INVESTORS

FAQs (by Category)

Year Year
  • Q

    The Animal Challenge Study showed that the aerosol administration of SNS812 had a good preventive effect (administration before infection). Since this preventive effect is good, can it be made into a COVID-19 preventive drug? How long is the effect limitation that hits the common vaccine? And how long is the preventive validity of SNS812? Is the preventive effect of SNS812 economically beneficial?

    A

    SNS812 can significantly reduce the amount of lung virus of the original virus strain in the Animal Challenge Study before (after) administration, and has the chance to become a novel coronavirus preventive (treatment) drug with the method of administration of taking once a day. Unlike a vaccine, SNS812 attacks parts of the virus that are not easily mutated, fighting all mutant strains. Trials are ongoing to verify the efficacy and safety of the drug. It is expected to contribute to the increasingly serious problem of vaccine breakthrough caused by mutant strains in the world.

  • Q

    The news said that NTU has developed a “nasal-spray COVID-19 vaccine” with remarkable results in animals! Human trials may be conducted at the end of the year! Does NTU also adopt the aptamer technology? Can SNS812 be developed as a “nasal-spray COVID-19 vaccine”?

    A

    Vaccines protect the human body by producing antibodies. SNS812 is a nucleic acid therapy drug developed by OnenessBiotech. The two mechanisms of action are different and there is no correlation between them. 

  • Q

    Have you obtained the test results of SNS812? What is the follow-up research and development?

    A

    1. The results of the fourth challenge of ACE2 transgenic mice showed that the expression level of virus genes in the lungs of the mice in the administration group was reduced by more than 99.9%, and the quantitative difference of living virus reached 105.

    2. Animal challenge experiments show that aerosol administration of SNS812 has a good preventive effect through administration first before infection. The R&D team is exploring the therapeutic effect through infection first before administration, and different dosages shall be given to determine the effective dose range.

    3. We confirm that SNS812 can completely inhibit various mutant strains currently known, including Delta strains through new cell experiments. 

  • Q

    What is the pharmacological effect of the experimental drug FB704A the company expected to be used this year for patients of severe COVID-19 pneumonia? Give an injection or take medicine orally? What is the cost? What is the advantage over the current EUA drugs for COVID-19 pneumonia? What are the advantages compared with domestic competing companies?

    A

    1. FB704A is a fully humanized anti-IL6 monoclonal antibody by neutralizing IL6 cytokine and inhibiting the immune trans-signaling pathways of IL6/IL6R to suppress the cytokine storm. The excessive activation of the immune trans-signaling pathways of IL6/IL6R triggers a cytokine storm, which is the main reason for the deterioration of the severe patients. Therefore, it is expected that FB704A can alleviate the deterioration of severe COVID-19 pneumonia.

     

    2. FB704A is currently administered by intravenous infusion, and the dosage form for subcutaneous injection is under development.

     

    3. FB704A is a drug in research and development without the price released yet.

     

    4. Among the EUA drugs currently approved by FDA, Roche’s Actemra (Tocilizumab), already on the market, has the same mechanism of action as FB704A. Preclinical experiments have shown that the advantages of FB704A include: it is a fully humanized antibody with high immunocompatibility; it targets free IL6, ensuring highly safety of human cells; it has a stronger ability to inhibit the immune trans-signaling pathways of IL6/IL6R than Tocilizumab in cell experiments.

    The mechanism of action of FB704A is different from that of other drugs, but it is impossible to contrast without clinical data available at present.

  • Q

    Does the company have other development plans after the Phase IIa clinical trial of FB825?

    A

    After the Phase IIa clinical trial of FB825, LEO Pharma is solely responsible for the development planning with Oneness’s assistance in product knowledge. In order to improve the value of FB825, LEO Pharma is actively trying to determine its other potential indications. Currently, 7 potential indications have been evaluated and further research will be made based on the results. At the same time, the company is looking for a drug in combination with FB825 to develop a more economical dual-effect antibody with good efficacy.

  • Q

    1. What is the effect of the FB704a+, a traditional Chinese medicine formula NRICM101, developed by the company on acute respiratory distress syndrome (ARDS)? Similar IL6 drugs abroad have little effect when combined with concomitant drugs such as steroids, antibiotics, and remdesivir. If it is combined with traditional Chinese medicine, it may have a surprising effect.
    2. Does the company believe that the best way to treat severe symptoms of Covid-19 is FB704a (resolvable side effects of RNA drugs) + antiviral drug SNS812 (under development, the schedule will take some time). Or is it sufficient to rely on SNS812 alone?
    3. Nucleic acid-based drugs not only attack viruses but also destroy cancer cells. In addition to the treatment of COVID-19, will SNS812 of the company direct towards the treatment of cancer and other indications in the future?
    4. Will there be a combined treatment of FB704a+SNS812 in a. coronavirus; b. cancers such as lung cancer, liver cancer, and kidney cancer in the future?

    A

    1.The mechanism of action of FB704A is to neutralize IL6, the source of ARDS, and block the cytokine storm. In the guidelines issued by the NIH in the United States on May 27, 2021, it is recommended that patients who are hospitalized and who used High Flow Nasal Cannula (HFNC) or Noninvasive positive pressure ventilation (NPPV) can be treated with tocilizumab + dexamethasone, or tocilizumab + dexamethasone + remdesivir. Taiwan Centers for Disease Control also recommended in the tenth edition of Clinical Management of Covid-19 Interim Guidance that patients with severe pneumonia or higher and CRP≥7.5 mg/dL can be treated with concomitant drugs such as Remdesivir, Dexamethasone (steroid), and Tocilizumab (Roche Anti-IL6 receptor antibody drug). Therefore, the combined treatment of severe COVID-19 with Remdesivir, Dexamethasone, and Tocilizumab has currently become the guidelines for international standard treatment.

    To use it with the traditional Chinese medicine formula NRICM101, it is necessary to fully understand the mechanism of action and make a decision only after the experiment.

    2.According to the mechanism of action of the drug, SNS812 directly eliminates the virus and accelerates the recovery of the patient. However, critically ill patients are mainly caused by the secondary excessive immune response and cytokine storm, which cannot be cured simply by removing the virus alone. IL-6 plays a key role in the cytokine storm caused by COVID-19. However, a number of clinical trials in 2020 show that no significant difference in mortality reduction between Tocilizumab and the control group could be observed. According to the clinical trials published in scientific journals this year, administering drugs that inhibit IL-6 at the right time can indeed reduce the mortality rate and length of hospitalization days in critically ill patients. That is, by inhibiting IL-6, there is a chance to improve the symptoms of severely ill patients and relieve the pressure of ICU resources.

     

    3.SNS812 specifically targets the coronavirus gene without anti-cancer effects.

    4.There is currently no experiment on the combined treatment of SNS812 and FB704A.

  • Q

    Is it feasible to inhale SNS812 directly into the lungs through ultrasonic vibration atomization?

    A

    The drug administration of SNS812 in the form of ultrasonic vibration atomization should take into account the uniformity of the size of the atomized particles, and whether the atomized particles can be inhaled deep into the tissues of the lungs and be evenly distributed to achieve the effect of virus inhibition (still underway). However, ultrasonic vibration atomization may cause damage to nucleic acid-based drugs and still need to be evaluated. 

  • Q

    Is the company thinking about the possibility of FB704A because there are technical problems and cannot break through in SNS812? What is the company’s direction for the development of these two new COVID-19 drugs?

    A

    1.Both pharmaceutical drugs under research and development, SNS812 and FB704A have different mechanisms of action. As a small nucleic acid-based antiviral drug, SNS812 suppresses the virus to reduce the amount of virus and achieve the purpose of medical treatment. FB704A, on the other hand, is to target the cytokine storm and respiratory distress caused by severe COVID-19. By inhibiting the IL6 hormone, the key factor for inflammation, FB704A reduces the host’s excessive inflammation and relieves the symptoms.

    2.Having established a nucleic acid and antibody technology platform, Oneness Biotech has independently developed SNS812 and FB704A, both of which are pharmaceutical drugs that are first-in-class. Originally, we didn’t expect that the COVID-19 would continue to spread, therefore, we only initiate the R&D of SNS812. In view of the currently increasing number of critically ill patients, FB704A has an advantage over the anti-IL6 drugs of the international pharmaceutical companies in alleviating severe illness during a certain process of viral infection. Currently, it is still under further investigation.

  • Q

    Who does Taiwan apply to for the IND of SNS812, Taiwan or the United States? Which among the two is faster than the other in terms of R&D progress? Will it be faster if the two are carried out at the same time? Does the company have any ideas?
    There was news yesterday suggesting that a company in Australia and the United States is developing a COVID-19 nucleic acid-based aptamer antidote. Do you know about the R&D progress? Is the R&D progress faster or slower than yours?

    A

    It is originally planned to apply for IND to the United States if SNS812 is developed successfully. Considering that the nucleic acid-based drug belongs to a new generation of drugs, the US FDA has sufficient expertise and review experiment in this type of drug, and has the largest number of patients needing this type of drug, it is helpful for the progression of subsequent clinical R&D. However, with the spread of COVID-19 in Taiwan, we will consider the possibility of accelerating the progress at the same time.

    The experimental results of siRNA drugs developed by the academic institutions in Australia and the United States are published in the “Molecular Therapy” this month. In terms of R&D progress, they are still in the pre-clinical R&D stage. In particular, the animal data published shows that the drug has limited improvement in mouse body weight and mortality rate, thus further optimization is needed. 

  • Q

    Regarding the current COVID-19 pandemic, the vaccines have gradually reached market saturation, shifting major international manufacturers to the research and development of antiviral drugs. So far as I know, none of the antiviral drugs currently sold on the market has any significant effect, where Remdesivir only reduces the number of hospitalization days. On the R&D side, Pfizer’s PZ07321332 should have the fastest progress, which is expected to have the Phase I clinical trials carried out by the end of May this year. In terms of your company’s expertise, may I ask which companies in the world are currently conducting research and development on the antidote to COVID-19 (already in Phase I clinical trial)? If everything goes well, when is your company expecting to conduct Phase I clinical trial on SNS812?

    A

    1.In addition to Pfizer, representative COVID-19 drugs that have entered the clinical stage include Merck’s Molnupiravir, Ascletis’ Danoprevir, and Apeiron’s APN01. These are small molecule drugs that inhibit virus replication or prevent viruses from invading cells. Other than that, companies such as Regeneron and Lily were not originally intended to develop antibody drugs for COVID-19 but have been granted the Emergency Use Authorization (EUA).

    2.It depends on the results of the animal challenge study of SNS812. Such new drugs using small nucleic acid siRNA to treat COVID-19 in the world have not yet entered human subject research. The main reason is that it is not easy to accurately deliver the drugs to the lungs. Under the collaboration between Oneness Biotech and Microbio (Shanghai) Co., Ltd., the R&D team has tried a variety of ways to administer drugs. We are still unable to confirm whether or not SNS812 can enter the R&D stage for the investigational new drugs (IND) by the end of this month. We ask you for your patience and will send out a public announcement when there is a breakthrough.

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