4147.TWO TaiMed Biologics (中裕新藥) July 2025 法說會簡報

Company Overview

• Company Name: TaiMed Biologics (中裕新藥)
• Core Focus:
  • Innovative R&D in CD4-targeted therapies, particularly for HIV and autoimmune diseases.
• Business Segment:
  • Contract Development and Manufacturing Organization (CDMO):
    • Own GMP manufacturing facilities.
    • Extensive CDMO cooperation experience with international partners.

Products, Services & Technology

2.1 HIV Pipeline - CD4-Targeted Innovative R&D

Marketed Drug

• Product Name: Trogarzo® (ibalizumab-uiyk)
  • Description: Globally first and only monoclonal antibody for HIV.
  • Indication: Multi-drug resistant HIV patients.
  • Dosing: Injected every two weeks.
  • Market Status: Approved in the US.
  • Market Expansion: Middle East & North Africa (MENA), Hong Kong, Macau, Taiwan, Vietnam, Sri Lanka, and other regional markets.

Clinical Stage Development

• Product Name: TMB-365 / TMB-380
  • Description: Long-acting monoclonal antibody combination.
    • TMB-365: Second-generation CD4 receptor binding entry inhibitor.
      • Modified structure for broader antiviral spectrum, higher potency, and longer half-life.
    • TMB-380: Long-acting broadly neutralizing antibody (bNAb) targeting gp120 spike protein of HIV-1.
      • Enhanced potency and pharmacokinetic properties.
    • Combination Benefit: Complementary antiviral mechanisms, avoiding drug interactions and side effects of small molecule drugs.
  • Indication: Front-line maintenance therapy for HIV.
  • Dosing: Once every two months.
  • Clinical Status: Phase 2a completed.
    • Phase 2b Outlook: Initiating trial in 2025.
  • Self-Subcutaneous (SC) Injection Development:
    • Product Name: TMB-365/380 SC.
    • Status: Investigational New Drug (IND) stage.
    • Benefit: Improved convenience, adherence, and reduced patient burden.
    • Future Outlook: IND application expected by Q4 2025.

Pre-clinical Stage:

• Product Name: TMB-HIV ADC (CD4-targeted Antibody-Drug Conjugate (ADC))
  • Description: Precision HIV treatment.
  • Mechanism: Dual mechanisms with triple actions selectively targeting HIV-infected CD4+ cells via endocytosis.
    • Requires significantly reduced drug doses compared to traditional therapies.
  • Development Stage: Lead optimization ongoing, with promising in vitro proof-of-concept data.
  • Upcoming Presentation: Data to be revealed at ID Week 2025 (October 21).

2.2 Autoimmune Pipeline

Pre-clinical Stage:

• Product Name: TMB-IMMUNE ADC
  • Indication: Multiple autoimmune diseases.
  • Scientific Principle: Selective delivery of immunomodulatory payload to overactive CD4+ T cells to reduce off-target toxicity.
  • Market Potential:
    • Addresses unmet needs with over $30 billion market opportunity.
    • Potential for accelerated reviews due to significant medical demand.
  • Development Advantage:
    • Precision therapy offering improved safety and efficacy.
    • Long-term disease-modifying treatment strategy.

Recent Performance and Results

TMB-365 / TMB-380 Phase 2a Clinical Trial Results

• Efficacy:
  • 94% of subjects achieved viral load <50 copies/mL at Week 24.
  • No virologic failures (VF) observed among study completers.
• Safety and Tolerability:
  • Zero serious adverse events observed.
  • Low injection site pain compared to alternatives (<5%).

Future Outlook and Guidance

Development Plans

• TMB-365 / TMB-380:
  • 2025:
    • Discuss Phase 2b clinical trial design with FDA.
    • Apply for Breakthrough Therapy Designation (BTD).
    • Publish results in top-tier journals.
    • Initiate Phase 2b clinical trial and Phase 1 trial for monthly self-subcutaneous injection.
  • 2027-2028: Begin Phase 3 trials.
  • 2029+: Biologics License Application (BLA) submission.

Strategic Initiatives

• Market Positioning: TMB-365/380 as best-in-class long-acting HIV maintenance therapy.
• Partnerships: Engaging global advisors to seek strategic co-development or licensing partners.
• Pipeline Expansion: Transfer CD4-targeting ADC technology to autoimmune disease applications.

Key Charts, Graphs, and Data Points

Global HIV Market

• HIV Drugs Market Size 2022-2032 (USD): | Year | Market Size (USD Billion) | |-----------|---------------------------| | 2023 | $33.32 | | 2024 | $33.92 | | 2025 | $34.59 | | 2032 | $49.68 |

• Cabenuva Annual Sales (USD): | Year | Revenue ($M) | |---------|--------------| | 2021 | $52 | | 2022 | $419 | | 2023 | $881 | | 2024 | $1,294 | | 2025 Q1 | $382 |

• Key Competitive Data (CATNAP IC50 & Breadth): | Antibody | IC50 (mcg/mL) | Breadth (%) | |--------------------------|---------------|-------------| | TMB-365 | 0.014 | 100 | | TMB-380 (VRC07-523LS) | 0.027 | 97 | | Trogarzo (Ibalizumab) | 0.055 | 93 | | VH3810109 (N6LS) | 0.068 | 98 | | GS-5423 (3BNC117LS TAB) | 0.184 | 95 | | GS-2872 (10-1074LS ZAB) | 0.062 | 63 |

Patient Data

• Global HIV Patients (2023): 40 Million.
• US HIV Patients (2023): 1.5 Million.

Market Projections

• HIV drug market growth from USD 35 billion (2025) to USD 50 billion (2032).
• Long-acting therapies to dominate >30% of market share by 2030.
• TMB-365/380 US target population: ~450,000-600,000 patients.
• Autoimmune diseases' ADC market potential: Exceeds USD 30 billion.

Key Terms and Concepts

• Trogarzo® (ibalizumab-uiyk): First monoclonal antibody for HIV.
• TMB-365: Second-generation CD4 receptor entry inhibitor.
• TMB-380: Long-acting broadly neutralizing antibody (bNAb).
• ADC: Antibody-Drug Conjugate.
• CDMO: Contract Development and Manufacturing Organization.
• BTD, IND, BLA: Key regulatory milestones.
• SC, IV: Subcutaneous and intravenous administration.
• MENA: Middle East and North Africa.
• gp120, CD4 receptor: HIV target mechanisms.

Conclusion

TaiMed Biologics aims to advance HIV treatment through innovative CD4-targeted therapies and expand its pipeline to autoimmune diseases, meeting urgent clinical needs while pursuing strategic global partnerships and market-driven growth.