HANSOH PHARMA'S AMEILE MARKETING APPLICATION FOR ADJUVANT TREATMENT OF LUNG CANCER RECEIVED
On July 19, 2024, Hansoh Pharma's New Drug Application (NDA) for Ameile (almonertinib mesylate tablets), an independently-developed class 1 new drug, was accepted by the National Medical Products Administration (NMPA) for adjuvant treatment of mutation-positive non-small cell lung cancer (NSCLC) in adult patients with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution after tumor resection.
The marketing authorization application for this indication is based on research data from the HS-10296-302 clinical trial. The study was a randomized, controlled, double-blind, Phase III, multicenter clinical study led by Professor Cheng Ying of Jilin Provincial Cancer Hospital to evaluate the efficacy and safety of almonertinib mesylate tablets versus placebo for the adjuvant treatment of epidermal growth factor receptor (EGFR) mutation-positive stage II-IIIB NSCLC. The primary endpoint of the study was progression-free survival (PFS), as assessed by an independent review committee, and secondary endpoints included investigator-assessed DFS, two-, three-, and five-year DFS rates, overall survival (OS), five-year OS rate, and safety.
According to data on cancer epidemiology released by the National Cancer Center, China's new cases of lung cancer in 2022 reached 1.06 million, of which about 40% were NSCLC patients with EGFR mutations. Although 30% of NSCLC patients with EGFR mutations can be diagnosed at an early stage and receive surgery, disease recurrence is common in the postoperative patient population. Therefore, a substantial unmet clinical need still exists for patients with early to mid-stage NSCLC with EGFR mutations.
This is the third indication where Ameile has been submitted for marketing in China. As China's third-generation EGFR-TKI, Ameile has made history twice previously: In March 2020, Ameile was approved for use in patients with T790M mutation-positive locally advanced or metastatic NSCLC which had progressed after previous EGFR-TKI therapy, making it the first domestically developed third-generation EGFR-TKI approved for marketing; and in December 2021, Ameile was approved as the first-line treatment for adult patients with locally advanced or metastatic mutation-positive NSCLC with positive EGFR exon 19 deletion or exon 21 (L858R) substitution, becoming the first domestically developed third-generation EGFR-TKI approved for first-line treatment. It is worth mentioning that the drug's first- and second-line indications have been included in the National Reimbursement Drug List (NRDL). If the marketing application for this new indication is approved, Ameile will become the first domestic third-generation EGFR-TKI approved for post-operative adjuvant treatment, providing a new option for operable EGFR-positive NSCLC patients which more Chinese lung cancer patients can benefit from.
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).
