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AffaMed Technologies Secures Exclusive Rights to SIFI’s Intraocular Lens Products in Greater China
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AffaMed Technologies, a joint venture between China’s AffaMed Therapeutics and Italy-based SIFI S.p.A., has announced a significant licensing agreement with the SIFI Group. This deal grants AffaMed exclusive rights to manufacture, develop, and commercialize SIFI’s range of intraocular lens (IOL) products in the Greater China region. The financial details of…
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AffaMed Therapeutics’ Luminate Receives Clinical Trial Approval for Dry AMD in China
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AffaMed Therapeutics, a China-based biotech firm, has announced the receipt of its first clinical trial approval in China for its pipeline candidate, Luminate (risuteganib; AM011). This development marks a significant milestone for the company, which acquired the Greater China manufacturing, development, and commercial rights to risuteganib from Hanmi Pharmaceutical, a…
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AffaMed Therapeutics Gets NMPA Approval for Phase III Dextenza Study in Post-Ophthalmic Surgery
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China-based AffaMed Therapeutics has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase III regulatory study. The study will assess the efficacy and safety of Dextenza in subjects following ophthalmic surgery, marking a significant step forward for the company. Dextenza’s Development and…
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AffaMed Digital Initiates Clinical Study for AMD201 at Beijing Tiantan Hospital
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AffaMed Digital, a company wholly owned by AffaMed Technologies—a joint venture between AffaMed Therapeutics and SIFI S.p.A.—has announced the first patient enrollment in a clinical study for its AMD201 at the Beijing Tiantan Hospital. This marks a significant step in the development of digital therapies for post-stroke cognitive impairment (PSCI).…
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AffaMed Technologies’ EDOF Intraocular Lenses Receive FDA Approval in Taiwan
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AffaMed Technologies, a joint venture between AffaMed Therapeutics and SIFI S.p.A., has announced that it has received market approvals from the Taiwan Food and Drug Administration for its MINI WELL, MINI WELL PROXA, and MINI WELL TORIC intraocular lenses, as well as the monofocal intraocular lens MINI 4 Ready. These…
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AffaMed Technologies Completes First Patient Implantation for MINI WELL IOL
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AffaMed Technologies, a joint venture between AffaMed Therapeutics and SIFI S.p.A., has announced the completion of the first patient implantation in the regulatory clinical trial for its MINI WELL progressive Extended Depth-of-Focus (EDOF) intraocular lens (IOL). The procedure was successfully conducted at the EYE & ENT Hospital of Fudan University…
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AffaMed Secures China Rights to Eli Lilly’s Migraine Drug Galcanezumab
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China-based AffaMed Therapeutics has announced an agreement with Eli Lilly and Company to obtain sole commercialization rights for galcanezumab in mainland China. The monoclonal antibody, developed by Eli Lilly, selectively binds to the calcitonin gene-related peptide (CGRP) and was approved by the FDA in September 2018 for the preventive treatment…
