The Story of EFILA

EFILA™ is an abbreviation for "Enhanced Functional Insulin and Lifestyle Algorithm." It is not a single nutrient, but a comprehensive clinical intervention program designed by functional medicine experts to reverse type 2 diabetes. Its core is the systematic application of "multi-target cellular nutritional intervention."

At EFILA™, we believe true wellness begins at the cellular level. Our 100% natural formula, crafted from bioengineered mushroom mycelium, delivers targeted cellular nutrition to:
✓ Protect pancreatic beta cells from apoptosis
✓ Promote healthy insulin function through natural metabolic support
✓ Support your body’s innate ability to manage glucose

Why EFILA™?
🌿 IP Fortress: The World’s First Two Patented Strains 6 patents (KR/CN/PCT)
🛡️ HSA-Certified Safety
📊 70+ Clinical Cases, Improvement in Insulin Resistance | Kyung Hee University validated

Our Journey: From Forest Discovery to Global Innovation

Rooted in Nature, Validated by Science

2005: A Breakthrough in the Korean Forests

• Foundational Discovery: Dr. Kim Byoungcheon, a visionary scientist with a PhD in Biomedical Sciences (Western California Medical University), discovers Ceriporia lacerata — a rare medicinal mushroom growing on Korean pine trees.
• Initial Findings: In Vitro and In Vivo studies revealed its extraordinary potential to lower blood glucose level and protect pancreatic beta cells from apoptosis, etc., sparking a 20-year R&D mission
  

2005–2015: Decoding Nature’s Blueprint

• Strain Optimization: Patented fermentation technology refines Ceriporia lacerata into a standardized bioactive extract.
• Preclinical Validation:
  ✓ 4 Toxicity Tests — Confirmed safety across organ systems.
  ✓ Animal Studies — Demonstrated 30% blood sugar reduction in diabetic models (Int. J. Mol. Med, 2013).
• Global Recognition: Dr. Kim awarded the Grand Prize at EURO INVENT 2015 for advancing natural diabetes solutions.

2016–2021: From Lab to Life

• Human Trials Begin: Phase I trials at Kyung Hee University validate:
  ✓ 7.7 mg/dL fasting glucose reduction (BMC Complementary Medicine, 2023).
  ✓ Zero adverse effects across 70+ participants.
• Patented Evolution:
  ✓ Ceriporia lacerata K1 — 3 patents in KR.
  ✓ Irpex lacteus I.K —1 patent in KR; 1 patent in CN, 1 patent in PCT.
  

2022–Present: Rewriting Diabetes Care

• EFILA™ : Obtain global patents for  EFILA — a compound derived from dual-strain fermentation, targeting:
  ✓ Beta cell regeneration (Journal of Diabetes Research, 2022).
  ✓ Systemic insulin sensitivity (Food Sci Biotechnol, 2021).
• Industry Chain Mastery: Full-cycle control from strain cultivation (KACC-certified) to HSA-approved formulations.
• Global Vision: Partnering with health supplement/pharmaceutical companies to bring this unique dietary supplement to help 500M+ at-risk patients.

Longrunn Medical x A*STAR: Pioneering Natural Solutions for Diabetes Care

Longrunn Medical Technologies is proud to announce a strategic collaboration with Singapore’s Agency for Science, Technology and Research (A*STAR) under the T-UP Programme.

 Research Focus

This one-year project investigates the antidiabetic potential of Ceriporia lacerata K1 (CLK1), a rare white-rot fungus with unique bioactive compounds. The research will focus on:

• Large-scale cultivation of CLK1 and extraction of active metabolites

• Safety and efficacy validation through cytotoxicity and antidiabetic assays

• Elucidating molecular mechanisms (e.g., PI3K/Akt, AMPK pathways)

• Identifying and characterizing active antidiabetic compounds within CLK1, and advancing them into consumer-ready formats such as dietary supplements, functional foods, and complementary medicines

Strategic Significance

Through this partnership, Longrunn contributes expertise in nutraceutical innovation, while A*STAR brings world-class scientific research capabilities. Together, we aim to provide safer, natural, and effective solutions for diabetes management.

This collaboration not only addresses one of Singapore’s most pressing health challenges but also strengthens the nation’s position as a hub for translational health research and nutraceutical innovation.

EFILA ADVANCE BLOOD SUGAR SUPPORT — Officially Listed by HSA Singapore

Key Milestones

• July 2025 — HSA (Ms. Kwok) confirmed approval of our new active ingredient request, officially recognizing “Submerged culture of Ceriporia lacerata mycelium” under the Voluntary Notification System (VNS).
Note: The culture medium alone requires a separate safety submission.

• September 2025 — HSA (Ms. Ria) completed document verification and confirmed that EFILA ADVANCE BLOOD SUGAR SUPPORT is included in the List of Notified Health Supplements and Traditional Medicines.

• VNS Number: VNS-2025-07-00175

Significance

• Official HSA recognition of Ceriporia lacerata as a functional, safe, and verified ingredient in Singapore.

• Validates EFILA’s scientific and regulatory strength in product formulation and compliance.

• Enhances EFILA’s brand credibility and supports future expansion across the Southeast Asian market.

EFILA FDA Development Process & Current Progress

The EFILA® active ingredient has completed comprehensive pre-clinical validation, including toxicology, efficacy, and pharmacological studies required for IND application.

Completed Research Achievements

1. Strain Development & Characterization

• Isolation, identification, and genetic stability verification of CL-K1
• Established large-scale fermentation process and quality control system

2. Completed GLP Toxicology Studies

• Single-dose acute toxicity
• 4-week DRF (Dose Range Finding) study
• 13-week repeated oral toxicity (Rat & Beagle dog)
  → Demonstrated an excellent safety profile with no toxicity-related mortality or organ damage

3. Genetic Toxicity Studies

• Ames mutagenicity test
• Mouse micronucleus assay
• CHL chromosomal aberration test
  → All negative, confirming no genotoxic or mutagenic risk

4. Safety Pharmacology

• CNS safety study
• Cardiovascular safety, including hERG channel
  → No adverse pharmacological effects observed

5. Pharmacodynamic / Efficacy Studies

• OGTT glucose tolerance improvement (ICR mouse)
• Long-term metabolic improvement in db/db mice
• β-cell protection mechanism (anti-apoptosis, anti-oxidative stress)
• GLUT4 transporter activation mechanism
  → Confirmed multi-target antidiabetic potential of CL-K1

6. Completed Phase 1 Human Clinical Trial

• Conducted at Kyung Hee University, Korea

Demonstrated good tolerability and positive metabolic improvement trends

 Upcoming Development Milestones 

1. Initiate FDA Pre-IND Consultation

Discuss regulatory pathway and clinical protocol with FDA.

2. Proceed with IND Submission

Upon approval, U.S. clinical trials may formally begin.

3. Plan and Conduct Phase 2 & Phase 3 Clinical Trials

• Validate efficacy
• Expand to larger population
• Build long-term safety & dose–response data

4. NDA (New Drug Application) Submission

Prepare full dossier including CMC, toxicology, and clinical data.

5. Expansion to Additional Indications

Based on mechanism-of-action insights:

• Liver metabolic diseases (e.g., NASH)
• Inflammation-associated metabolic disorders
• Obesity & metabolic syndrome

6. Post-Marketing Long-Term Safety Evaluation

Generate real-world evidence (RWE) after commercial launch.

Why Trust EFILA?

• 20 years’ basic and clinical research, 9 SCI papers: Rigorously validated by institutions like Kyung Hee University,
• Ethics in Action:
  ✓ 100% natural, traceable ingredients.