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Thumbs-Up from CDE! Hansoh Pharma's Ameile® Included in Annual Drug Review Report 2020 as a New Good Drug

2021.07.28 Size

Recently, the National Medical Products Administration (NMPA) released the Annual Drug Review Report 2020. Ameile® (Almonertinib Mesilate Tablets), a new Class 1 drug independently developed by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. ("Hansoh Pharma" or the "Company"), was listed in the report as a "Good New Drug with High Clinical Value" due to its excellent efficacy and safety, providing patients with more clinical choices.

▲ Screenshot of information on the official website of CDE 

In recent years, benefiting from the reform of the national drug review and approval system and innovative R&D policies, Hansoh Pharma has promoted development through innovation and kept increasing R&D investment with high intensity. The Company has successfully marketed five new Class 1 drugs including Ameile®, and entered more than 20 innovative drugs in the clinical stage; it has been ranked among top 3 Chinese pharmaceutical companies in terms of innovation capability for consecutive years, and ranked 37th among pharmaceutical companies worldwide.

Ameile®, included as a "Good New Drug with High Clinical Value" in CDE's Annual Drug Review Report 2020 this time, is China's first original third-generation EGFR-TKI innovative drug independently developed by Hansoh Pharma and approved for marketing in March 2020, and also the world's first third-generation EGFR-TKI with a median progression-free survival (MPFS) exceeding one year (for second-line use)。 It was included in the National Reimbursable Drug List in December 2020. With huge clinical demand and excellent clinical value, Ameile® has also been successfully selected into the Reference List of Medical Institutions Providing Some Negotiated Drugs Newly Included in National Reimbursable Drug List 2020 (First Batch), greatly improving the accessibility of domestic innovative drugs.

In order to explore the therapeutic potential of Ameile® in the lung cancer segment after its approval for marketing, Hansoh Pharma has further initiated a number of registered clinical studies. In June this year, the research data of Chinese population for first-line treatment of NSCLC, the second indication of Ameile®, was released at ASCO. With a mPFS of 19.3 months, it brings a major breakthrough for first-line lung cancer treatment. The marketing license application for this indication has been accepted by the NMPA and included in the priority review category. It is expected to benefit more lung cancer patients after approval.

While engaged in innovative R&D, Ameile® has steadily advanced its go-global efforts to bring the benefits of new good drugs to patients worldwide at an accelerated pace. In July 2020, the Company entered into a strategic partnership with EQRx.Inc., authorizing the latter to develop, manufacture and commercialize Ameile® overseas, which became an important milestone in the Company's global layout of innovative drugs.

Upholding the corporate mission to "create excellence in pharmaceuticals, enhance innovation in China", Hansoh Pharma insists on the patient benefit centered and clinical value oriented approach, continues its dedication to meeting unmet clinical needs in clinical practice, and keeps developing more innovative drugs through continuous innovation to enhance human health and well-being.