Fespixon® (research code: ON101), is known as the only etiology-driven solution by regulating macrophages to promote tissue repair. This blockbuster new drug in Oneness Biotech (Oneness) portfolio has been out-licensed to CR Double-Crane who stands out from the pharma partner candidates after more than 7 months business negotiation. Oneness and Microbio (Shanghai) have jointly signed a 20-year exclusive agreement of Fespixon® commercialization right in China with CR Double-Crane.
This partnership is a significant milestone in global wound care market as diabetic foot ulcers (DFUs) have imposed a huge medical burden globally due to the lack of etiology-driven solutions. The annual increase in amputations reported by Geiss et al. also suggests that DFU treatment improvement is urgently needed.
China, the second largest pharmaceutical market in the world, has over 8.3 million DFUs patients and 1.6 million amputation, which further leads to death and disability, every year. The commercialization of Fespixon®, the first and only Class 1.1 new drug for DFUs, will fulfil the huge unmet medical need in China.
CR Double-Crane said that DFU is the most serious complication of diabetes mellitus. Patients and their families are physically and economically suffering from the high incidence, amputation and mortality.
According to the Agreement, CR Double-Crane will make an upfront fee up to US$34 million to Microbio (Shanghai) and sales milestone payment of US$13.6 million for each integer of RMB 1 billion net sales achieved (non-accumulated). If the annual net sales achieve RMB 5 billion, the upfront fee plus milestone payments will exceed US$100 million. The Agreement lasts for 20 years, till 2043.
Dr. Shuling Cheng, the President of Oneness commented that Oneness’s chronic wound portfolio, either as the new drug or as the medical device, has being launched to the global market rapidly. In May, the US FDA 510k clearance on Bonvadis®, for management of partial-thickness wounds (diabetic foot ulcers, venous leg ulcers, pressure ulcers), closed post-surgical wounds, 1st and superficial 2nd degree burns, was received, and now Fespixon® is entering into China market. According to the Agreement, Oneness will supply Fespixon® cream with the reasonable profit margin based on the scale of commercial purchase. In addition, Oneness will receive royalties based on Microbio (Shanghai)’s net sales per its agreement with Microbio (Shanghai). Oneness can recognize Microbio (Shanghai)’s revenue by 31.5% per its shares ownership of Microbio (Shanghai).
Chao-Long Chen, the Chairman of Microbio (Shanghai) and the Academician of Chinese Academy of Engineering, also pointed out that Fespixon® is the only new drug targeting the etiology of DFUs. The collaboration builds up a strong partnership between Microbio Group’s vigorous R&D innovation and CR Double-Crane’s well-established commercial capability. Based on the collaboration and solid clinical evidence, Fespixon® will soon become the best DFUs treatment option to the clinicians in China. With the mutual trust, it is also believed that both parties will expand their collaboration in the near future.
Wenchao Lu, the Chairman of CR Double-Crane said that the strategic collaboration with Oneness and Microbio (Shanghai) will benefit diabetic patients with a healthier and brighter future, which certainly brings synergy to the cross-strait new drug alliance. This year is CR Double-Crane’s 85th anniversary since establishment, and this collaboration is precious to CR Double-Crane. Having Fespixon® in China, CR Double-Crane’s team will be fully committed to patients’ access to the best treatment.
Oneness Biotech has submitted an application to National Health Security Administration for the inclusion in National Reimbursement Drug List (NRDL) last week (Jul 12th). China’s current treatments in DFUs include growth factors, dressings, traditional Chinese medicines and hospital pharmacy compounding drugs, but there are still needs for an evidence-based new drug with clinical value. The inclusion of Fespixon® in China’s NRDL will be the crucial determination of whether the patients in China will have access to this breakthrough treatment.
About Oneness Biotech Co., Ltd. (4743.TWO）
Oneness Biotech was established in 2008 and went public in 2011. Oneness has been dedicated to research and development of game changing treatments and its key pipelines include Fespixon® new drug and Bonvadis® medical device for chronic wounds, FB825, the Anti-IgE B cells mAb out-licensed to global pharma for US$530 mn, and SNS812, the pan-COVID siRNA new drug of which phase 2 study will be unblinded later this year. Oneness is committed to ESG and has been selected as an index component of the Dow Jones Sustainability Emerging Markets Index, included in the S&P Sustainability Yearbook 2023 and 2024, etc. It is also the only biotech company in Taiwan that received such ESG achievements.
About Microbio (Shanghai) Co., Ltd.
Microbio (Shanghai) is the subsidiary of Microbio Co., Ltd. in Taiwan and is also an important footprint in China for Microbio Group’s. Microbio (Shanghai) has obtained the China exclusive right of Oneness key pipelines, including Fespixon®, FB825 (anti-IgE B cells mAb), FB704A (anti-IL6 mAb), etc. Microbio (Shanghai) has established its own core technology in nucleic acid new drugs by targeting viruses and bacteria. One of the breakthrough new drugs developed from this platform technology is SNS812, the pan-COVID siRNA new drug of which the phase 2 study will be unblinded in Q4 this year.
About China Resources Double-Crane Pharmaceutical Co., Ltd. (SHSE: 600062)
CR Double-Crane has been established for 85 years and became public on Shanghai Stock Exchange since 1997. CR Double-Crane plays an important part in China Resources Pharmaceutical Group for new chemical entity development. CR Double-Crane has 16 subsidiary companies and approximately 13,000 employees. Its business includes new drug development, pharmaceutical sales and marketing, finished products production, manufacturing equipment, API production, etc. CR Double-Crane has diversified portfolio, quality products, strong capability in channel and end-users coverage, reputable brands and globalization advantages. Its ranking and competitiveness in pharmaceutical industry in China is among the top tier. It has received the designation of High and New Technology Enterprises, of Key High-Tech Enterprises in the National Torch Program, been ranked among Top 100 China Pharmas and been graded AAA for enterprise credibility.
