Hansoh Pharmaceutical's Aumetinib Gains Momentum in Global Expansion with MHRA Filing
Hansoh Pharma
Pharmaceutical Research, Production, and Sales
Medicines and Healthcare products Regulatory Agency
The MHRA is an executive agency of the UK Department of Health and Social Care, responsible for ensuring that medicines and medical devices work effectively and are safe and reliable. Established in 2003 through the merger of the Medicines Control Agency and the Medical Devices Agency, the organization employs more than 1,300 staff members.
China Economic Net, June 27 (Reporter Guowang Zhu) Following the online publication of the AENEAS study on Aumolertinib in the internationally renowned oncology journal JCO, which affirmed Aumolertinib’s "efficacy" and "safety" as comparable to cutting-edge international treatment outcomes and highlighted its clinical value, more good news about Aumolertinib has emerged – its first overseas marketing authorization application has been officially accepted by the UK MHRA, marking a new "acceleration" in the internationalization strategy of Hansoh Pharma's innovative drugs.
On June 15, 2022, Hansoh Pharma announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) had officially accepted the Marketing Authorization Application (MAA) for the third-generation EGFR inhibitor, Aumolertinib, for first-line treatment of EGFR-mutated advanced or metastatic NSCLC and other indications. This is the first MAA for Aumolertinib outside of China, indicating that it is expected to officially step onto the international stage for targeted lung cancer treatment and begin benefiting patients overseas.
Ameitinib is the first original EGFR-TKI in China and the world's first third-generation EGFR-TKI with a median progression-free survival (mPFS) of over one year (for second-line use). To date, Ameitinib has been approved for two indications in China, and multiple clinical studies targeting lung cancer are actively underway.
The UK marketing application for Aumolertinib is based on the pivotal Phase III AENEAS clinical study previously published in JCO. The study results show that Aumolertinib has demonstrated superior advantages in terms of safety and efficacy when used as a first-line treatment for EGFR mutation-positive locally advanced or metastatic NSCLC.
Currently, the value of EGFR mutation-targeted therapy in the global lung cancer field is becoming increasingly prominent, with the rapid development of third-generation EGFR-TKIs for first-line treatment of NSCLC. However, NSCLC patients in many regions around the world still face the challenges of limited treatment options and high costs, urgently needing innovative drugs with excellent efficacy and better drug accessibility to meet the significant unmet clinical needs.
In 2021, Aumolertinib received the "Innovation Passport" in the UK through the Innovative Licensing and Access Pathway (ILAP). Now, the marketing authorization application for Aumolertinib has been officially accepted by the UK MHRA. With the support of the "Innovation Passport," Aumolertinib is expected to soon welcome its first overseas market launch.
It can be seen that the internationalization journey of Aumolertinib has fully shifted into "high gear." In the future, it is expected to further unleash the therapeutic potential of being the first China-originated third-generation EGFR inhibitor on the international stage of targeted lung cancer treatment. This will also accelerate the advancement of China's innovative drug development, securing a competitive edge in the global landscape, and allowing more patients worldwide to benefit sooner from China's high-quality innovative achievements.