Hansoh Pharmaceutical Group Co. Ltd. has won a green light for inebilizumab, approved by China’s NMPA for the treatment of adults with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive. The decision marked Hansoh’s first biologic approval.
Cellusion Inc. recently closed a ¥1.1 billion ($9.5 million) financing, bringing its total 2021 fundraising to ¥1.7 billion. The company is preparing to enter the clinic with CL-S001, its corneal endothelial substitute cell candidate for treating corneal edema due to endothelial dysfunction, or bullous keratopathy.
Biogen Inc. and Samsung Bioepis Co. Ltd. gained FDA clearance for Byooviz (ranibizumab-nuna), a biosimilar that references the VEGF therapy Lucentis (ranibizumab) from Roche Holding AG, as a treatment for wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization.
Samsung Bioepis Co. Ltd. has emerged as the first company to obtain marketing authorization from the EMA for a biosimilar of Lucentis (ranibizumab), a significant development for the Korean biosimilar specialist. The approval comes less than two months after the company received a positive opinion from the EMA’s CHMP for Byooviz (ranibizumab), formerly called SB-11.
In a deal worth up to $108 million, ophthalmic startup Eluminex Biosciences Ltd. has licensed the global rights to Fibrogen Inc.’s biosynthetic cornea derived from recombinant human collagen (RHC) type III intended to tackle corneal blindness.
Lianbio Co. Ltd. has inked a $200 million deal with Tarsus Pharmaceuticals Inc. for greater China rights to the phase IIb/III-stage candidate, TP-03 (lotilaner ophthalmic solution, 0.25%), designed to treat Demodex blepharitis and Meibomian gland disease (MGD). Lianbio will pay $15 million up front and up to $185 million in development and commercialization milestones.
HONG KONG – Uni-Bio Science Group Ltd. and Dotbio Pte. Ltd. formed a partnership to develop therapeutics for patients with retinal diseases, such as age-related macular degeneration, diabetic macular edema, retinal vein occlusion and myopic choroidal neovascularization.
Chinese eye disease specialist Arctic Vision Biotechnology Co. Ltd. raised more than $100 million in a series B financing round. The clinical-stage company will use the funds to initiate a phase III trial for its core asset, ARVN-001 (triamcinolone acetonide suprachoroidal injectable suspension), for uveitic macular edema in China this year.
PERTH, Australia – Sydney-based Azura Ophthalmics Ltd. has moved into a registration trial following positive phase II results for lead candidate AZR-MD-001 in Meibomian gland dysfunction, the leading cause of dry eye disease.
HONG KONG – Olix Pharmaceuticals Inc. has raised ₩41.5 billion (US$37.90 million) to support the company’s U.S. expansion and advance its pipeline globally.