EF-009


EF-009 Wafer
Pancreatic Cancer Treatment
Curing Rare Cancers
- Rare Cancers are a subset of orphan diseases that affect so few people that trying to cure them makes little economic sense without public incentives and special regulatory benefits.
- Our mission is to develop orphan drugs to treat rare cancers chosen for their low probability of survival due to the lack of effective treatments, the presence of few competitors offering objectively inferior products based on key medical metrics, and the possibility of rapidly gaining market share via licensing agreements with global pharma partners.
Pancreatic cancer (PC)
While the mortality rate of pancreatic cancer (PC) is rising rapidly, treating it remains a formidable challenge. Surgery followed by adjuvant chemotherapy is the standard of care but, without additional therapy, over 90% of patients relapse and die. PC remains highly resistant to conventional chemotherapy and only 5% of patients survive more than 5 years.
Our Innovative Approach

Harness the Power of the Human Immune System
We seeks to identify and develop active compounds with the ability to amplify the body’s natural defense across many metrics, both by fortifying the patients’ immune system and weakening the disease to increase its vulnerability to medical treatments.

Use Small Molecules Drugs as Our Key Therapeutics
Given their relatively low molecular weight, simple chemical structures, more predictable pharmacokinetics and pharmacodynamics, small molecule drugs not only have superior safety profiles, but they can pass through cell membranes to reach intracellular targets and be formulated in many forms.

Improving Efficacy with Targeted Drug Delivery
We use targeted drug delivery platforms to improve the efficacy of our products with options like slow-released local delivery system, systemic drug delivery system, dripping pill formulation, dermal application formulation and injectable formulation.
Product Profile
Product Name
EF-009 Wafer
Disease
Pancreatic cancer
Target Market
North America, Europe, China, Japan
Market Size
US market worth around USD 26.31 billion
Competition Size
Animal study revealed much more survival than the chemotherapy drug, Gemcitabine.
Objective Size
First-in-class surgical combination therapy targeting both chemotherapy and targeted therapy markets, aiming to secure a 15% market share through direct competition.
EF-009 Wafer

The mortality rate of pancreatic cancer (PC) is rising rapidly.
However, the treatment of pancreatic cancer remain a formidable challenge and has 5-year survival rate of approximately less than 5%. Surgery followed by adjuvant chemotherapy the standard of care – without additional therapy, over 90% of patients relapse and die. However, PC remains highly resistant to conventional chemotherapy.
The great challenges lies firstly, in delivering chemotherapeutic agents effectively to bypass the protective barriers around pancreatic cancer; and secondly, in reversing the immunosuppressive environment caused by the presence of cancer stem cells.
EF-009 is a slow-releasing drug for the treatment of pancreatic cancer with multiple targeting effects. It can accumulate in targeted areas around the tumor, make it vulnerable and easily killed by chemotherapy or immune cells, with manageable toxicity.
Why EF-009 Wafer Does It Better on Curing Pancreatic Diseases?
■ Promising Results and Low Toxicity
Preclinical studies on animal models have shrunk tumors with manageable toxicity.
■ Local Drug Delivery
After implantation, the tablets will slowly decompose and release small-molecule targeted drugs directly into the tumor, so that sufficient drug concentration can be achieved locally in the lesion.
■ Longer Life Expectancy
Preclinical studies on animal models have proven to prolong survival by 3.2 times.
■ Poor Alternatives
No effective target drugs despite survival period of 8-11 months from diagnostic.
■ Pancreatic cancer belongs to rare disease, US FDA Orphan Drug Certification will be applied soon
– the protection and preferential measures are granted under the Orphan Drug Development Act.
How EF-009 Wafer Compares to Conventional Treatments

Market Share (Forecast)

Key Active Ingredients

Active Pharmaceutical Ingredient (API): EF-API-001
- Small molecule
- Low toxicity: Rat LD50 = 1,850 mg/kg
- PIC/S GMP product
EF-API-001 is a small molecule, discovered from natural product researches and synthesized and manufactured through strict GMP processes and controls. EF-API-001 revealed excellent safety profiles and is an exciting discovery of multiple disease treatment capabilities.
KEY anti-cancer effects of EF-API-001: inhibiting tumor growth, inhibiting stemness, inhibiting chemo drug resistance, and immune response stimulation.

Excipient
- FDA approved, bio-degradable material
- Excellent bio-compatibility
- PIC/S GMP product
The Treatment of EF-API-001

Clinical Study Status
- IND application approved by USFDA and TFDA
Awards & Achievements
2019 IND application approved by USFDA
2020 IND application approved by TFDA
2021 National Innovation Award*
*Taiwan Government Awarded
Patents

Publications
Partnering And Collaboration
EFB is looking for the opportunity to cooperate with international pharmaceutical companies or venture capitals.
Please mail us on efbiotech@efbiotech.com