On June 15, Hansoh Pharmaceutical Group Company Limited (3692.HK, "Hansoh Pharma" or the "Company") announced that the UK's Medicines and Healthcare products Regulatory Agency ("MHRA") had formally accepted the Marketing Authorization Application ("MAA") from the Company's partner, EQRx, INC. ("EQRx"), for aumolertinib, a third-generation epidermal growth factor receptor-tyrosine kinase inhibitor ("EGFR-TKI") for the first-line treatment of locally advanced or metastatic non-small cell lung cancer ("NSCLC") with sensitizing EGFR mutations and for the treatment of locally advanced or metastatic T790M mutation-positive NSCLC that has progressed on prior EGFR-TKI therapy. This is the first MAA for aumolertinib filed outside China.
Aumolertinib is the first EGFR-TKI independently developed in China and the first third-generation EGFR-TKI with median progression-free survival (mPFS) exceeding one year (for second-line use) worldwide. Up to now, aumolertinib has two indications approved in China and is currently being evaluated in several clinical development programs for lung cancer.
This MAA is primarily based on data from the Phase III AENEAS study on aumolertinib for the treatment of EGFR-mutated locally advanced or metastatic NSCLC. The study demonstrated the superior safety and efficacy of aumolertinib for the first-line treatment of EGFR-mutated locally advanced or metastatic NSCLC.
In July 2020, Hansoh Pharma signed an overseas collaboration agreement with EQRx, under which EQRx would be responsible for the development and commercialization of aumolertinib outside Greater China to further expand the reach of aumolertinib as a potential treatment and to accelerate the global presence of Hansoh Pharma's innovations. In 2021, aumolertinib was granted Innovation Passport designation in the UK through the Innovative Licensing and Access Pathway (ILAP), with a view to being approved and reaching NSCLC patients in the UK as soon as possible.
"In the UK, approximately 39,000 people are diagnosed with lung cancer each year, and about 10 to 15 percent of these patients have EGFR-sensitizing mutations." said Melanie Nallicheri, President and Chief Executive Officer of EQRx. "We will work closely with the MHRA as it conducts its review and look forward to the approval of aumolertinib for marketing in the UK soon to bring an additional and differentiated treatment option for local patients with EGFR-mutated NSCLC and expand access to third-generation EGFR inhibitors."
"Given the superior safety and efficacy of aumolertinib in the AENEAS study, the MHRA’s acceptance of this MAA further proves that the innovative value of aumolertinib has reached an internationally leading level." said Yuan Sun, Executive Director of the Board of Hansoh Pharma. "This is a milestone for the global reach of aumolertinib, and will also help promote China's research and development of innovative drugs to a leading position in the global landscape to serve patients worldwide with high-quality innovation."
About Aumolertinib
Ameile (aumolertinib mesilate) is China's first original third-generation EGFR-TKI innovative drug independently developed by Hansoh Pharma, and also the world's first third-generation EGFR-TKI with median progression-free survival (mPFS) exceeding one year (for second-line use). It is highly effective in the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC who have experienced disease progression on or after prior EGFR-TKI therapy. In March 2020, the first indication of Ameile was approved for marketing, filling a void for third-generation EGFR-TKI in China; and in December 2021, Ameile was approved as first-line therapy for adult patients with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation-positive locally advanced or metastatic NSCLC, opening a new era of first-line treatment with China's original third-generation EGFR-TKI.
About the AENEAS Study
The AENEAS Study is a randomized, controlled, double-blind, multicenter Phase III trial of aumolertinib versus gefitinib as first-line therapy for patients with locally advanced or metastatic EGFR-mutated NSCLC, with a total of 400+ subjects enrolled. The study met its primary endpoint, demonstrating statistically significant improvement in progression-free survival and a favorable safety profile as compared to gefitinib. On May 18, 2022, the JCO published the results of the AENEAS study, which was the first time that clinical data of a Chinese original third-generation EGFR-TKI had been published in the official ASCO journal.
About EQRx
EQRx is a bio-pharmaceutical company based in the United States which focuses on making innovative medicines at prices that are affordable for people and sustainable for society. EQRx is principally engaged in the business of innovative drug discovery, development and commercialization.
