Recently, Jiangsu Hansoh Pharmaceutical Group Co., Ltd. ("Hansoh Pharma" or "Company") received the Notice of Approval for Drug Clinical Trial ("Notice") from the National Medical Products Administration, which approves the conduct of a randomized, controlled, open, phase III, multicenter clinical study on Almonertinib Mesilate Tablets, a Class 1 innovative drug independently developed by the Company, in the treatment of NSCLC, with an aim to expand the efficacy and safety of first-line treatment with combined dual-drug chemotherapy.
Acceptance No. | Name of Drug | Name of Applicant | Indication | Registration Category |
CXHL2100033 | Almonertinib Mesilate Tablets | Jiangsu Hansoh Pharmaceutical Group Co., Ltd.; Jiangsu Hansoh Pharmaceutical Group Co., Ltd. | Advanced NSCLC with EGFR mutation | Chemicals, Category 2.4 |
Screenshot of information from the Center for Drug Evaluation of the National Medical Products Administration
About Almonertinib
Almonertinib Mesilate Tablets 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 (second-line use). Recently, the phase III clinical study on Almonertinib Mesilate Tablets for first-line treatment has achieved positive results and reached the pre-defined primary study endpoint.
In December 2020, Almonertinib Mesilate Tablets was officially included in the National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2020), and on March 1, 2021, the new version of the National Reimbursement Drug List was officially implemented, which will help improve the accessibility and affordability of domestic innovative drugs as well as the standardization of clinical treatment, thus benefiting more patients and bringing more social benefits.
