Qilu Pharmaceutical's Aflibercept Biosimilar, China's First Domestic Version, Demonstrates Equivalent Efficacy and Safety in Phase III Trial for nAMD
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
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Note:This article does not constitute any investment opinions or suggestions; please refer to official/company announcements for accuracy.This article only introduces drugs related to medical health, not a recommendation of treatment options (if involved), and does not represent the platform's position.Any article reprinted needs to be authorized.
PharmaCircleLearned: The molecular structure, amino acid sequence, efficacy, and safety of China's first aflibercept biosimilar are basically consistent with aflibercept, and the drug has a higher purity. On December 18, 2023, it was officially approved for marketing by China’s National Medical Products Administration (NMPA) for the treatment of adult neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). This product was developed by Qilu Pharmaceutical.
This randomized, double-blind, parallel, positive-controlled trial enrolled 366 treatment-naïve patients aged 50 years or older with neovascular age-related macular degeneration (nAMD), all of whom had choroidal neovascularization (CNV) secondary to nAMD beneath the fovea centralis, with a best-corrected visual acuity (BCVA) letter score ranging from 73 to 34 (equivalent to Snellen visual acuity 20/40 to 20/200). The study compared the efficacy, safety, and immunogenicity of clinical treatments for nAMD between the study group and the control group.
https://link.springer.com/article/10.1007/s40123-023-00836-4
In addition, at the beginning of 2024, the ranibizumab injection from Qilu Pharmaceutical received consecutive marketing approvals from the EU and the UK. It is the first China-produced ranibizumab approved by the EU and also the first ophthalmic biologic agent from China to "go global." In August of the same year, it became the first approved biosimilar of ranibizumab in China.
Biosimilars and generic drugs will increase the accessibility of medications for patients in the future.
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Rooted in Shanghai and radiating globally, PharmaCircle serves as a strategic platform for the biopharmaceutical industry. With the mission of "enabling the borderless flow of intelligence and networks," it has built an empowering system covering the entire pharmaceutical industry chain, including R&D, production, distribution, and commercialization. Through four core engines—intelligent cloud services, precise resource connections, industry think tanks, and ecosystem communities—it creates the infrastructure for the flow of pharmaceutical value in China.
Under the dual waves of globalization and digitalization, PharmaCircle is redefining the circulation paradigm of pharmaceutical resources — it is not only a hub for information and networking but also a catalyst for industrial transformation. With China as the origin, we are weaving a global network of pharmaceutical intelligence, making every precise connection a catalyst for leapfrog growth of enterprises.
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▲November 6-7The 10th Guangzhou (Greater Bay Area) BiomedicalInnovators Summit Scan to register
Note:This article does not constitute any investment opinions or suggestions; please refer to official/company announcements for accuracy.This article only introduces drugs related to medical health, not a recommendation of treatment options (if involved), and does not represent the platform's position.Any article reprinted needs to be authorized.
This randomized, double-blind, parallel, positive-controlled trial enrolled 366 treatment-naïve patients aged 50 years or older with neovascular age-related macular degeneration (nAMD), all of whom had choroidal neovascularization (CNV) secondary to nAMD beneath the fovea centralis, with a best-corrected visual acuity (BCVA) letter score ranging from 73 to 34 (equivalent to Snellen visual acuity 20/40 to 20/200). The study compared the efficacy, safety, and immunogenicity of clinical treatments for nAMD between the study group and the control group.
https://link.springer.com/article/10.1007/s40123-023-00836-4
In addition, at the beginning of 2024, the ranibizumab injection from Qilu Pharmaceutical received consecutive marketing approvals from the EU and the UK. It is the first China-produced ranibizumab approved by the EU and also the first ophthalmic biologic agent from China to "go global." In August of the same year, it became the first approved biosimilar of ranibizumab in China.
Biosimilars and generic drugs will increase the accessibility of medications for patients in the future.
Rooted in Shanghai and radiating globally, PharmaCircle serves as a strategic platform for the biopharmaceutical industry. With the mission of "enabling the borderless flow of intelligence and networks," it has built an empowering system covering the entire pharmaceutical industry chain, including R&D, production, distribution, and commercialization. Through four core engines—intelligent cloud services, precise resource connections, industry think tanks, and ecosystem communities—it creates the infrastructure for the flow of pharmaceutical value in China.
Under the dual waves of globalization and digitalization, PharmaCircle is redefining the circulation paradigm of pharmaceutical resources — it is not only a hub for information and networking but also a catalyst for industrial transformation. With China as the origin, we are weaving a global network of pharmaceutical intelligence, making every precise connection a catalyst for leapfrog growth of enterprises.