Oneness Biotech Co., Ltd.

FAQs (by Category)

Year Year

Q
Are you confident with the replies to be received on contents of the supplementation for the new drug approval issued in Mainland China? Are you confident about acquiring the new drug approval in Mainland China?

A

1. The CDE of Mainland China issued the notification on supplementation for the new drug approval of ON101 in April. Oneness already solicited advisory opinions on the supplementation from the regulatory perspective and the scientific perspective. According to the data released in the China Guide to Prevention Against Diabetic Foot (2021), the annual incidence rate of DFU in Mainland China is 8.1%; the annual recurrence rate is 31.6%; the annual mortality rate is 14.4%; 45% of the patients are of Wagner Grade 3 and above (moderate to severe condition); and the total amputation rate is 19.03%. It is obvious that DFU in Mainland China is seriously life-threatening for the patients, which is even worse than certain types of cancer. No effective treatments are available at present.
2. Fespixon is based on robust scientific research findings and supported by clinical trials in terms of its efficacy. Oneness will continue to promote the marketing of Fespixon in Mainland China so that the local patients have access to the new drug, Fespixon, too.
Q
According to the international multi-center Phase III clinical trial that has been completed, for the dosing and treatment cycle, when estimated by the area and size of the wound, in the case of an ulcer area of ≦2 cm2, 2 - 3 cm2, 3 - 4 cm2, 4 - 5 cm2, and 5 - 10 cm2, time to healing is estimated to be 64 days, 73 days, 75 days, 80 days, and 80 days and the amount of medicine expected to be used is 2 tubes, 3 tubes, 4 tubes, 5 tubes, and 7 tubes, respectively.
International multi-center Phase III clinical trials are known for their stricter criteria, such as no enrollment in the study of patients within 4 weeks following revascularization and no treatment with negative pressure or hyperbaric oxygen, etc. In the real post-marketing world, there are no restrictions at all so far. The wound/ulcer will heal within an even shorter period of time with the use of 1-3 tubes of Fespixon.

A

The certification procedures for both medical devices and medicinal products is based on the US FDA’s regulations. Medical devices differ from medicinal products in their approval process primarily in the review procedure and time. Medicinal products need to go through Phase I, II, and III clinical trials and a lengthy review process while medical devices may be reviewed on the basis of their documentation or be applied for upon completion of one clinical trial. Prior to distributing medical devices or medicinal products, talks with the insurance company over the pricing strategy and scope of payment are needed in the US. Inclusion for insurance benefits is the key. The so-called difficulty, on the other hand, does not apply in the doctor’s prescription. Whether or not a medical device or medicinal product is covered by insurance and its market price have to do with demand on the market and product innovation/superiority.