On the 21st, the Microbio Co., Ltd. announced that its subsidiary, Oneness Biotech, has licensed its new diabetic foot ulcer drug, FESPIXON®, to China Resources Double Crane Pharmaceutical Company. The two parties have signed a 20-year long-term agreement, granting CR Double Crane the exclusive sales rights for FESPIXON® in the Chinese market.
According to the contract, the Microbio will initially receive approximately NT$1.1 billion in signing fees, with additional milestone payments and sales royalties based on sales performance with no upper limit.
Industry insiders point out that given the 20-year agreement, the urgent need for diabetic foot ulcer treatments in China, and CR Double Crane’s extensive medical network, FESPIXON® is expected to become a billion-dollar blockbuster in China. This represents the most significant operational milestone for the Microbio since the pandemic.
FESPIXON®, known as "Shang Le Tang Foot Ointment" in China, was developed, approved, and produced by Oneness Biotech, with market rights in China managed by Microbio (Shanghai), a subsidiary of the Microbio.
The signing ceremony, involving Oneness, Microbio (Shanghai), and CR Double Crane, anticipates sales to begin in August, aiming for inclusion in China's National Medical Insurance by November. From January next year, patients in need across China could benefit from the drug under insurance coverage.
Microbio (Shanghai) is a 58.32% subsidiary of the Microbio, with Oneness Biotech holding a 31.5% stake. Market expectations suggest that the partnership with CR Double Crane will benefit both Oneness and the Microbio.
CR Double Crane is expected to pay a signing fee of up to USD 34 million (approximately NT$1.12 billion), with around USD 6.8 million contingent on the outcome of the insurance inclusion. Additionally, for every additional RMB 1 billion (approximately NT$4.5 billion) in sales, CR Double Crane will pay a milestone payment of approximately USD 13.6 million (around NT$446 million) to the Microbio, continuing until 2043.
In terms of production and profit-sharing, Oneness Biotech will supply FESPIXON® from its Nanzhou plant to Microbio (Shanghai) under the contract, ensuring reasonable production and sales profits. Based on the licensing agreement between Oneness and Microbio (Shanghai), a certain percentage of royalties will be derived from net sales, and Oneness will share in the operational results through equity accounting.
Oneness's development of FESPIXON® spans 15 years, obtaining drug approval in China in November 2023. It is China’s first Class 1.1 natural drug and the first specialized new drug for diabetic foot ulcers in China. Oneness Biotech submitted an application for "Shang Le Tang Foot Ointment" to be included in China's National Medical Insurance on July 12, aiming for approval by the end of November and full sales under insurance prices from January next year. Additionally, FESPIXON® has undergone clearance inspections in Beijing and is expected to be available for self-paid sales in August.
Oneness Biotech's President, Chen Shuling, noted that there are 140 million diabetes patients in China, with diabetic foot ulcers being a significant complication. The demand for medication is urgent, and CR Double Crane’s sales network will efficiently provide patients with the benefits of this new treatment. Chen Chao-Long, Chairman of Microbio (Shanghai), indicated that the collaboration with CR Double Crane could extend beyond FESPIXON® to other joint ventures.
CR Double Crane's Chairman, Lu Wen-Chao, expressed that this strategic partnership with Oneness Biotech and Microbio (Shanghai) will bring a healthier and more hopeful future for diabetes patients. This collaboration injects new vitality into cross-strait joint new drug development, ensuring that Chinese patients receive the best new drug treatments.
Resource (mandarin): 合一新藥攻大陸千億市場 11億元簽約金到手
