On August 19, 2024, Hansoh Pharmaceutical Group Co., Ltd. ("Hansoh Pharma," 03692.HK) announced that the new drug application ("NDA") for a new indication of Ameile (Aumolertinib Mesilate Tablets) has been accepted by the National Medical Products Administration ("NMPA") for the treatment in patients with locally advanced, unresectable, epidermal growth factor receptor ("EGFR") exon 19 deletions or exon 21 (L858R) substitute mutations, non-small cell lung cancer ("NSCLC") without progression following definitive platinum-based chemoradiotherapy. This is the fourth indication marketing application for Ameile submitted in China. This indication of Ameile was included in the NMPA's list of breakthrough therapies on August 9, 2024.
This marketing application for the new indication is based on clinical trial data from the HS-10296-304 study. It is a randomized, controlled, double-blind Phase III clinical study aimed at evaluating the efficacy and safety of Aumolertinib Mesilate compared to the placebo in treating patients with unresectable, locally advanced NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitute mutations, who have not experienced disease progression following platinum-based chemoradiotherapy. The primary endpoint of the study is progression-free survival ("PFS") as assessed by an independent review committee. The secondary endpoints include overall survival ("OS"), time to central nervous system ("CNS") progression as assessed by an independent review committee, time to death or distant metastasis ("TTDM"), objective response rate ("ORR"), disease control rate ("DCR"), duration of response ("DoR"), and safety.
Ameile is the first innovative third-generation EGFR-TKI drug wholly developed in China. In March 2020, Ameile obtained approval for the treatment of patients with locally advanced or metastatic NSCLC with T790M mutation, who have progressed on or after EGFR-TKI therapy. In December 2021, Ameile obtained approval to be used as the first-line treatment for adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitute mutation positive; and the drug's first- and second-line indications have been included in the National Reimbursement Drug List ("NRDL"). In July 2024, the NDA of Ameile for adjuvant therapy after tumor resection in patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations was accepted by the NMPA.
Lung cancer has the highest incidence and mortality rates in China. According to statistics released by the National Cancer Center(1), there were 1.0606 million new cases of lung cancer and 733,300 deaths in China in 2022, highlighting a significant unmet clinical need. Hansoh Pharma has long been dedicated to improving the treatment of lung cancer patients and continues to explore new treatment regimens for patients in China and globally.
References
(1) //www.sciencedirect.com/science/article/pii/S2667005424000061
Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise headquartered in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative drugs that generate product sales in China, with the revenue from innovative drugs and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).
1. This announcement is intended for healthcare professionals only and not for advertising purposes.2. Hansoh Pharma does not recommend the use of any unapproved drugs or off-label indications, nor does it make recommendations regarding any drug or indication.3. The information provided in this announcement is for reference only; please follow the advice or guidance of a physician or other healthcare professional. Any treatment-related decisions made by healthcare professionals should be based on the specific circumstances of the patient and should be used in accordance with the instructions for the drug.4. For more detailed information about any company products, medical treatments, or diseases, please consult a healthcare professional.
Forward-Looking Statements
This press release is intended to provide information about Hansoh Pharmaceutical Group Co., Ltd. and its affiliates, including their subsidiaries (collectively referred to as "Hansoh Pharma"). It does not constitute a disclosure of information about Hansoh Pharma or any investment recommendations.The information contained in this release may include forward-looking statements related to Hansoh Pharma's business and product prospects, as well as its plans, beliefs, expectations, and strategies. These statements are predictions based on speculative assumptions and are not guarantees of future performance. They are subject to risks and uncertainties, such as scientific, commercial, political, economic, financial, legal factors as well as competitive environment and social conditions, many of which are beyond Hansoh Pharma's control and difficult to predict, thus actual results may differ significantly from what is stated here, and past securities price trends should not be used as a guide for future market conditions. As such, investors should exercise caution when using this information to make investment decisions. Phrases such as "commit," "expect," "believe," "predict," "anticipate," "forecast," "intent,"“project,” “may,” “will,” “should,” “plan,” “could,” “continue,” “target,” “contemplate,” “estimate,” “guidance,” “possible,” “potential,” “pursue,”“likely,”and words and terms of similar terms substance used in connection with any discussion of future plans, actions or events indicate forward-looking statements.Hansoh Pharma does not commit to or guarantee the accuracy, timeliness, or completeness of forward-looking information and assumes no obligation to update or revise these forward-looking statements. Neither Hansoh Pharma nor any of its directors, employees, or agents will be responsible for any forward-looking statements that prove to be inaccurate or unachievable and any losses or damages incurred by users due to reliance on the information provided herein, including but not limited to direct, incidental, indirect, or punitive damages.All information in this press release is current as of the date of release. Hansoh Pharma assumes no responsibility to update or revise this information in light of new developments, future events, or other circumstances, except as required by law. Additionally, Hansoh Pharma reserves the right to make changes, corrections, or discontinuations to all or part of the content of this press release at any time without notice. For information specifically related to the listed company, investors are encouraged to refer to the announcements and financial reports of Hansoh Pharma (03692.HK).
