

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PharmaEssentia

TWSE 6446

PharmaEssentia


Forward-looking Statements

This presentation contains forward-looking statements, including statements regarding the plans and expectations for commercializing BESREMi® in the United States and globally, and the potential benefits or competitive position of BESREMi®. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and similar legislation and regulations under Taiwanese law. These forward-looking statements are based on management expectations and assumptions as of the date of this presentation, and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include PharmaEssentia's ability to launch BESREMi® in the United States and globally, whether BESREMi® is successfully commercialized and adopted by physicians and patients, the extent to which reimbursement is available for BESREMi®, and the ability to receive FDA and other regulatory approvals for additional indications for BESREMi®. Any forward-looking statements set forth in this presentation speak only as of the date of this presentation. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

PharmaEssentia


Q1'26 Financial Results

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PharmaEssentia


Q1 revenue reached a record high of NT$5.12 billion

Marking the 14th consecutive quarter of record-high performance with 57% YoY growth

Unit: NTD 100 million

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PharmaEssentia


Q1 revenue grew 57% YoY with significant expense ratio improvement

Unit: NTD 100 million

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Operating Revenue

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Operating Expense

5

PharmaEssentia


Q1 net operating income increased by nearly NT$1B YoY

Net income rose 70% YoY

Unit : NTD 100 million

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Net Operating Income

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Net Income

6

PharmaEssentia


Q1 operating margin reached 40%, comparable to leading Big Pharma, expanding 6.8pp YoY

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PharmaEssentia


Q1 2026 EPS reached NT$5.79, up 69% YoY

Unit: NTD

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Note: Due to the impact of stock dividends, EPS prior to Q2 2025 (inclusive) has been retrospectively adjusted.

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PharmaEssentia


Company Overview

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PharmaEssentia


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A fully integrated innovative biopharmaceutical company

Our Commercial Product and R&D Pipelines

ROPEG (Ropeginterferon alfa-2b)

  • Approved for adults with polycythemia vera (PV)
  • "Treatment is First FDA-Approved Option Patients Can Take Regardless of Previous Therapies"
  • Early intervention – freedom of phlebotomy
  • Japan: Higher-Initial-Dose Accelerated Titration (HIDAT) approved

Growth Drivers

  • Geographic expansion for PV market
  • Anticipated label expansion globally in Essential Thrombocythemia (ET) in 2026
  • Ph3 Early Pre-Myelofibrosis (PMF) study with approvals in 2028
  • ~Ten IITs are ongoing for additional new indications beyond MPN

Promising Pipeline

  • Maximizing novel PEG-cytokines platform
  • Developing multiple candidates
  • ADCs
  • Bi-specific
  • Cell-therapy

PharmaEssentia 6446.TW

ROUGE (Ropeginterferon alfa-2b)

  • FUJUNDED 2003
  • HEADQUARTER AND R&D Taipei, Taiwan
  • EMPLOYEES Will reach 1,000 by 2026

ROUGE (Ropeginterferon alfa-2b)

  • COMMERCIAL OPERATIONS Boston (USA), Tokyo, Seoul, Beijing, HK, SG, Toronto (CA)

ROUGE (Ropeginterferon alfa-2b)

  • COMMERCIAL PARTNERSHIP Pint (Latin America)

2026 Q1
Global Revenue
NT$ 5.1B
57% y/y growth

Fully-integrated manufacturing capabilities

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PharmaEssentia


The global MPN treatment market exceeds USD 20 billion, with ROPEG poised to lead the next wave of innovation

Myeloproliferative Neoplasm (MPN)

Global MPN Market size (2025)
$15.33Bn

CAGR
(2025-2035)
3.32%

Global MPN Market size (2035)
$21.25Bn
Unit: USD Billion

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Source: 1. Myeloproliferative Neoplasms Treatment Market Forecast, 2032; 2. Aetiology of Myeloproliferative Neoplasms – PMC; 3. Polycythemia Vera Market Size, Analysis and Forecast; 4. Myeloproliferative Disorders Treatment Market Report 2035 - Size, Share, Trends; 5. Market Research Future analysis; 6. analyst assumptions: Delvelnought, GlobalData, Coherent

PharmaEssentia


A significant opportunity just from US Patients with PV

Geographically Expanding ROPEG's Reach to Benefit More Patients with PV Worldwide

Fast Growth !!

163K

Polycythemia Vera (PV)

  • 2019 EMA approval
  • 2021 US approval
  • 2023 Japan approval
  • 2024 China, Singapore, and Malaysia approval
  • 2025 Brazil, Argentina, Hong Kong approval

PV

325K

US market prevalence

PMF

148K

Essential Thrombocytemia (ET)

  • SURPASS – data readout Jan 6, 2025
  • NCCN Guideline listed (Version 1.2026)
  • 2025 China, Taiwan, Japan submission
  • 2025.10.30 BLA submission to US FDA
  • 2026.08.30 PDUFA Date from US FDA
  • 2026.02.27 Korea submission
  • 2026.05.12 Taiwan Approval

14K

Pre-fibrotic/Early Primary Myelofibrosis (PMF)

  • Phase 3 trial initiated; enrollment expected to complete by H1 2026

Patient numbers are U.S. prevalence from PharmaEssentia market research

*Source: PharmaEssentia Internal Analyses

PharmaEssentia


ROPEG approved in nearly 50 Countries for PV, with global patient access steadily expanding

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Approved

In Preparation

PharmaEssentia


Ropeg HIDAT regimen approved in Japan, demonstrating enhanced efficacy at Week 24

250 μg at W0 → 350 μg at W2 → 500 μg at W4

HIDAT*

研究名稱 China – Study A20-202 Japan – Study A23-301 Europe – PROUD-PV
研究名稱 A Phase II Study of Ropeginterferon Alfa-2b in Chinese Patients With Polycythemia Vera A Phase III b, Single-arm, Multicenter, Optimal Dose Finding Study to Assess the Efficacy and Safety of PI101 in Japanese Patients With Polycythemia Vera (PV). Ropeginterferon alfa-2b versus standard therapy for polycythaemia vera: a randomised, non-inferiority, phase 3 trial
劑量設計 250 μg at Week 0 → 350 μg at Week 2 → 500 μg at Week 4, then maintained biweekly 250 μg at Week 0 → 350 μg at Week 2 → 500 μg at Week 4, then maintained monthly 100 μg subcutaneously every two weeks, increased by 50 μg increments every two weeks up to 500 μg every two weeks
完全血液學反應率(CHR) 61.2% at Week 24 57.1% at Week 24 31.2% at Week 24
安全性資料 Most adverse events were mild to moderate, with no new safety signals identified Most adverse events were mild to moderate, with no new safety signals identified Well tolerated. Most adverse events (AEs) were mild to moderate in severity and manageable
文獻出處 Exp Hematol Oncol. 2023 Jun 21;12(1):55. Internal clinical study report Internal clinical study report

*HIDAT劑量快速爬升方案 :Higher-Initial-Dose Accelerated Titration

PharmaEssentia


ROPEG recommended by NCCN Guidelines as the only first-line therapy for both low-risk and high-risk PV

Key updates on PV treatment in the NCCN Guidelines

Treatment For Low-Risk PV
age 60 years or younger with no history of thrombosis
• Manage cardiovascular risk factors • Monitor for new thrombosis or bleeding
• Evaluate for indications for cytoreductive therapy and monitor signs/symptoms of disease progression as clinically indicated Symptomatic with potential indications for cytoreductive therapy
(New thrombosis, Frequent phlebotomy, Splenomegaly, etc.)
• Aspirin • Asymptomatic with no indications for cytoreductive therapy Preferred regimens:
• Clinical trial or
Ropeginterferon alfa-2b-njft
Other recommended regimens
• HU or
• Peginterferon alfa-2a
• Phlebotomy Continue aspirin with phlebotomy
Treatment For High-Risk PV
Age > 60 years or thrombosis history present
• Manage cardiovascular risk factors • Monitor for new thrombosis or bleeding Inadequate response or
Loss of response
• Aspirin • Monitor response and signs/symptoms of disease progression as clinically indicated Preferred regimens:
Hydroxyurea
Ropeginterferon alfa-2b-njft
(Only preferred interferon)
• Phlebotomy Other recommended regimens:
Peginterferon alfa-2a
Regimens for cytoreductive therapy
Preferred regimens :
• HU or
Ropeginterferon alfa-2b-njft
Other recommended regimen :
• Peginterferon alfa-2a
NCCN Guideline 2025 Version 2
--- ---
Low - risk Preferred regimens:
Ropeginterferon alfa-2b-njft
(Only preferred treatment)
High - risk Preferred regimens:
Hydroxyurea
Ropeginterferon alfa-2b-njft
(Only preferred interferon)
Other recommended regimens:
Peginterferon alfa-2a

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PharmaEssentia


Early Intervention: ROPEG + Phlebotomy for Low-Risk PV showed superior reduction of phlebotomy and hematocrit control - 2023 publication

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Takeda and Protagonist

January 5th, 2026

Announce Submission of New Drug Application (NDA) for Rusfertide for Treatment of Polycythemia Vera (PV)

Data Underscore the Potential to Shift the Treatment Paradigm for PV Patients to Reduce the Burden of Frequent

Phlebotomies and Meaningfully Improve Hematocrit Control

Barbui et al. NEJM Evid. 2023

https://www.takeda.com/newsroom/newsreleases/2025/new-drug-application-pv/

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PharmaEssentia


Ropeg: Early Interferon Therapy Paradigm Shift in PV, Driving Disease-Modifying Treatment (Silver & Hasselbalch, 2026)

Leukemia

Explore content ☑ About the journal ☑ Publish with us ☑

nature > leukemia > review articles > article

Review Article | Open access | Published: 08 April 2026

A paradigm shift in the treatment of patients with polycythemia vera. The initial early use of recombinant interferon-alpha

Richard T. Silver | Hans Carl Hasselbalch ☑

Leukemia (2026) | Cite this article

  • Early Advantage: Supports early interferon for long-term efficacy & disease control
  • Clinical Evidence: Durable hematologic control
  • Disease-Modifying: Reduces mutant allele burden
  • Mechanism: Immunomodulatory & antitumor effects on malignant HSCs
  • Paradigm Shift: Transforms PV treatment to early disease-modifying therapy

A paradigm shift in the treatment of patients with polycythemia vera. The initial early use of recombinant interferon-alpha | Leukemia

PharmaEssentia


Expected launch of Ropeg pen in the U.S. in 2026

Ropeg pen is expected to launch in 2026, further improving treatment accessibility and convenience for PV patients in the U.S.

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Expected to obtain U.S. and Global ROPEG ET drug approvals in 2026, benefiting nearly 100,000 patients

ET patient population in the US effectively doubles the market potential

163K

Polycythemia Vera (PV)

  • 2019 EMA approval
  • 2021 US approval
  • 2023 Japan approval
  • 2024 China, Singapore, and Malaysia approval
  • 2025 Brazil, Argentina, Hong Kong approval

PV

325K

US market prevalence

PMF

ET

Great Start !!

148K

Essential Thrombocytemia (ET)

  • SURPASS – data readout Jan 6, 2025
  • NCCN Guideline listed (Version 1.2026)
  • 2025 China, Taiwan, Japan submission
2025.10.30 BLA submission to US FDA
2026.08.30 PDUFA Date from US FDA
2026.02.27 Korea submission
2026.05.12 Taiwan Approval

14K

Pre-fibrotic/Early Primary Myelofibrosis (PMF)

  • Phase 3 trial initiated; enrollment expected to complete by H1 2026

Patient numbers are U.S. prevalence from PharmaEssentia market research

*Source: PharmaEssentia Internal Analyses

PharmaEssentia


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Estimated Approval (submission date):

  • TW – 2026.05.12 (2025.09.05 submitted)
  • US – 2026.08.30 PDUFA date (2025.10.30 submitted)
  • JP – 2026.08 (2025.09.18 submitted)
  • CN – 2026.11 (2025.07.16 submitted)
  • KR – 2026.12 (2026.02.27 submitted)

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ET regulatory submission completed; approval all expected in 2026

A key breakthrough for treatment of ET in 30 Years

  • Submission Completed
  • In Preparation

PharmaEssentia


Ropeg ET Integrated Analysis: First-line EXCEED-ET and second-line SURPASS-ET, supporting treatment for all ET patients

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SURPASS ET

ESSENTIAL THROMBOCYTHEMIA

A Phase 3, 52-week, Open-Label, Randomized, Active-controlled Study to Assess Pharmacokinetics and to Compare the Efficacy, Safety, and Tolerability of P1101 vs Anagrelide as Second Line Therapy

  • Global Phase 3 trial
  • Enrolled 174 high-risk ET patients naïve to IFN-α therapy and resistant or intolerant to HU

The results of SURPASS-ET serve as the pivotal evidence for safety and efficacy while EXCEED-ET serve as confirmatory evidence

Latest Updates:
The formal review process has started from December 29, 2025. As of February 23, 2026, the FDA has completed on-site GCP inspections at 3 hospitals.

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EXCEED ET

ESSENTIAL THROMBOCYTHEMIA

A Phase 2b, 56-week, A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon Alfa-2b-njft (P1101) in Adult Patients With Essential Thrombocythemia

  • Single-arm trial (North America only)
  • Overenrolled with 91 patients naïve to cytoreductive therapy, INF, and ruxolitinib or received prior HU and/or anagrelide

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PharmaEssentia


Ropeg demonstrates superior clinical efficacy in the SURPASS-ET trial

SURPASS
ESSENTIAL THROMBOCYTHEMIA

Primary endpoint
Durable Modified ELN Response at Month 9 and 12

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PharmaEssentia


SURPASS RESENTIAL THROMPHOCYTHEMIA

Ropeg shows better efficacy than Anagrelide across all individual parameters

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Reference: PEC data on file
PharmaEssentia

EXCEED-ET shows comparable efficacy to SURPASS-ET (without TSS), with superior results in treatment-naïve patients

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EXCEED ET
ESSENTIAL THROMBOCYTHEMIA

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SURPASS
ESSENTIAL THROMBOCYTHEMIA

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EXCEED ET
ESSENTIAL THROMBOCYTHEMIA


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EXCEED-ET also demonstrates significant reduction of mutation allele burden with ROPEG

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JAK2V617F Allele Frequency

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CALR Allele Frequency

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MPL Allele Frequency

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PharmaEssentia


Substantial PMF Patient Population Represents a Critical Market Opportunity to Prevent Progression to Myelofibrosis

A High-Value Market Opportunity Driven by the Significant PMF Patient Population

163K

Polycythemia Vera (PV)

  • 2019 EMA approval
  • 2021 US approval
  • 2023 Japan approval
  • 2024 China, Singapore, and Malaysia approval
  • 2025 Brazil, Argentina, Hong Kong approval

PV

325K

US market prevalence

PT

PMF

148K

Essential Thrombocytemia (ET)

  • SURPASS – data readout Jan 6, 2025
  • NCCN Guideline listed (Version 1.2026)
  • 2025 China, Taiwan, Japan submission
  • 2025.10.30 BLA submission to US FDA
  • 2026.08.30 PDUFA Date from US FDA
  • 2026.02.27 Korea submission

14K

Pre-fibrotic/Early Primary Myelofibrosis (PMF)

  • Phase 3 trial initiated; enrollment expected to complete by H1 2026

Patient numbers are U.S. prevalence from PharmaEssentia market research

*Source: PharmaEssentia Internal Analyses

PharmaEssentia


ROPEG powers near-term revenue; HOPE-PMF drives mid- to long-term growth, with additional new indication anticipated by 2028

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~150

Target Patient Number

Ropeginterferon alfa-2b (P1101) in Pre-fibrotic/ Early PMF

Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 3 Clinical Study to Assess Efficacy and Safety of Ropeginterferon alfa-2b (P1101) in Adult Patients with Pre-fibrotic/Early Primary Myelofibrosis (Early PMF) or Overt PMF at Low to Intermediate-1 Risk According to DIPSS Plus

Countries: US, China, Hong Kong, Taiwan, South Korea, Japan, Singapore, Canada

Main study

JAK2 V617F-positive, pre-PMF or overt PMF at low to intermediate-1 risk according to DIPSS Plus

R 2:1

Study Group: Ropeginterferon alfa-2b (n ~100)

250(W0) → 350 (W2) → 500(W4)

Double-blinded study

Control Group (n ~50)

Safety follow up

Endpoint Analysis at 80W

  • Updates: 157 patients enrolled and enrollment completion is expected in May

PharmaEssentia


ROPEG phase III and IIT trials accelerating, with new indications, driving future growth

Oncology and Immunology

CANDIDATE INDICATION DISCOVERY IND ENABLING PHASE 1* PHASE 2* PHASE 3 DEVELOPMENT UPDATE
ROPEG Polycythemia Vera (PV) Commercialization
Essential Thrombocythemia (ET) Under Approval Review
Early-stage Primary Myelofibrosis (PMF) Ph3 HOPE-PMF ongoing
ROPEG + dasatinib Chronic Myelogenous Leukemia (CML) IND approved for Phase 1/2 (IIT)
ROPEG + anti PD-1 Hepatocellular Carcinoma (HCC) Ph1 data published*
ROPEG Acute myeloid leukemia (AML / post-transplant) Phase 1 ongoing (IIT)
Cutaneous T-cell Lymphoma (CTCL) According to the NCCN Guidelines, when other interferons are unavailable, Ropeg may serve as an effective alternative treatment option for CTCL. IND Preparation for Phase 2 (IIT)
Chronic Myelomonocytic Leukemia (CMML) IND Preparation for Phase 2 (IIT)
ROPEG + ruxolitinib Myelofibrosis (MF) IND submitted for Phase 1 (IIT)

P11838: Data presented at ICIS Cytokine conference, 2025; PD-1-IL-2v: a bispecific immunocytokine combining a PD-1 antibody with an IL-2 variant; ADC: antibody Drug Conjugate; TCR-T, T cell receptor T cell therapy

PharmaEssentia


Ropeg combined with sequential anti-PD-1 therapy: reducing postoperative recurrence risk in HBV-related liver cancer

第一期臨床試驗摘要:

Ropeginterferon alfa-2b 與 Nivolumab 接續治療於B型肝炎導致肝細胞癌術後患者

  1. 研究設計:第一期、開放性、單臂臨床試驗
  2. 主要目的:評估安全性、耐受性與初步療效
  3. 適應族群:B 型肝炎相關肝癌術後患者
  4. 治療方案:
  5. Ropeginterferon alfa-2b:450 微克,每兩週一次,共 6 劑
  6. Nivolumab:每兩週一次,共 3 劑
  7. Cohort 1: 0.3 mg/kg;Cohort 2: 0.75 mg/kg
  8. 符合條件的受試者人數:15名患者

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初步療效結果:

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中位追蹤 1,024 天 100% 無復發存活率;
超過 2 年(>730天)存活的人數:13 人;
超過 4 年(>1,095天)存活的人數:6 人;
超過 5 年(>1,825天)存活的人數:3 人

References:

  1. Albert Qin, et al. (2025). Sequhttps://statics.teams.cdn.office.net/evergreen-assets/safelinks/2/atp-safelinks.htm

  2. Sequential combination with ropeginterferon alfa-2b and anti-PD-1 treatment as adjuvant therapy in HBV-related HCC: a phase 1 dose escalation trial - PubMed

PharmaEssentia


Accelerating Ropeg indication expansion via IITs at leading global medical centers

Investigator-Initiated Trial (IITs)

疾病適應症 Ropeg 市場潛力 未滿足需求
早期骨髓瘤維化
(Early-Stage MF) • 根據 EvaluatePharma 與 Fortune Business Insights,MF 藥物市場預計至 2030 年將擴大至近 30 億美元。 • 缺乏能延緩病情惡化的早期治療,JAK 抑制劑對疾病進程的控制仍有限。
骨髓瘤維化
(MF) • Ropeg 已被證實可降低 JAK2 突變負荷,並可能發揮疾病調控效果。 • 高風險患者缺乏長期控制藥物,需要安全且可長期使用的治療
皮膚性 T 細胞淋巴瘤
(CTCL) • 根據 GlobalData 與 DelveInsight 預測,全球 CTCL 藥物市場將於 2028 年成長至約 15 億美元。
• Ropeg 的長效干擾素作用具備調節免疫微環境、抑制腫瘤進程的潛力。 現有藥物效果有限,缺乏長期安全治療
慢性骨髓性白血病
(CML) • 根據 IQVIA 與 GlobalData,CML 療法市場目前規模已超過 50 億美元,干擾素仍具重要臨床價值。
• Ropeg 可調控造血微環境,增強免疫監控,提供對 TKI 耐藥或不耐受患者的替代治療 對現有藥物不耐受或抵抗患者缺乏替代方案
急性骨髓性白血病
(AML / 特別針對骨髓移植後患者) • 全球 AML 治療市場規模約 30-40 億美元 (2025 年),未來可增至 60-80 億美元。
• 骨髓移植後 AML 患者市場持續成長,Ropeg 可透過長效干擾素調節免疫、抑制殘留白血病細胞,降低復發風險。 • 移植後 AML 患者復發率高,缺乏有效預防方案。
• 需要兼顧免疫調控與造血恢復的治療

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PharmaEssentia


Five products entering phase 1 in 2026, strong early-stage oncology and immunology pipeline propelling future growth

Oncology and Immunology

CANDIDATE INDICATION DISCOVERY IND ENABLING PHASE 1* DEVELOPMENT UPDATE
PEG cytokine PEG-IL-2 (P11838) Immunology Planned IND in 2026
PEG-Cytokines Solid Tumors Planned IND in 2027
Bispecific PD-1-IL-2v Solid Tumors Planned IND in 2026
ADC ADC (novel target) Solid Tumors Planned IND in 2026
ADCs Planned IND in 2027
Cell Therapy NY-ESO-1 TCR-T Solid Tumors Planned IND in 2026
KRAS TCR-T Planned IND in 2026

P11838: Data presented at ICIS Cytokine conference, 2025; PD-1-IL-2v: a bispecific immunocytokine combining a PD-1 antibody with an IL-2 variant; ADC: antibody Drug Conjugate; TCR-T, T cell receptor T cell therapy

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PharmaEssentia


Billion-Dollar Revenue, Tens of Billions in Ambition: Four Strategic Forces Accelerating Rapid, Risk-controlled Growth

| Top-tier Innovation Drugs | Develop novel best-in-class (BiC) and first-in-class (FiC) immune checkpoint inhibitors
• Advance TCR-T cell therapy targeting both surface and intracellular antigens
• Proactively pursue strategic partnerships to expand pipeline reach, with a focus on ADCs, bispecifics, and cell therapies. |
| --- | --- |
| Expand PEG Platform Applications | Utilize PharmaEssentia’s proprietary PEGylation platform for long-acting cytokines
• Develop BiC/FiC PEGylated cytokines (e.g. IL-2, IFN-γ)
• Address hard-to-treat tumors (renal, pancreatic) and immune-mediated diseases |
| Broaden ROPEG’s Therapeutic Use | Expand to new indications of ROPEG targeting high unmet needs
• Expand ROPEG into new hematologic and solid tumor indications
• Explore ROPEG combinations (e.g., with anti-PD-I) for diseases like HCC |
| Global Leader in MPNs | Establish ROPEG as the global standard for MPN treatment
Approved for PV in multiple countries
• ET Regulatory submissions completed in 2025: the U.S., China, Taiwan, and Japan
• MF: Development in early-stage or low/intermediate-T risk patients |

PharmaEssentia


PharmaEssentia is the first Taiwan biotech company included in both the DJ BIC 2026 World Index and the Emerging Markets Index, highlighting ESG leadership and enhanced global investor visibility.

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PharmaEssentia


Thank You

Better Science, Better Lives.

PharmaEssentia