INVESTORS

FAQs (by Category)

Year Year
  • Q

    It is covered in news that
    Two SN812 products will be developed, that is, the therapeutic aerosol dosage form and the preventive nasal spray dosage form. The aerosol dosage form is ahead of schedule now. It is to be used in combination with medical face masks. Where the clinical trials will be headed has been discussed with the US FDA multiple times; it is expected that trials will be officially applied for in the second half of the year. In Taiwan, on the other hand, expedited review will be applied for once the clinical trial application is approved in the US.
    As for the preventive nasal spray, collaboration is ongoing with nasal spray manufacturers and viral research institutes in China. Safety qualification is expected to be completed in the second half of the year. Based on the trial and governing authority review status, clinical trials involving human subjects will begin in the future.
    Here are a few questions
    1. Is the said coverage correct?
    2. If it is correct,
    does it mean that the development of SNS812 occurs in two ways?
    The aerosol formulation is meant for therapeutic purpose; are the clinical trials taking place in the US?
    The nasal spray, on the other hand, is preventive in nature; are the clinical trials taking place in Mainland China?
    3. And what will be the clinical trials to take place in Taiwan?
    4. For the clinical trials to take place in Mainland China, the IND application is submitted locally or does the trial take place together following submission of the IND application in the US?

    A

    1.    For your questions, except for the nasal spray, which is pending communication between the State Key Laboratory and the regulatory authority in Mainland China and the fact that the actual timeframe of clinical trials is subject to the stance of the said regulatory authority, all the other information is correct. 
    2.    There are the nasal spray and aerosol dosage forms of SNS812. In vivo studies show that they render the preventive and therapeutic effects against COVID-19, respectively. In the US, the focus will be the aerosol therapy. In Mainland China, on the other hand, the dosage forms to be adopted in trials will be decided following communication with the governing authority.
    3.    In the US, the focus will be the  aerosol therapy.
    4.    Clinical trials in Mainland China are subject to communication between the State Key Laboratory and the regulatory authority on IND submission and whether they will take place concurrently as those in the US will depend on the regulatory’s opinion.
     

  • Q

    The clinical phase of SNS812 is yet to begin. Given the fact that there are already COVID-19 vaccines and oral drugs on the market now, once SNS812 is available in the clinical setting or on the market, will it have a promising future? What do you think will be the future for the pandemic and what is your strategy?

    A

    According to a recent report of a well-known analytical institution, as COVID-19 turns flu-like, the market size for the treatment and that for the prevention of COVID-19 in the coming 5 years will be worth at least USD 14 billion and USD 50 billion, respectively, a year. Although multiple vaccines are now available on the market, none of them can successfully inhibit the mutation and spread of the virus. The market remains huge for therapeutic drugs. Among the two types of oral therapeutic drugs that are already available on the market, the Merck’s nucleoside analog Molnupiravir does not work well and is associated with the risk of mutagenicity and the Pfizer protease inhibitor Paxlovid will interact with multiple drugs and hence is not indicated for many patients currently on medication. According to prior experience in the treatment of hepatitis and HIV, such drugs tend to trigger drug resistant viral strains to make the drug ineffective. In addition, a similar drug of Shionogi & Co., Ltd. was found with the risk of teratogenicity in April, which drove the Company’s share price to take a dive.
    Prevention or treatment, COVID-19 remains as unmet medical needs and wide-spectrum and safe drugs are urgently wanted while COVID-19 continues to mutate in particular. SNS812 is known for its unique mechanism and can fight against all viral variants that have been known so far. Subsequent assessments in clinical trials will be performed with the aerosol dosage form and nasal spray dosage form. It is likely to secure a presence on the market for preventive and therapeutic drugs. Nevertheless, we are highly cautious about its subsequent developments.
     

  • Q

    Is SNS812 defined in terms of delivery, synthesis, and conjugates? Are there preliminary findings on its biological effects?

    A

    Synthesis, modification, and biological efficacy data of SNS812 were released in the EMBO Molecular Medicine journal in February this year; journal link:https://doi.org/10.15252/emmm.202115298

  • Q

    According to the video you played yesterday, does the mechanism of action of SNS812 nearly cover all so-called flu viruses, including SARS-CoV-2 and prior prevalent flu viruses?

    A

    A cold can be a common one and an influenza. Experiments have proven that besides all mainstream COVID-19 variants, SNS812 can effectively inhibit the coronavirus strain (HCoV-229E) that leads to a common cold in humans.
    In other words, SNS812 is not only a SARS-CoV-2 drug but also a pan-coronavirus medicine.
    The flu virus and a coronavirus belong to different families. SNS812 is yet to be thoroughly tested in flu viruses.
     

  • Q

    The variants BA.4 and BA.5 of Omicron start to spread in South Africa, Singapore, and the United States again and they are even more contagious. The existing Delta virus is likely to be prevalent this summer. Does SNS812 work for these three new variants?

    A

    The variants BA.4 and BA.5 of Omicron are considered as “variants of high interest” as they are highly contagious and can evade the immunity following vaccination or a confirmed diagnosis. Oneness Biotech has finished comparing these variants versus Delta through DNA sequencing. All of them are still within the effective control range of SNS812.

  • Q

    The variants BA.4 and BA.5 of Omicron start to spread in South Africa, Singapore, and the United States again and they are even more contagious. The existing Delta virus is likely to be prevalent this summer. Does SNS812 work for these three new variants?

    A

    The variants BA.4 and BA.5 of Omicron are considered as “variants of high interest” as they are highly contagious and can evade the immunity following vaccination or a confirmed diagnosis. Oneness Biotech has finished comparing these variants versus Delta through DNA sequencing. All of them are still within the effective control range of SNS812.

  • Q

    I remember that you have said that SNS812 can “prevent against” and “treat” SARS-CoV-2.
    We would like to know, in your mice experiment, how long did the “prevention” last?
    Most of the people in Taiwan are getting their third dose now. Have you investigated for approximately how long will one be protected against the disease after he/she receives the third dose (that is, how long is duration of prevention?)
    Are there many countries in the world where people are receiving their fourth dose now? Do you recommend such vaccination practice?
    If your SNS812 can offer protection for a sufficient period of time, will it also exercise an efficacy similar to that of a vaccine?

    A

    1.    Experimental data have shown that SNS812 is capable of protecting against or treating the virus in 12-24 hours and such ability can last for 2-3 days.
    2.    Many related publications are released around the world. It is universally accepted that vaccination helps prevent against critical conditions. The effect in the prevention against infections, however, differ significantly according to data contained in different publications. The actual data in Israel and other countries with the vaccination rate is high show that vaccines can no longer effectively prevent against the infection and the spread in the face of variants of the virus and hence the R&D of therapeutic drugs is even more important.
    3.    Currently, vaccination with the fourth dose is being encouraged in countries such as Israel, Switzerland, and Chile. Whether vaccination shall be continued or not depends on viral variance, the effect of the vaccine, and public health policies in respective countries.
    4.    SNS812 works differently from a vaccine and does not give rise to antibodies through the immune system; instead, it kills the virus directly to render a therapeutic effect. Protection over several months, several years, or even throughout one’s life, which is associated with traditional vaccines, is impossible. Experimental data have shown that SNS812 is superior in that it acts quickly and extensively and can prevent against or treat the virus in 12-24 hours following administration. A vaccine, on the other hand, becomes protective in 3-4 weeks after injection. The current scope of action of SNS812 covers all variants of SARS-CoV-2 having announced by the WHO so far.
     

  • Q

    It is indicated in the CNN coverage that to prevent against contracting the virus, vaccines need to be able to kill it. The measles vaccine can realize sterilizing immunity yet the COVID-19 vaccine that is currently available is unable to do so.
    Can your SNS812 bring about sterilizing immunity?

    A

    “Sterilizing immunity” means that the human body becomes immune to specific pathogens through vaccination. Once immune cells are activated, they generate cytotoxic or neutralizing antibodies that help remove infected cells or antibodies that neutralize the virus inside the body in order to fight against the virus. “Sterilizing immunity” exactly refers to the memory effect caused by activated immune cells that can exists inside the body over the long term and can quickly respond to the virus upon re-infection to render herd immunity so that the pathogen cannot spread in the population and disappear accordingly. It is a preventive public health approach.
    SNS812 is not a vaccine and does not prevent against infections by generating antibodies through immune activation; instead, it specifically destroys key genes replicated upon proliferation of the virus to block viral replication and accordingly kill the virus and render the therapeutic effect. Therefore, SNS812 does not trigger the "sterilizing immunity" effect just like what a vaccine will do.
    According to the latest findings of scientists at the Boston Children's Hospital released early this month in Nature, SARS-CoV-2 can infect immune cells without going through the familiar ACE2 receptor and the antibody naturally generated inside the body of someone infected with SARS-CoV-2 can become a pathway for SARS-CoV-2 to infect monocytes. The antibody of someone inoculated with an mRNA vaccine, on the other hand, does not act this way. Such an important invention shall be subject to more scientific research subsequently.
     

  • Q

    According to the data that are available now, an explosion in the COVID-19 cases is likely to occur in May in Taiwan. It is already pointed out in related studies that infection with COVID-19 is likely to trigger brain inflammation and chronic hypoxia not only in severe cases but also in patients with mild symptoms. It is shown in a report recently published in Nature that even with "mild brain hypoxia", it can lead to localized hypoxia in the central nervous system and energy deterioration.
    This aftereffect is horrifying. If it does occur, nearly no one can be saved from it in the coming year. I would like to know how to join in a human experiment in Taiwan or how to join your experiment plan?
    Thank you.

    A

    SNS812 is significantly inhibitive of all major viral strains of COVID-19 that have been found so far and covers up to 99.8% of all variants as shown through DNA sequencing. For SNS812, the CMO has been authorized to expedite the manufacturing of nucleic acid drugs and the toxicology experiment advised by the US FDA is being conducted with the CRO. Clinical trials will begin as soon as possible. The IND application is scheduled in the US at present. Depending on the developments of the pandemic, it is not excluded to also submit the applications in Taiwan and in Mainland China. An announcement will be made as required upon approval of the said trials.

  • Q

    We would like to know if SNS812 works in all viral strains that have been released so far and what are the business opportunities and developmental strategies in the future?

    A

    Yes, new experiment data support the efficacy of SNS812 and cover other coronaviruses in addition to SARS-CoV-2. SARS-CoV-2 has progressed from Alpha, Delta, Omicron, to BA.2; the variance is astonishing within more than a year. While governments around the world decide to co-exist with the virus, it will be transmitted back and forth in the huge population and there will be new variants one after another. SNS812 is the most potential drug in the fight against viral variants that is currently available on the table. Strategically, Oneness Biotech and Microbio Shanghai are promoting clinical trials at the fastest speed and are validating the safety and efficacy of SNS812 in humans. In addition, collaboration with international pharmaceutical companies will be deployed concurrently after clinical data in humans are obtained.

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