Oneness Biotech Co., Ltd.

FAQs (by Category)

Year Year

Q
We would like to know if the FDA disapproval of waiver of the ON101 skin and systemic carcinogenicity study will affect the scheduled submission of the US NDA of ON101.

A

The completed long-term toxicology study, genotoxicology study, and reproductive toxicology study among others, consistently show that ON101 is highly safe. As such, Oneness Biotech is optimistic about the waiver of the ON101 carcinogenicity study and the scheduled NDA submission in the US is not affected.
Q
It was mentioned during the investor conference that patent application is prioritized for FB825. We would like to know what the impacts of the patent on FB825 are.

A

The patent priority is meant to protect the results of the FB825 exploratory trial. The new IgE B-cell sub-group that is found features a greater quantity of cells and easier analysis. It is in the early division stage where a new mechanism for the FB825 to quickly bring down the AD disease index is likely to be inferred. The surface antigen properties of the cells can render analytical and test methods. As experimental data accumulates in the future, chances are that they will become useful biomarkers and help with the selection of the target population for FB825 or serve as a reference in the evaluation of the efficacy. If companion diagnostic reagents are further developed with said biomarkers and linked to the efficacy of FB825, it will be exclusive and contribute to the monopoly of the market for FB825.
Q
We would like to know, since Fespixon is primarily prescribed by plastic surgery specialists and is also prescribed by orthopedists, general surgeons, and dermatitis, if these physicians are using it consistently in diabetic foot ulcers.

A

Study data of “Fespixon” are released in JID innovations. Study data have shown the pathway characteristics of “Fespixon” in activating ADPC and stimulating M2a and M2c macrophages, demonstrating that it is highly potential of treating wounds. These two proven pathways inspired clinicians to try using “Fespixon”in varous types of wounds. Physicians in multiple disciplines are prescribing “Fespixon” now, with the primary indication being diabetic foot. Some physicians, however, use “Fespixon” in pressure sores, acute wounds, burns, and various wounds that do not heal easily after surgery; all of them show optimal efficacy, too. For these indications, subsequent planning will be activated once exploratory clinical trial results are available.
Q
About Fespixon, we have one small suggestion and would like to know what you think:
Although it is indeed good news for DFU patients that require chronic treatment with the current 15 mg package, for small wounds or for other indications in the future, one tube can be used over an extended period of time (the amount used in plastic surgery or surgical scars can be less than that needed for DFU), which might impact promotion on the market or the revenue to a certain extent. The packing size on the market for medical devices in Europe plays a role to a certain extent, too, in the future.

A

For the Nanzhou Plant, production processes for different sizes, namely, 3g, 15g, and 50g, are currently in place. Permits for different packing sizes are being applied for. Products will be supplied reflective of the market demand and indications in the future.
Q
Fespixon has been available on the market in Taiwan for a year. There should be several thousands of users over the past year. Are there any reports of adverse effects? What did first-line physicians say? Data from the users over the past year should be considered as those of a Phase 4 experiment. Can they be used to support applications in respective countries for additional indications in the future?

A

1. No adverse effects have been reported to this date since Fespixon became available on the market. In addition, no adverse events were included in the PBRER reporting during the pharmacovigilance period (statistics as of March 26, 2022).
2. Post-marketing cases show that it contributes to quick healing of wounds such as foot ulcers, pressure ulcers, and venous ulcers in diabetes. It takes care of blood circulation and infection control at the same time. The real-world (post-marketing) cases of completely healed diabetic foot ulcers were presented to the American Diabetes Association (ADA) this year and released in Diabetes 2022: 71 (Supplement_1): 490-P, too.
https://diabetesjournals.org/diabetes/article/71/Supplement_1/490-P/145905/490-P-Macrophage-Regulating-Drug-Promotes-Tissue
Q
Next, FB825 will enter Phase 2b in research and development. For the subsequent R&D budget of FB825, it will be coming from LEO Pharma’s investment.
As far as Oneness is concerned, it saves expenditure on the research and development of the drug. Where will the Company be headed for in R&D or what will be the Company’s new plan while it takes us, the shareholders, towards the next goal?
From a different perspective, the annual R&D budget of the Company or other expenses shall reach a certain amount. Following issuance of the GDR, the Company now has plenty of cash in hand. With the investment in Diamond BioFund, lots of additional income shall be recognized, too.
Will you take advantage of the cash or the income while leading shareholders towards research and development or making re-investments? What are your plans?

A

The new drugs being researched and developed at the moment by Oneness include ON101-DFU (Ph3-US), ON101-VLU (Exploratory), ON101-Radiation ulcer (Exploratory), PAF4-IBD (Exploratory), FB825-AD (Ph 2a), FB825-AA (Ph 2a), FB704A-Neutrophilic Asthma (Ph 2a), FB704A- CBD (CKD induced CBD) (Exploratory), OB318 (Ph1), and SNS812 ( 2022Q3- Ph1). All of them are primarily meant to fulfill unmet medical needs around the world. With competitors being powerful international pharmaceutical companies, Oneness must devote itself to science and follow regulatory requirements while progressing proactively. Risks have to be carefully controlled for each step taken so that risks may be mitigated in the pursuit of maximum benefits.
Q
Questions from corporations:
When will “Fespixon” be included in National Health Insurance?

A

The NHI reimbursement pricing was already submitted to the National Health Insurance Administration in December 2021 and supplementation of documents was completed in February 2022. The CDE issued the first draft of the Health Technology Assessment (HTA) Report on the 12th day of this month and Oneness Biotech already addressed them last week. According to the single submission cases of the National Health Insurance Administration (NHIA), the median time to approval of price of a new drug, that is, from acceptance of complete application documents to the drug price taking effect, over the past 5 years is 8.7 months and the mean time is 9.7 months (excluding supplementation of documents). For the actual review duration, however, it depends on the review findings of the NHIA.
Q
Hi, I have a Swiss friend who says that his relative had an amputation due to DFU. I remember that you said that the five-year survival was less than 60%. I would like to know whether ON101 can be used to increase chances of a recovery. Life is wonderful and I do hope that it can become available on overseas markets as soon as possible to benefit DFU patients around the world.

A

1. In case of new ulcer, post-amputated patients can use the Fespixon cream. Among the 236 subjects enrolled in the international multi-center Phase III clinical trial, around half of them had amputation prior to entry to the trial. Phase III clinical results show that even in patients who had prior amputation, the ratio of complete healing with the use of Fespixon is far greater than the standard of care currently available.
2. Oneness Biotech already works with international consulting companies now to provide the Early Access Program in regions where Fespixon is yet to be available on the market to benefit DFU patients early on. You can send a letter to fespixon@tannerpharma.com; for related information, refer to https://tannerpharma.com/oneness-biotech-and-tanner-pharma-group-initiate-early-access-program-for-fespixon-a-novel-macrophage-regulating-new-therapy-for-the-treatment-of-diabetic-foot-ulcers/.
Q
When will the royalties of FB825 be recognized?

A

The royalty income of FB825 can be fully recognized in Q2 2022 when the CSR is completed.