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THE NMPA HAS GRANTED BREAKTHROUGH-THERAPY-DESIGNATED DRUG FOR FOURTH-GENERATION EGFR-TKI HS-10504 TABLETS FOR NSCLC
Release Date:2026/05/21
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SHANGHAI, May 21, 2026—Hansoh Pharmaceutical Group Co., Ltd. (“Hansoh Pharma,” 03692.HK) today announced that the Group’s self-developed fourth-generation Epidermal Growth Factor Receptor (“EGFR”) Tyrosine Kinase Inhibitor (“TKI”) HS-10504 tablets has obtained approval to be included as Breakthrough-Therapy-Designated Drug by the National Medical Products Administration (NMPA) of China, with the proposed indication for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the EGFR C797S mutation after prior EGFR-TKI therapy failure.


HS-10504 tablets is a novel, potent, highly selective, fourth-generation EGFR-TKI under clinical development for NSCLC patients. At AACR 2026 (held from April 17-22 in San Diego, California.), the encouraging results of HS-10504 tablets for the treatment of advanced NSCLC post EGFR- TKI therapy were presented in an oral session.


The study results indicated, HS-10504 tablets has demonstrated a promising anti-tumor activity in advanced NSCLC harboring EGFR C797S mutation with the ORR 52.9% and mPFS 9.6 months at the RP2D of 400 mg QD. Given its quick and durable response, HS-10504 tablets is expected to provide a novel, effective, precise, and convenient treatment option for these patients, who currently have a poor prognosis and no available targeted therapy.


The NMPA's Breakthrough Therapy Designation for HS-10504 tablets marks a significant step towards its availability to patients, as Hansoh Pharma continues to focus on unmet medical needs, and prioritize developing differentiated, high-quality innovative therapies to benefit more patients worldwide.

 

References

1、AACR 2026 | Hansoh Pharma Presented Results of HS-10504 (A Novel, Potent, Highly Selective, Fourth-Generation EGFR TKI) from a First in Human Phase 1 Study in Patients with Advanced NSCLC-Press Releases-Hansoh Pharmaceutical Group Co., Ltd. 

 https://www.hspharm.com/news/news-detail-513449.htm



About Hansoh Pharma

Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise 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 medicines that generate product sales in China, with the revenue from innovative medicines 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).

Statements

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).