The final results of the clinical study (APOLLO study) on the use of Ameile (Almonertinib Mesilate Tablets), a new Class 1 drug independently developed by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. ("Hansoh Pharma" or the "Company"), for the second-line treatment of EGFR T790M mutation-positive locally advanced or metastatic NSCLC, were announced at the 2021 ESMO (European Society for Medical Oncology) Annual Meeting: The median overall survival (OS) is 30.2 months, creating the longest OS for EGFR-TKI second-line treatment of advanced NSCLC in the world, demonstrating the Company's strong and sustainable innovation capability, and providing longer survival benefits for patients with advanced NSCLC.

Ameile defines new standard for second-line treatment of T790M mutation-positive NSCLC

Ameile is the first Chinese original third-generation EGFR-TKI innovative drug independently developed by Hansoh Pharma. It has been widely used in clinical practice since its launch one year ago, and has won unanimous praise from doctors and patients for its excellent efficacy and safety.

The APOLLO study results showed that 100% of the patients enrolled in the study were Chinese, so it's more targeted for Chinese population compared with other studies and can more truly reflect the clinical medication of Chinese patients, and the study results are more applicable in China's clinical practice of NSCLC. With a median progression-free survival (mPFS) of 12.3 months and a median OS of 30.2 months, Ameile is currently the most competitive preferred drug for second-line treatment of EGFR T790M positive patients with advanced NSCLC in the world, and is expected to redefine the standard for second-line treatment of T790M mutation-positive NSCLC, so that more patients with advanced lung cancer can obtain new hope of long-term and high-quality survival.

 

Multiple indications for first-line treatment, etc. are under development at the same time

Based on the Company's strong R&D capability and sustainable innovation, and in order to tap the treatment potential of Ameile in the lung cancer segment, the Company has further initiated a number of registered clinical studies. The clinical study data of Ameile for first-line treatment of NSCLC has achieved an excellent result of 19.3-month mPFS; the indication for single-drug first-line treatment of NSCLC has been submitted for production and included in CDE priority review, and is expected to be approved within this year. At the same time, the Company has been working intensively on a number of clinical studies of Ameile in combination with platinum-containing two-drug chemotherapy for first-line treatment of NSCLC with sensitive mutations and adjuvant treatment of NSCLC, which will provide more NSCLC patients with a full range of multi-dimensional drug regimens from early to advanced stages, from perioperative adjuvant treatment, second-line and post-line treatment to first-line treatment.

Upholding the corporate mission to "create excellence in pharmaceuticals, enhance innovation in China", Hansoh Pharma always puts the benefits of patients first, actively assumes social responsibility, and strives to accelerate transformation and upgrading through scientific and technological innovation, promote national original research and innovation to benefit patients in China and around the world, and help facilitate China’s progress from "a big pharmaceutical manufacturer" to "a strong pharmaceutical manufacturer". 

About ESMO Annual Meeting 

The European Society of Oncology (ESMO) Annual Meeting is the most prestigious and influential oncology meeting in Europe and a leading professional organization for medical oncology in the world. Focusing on the latest advances and discoveries in basic research and cancer immunotherapy, the 2021 ESMO Annual Meeting aims to enhance the professionalism of medical oncology and advance multidisciplinary approaches to cancer treatment and care.