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For the current investor conference, the seven Persian Gulf countries are added for market availability of Fespixon. What were your company's considerations while applying for marketing authorization in these seven countries?
Primary considerations include: 1) Fespixon has been available on the market in Taiwan for a year and meets one of the review criteria of the seven Persian Gulf countries. For the NDA submission route, after evaluation, the centralized submission expedited investigation procedure could hopefully be adopted. 2) Countries such as Saudi Arabia and the United Arab Emirates are known for their high morbidity rate of diabetes and also high per-capita income. In light of the market opportunities and regulatory strategy, the seven Persian Gulf countries were prioritized and included in the global medication accession program.
We would like to know what the primary considerations are in using a medical device as the market access route in India?
India is known for its huge number of diabetic patients and an extremely high incidence rate of foot ulcers; it is an important market for diabetic foot ulcers. In light of the low tolerance for prices of new drugs on the market of India, however, Oneness Biotech has decided to adopt the medical device Bonvadis that has a relatively friendly price while applying for market access so that the accession timeline can be expedited and accession to the market in India can take place as early as possible.
Why do the indications of the medical device applied for in Europe and in the US differ?
For the medical device applications in the US and the EU, the different indication strategy is adopted to reflect the regulatory strategy and accession requirements in the hopes of gaining market access as early as possible. At present, the medical device in the US has been approved for 510(k), with the indication being external wound care; expansion of indications is currently ongoing. The access application as a medical device in Europe, on the other hand, is based on the new medical device regulation MDR in Europe. First, the application is submitted with scar care as the indication and expansion of indications will be ongoing in the future as well.
With symptoms of coronavirus infections gradually turning mild, will it affect the market size of SNS812 in the future?
One of Oneness Biotech’s goals in the development of the new drug SNS812 is to turn COVID-19 flu-like. Over the long term, coronavirus can become cyclic epidemiology that recurs on a yearly basis. In the latest Science, the famous journal, released on 27th day of this month, it is indicated in the article entitled “Big COVID-19 waves may be coming, new Omicron strains suggest” that sub-variants of coronavirus, including the BA2 sub-variant BA.2.75.2 and the BA.5 subvariant BQ.1.1, will lead to “immune escape,” which is likely to trigger another big pandemic this winter. The winter is likely to be even colder with the rampage of the virus. SNS812 is a wide-spectrum small nucleic acid new drug, whose treatment effects are not compromised by mutant viral strains; it exercises significant preventive effects, too. Oneness Biotech will speed up in clinical trials and drug development schedule.
What is distinctive of FB704A with severe asthma as its indication compared to other drugs on the market?
Most of the biopharmaceuticals treating severe asthma that are available on the market around the world target the TH2 immunogenic pathway, such as the IgE neutralizing Xolair, IL4 receptor-targeting Dupixent, anti-IL5 Cinqair and Nulcala and TSLP-neutralizing Tezspire. FB704A targets patients with severe asthma who have more neutrophils in their sputum. Specialized drugs for this condition remain lacking. Regarding this medical cap, FB704A neutralizes IL6 while at the same time blocking the conventional and trans signaling pathway of IL6 so pharmacologically it can address severe asthma that recurs as a result of IL6 elevation and the triggered neutrophils entering the airway in large quantities. FB704A will offer patients with high-neutrophil count and severe asthma a treatment opportunity through a different pharmacological mechanism and hence is distinctive from drugs that are currently available on the market.
The Company will apply for fast-track registration through US FDA 510(k). Marketing authorization will be applied for in India, South Africa, New Zealand and Australia first. Will applications be submitted later in other countries, too?
US 510(k) approval is important reference for market accession of topical medical devices around the world. Based on the approval, the Company screened 27 countries where fast-track registration is allowed and conducted comprehensive assessments taking into consideration the review timeline/requirements for medical devices, the market size and the per-capita GDP, etc. Applications are planned to be submitted in India, South Africa, New Zealand, and Australia first and their status will be evaluated before market accession applications begin in other countries.
According to the QA on August 5, 2022, the indication to be applied for as a strategy in terms of a medical device is wound care in the US and scars in the European Union. Related indications are to be further broadened depending on subsequent market access.
What is the market size for wound care in the US? What is the market size for wound care in the European Union? What is the market size for wound care around the world?
What is the market size for scars in the European Union?
What is the market size for scars in the US?
What is the market size for scars around the world?
(a) According to the market survey of Precedence Research, the global scar treatment market in 2020 was approximately worth USD 20.6 billion and it is expected to reach USD 56.76 billion in 2030; that is, it will be growing at a compound annual rate (CAGR) of 10.7% from 2021 to 2030 and Europe and America will account for half of it.
(b) For the global market of advanced wound care products, according to a Reportlinker.com market survey, it is expected to reach USD 13.944 billion in 2026 and Europe and America will account for half of it.
Currently, there are multiple new drugs treating SARS-CoV-2 available on the market. We would like to know what is your estimated market share for SNS812. Once COVID-19 turns flu-like, given the fact that several years are needed in conducting a Phase 1-3 clinical trial, is it still of developmental value?
According to a recent report of a well-known analytical institution, the market size for the treatment and that for the prevention of COVID-19 in the coming 5 years will be worth USD 14 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 is still full of potential 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 last month (April), which drove the Company’s share price to take a dive.
To sum up, in terms of either prevention or treatment, COVID-19 remains as unmet medical needs and effective and safe drugs need to be developed urgently. SNS812 is known for its unique mechanism and can fight against all viral variants that have been known so far. It is likely to secure a presence on the market for preventive and therapeutic drugs. Nevertheless, we are highly cautious about its subsequent developments.
Questions from corporations:
What do companies think about ON101 Target TAM?
1. The latest data of the International Diabetes Federation (IDF) show that there are 537 million adults with diabetes around the world and it is expected that the number will reach 643 million by 2030.
2. Publications reviewed of the NEJM show that up to 19% - 34% of diabetic patients will develop diabetic foot ulcer at some point in their life while systemic review of global DFU epidemiology reveals that among the global DM population, the prevalence of DFU is up to 6.3% (13% in North America, 5.5% in Asia, and 5.1% in Europe). That is, more than 33 million patients around the world have DFU now and in North America, there are 6.6 million DFU patients; the number continue to climb as the DM population rises.
3. According to the 2020 global DFU drug market forecast of Frost & Sullivan, it will exceed USD 14 billion by 2030. ON101 is known for its unique macrophage regulating action and its market potential for treating different indications. It is now approved for treating diabetic foot ulcer. Other chronic wounds, such as bedsore, venous leg ulcers, or different chronic skin disorders, such as psoriasis, etc. For different indications, animal models and clinical trials are being conducting for exploratory purpose. All of these indications have a market size worth more than USD 10 billion and are opportunities for ON101 on the market.
Questions from corporations:
What is the current ratio of it in the treatment of diabetic foot ulcers?
The treatment ratio of diabetic foot ulcers is up to 90%-100%. Unlike ordinary chronic disorders, where the treatment rate is only 50%, a diabetic foot ulcer, once it occurs, tends to lead to amputation, which means disability in the daily life or mortality rate comparable to that of cancers. Therefore, the treatment rate of diabetic foot ulcers is high but the cure rate is low. In all cases, once a wound becomes ulcerative, the patient needs to see treatment.
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