| Subject |
Fespixon has been included in CSE Expert consensus on wound treatment of diabetic foot ulcer (2024). The health economics analysis supports its cost-effectiveness. |
- Date of occurrence of the event: 2024/07/25
- Company name: ONENESS BIOTECH CO., LTD.
- Relationship to the Company (please enter ”head office” or ”subsidiaries”): head office
- Reciprocal shareholding ratios: NA
- Cause of occurrence:
- (1)Fespixon developed by Oneness is the first approved class 1.1 new drug in China under natural drug category. After a strict and thorough review, Fespixon has been included in the ”Expert Consensus on Diabetic Foot Ulcer Wound Treatment (2024)” issued by the Chinese Society of Endocrinology (CSE). It recommends physicians to provide patients with innovative treatment options. It is also listed as the first therapeutic dressing in China, which is differentiated from the existing topical medications or dressings.
- (2)The expert consensus includes following:
- i)Based on the studies in diabetic ulcer etiology, the hyper-inflammation caused by high blood sugar is one of the main contributors to non-healing chronic ulcers. The imbalance between the two macrophage subtypes, pro-inflammatory M1 macrophages and pro-healing M2 macrophages is the key mechanism that intrigued the development of the chronic ulceration. Targeting the two macrophage subtypes is a new approach to treating diabetic foot ulcers (DFUs).
- ii)Fespixon is able to downregulate the activation of NLRP3 inflammasome and downstream inflammatory cytokines (IL-6、TNF-α、IL-1β) to inhibit M1 macrophage polarization and activates adipose progenitor cells to secrete GCSF and CXCL3, thereby promoting M2a/M2c macrophage polarization to control inflammation and accelerate the transition to the proliferative phase for promoting ulcer healing.
- iii)Targeting the two macrophage subtypes is a new approach to treating DFUs. The Class 1.1 Natural Drug, ON101 cream approved by NMPA in 2023 is targeting the macrophages to treat DFUs. It is also listed as the therapeutic dressing.
- iv)The post-market study results show that Fespixon has significant efficacy in hard-to-heal DFUs i.e. on dialysis patients, with bone exposure, with tendon exposure and with large ulcer size, which is an important progress in the treatment of DFUs, and health economics analysis supports its cost-effectiveness.
- (3)This consensus is published on Chinese Journal of Endocrinology and Metabolism, the top ranking journal organized by Chinese Medical Association on 2024.07.25
- Countermeasures: None
- Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 9 of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of the securities on public companies.):
- (1)This expert consensus was published by 21 multidisciplinary clinicians including Prof. Guang Ning, the past President of the Chinese Society of Endocrinology (CSE) and the Academician of Chinese Academy of Engineering, Prof. Weiqing Wang, the President elect of the CSE, Prof. Dalong Zhu, and Prof. Yemin Cao. It is clear in the expert consensus that ”Fespixon” can provide a novel treatment option for patients with diabetic foot ulcers.
- (2)The CSE expert consensus on wound treatment of diabetic foot ulcer acknowledged that Fespixon has significant clinical efficacy in hard-to-heal ulcers and is an important program in DFU treatment. The health economic analysis supports its cost-effectiveness. This will support the marketing and promotion in China where the clinicians and patients will use the product with confidence.
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