Apomivir®/ New antiviral drug
New antiviral drug
FEBICO’s Apomivir obtained the approval of US (IND120123) and Taiwan INDs application in 2013 and 2014, respectively. In previous experiments, FB-1603, the active pharmaceutical ingredient of Apomivir, was found to inhibit a variety of viruses in cellular experiments, including influenza A/H1N1, A/H3N2, influenza B, novel influenza viruses (2009), and influenza viruses resistant to tamiflu. Animal experiments have shown oral administration of FB-1603 can effectively reduce the mortality rate of mice caused by influenza A. Apomivir® is designed as oral capsule and given to patients infected with influenza within 48 hours of confirmed infection. The primary outcome measures the time reaching afebrile compared to the control group.
2. COVID-19 (SARs-CoV-2)
The new coronavirus hit the world in 2020, causing tens of millions infections and millions of deaths. In addition to the typical clinical pathology includes respiratory symptoms, severe patients will progress to severe pneumonia, acute respiratory distress syndrome (ARDS) or multiple organ failure, shock or even death. Therefore, the threat is quite big.FB-1603 has been proven in cellular and animal experiments to effectively reduce inflammation and accelerate the healing of scarred tissues. It has also been found in cellular experiments to inhibit pulmonary fibrosis. Because FB-1603 is the active pharmaceutical ingredient of Apomivir. Previous IND 120123 documents and new cellular data against COVID-19 were used to file a pre-IND (151566).
3. Treat liver damage
Current available treatments for liver cancer include surgical resection, liver transplantation, local destruction therapy, transarterial chemoembolization (TACE), chemotherapy and targeted therapy. However, according to clinical literature statistics, about 10% of patients treated with surgical resection or TACE will have postoperative complications such as deterioration of liver function (increased AST/ALT), jaundice, liver failure, and leads to 5% mortality rate. However, there are no effective preventive measures or therapeutic drugs to reduce the incidence of postoperative liver injury. In early phase of clinical trials, it has been observed that FB-1603 help the improvement of patients' liver function after hepatectomy or chemoembolization therapy.
4. Treat Herpes Virus
Herpes virus is a common infectious virus. Depending on the type of virus, it can cause redness and swelling of the skin on the lips or external genitals, resulting in blisters and ulcers, causing stinging and discomfort. Once infected with the herpes virus, the virus will be permanently latent in the human ganglion, and will repeatedly attack when the immune system is weakened. FB1706 has been proven in cellular study to effectively inhibit herpes type 1 and type 2 viruses with a very low dose, and some data show that topical application can shorten the course of the individual’s disease and accelerate the recovery time. The animal module for the herpes virus is currently under establishment. We expect to complete the animal studies before June 2021 and complete documentation of toxicology study and CMC (Chemistry, manufacturing, and control) report.
5. Liver fibrosis treatment
In the past, liver disease was considered a national disease in Asian community. So far, about 10,000 people in Taiwan are diagnosed with liver cancer and 7,700 people die from liver cancer every year. It still ranks as third in cancer incidence and second in mortality. Therefore, chronic liver disease cannot be underestimated. A familiar trilogy is liver inflammation, cirrhosis, and finally liver cancer.
The major cause is that when liver cells are damaged for a long time, liver tissue is formed into fibrosis, leads to hardening of liver, i.e. cirrhosis. Therefore, the key to treatment is to slow down the formation of fibrosis. Currently there is no approved drug to treat liver fibrosis in the world. FB-1807 has been observed in early phase of clinical trials to effectively reduce the liver fibrosis index of liver cancer patients. Preclinical study includes identification of active ingredient and animal studies are currently underway.
6. Cure Hepatitis B
Chronic hepatitis B virus (HBV) infection is still an important issue of global health, causing nearly one million people die every year from major complications of liver cirrhosis and liver cancer. In recent years, the natural history of HBV and the replication mechanism have been clearly studied. Therefore, it is very important to know how to completely eliminate the virus to prevent viral infection. Although many different drugs have been developed to treat HBV, the long-term use of existing drugs is a heavy burden but still cannot achieve a complete cure. Therefore, a new generation of anti-viral medication is still needed.
FB-1808 has been observed in early clinical trials with significant anti-virus effects. We have confirmed the active ingredient and mechanism study is still ongoing.
7. COVID-19 rapid test
COVID-19 spreads worldwide very rapidly, and the existing screening is mostly done by antigen /antibody rapid test. It is easy to have false positive or false negative results that might have misguided diagnosis. Nucleic acid rapid test is more accurate, but it requires special equipment and complicated operation technique. Large number of tests can’t be completed in time. FEBICO is currently developing a isothermal nucleic acid rapid test, which combines the advantages of antigen-antibody screening and nucleic acid screening to improve the sensitivity and screening efficacy. Besides from COVID-19, this technology platform can also develop screening tests for other viruses.
History & News
FB-1603 registered as Drug Master File (DMF) on U.S. Food and Drug Administration (FDA)
Obtained China Patent-CN106267157A
A composition for preventing or/and treating periodontal disease and its application
Obtained US patent - US 10555886B2
Composition of algal extracts for preventing and treating periodontal disease
"ApoX Anti-virus Surface Spray" won the SNQ National Quality Label and Bronze Award of the 21st National Biotechnology and Medical Quality under Epidemic prevention category.
Obtained Taiwan patent-I587866
Composition of algae extract for preventing and treating periodontal disease
Obtained US patent -US9657263 B2
Pharmaceutical composition for inhibiting infection and replication of influenza A and B virus, and the manufacture thereof
Obtained Taiwan Patent-I526217
A cyanobacteria extract to improve liver function
Obtained Taiwan patent-I542354
A composition for inhibiting influenza virus hemagglutinin and the manufacture thereof
China patent authorization (CN102462702 B ), A medicinal composition capable of
restraining influenza virus hemagluatinin (HA) and preparation method.
2014/08 TW IND approved, Anti-Influenza new drug, Apomivir® , to enter phase II clinical trial.
2014/06 Taiwan patent authorization (1439278), A composition for assisting treatment effect of
hepatitis B medicament.
USA IND approved, Anti-Influenza new drug, Apomivir®, to enter phase II clinical trial.
China patent authorization (1295688), A composition for assisting treatment effect of
hepatitis B medicament.
FEBICO submits Investigational New Drug (IND) application of Apomivir® for the
Treatment of Influenza.
Taiwan patent authorization (1295688), A method for inhibiting enterovirus and/
or Influenza virus reproduction by allophycocyanin in vitro.
Taiwan patent authorization (1272947), Inhibiting pharmaceutical composition of
influenza virus infection and replication.
FEBICO collaborates with National Taiwan University in researching the inhibition of
rotavirus, respiratory syncytial virus (RSV), and herpes simplex virus (HSV) infection of
FEBICO collaborates with Hepatitis Research Center (HRC) of National Taiwan
University Hospital in studying prevention of liver cirrhosis and fatty liver of Bpogen.
FEBICO obtains subsidies of Small Business Innovation Research (SBIR) from Taiwan
Taiwan patent authorization (1240631), The oral administration dosage form of viral
infection prevention agent.
ㆍFEBICO shows the IC50 of Apogen® and Tamiflu are quite similar.
ㆍFEBICO shows that Apogen® could prevent experimental animals from death
induced by Influenza type A and B virus.
Research results of Apogen® in inhibiting enterovirus 71 are published on Journal of
Medical Virology, Vol. 70:119-125
FEBICO gets the U.S. patent (US patent 6346408) for a method of allophycocyanin
inhibition of enterovirus and influenza virus reproduction resulting in cytopathic effect.
FEBICO collaborates with Chang Gung University in researching drugs of anti-viral
infection and replication.