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FEBICO's current major development of new drug focuses on the treatment of global emerging infectious diseases and hepatitis-related diseases.

1.  Influenza

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.

At FJS Biopharmaceutical Inc., we combine technological innovation with world class process excellence. These enable our customers to deliver their discoveries. In our extensive contract development services portfolio we use advanced technologies to quickly and efficiently deliver products such as monoclonal antibodies, complex proteins and recombinant proteins.

Changes in the global marketplace are quickly altering the demands on biopharmaceutical manufacturing facilities. we have changed to Continuous Manufacturing Processes design that is cost-effective, flexible and responsive to a diversified product line. Continuous manufacturing processes offers a number of advantages:
1. More agile and flexible, and can therefore respond more rapidly to changes in supply or demand.
2. Reducing or eliminating scale-up bottlenecks could also help to accelerate the path to market for breakthrough
pharmaceuticals.
3. More efficient, reliable and cost-effective than traditional batch methods, resulting in significant cost savings down the line.
4. Producing smaller environmental footprint and reduce the risk of product quality failures compared to batch systems.
5. Supports a systematic, scientific and risk-based approach to pharmaceutical development. Development of a robust
process relies on utilizing the acquired product and process understanding to identify sources of variation to product quality
and to design appropriate control strategies to address these risk areas.
6. provides an opportunity to utilize this enhanced product and process understanding to adopt advanced manufacturing
controls and to produce uniformly high-quality products with reduced waste resulting from the generation of out-of-
specification material.

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