On the 6th, TWi Biotechnology announced that it has signed a term sheet with renowned Russian pharmaceutical company R-Pharm, granting R-Pharm the exclusive rights to develop and commercialize AC-203, a new drug for the treatment of Epidermolysis Bullosa Simplex (EBS), in the Russian Federation. Under this agreement, R-Pharm will be responsible for regulatory affairs, importation, and future marketing and sales of AC-203 in the Russian Federation, while TWi Biotechnology will oversee the production, manufacturing, and export of the drug.
Following the signing of the term sheet, TWi Biotechnology and R-Pharm will further negotiate the exclusive licensing agreement for AC-203 in the Russian Federation, along with subsequent procedures. A formal announcement will be made upon the finalization of the agreement.
This collaboration marks another significant step in the global commercialization strategy for AC-203, following TWi Biotechnology’s 2020 exclusive licensing agreements with Hong Kong Winhealth Pharma Group for the China, Hong Kong, and Macau markets and with Japan’s Minophagen for the Japan and South Korea markets. TWi Biotechnology remains committed to pursuing global licensing partnerships to make AC-203 available to EBS patients worldwide, enhancing its economic value and creating long-term value for shareholders.
TWi Biotechnology explained that Epidermolysis Bullosa (EB), known internationally as "Butterfly Children" and locally in Taiwan as "Bubble Dragon," is a rare genetic disorder caused by gene mutations. Even minor friction or irritation to the skin can result in blistering, which may expand, rupture, and develop into wounds. The disease often manifests in early childhood and recurs throughout the patient’s life, leading to frequent skin infections, sepsis, and in severe cases, life-threatening complications.
Globally, EB affects approximately 500,000 individuals and includes multiple subtypes, with Epidermolysis Bullosa Simplex (EBS) accounting for about 70% of cases. Currently, there are no approved treatments for this condition. The most advanced therapy in clinical development globally is TWi Biotechnology’s AC-203, a topical medication. AC-203 is undergoing global multicenter Phase II/III clinical trials, with patient recruitment underway in Taiwan, the United States, the Philippines, Australia, South Korea, and European countries including Italy, Poland, and France. An interim analysis is expected in the second half of this year.
TWi Biotechnology emphasized that the Russian Federation, with a population of nearly 150 million, represents a significant market. Its partner, R-Pharm, is a leading player in the Russian pharmaceutical industry. R-Pharm collaborates strategically with global pharmaceutical and medical device manufacturers, engages in local production and technology transfer, and operates 11 state-of-the-art manufacturing facilities adhering to international quality standards. With over 5,000 employees, R-Pharm places a strong emphasis on pharmaceutical research and development and is dedicated to improving and extending human life. Currently, R-Pharm has over 100 drugs in development, many of which aim to address high-burden diseases and enhance healthcare quality.
TWi Biotechnology is advancing its global multicenter Phase II/III clinical trials for AC-203 and continues to seek high-quality partners to accelerate its development and commercialization. The company hopes to bring new therapeutic options to EBS patients worldwide who currently lack effective treatments.
Resource: 安成生技傳捷報 與俄羅斯藥廠R-Pharm簽新藥專屬授權
