Qilu Pharmaceutical's Ranibizumab Injection (Rimmyrah), a Blockbuster Ophthalmic Biologic Exceeding RMB 1.5 Billion in Sales, Becomes China’s First Domestically Developed Biosimilar to Gain Approval
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On August 19, according to the NMPA announcement,Qilu PharmaceuticalTheRanibizumab Injection（QL1205）It has been approved for marketing and is the first biosimilar of ranibizumab successfully approved in China.
RanibizumabByRocheOriginal Research, a VEGF(Vascular Endothelial Growth Factor)Inhibitors can reduce vascular endothelial cell proliferation, vascular leakage, and new blood vessel formation while promoting the regression of existing new vessels by binding to and blocking VEGF receptors. It was first launched in the United States in June 2006, becoming the world's first anti-VEGF drug applied in ophthalmology. According to the PharmaOcean database,Ranibizumab InjectionSales in the Chinese hospital market exceeded 1.5 billion yuan in 2023, with a year-on-year increase of 13.65%.
Previously, Qilu Pharmaceutical Co., Ltd. in ChinaRanibizumab InjectionImportant progress has been made in the project's research and development, and two rigorous clinical trials have been successfully completed. One of them is an international multi-center, randomized, double-blind, parallel-controlled Phase 3 clinical trial, focusing on patients with neovascular age-related macular degeneration, aiming to scientifically evaluateRanibizumab InjectionDifferences and similarities in safety and efficacy compared to the original drug; the other is a phase 1 clinical trial, also using a randomized, double-blind, parallel control design, targeting patients with wet age-related macular degeneration, conducting an in-depth exploration ofRanibizumab InjectionComparison with the original research drug in terms of safety, pharmacokinetic properties, and pharmacodynamic performance.
Qilu Pharmaceutical Co., Ltd. initiated the development of Ranibizumab Injection in 2012. Researchers established a reliable production process through small-scale trials, pilot tests, and commercial production. According to biosimilar standards, they comprehensively evaluated the product's structure, physicochemical properties, and biological activity, demonstrating its high similarity to the originator drug. Clinical data also showed that this product is essentially consistent with the originator drug in terms of safety and efficacy.
This year, Qilu Pharmaceutical Co., Ltd. has once again delivered good news, with itsRanibizumab Injection(Product name: Rimmyrah)In January, it was granted marketing authorization by the EU, becoming the first ranibizumab from a Chinese pharmaceutical company to be approved in the EU, as well as the first domestically produced ophthalmic biologic to successfully "go global."
From 2024 to present, Qilu Pharmaceutical's biopharmaceutical innovation has accelerated even further, with several advancements already made, includingDenosumab Injection, Romiplostim for Injection N01, Trastuzumab for InjectionAndRanibizumab InjectionFour new biopharmaceutical products have been successively approved, further enriching the company's product pipeline and solidifying its leading position in the biopharmaceutical field.
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