On April 28, People's Daily Health Client and Health Times published a series of honorary lists including the 13th Health China Forum · Breakthrough New Drug of the Year, and the first Chinese original third-generation EGFR-TKI innovative drug Ameile® (Almonertinib Mesilate Tablets) independently developed by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. ("Hansoh Pharma") came on the list.
The award is finally determined by an advisory committee composed of experts and scholars in the field, such as policy experts, research institutes and professional associations, in line with the principle of "fairness, impartiality and openness", based on clinical effects and other indicators, and after a number of procedures including preliminary listing, advisory opinion solicitation and peer review. It provides an objective, authoritative demonstration of the new breakthroughs, new achievements and new image towards Healthy China.
Ameile®, selected as Breakthrough New Drug of the Year this time, is the first Chinese original third-generation EGFR-TKI innovative drug independently developed by Hansoh Pharma. Approved for marketing in March 2020, it is used to treat NSCLC while addressing T790M drug resistance. It is also the world's first third-generation EGFR-TKI with a median progression-free survival (mPFS) exceeding one year (second-line use). With its inclusion in the National Reimbursable Drug List since December 2020, Ameile® not only provides a new clinical option that is potent, safe and accessible, but also brings hope for long-term and high-quality survival to more patients with advanced NSCLC.
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 February 2021, the Phase III study on first-line treatment of EGFR mutation-positive locally advanced or metastatic NSCLC reached the primary study endpoint.
With excellent R&D strength and more than 20 years of R&D experience, Hansoh Pharma has established R&D centers in Shanghai, Lianyungang, etc., focusing on innovative R&D in the treatment of major diseases such as anti-tumor, central nervous system, anti-infection and diabetes, and has been ranked top 30 among China's Top 100 Companies in Pharmaceutical Industry and top 3 among China's Best Industrial Enterprises in Pharmaceutical R&D Pipeline for consecutive years. It is also a national key high-tech enterprise and a national technology innovation demonstration enterprise. Up to now, Hansoh Pharma has marketed four Class 1 innovative drugs, and its Class 1 innovative drug Hengmu® (Tenofovir Amibufenamide Tablets) for the treatment of hepatitis B will be approved for marketing in the first half of 2021.
In the future, Hansoh Pharma will continue to stay concentrated, focused and professional, uphold the mission to create excellence in pharmaceuticals and enhance innovation in China, and keep increasing R&D investment, so as to meet the unmet clinical medical needs through continuous innovation, help implement the Healthy China 2030 strategy with practical actions, and contribute to the high-quality development of China's health cause.