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Alcon Laboratories Acquires Majority Stake in Aurion Biotech to Advance Eye Disease Cell Therapy
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US-based eye care firm Alcon Laboratories, Inc. has announced the acquisition of a majority stake in Aurion Biotech, Inc., a clinical-stage cell therapy specialist focused on eye diseases. This strategic move aims to enhance Alcon’s portfolio in innovative ophthalmic treatments. Aurion Bio’s Leading TherapyAurion Bio’s flagship product, AURN001, is an…
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Formosa Pharmaceuticals Inks Licensing Pact with Cipla for APP13007 in 11 Countries
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Taiwan-based Formosa Pharmaceuticals (TPE: 6838) announced a licensing agreement with India-headquartered Cipla Limited (BOM: 500087, NSE: CIPLA). Formosa is granting Cipla commercialization rights for its APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) in 11 countries, including India, Nepal, Sri Lanka, Bangladesh, Malaysia, Myanmar, Kenya, Nigeria, South Africa, Argentina, and Colombia. Deal…
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Frontera Therapeutics Receives NMPA Approval for FT-003 in Diabetic Retinopathy Study
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Sino-US firm Frontera Therapeutics, Inc. announced receiving approval from China’s National Medical Products Administration (NMPA) to initiate a clinical study for its FT-003, a recombinant adeno-associated virus (rAAV) gene therapy for diabetic retinopathy (DR). This follows previous approvals for studies in neovascular age-related macular degeneration (nAMD) and diabetic macular edema…
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Innovent Biologics’ Sycume Approved by China’s NMPA for Thyroid Eye Disease
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China-based Innovent Biologics Inc. (HKG: 1801) announced that its New Drug Application (NDA) for Sycume (teprotumumab), a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, has been approved by China’s National Medical Products Administration (NMPA). This approval marks Sycume as China’s first and the world’s second approved IGF-1R antibody drug,…
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Gaush Meditech’s ANTERION Ophthalmic Detector Receives NMPA Market Approval
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Suzhou-based Gaush Meditech Ltd (HKG: 2407) announced receiving market approval from the National Medical Products Administration (NMPA) for the ANTERION ophthalmic detector. This multimodal imaging diagnostic platform, developed by its German partner Heidelberg Instruments, integrates three functions into one device, enhancing precision and efficiency in ophthalmic diagnostics. Technical Specifications and…
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Gaush Meditech Receives NMPA Approval for Femtosecond Laser Corneal Refractive Surgery System
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Suzhou-based Gaush Meditech Ltd (HKG: 2407) announced receiving market approval from the National Medical Products Administration (NMPA) for its femtosecond laser corneal refractive surgery system and accompanying disposable eye fixation patient interface. Developed in collaboration with German partner SCHWIND eye-tech-solutions GmbH, the system is designed for producing corneal flaps in…
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TowardPi Medical Secures RMB500 Million in Series E Round for Ophthalmic Equipment Expansion
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China-based TowardPi (Beijing) Medical Technology Ltd, a leading ophthalmology equipment R&D company, has reportedly secured RMB500 million (USD69 million) in a Series E financing round. The investors include SSF Zhongguancun Independent Innovation Special Fund, Beijing Robotics Industry Development Investment Fund, and Qiming Venture Partners. This funding, the largest primary market…
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Sinocelltech Group Receives NMPA Approval for SCTT11 Clinical Study in Thyroid Eye Disease
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SCTT11 therapy in thyroid eye disease (TED). This marks a significant step forward in addressing a complex autoimmune condition closely linked to thyroid disorders. Understanding Thyroid…
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Zeiss Group’s VISUMAX 800 with SMILE pro Software Approved by China’s NMPA
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Germany-based Zeiss Group, a specialist in optical systems and optoelectronic product manufacturing, announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its new-generation femtosecond laser system VISUMAX 800 with the innovative minimally invasive surgery SMILE pro software. Product HighlightsThe addition of SMILE pro software…
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Eyebright Medtech Plans Private Placement to Expand Contact Lens Production
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China-based Eyebright Medical Technology (Beijing) Co., Ltd. (SHA: 688050), an ophthalmic medical device manufacturer, announced plans for a private placement of 3,593,615 shares at RMB 79.2 (USD 10.9) per share. The proceeds, expected to reach RMB 285 million (USD 39 million), will be used to expand its contact lens production…
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Hengrui Pharma’s HR19034 Eye Drops for Myopia Delay Accepted by NMPA
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its market filing for HR19034 eye drops, designed to delay myopia progression in children aged 6-12, has been accepted by the National Medical Products Administration (NMPA). The product targets children with spherical diopters ranging from -0.50D to -4.00D and astigmatism/anisometropia ≤…
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Astellas Pharma’s Izervay Gets FDA Approval for GA Treatment Without Dosing Limit
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the US Food and Drug Administration (FDA) has approved its label extension application for Izervay (avacincaptad pegol intravitreal solution). The approval allows the drug to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD) without any limitation on the duration…
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Bayer Files for Eylea 8 mg EMA Approval to Extend AMD, DME Treatment Intervals
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Bayer (ETR: BAYN) has submitted a marketing application to the European Medicines Agency (EMA) for Eylea 8 mg (aflibercept 8 mg), seeking to extend anti-VEGF injection intervals to 6 months in neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). The filing builds on positive data from the PULSAR…
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Regeneron’s Q4 Financials Show 10% Revenue Growth, Driven by Eylea and Libtayo
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US-based biopharmaceutical company Regeneron (NASDAQ: REGN) released its Q4 2024 financial report, showing revenues up 10% year-on-year (YOY) to USD 3.79 billion. For the full year, sales grew by 8% to USD 14.2 billion. The results highlight the continued strength of Regeneron’s portfolio, particularly its top-selling products. Top Performers in…
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Astellas Pharma Submits NDA for Avacincaptad Pegol in Japan for Geographic Atrophy
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Japan-based major Astellas Pharma (TYO: 4503) announced that it has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) seeking conditional approval for its avacincaptad pegol intravitreal solution (ACP). The drug is a synthetic aptamer that inhibits the complement C5 protein and is intended…
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Roche’s Susvimo Approved by FDA for Diabetic Macular Edema
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Swiss pharmaceutical giant Roche (SWX: ROG) announced that it has received approval from the US Food and Drug Administration (FDA) for another indication of its Susvimo (ranibizumab) 100 mg/mL, this time to treat diabetic macular edema (DME). With this approval, Susvimo becomes the first and only FDA-approved treatment shown to…
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Zhaoke Ophthalmology Partners with AFT for Brimochol PF Distribution in ANZ
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China-based Zhaoke Ophthalmology Ltd (HKG: 6622) has announced a strategic distribution and supply agreement with New Zealand-headquartered AFT Pharmaceuticals Limited, a leading healthcare product manufacturer and distributor. The agreement pertains to Brimochol PF, a fixed dose of carbachol and bromonidine tartrate that is preservative free, co-developed by Tenpoint Therapeutics Ltd.…
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HuidaGene Therapeutics Receives EMA Orphan Designation for HG004 Gene Therapy
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Shanghai-based genome medicines specialist HuidaGene Therapeutics has announced a positive opinion from the European Medicines Agency (EMA) for the Committee for Orphan Medicinal Products (COMP) on the orphan designation filing for its HG004. The gene therapy is designed for the treatment of inherited retinal dystrophy caused by dysfunction in the…
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Eyebright Medical’s Loong Crystal PR Receives NMPA Class III Medical Device Approval
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China-based Eyebright Medical Technology (Beijing) Co., Ltd. (SHA: 688050) has announced that it has received a Class III Medical Devices Certificate from the National Medical Products Administration (NMPA) for its phakic intraocular lens, Loong Crystal PR. The approval, granted with fast-track status, allows the product to be used for treating…
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Sinobioway Medicine Partners with Happy Life Tech for Clinical Trial Services
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China-based Contract Manufacturing Organization (CMO) Sinobioway Medicine (SHE: 002581) has announced a clinical trial technical service agreement with compatriot firm Happy Life Tech (HLT), an affiliate of Yidu Tech (HKG: 2158). The agreement focuses on recombinant human nerve growth factor eye drops, targeting moderate to severe dry eye conditions. Phase…
