Aumolertinib Mesilate Tablets Gain MHRA Approval for Marketing

Hansoh Pharmaceutical's Aumolertinib Mesilate Tablets have been approved by the MHRA for marketing. The company is engaged in research, development, production, and sale of pharmaceutical products, primarily in oncology, anti-infective diseases, CNS diseases, and metabolic diseases. Its innovative drug products include Ameile, Hansoh Xinfu, Mailingda, Fulaimei, Hengmu, XINYUE, and Saint Luolai. The company mainly operates in the domestic market.

Hansoh Pharmaceutical Group's shares surged to their highest levels since August 2021, rising 3.8% to HK$27.5, following the news that its innovative drug Aumolertinib Mesilate Tablets for lung cancer has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK for marketing [1]. The stock marked its biggest intraday percentage gain since May 20 and is on track for a third straight session of rise, if current trends hold.

The approval by the MHRA is a significant milestone for Hansoh, which specializes in the research, development, production, and sale of pharmaceutical products, primarily in oncology, anti-infective diseases, CNS diseases, and metabolic diseases. The company's innovative drug products include Ameile, Hansoh Xinfu, Mailingda, Fulaimei, Hengmu, XINYUE, and Saint Luolai.

The Hang Seng Biotech Index (HHSHKBIO) rose 3.1% and the Hang Seng Index (HSI) added 0.5% in response to the news. Year-to-date, Hansoh's stock has gained 56.8%. This approval follows a series of successful clinical trial approvals and breakthrough therapy designations for other innovative drugs, including HS-10542 for paroxysmal nocturnal hemoglobinuria (PNH) and immunoglobulin A nephropathy (IgAN) [2], and HS-20093 for B7-H3-targeted antibody-drug conjugate for osteosarcoma [3].

Hansoh's robust pipeline of innovative drugs and its commitment to research and development have positioned the company as a leader in the domestic market. The company continues to focus on expanding its portfolio and exploring new therapeutic areas to meet the growing demand for effective treatments.

References:

[1] https://www.tradingview.com/news/reuters.com,2025:newsml_L2N3S704L:0-hansoh-hits-near-4-year-peak-as-its-cancer-drug-gets-uk-marketing-approval/
[2] https://www.marketscreener.com/quote/stock/HANSOH-PHARMACEUTICAL-GRO-103505406/news/Hansoh-Pharmaceutical-Group-Company-Limited-Obtains-Clinical-Trial-Approval-Issued-by-the-National-M-50104962/
[3] https://www.hansoh.cn/en/news/company-news.jsp