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Shanghai, Haihe Biopharma Co., Ltd. (hereby referred to as “Haihe Biopharma”) today announced that the innovative drug "Fespixon^®" (research code: ON101) developed in collaboration with Microbio (Shanghai) Co., Ltd. (referred to as " Microbio Shanghai"), the subsidiary of Taiwan's Microbio Group, has obtained approval from the National Medical Products Administration (NMPA) for the treatment of diabetic foot ulcers (DFU) in Chinese mainland on Nov 9,2023.

DFU, an unmet medical need worldwide, is one of the leading causes of disability and death among diabetic patients, posing a serious threat to their lives and impact on quality of life as well as causing a huge medical burden and expenditure. The Phase III clinical trial of Fespixon^® is the first international multicenter randomized controlled trial led by academician Guang Ning, the superintendent of Ruijin Hospital Affiliated To Shanghai Jiao Tong University School of Medicine in China, to explore the efficacy of the M1/M2 macrophage-regulating drug for treating DFU.

This study has demonstrated the excellent therapeutic efficacy of ON101 in promoting complete healing of DFUs. The results of this study were successfully published in JAMA Network Open¹, an internationally renowned SCI journal., It has brought a new dawn to the worldwide DFU patients in getting back on their feet, and the approval in Chinese mainland will certainly benefit more patients.

The primary outcome of this study showed that 60.7% (74/122) of patients in the ON101 group achieved wound closure within 16 weeks versus 35.1% (40/114) of patients in the hydrofiber dressing control group (OR: 2.84; 95% CI: 1.66–4.84; P = .0001). Furthermore, the secondary outcome exhibited faster wound healing in the ON101 group than the hydrofiber dressing control group, with time to reach median population healing in 98 days, whereas the hydrofiber dressing group had undetermined outcome due to only 35.1% of patients reaching wound closure during the treatment period. In terms of safety, there were no statistically significant changes or differences between the two groups, demonstrating that ON101 is supported by good clinical safety.

"Congratulations to Fespixon^® for obtaining NMPA approval for marketing! Fespixon^® has a unique mechanism of action. The efficacy and safety profile for the treatment of DFU have been clearly demonstrated, and I believe that the market access of Fespixon^® can better solve the unmet clinical needs of patients."

Chronic DFU is attributed to hyperglycemia, delaying the transition of M1-M2 macrophages and prolonging the inflammatory phase. ON101, composed of PA-F4 extracted from Plectranthus amboinicus and S1 extracted from Centella asiatica, suppresses the expression of M1 macrophages by inhibiting the NLRP3-mediated inflammasome signaling pathway and the production of downstream inflammatory cytokines such as interleukin (IL)-6, tumor necrosis factor (TNF)-α, and IL-1β during the inflammatory phase. also facilitates the polarization of M2 macrophages by activating adipocyte precursors cells to increase GCSF cytokine and CXCL3 chemokine². Thus, the dysregulated expression of M1/M2 macrophages due to hyperglycemia will be rebalanced to enable the M1-M2 transition. This accelerates tissue repair and wound healing through regulating the transition from the inflammatory phase to the proliferative phase, enhancing collagen synthesis, stem cell infiltration. ON101 can not only treat new ulcers but also address those with high-risk factors, including ulcers with a duration of more than 6 months, ulcer size larger than 5 cm², and HbA1c levels greater than 9%, which demonstrate the efficacy robustness of ON101.

Diabetes has evolved from a rare disease to an epidemic one in China. According to the International Diabetes Federation (IDF) data in 2021, there are 141 million adult diabetes patients³ in China, with a prevalence rate of 13.0%³. The increase in diabetic foot ulcers has also been significant, at approximately 6.3%⁴ prevalence globally. Among Chinese diabetic patients over 50 years old, the incidence of diabetic foot ulcers reached 8.1%⁵ with an estimation of over 7.5 million DFU patients in China. The amputation of a diabetic limb occurs per 20 seconds worldwide, and 19.03% of DFU patients in China had an amputation. The mortality rate of DFU patients is 11%⁵ per year while it is even higher, reaching 22%⁵ if they had an amputation. The five-year mortality rate for DFU patients after amputation is approximately 50%, posing a severe threat to their lives. The costs of treating diabetic foot ulcers is enormous, accounting for approximately one-third⁵ of the total diabetes-related medical expenses, causing significant burdens on patients, families, hospitals, and society. Effectiveness in tissue repair is a crucial aspect of DFU treatment. On the basis of the internal medical interventions, timely and effective surgical interventions can facilitate wound closure early. However, there is a lack of innovative DFU-specific drugs clinically supported by high-level evidence. There is a significant unmet need.

Haihe Biopharma is a leading Chinese biotechnology company dedicated to the discovery, development, production, and commercialization of innovative anti-tumor drugs, aiming to provide safer and more effective treatment options for cancer patients worldwide. As a new drug development company led by academicians of the Chinese Academy of Engineering, Haihe Biopharma adheres to the path of independent innovation and has a research and management team with a global perspective, actively pursuing international development of innovative drugs. Currently, Haihe Biopharma has one approved product (Gumarontinib Tablets) and several candidate drugs in its focus pipeline.

Mircobio Shanghai, a subsidiary of Taiwan’s Microbio Co., Ltd., focuses on the research and development of global innovative drugs for the treatment of liver diseases, diabetes and infectious diseases.. In addition to the exclusive license of new drug Fespixon^® for China, Microbio Shanghai has established a unique microbial fermentation and nucleic acid technology platform as well as developed SNS812, an innovative drug under phase II clinical trials in the United States. The rest of the pipeline of Microbio Shanghai, including FB825 (new antibody drug for atopic dermatitis and asthma) and FB704A (antibody new drug for neutrophilic asthma) in Microbio Shanghai, are currently under phase II clinical trials.

References：
1、Huang YY, Lin CW, Cheng NC, et al. Effect of a Novel Macrophage-Regulating Drug on Wound Healing in Patients With Diabetic Foot Ulcers: A Randomized Clinical Trial. JAMA Netw Open. 2021;4(9):e2122607. DOI: 10.1001/jamanetworkopen.2021.22607
2、Lin CW, Chen CC, Huang WY, et al. Restoring Prohealing/Remodeling-Associated M2a/c Macrophages Using ON101 Accelerates Diabetic Wound Healing. JID Innov. 2022 Jun 2;2(5):100138. DOI: 10.1016/j.xjidi.2022.100138.
3、IDF Diabetes Atlas 2021 – 10th edition.
4、Zhang P, Lu J, Jing Y, et al., Global epidemiology of diabetic foot ulceration: a systematic review and meta-analysis. Ann Med. 2017 Mar;49(2):106-116. doi: 10.1080/07853890.2016.1231932.
5、中华医学会糖尿病学分会, 中华医学会感染病学分会, 中华医学会组织修复与再生分会. 中国糖尿病足防治指南（2019版）（Ⅰ）[J]. 中华糖尿病杂志, 2019,11(2):92-108. DOI: 10.3760/cma.j.issn.1674-5809.2019.02.004.