Expands Portfolio of Cataract Surgery Solutions for Patients in Greater China to New Extended Monofocal Segment

 AffaMed Therapeutics and SIFI Leadership Celebrate Strong Progress of the AffaMed Technologies Joint-Venture

Beijing, China, October 10, 2023— AffaMed Technologies (“AffaMed”), a joint venture established between AffaMed Therapeutics and SIFI S.p.A. (“SIFI”), today announced it has entered into a licensing agreement with SIFI under which AffaMed has obtained the exclusive rights to manufacture, develop and commercialize EVOLUX^®, a novel extended monofocal intraocular lens (IOL), in Greater China. During a signing ceremony held in Beijing, the CEOs of AffaMed Therapeutics and SIFI celebrated this important expansion of AffaMed’s portfolio of innovative premium IOLs for the Greater China market, and the strong progress achieved by their joint venture since its inception in April 2021.

EVOLUX^® is a novel extended monofocal intraocular lens (IOL), based on a hydrophobic material and a non-diffractive profile, designed to provide better intermediate vision and equivalent distance vision when compared to a standard monofocal IOL. EVOLUX^® was developed on a patented technology platform, pioneering the extension of the depth of focus through wavefront engineering. The applied optical technology provides an improved intermediate vision maintaining a well-performing distance vision, very low pupil dependency at far and intermediate distances, and similar image contrast with different pupil dimensions. Moreover, Evolux guarantees the safety of a standard monofocal IOL in terms of tilt and decentration and photic phenomena and provides a good tolerance to residual refractive errors. In this way, the new extended monofocal IOL Evolux can help patients with their everyday activities, making everyday life easier.

Following today’s announcement, AffaMed Technologies has the exclusive rights to develop, manufacture and commercialize the MINI WELL^®, MINI WELL TORIC^®, MINI WELL PROXA^®, EVOLUX^® and MINI 4^® Ready lines of IOLs in the Greater China market, including Mainland China, Taiwan, Macau and Hong Kong. As the industry-leading solutions for cataract refractive surgery, these IOLs can effectively correct refractive error, presbyopia, and astigmatism, and help patients achieve spectacle-free, high-quality vision at all distances and at all times.

During the signing ceremony in Beijing, the CEOs of AffaMed Therapeutics and SIFI further hailed the significant progress made by the AffaMed Technologies joint venture to offer patients in Greater China better outcomes in cataract refractive surgery. Key milestones achieved since the establishment of the joint venture include:

-        Completion of enrollment in the China Registrational Clinical Trial of its MINI WELL^® Extended Depth-of-Focus (“EDOF”) IOL.

-        Completion of the first patient implantations of its EDOF IOLs conducted in Boao, China, under the "Early and Pilot Implementation" policy.

-        TFDA Approval of MINI WELL^®, MINI WELL PROXA^®, MINI WELL TORIC^® and MINI 4^® Ready IOLs for cataract treatment in Taiwan.

-        Successful relaunch of MINI WELL^®, MINI WELL PROXA^®, MINI WELL TORIC^® and MINI 4^® Ready IOLs in Hong Kong and Macau under a strategic sales and distribution partnership.

“We are excited about the potential of Evolux to address the growing needs of patients in China in this new age” commented Dr. Dayao Zhao, CEO of AffaMed Therapeutics. “Visual needs have evolved in the recent decades, many older adults work beyond retirement age and live a more active life than in the past, they spend several hours per day on activities requiring good intermediate vision such as driving, reading price tags when shopping, cooking, reading at PC/tablet distance, or walking on uneven ground conditions. Choosing a monofocal IOL improving intermediate vision means helping patients with their everyday activities and making their life easier. We look forward to advancing Evolux towards regulatory approval, and to be able to bring its significant benefits in vision correction to patients in China in the near future.”

“I was delighted to finally have the opportunity to come to China, after the establishment of AffaMed Technologies in 2021.” commented Fabrizio Chines, CEO of SIFI. “I could experience first-hand the impressive progress the team is making towards availability of our pioneering cataract refractive solutions to Chinese patients. In only 2 years, we have seen many exciting advancements in clinical development, regulatory, marketing and sales. Making good on our pledge to bring further innovation to Greater China, Evolux will allow a broader patient population to achieve uninterrupted high-quality vision from far to intermediate distance, once approved by regulatory authorities.”

About AffaMed Technologies

 Established in 2021, AffaMed Technologies is the joint venture between AffaMed Therapeutics and SIFI S.p.A. ("SIFI"), a leading international ophthalmology company headquartered in Italy, to develop, manufacture and commercialize premium intraocular lenses (“IOLs”) in the Greater China market.

About AffaMed Therapeutics

AffaMed Therapeutics is a clinical stage biopharmaceutical company focused on developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmological, neurological and psychiatric disorders for patients in Greater China and around the world. The leadership team at AffaMed Therapeutics has gained deep industry expertise and an extensive track record in high-quality discovery, clinical development, regulatory affairs, business development, manufacturing, and commercial operations at leading multi-national biopharmaceutical companies in China and globally.

About SIFI

SIFI is a leading international ophthalmic company, headquartered in Italy, focusing on eye care since 1935. SIFI develops, manufactures, and markets innovative therapeutic solutions for patients with ophthalmic conditions. SIFI is fully committed through its R&D to improving the quality of life of patients, exporting treatments to more than 40 countries worldwide with a direct presence in Italy, Spain, France, Romania, Mexico, and Turkey.