TWi Biotechnology Signs Exclusive License Term Sheet with R-Pharm for AC-203 to Treat Epidermolysis Bullosa Simplex

TWi Biotechnology, Ltd. (hereinafter referred to as "TWi Biotech" stock code: 6610) today (January 6th 2024) resolved to sign an exclusive license term sheet with R-Pharm, JSC (hereinafter referred to as "R-Pharm"), a well-known Russian pharmaceutical company, referring to AC-203, a new medicine in development for the treatment of Epidermolysis bullosa simplex (EBS). The exclusive development and commercialization rights in the territory of the Russian Federation were granted to R-Pharm, and in the future R-Pharm will be responsible for the regulatory activities, import, post-marketing and sales of AC-203 in the Russian Federation, while TWi Biotech is responsible for the production, manufacturing and export of the medicine.

Following the signing of the Term Sheet, TWi Biotech will enter negotiations with R-Pharm an exclusive license agreement for AC-203 in the Russian Federation. Further updates will be announced upon formal signing. This comes after exclusive agreements with Hong Kong Winhealth Pharma Group in 2020 for China, Hong Kong, and Macau, and Minophagen Pharmaceutical for Japan and Korea. With these partnerships, the global commercialization of AC-203 for EBS has reached a significant milestone, as TWi Biotech continues seeking worldwide licensing partners to benefit patients.

Hereditary epidermolysis bullosa (EB), often referred to as 'Butterfly Skin' globally, is a rare genetic disorder. It causes the skin to blister easily from minor friction or irritation, with wounds forming as blisters rupture. Symptoms typically begin in childhood and repeat throughout life, leading to severe skin damage, susceptibility to infections, and, in severe cases, life-threatening complications such as sepsis. This debilitating condition severely impacts the quality of life for those affected.

There are approximately 500,000 individuals worldwide affected by Epidermolysis Bullosa (EB), with Epidermolysis Bullosa Simplex (EBS) making up about 70% of cases. Currently, there is no approved treatment in Russian Federation. Global phase II/III EBS clinical trial called EBShield study is underway in multiple countries, including Taiwan, the United States, the European Union, the United Kingdom, Australia, Philippines, Israel, Korea and Malaysia.

TWi Biotech highlighted that the Russian Federation, with a population of nearly 150 million, presents a significant market opportunity. Licensing partner R-Pharm offers comprehensive healthcare solutions, focusing on research, development, manufacturing, and commercialization of pharmaceuticals, laboratory equipment, and medical devices. R-Pharm's mission is to enhance accessibility to advanced diagnostics, preventative care, and therapies both in Russia and internationally, aligning well with the commercialization strategy for AC-203.

With over 5,000 employees, R-Pharm is dedicated to improving and prolonging lives through innovative healthcare solutions. R-Pharm’s 11 state-of-the-art manufacturing sites are functioning in accordance with international quality standards. The group has signed agreements on strategic partnership, production localization and technology transfer with the world's leading manufacturers of pharmaceuticals and medical equipment. The most important activities of R-Pharm include research and development. Today, R-Pharm’s research pipeline contains more than 100 knowledge-intensive products, many of which are capable of making a serious contribution to the fight against high burden diseases. Following corporate social responsibility policies, R-Pharm organizes projects aiming to increase awareness about dangerous diseases, promote healthy lifestyle, improve the educational system and foster a new generation of professionals in the pharmaceutical industry.

TWi Biotech expressed its eagerness to accelerate the development and commercialization of AC-203 for the treatment of Epidermolysis Bullosa Simplex (EBS) in the Russian Federation. This collaboration with R-Pharm aims to bring new treatment opportunities to EBS patients, enhancing access to innovative therapies in the region.

Press Contact:

Chief Financial Officer Ruth Yang 

Tel: 02-26571788 ext. 600 

Email：pr-ir@twibiotech.com