ONENESS Biotech Co., Ltd. (Oneness Biotech Co., Ltd.) 2024Q2 法說會簡報

Company Overview

• Company Name: ONENESS (Oneness Biotech Co., Ltd.)
• Mission/Vision: 生技創新結合商化,共創下一代重磅產品 (Biotech innovation combined with commercialization, co-creating the next generation of blockbuster products)
• Core Competency: 創新 (Innovation) + 商化 (Commercialization)
• Business Segments/Product Categories:
  • 商化產品 (Commercialized Products)
  • 次世代重磅產品 (Next Generation Blockbuster Products)
• Technology Platforms:
  • siRNA
  • 專利平台針對高度突變的呼吸道病毒 (Patented platform for highly mutated respiratory viruses)

Financial Highlights

• Global Wound Care Expenditure:
  • 2019: US$233.5 Billion
  • 2022: US$301.1 Billion
  • Growth (2019-2022): +29%
• FB825 Licensing Value: US$530 Million
• SNS851 Sales (2024 H1): Expected IND submission in 2025 (no current sales data)
• Wegovy® Sales (2024 H1): US$3.1 Billion
• Zepbound™ Sales (2024 H1): US$1.7 Billion

Business Segments

• Commercialized Products:
  • ON101 (Breakthrough Wound Healing Product)
  • FB825 (Long-acting Anti-allergy Drug)
• Next Generation Blockbuster Products:
  • SNS812 (Next-Generation Antiviral Therapy)
  • SNS851 (Next-Generation Obesity Treatment)

Products & Technologies

Commercialized Products

• ON101:
  • Description: 突破性傷口癒合產品 (Breakthrough wound healing product)
  • Indications: DFU, VLU, PrU, 手術傷口及燒燙傷 (Surgical wounds and burns)
  • Benefits: 減少疤痕形成 (Reduces scar formation)
  • Mechanism of Action:
    • 抗發炎 (Anti-inflammation): M1/M2 Macrophage modulation
    • 組織重建 (Tissue remodeling): Preadipocytes, Myofibroblasts
    • 預防疤痕形成 (Prevents scar formation): Fibroblasts, TGF-β
  • Forms:
    • Bonvadis® (醫材 Medical Device): For DFU, VLU, PrU, Burns, Surgical Wounds, Scar Management.
    • FESPIXON® (新藥 New Drug): For DFU.
• FB825:
  • Description: 首款針對 IgE B 細胞 長效抗過敏藥物 (First long-acting anti-allergy drug targeting IgE B cells)
  • Indications: 中重度異位性皮膚炎 (Moderate to severe atopic dermatitis), 過敏性氣喘 (Allergic Asthma)
  • Mechanism of Action: IgE B-cell depletion (targets IgE+ B Cell, prevents IgE storage at the source)
  • Administration Route: SC injection + TCS (Subcutaneous injection + Topical Corticosteroids)
  • Dosing Frequency: Q4W-12W (Once every 4 to 12 weeks)
  • Key Advantages: Long dosing interval, does not affect normal immunity, high safety, suitable for long-term use.

Next Generation Blockbuster Products

• SNS812:
  • Description: 首個經臨床驗證 的吸入式抗病毒 siRNA (First clinically validated inhaled antiviral siRNA)
  • Technology: Patented platform for highly mutated respiratory viruses.
  • Target: Highly conserved region in viral RdRP (e.g., in Coronavirus, Influenza Virus, Respiratory Syncytial Virus, Parainfluenza Virus, Metapneumovirus).
  • Administration Route: Inhalation
  • Key Features: Broad-spectrum efficacy, excellent efficacy, excellent safety, rapid development.
• SNS851:
  • Description: 增強能量燃燒 治療 肥胖症 & 脂肪肝 (Enhances energy burning, treats obesity & fatty liver)
  • Composition: siRNA
  • Indications: Obesity, Fatty Liver (MAFLD/MASH)
  • Mechanism of Action:
    • Induces liver-specific mitochondrial uncoupling (via Gene X, a novel target), promoting liver cells to burn excess energy.
    • Reduces lipid synthesis in the liver.
    • Triggers lipolysis in adipose tissue.
    • Increases basal metabolic rate.
  • Key Features: 100% blocks obesity caused by high-fat diet, does not cause loss of appetite, does not cause muscle loss, no rapid weight regain after stopping treatment, no drug-related adverse reactions.
  • Administration Route: SC (Subcutaneous injection) - implied from animal studies (QW, SC)

Clients & Markets

• Global Wound Care Market: Estimated to grow due to increasing prevalence of chronic wounds and advancements in wound care technologies.
• Allergy Treatment Market: Expected to grow due to increasing prevalence of allergic diseases and demand for effective treatments.
• Obesity and Fatty Liver Treatment Market: Growing due to increasing prevalence of obesity and related metabolic disorders.

ESG / Sustainability

• Commitment to Innovation: ONENESS Biotech is committed to developing innovative treatments for unmet medical needs, promoting sustainable healthcare solutions.
• Environmental Sustainability: The company aims to minimize its environmental footprint through responsible operations and supply chain management.

Outlook & Strategy

• ON101:
  • Market Access Target: Estimated 2025, target coverage global 50+ countries
  • Growth Strategy: Achieve sustained growth in the global market
  • Market Discussions: Major market collaborations in discussion
• SNS851:
  • IND Application: Q4 2025
  • Phase I Clinical Trial Completion: Q3 2026
  • Phase I Study Design: Will include overweight healthy subjects with fatty liver to validate clinical value in reducing liver fat and body weight
• Strategic Initiatives: Early licensing and partnership negotiations for SNS851 will proceed simultaneously
• R&D Focus: Committed to developing other antiviral new drugs

Additional Data

• ON101 Clinical Efficacy:
  • Wound healing within 4 months: ON101 76% vs. Current Best Care 23% (P=0.0001)
  • One-year follow-up after treatment: ON101 0% Amputation Rate vs. Current Best Care 17%
  • Average healing time: ON101 139 days vs. Current Best Care 239 days
• FB825 Clinical Trial Status: Phase II Clinical Trials (for Atopic Dermatitis and Allergic Asthma)
• SNS812 Phase II Clinical Trial Results: >90% patients cleared virus in 3 days; median symptom resolution 3.6 days; 12/14 symptoms improved
• SNS851 Mouse Study Results:
  • Weight Change: SNS851 (High fat diet) shows minimal weight gain compared to Control (High fat diet)
  • Fat Accumulation: Significant reduction in Epididymal (70%), Retrorenal (48%), Inguinal (65%) WAT compared to Control
  • Muscle Weight: SNS851 shows no muscle loss, tibialis anterior increased by 20%, while Semaglutide shows ~20% muscle loss
  • Lipid Metabolism: Total Cholesterol reduced by 33%, LDL-C reduced by 56%
  • Carbohydrate Metabolism: Fasting Blood Glucose reduced by 36%