INVESTORS

FAQs (by Category)

Year Year
  • Q

    Given global climate change, how can the ingredients of Fespixon be unaffected and remain sufficient?

    A

    Oneness Biotech has the technology and experience in planting herbs that have been available since more than 10 years ago and has completed three larger sites for planting herbs in compliance with international laws and regulations governing botanical new drugs. We are aware of herbal properties and impacts of weather conditions. In addition, Oneness Biotech has kept a safety inventory of ingredients that can last for two years, which should be able to cope with the demand in cases of extreme weathers.

  • Q

    Regarding the layout of ON101 in the US market, does Oneness Biotech consider applying for an expanded access program to improve the visibility of new drugs? Is ON101’s positioning in the diabetic foot ulcer (DFU) suitable for the application of the expanded access program (EAP)? What are the considerations for your company to adopt or not to adopt this plan? Thank you for your hard work and dedication.

    A

    Drugs generally need to be approved for marketing before they can be used on patients, otherwise, they can only be used on the patients after enrolling them in the clinical trial. The US FDA sometimes referred to this as a Compassionate Use for the Expanded Access Program, which refers to drugs under development that are directly used on patients other than the clinical trials. Therefore, certain inclusion criteria must be met. For example, serious illness, no effective treatment, and the threat of immediate death, and it is impossible or infeasible for patients to be included in the clinical trial. Therefore, basically, the clinical trial of ON101 does not comply with the specifications of the expanded access program (EAP).

  • Q

    Greetings! Thank you Oneness Biotech for your hard work and dedication. In view of the accidental fire of SCI Pharmtech, Inc., the only production plant was burnt down, which seriously affected the subsequent resumption of work and production. As far as I know, Oneness Biotech only has one production plant in Nanzhou Township. I would like to ask whether the company has other alternatives or plans to establish a new plant in another location. After all, if there is an accident without other alternatives, it will seriously affect the company’s development and the rights and interests of many shareholders. Therefore, we must think ahead of time.

    A

    For the Nanzhou Plant of Oneness Biotech, we install a high-standard safety monitoring system, oxygen monitoring system, and nitrogen device to ensure that the pipelines in the plant equipment are below the concentration set. Additionally, there is also an organic solvent concentration monitoring system to ensure that the organic solvent concentration in the environment is lower than the control concentration. At present, we are not considering setting up a new factory. In the future, we will decide whether to increase the production line depending on the sales situation.

  • Q

    As a shareholder of Oneness Biotech, I deeply admire the company’s face-to-face confrontation for the third phase clinical trials on the US new drug ON101. Since ON101 is made of natural plant extracts instead of chemical synthesis, here are some of my questions for the company:
    1.Has the company been able to analyze the purified substances (components) of ON101’s natural plant extracts and convince the FDA in a scientific way?
    2.Since ON101 is not a chemical synthesis, how can the company ensure that each ON101 has the same standard treatment efficacy if no natural plant extracts (components) are analyzed?

    A

    The research and development of ON101 follow the “Botanical Drug Development Guidance for Industry” specification issued by the U.S. FDA in 2004 (revised in 2016) and uses Good agricultural and collection practice (GACP) to control plant sources and study API ingredients. Corresponding specifications are formulated based on the results of ingredient research to ensure quality consistency between batches. At the same time, the phase three clinical trial was carried out with multiple batches of drugs. The results of the trials showed that the efficacy of the batches was also consistent.

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