On November 25, 2019 Hansoh Pharma reported it’s new Class 1 drug, Flumatinib mesylate (trade name: Hansoh Xinfu), was approved by the National Medical Products Administration for the treatment of adult patients with Philadelphia chromosome positive chronic myelogenous leukemia (Ph＋CML) in the chronic phase (Press release, Jiangsu Hansoh Pharmaceutical, NOV 25, 2019, View Source [SID1234591475]). Hansoh Xinfu is China’s first innovative drug with independent intellectual property rights in this field and has been approved for marketing through the priority review and approval procedure. It is expected to become a better choice for first-line treatment of CML patients in China.
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▲ Information on the official website of the National Medical Products Administration
CML has changed from malignant tumor to "chronic disease" since the launch of Imatinib mesylate (first-generation TKI for CML treatment), and many treated patients have a survival period of more than 10 years. In 2013, Hansoh Pharma launched the first generic Imatinib mesylate (Xinwei), which has improved drug accessibility and benefited more Chinese patients. Honsoh Xinfu is "two-way optimized" in terms of curative effect and safety, and is a "second-generation+" tyrosine kinase inhibitor (TKI).
Clinical studies have confirmed that compared with Imatinib, Flumatinib has significantly improved safety while achieving the efficacy of second-generation TKI:
▪ Flumatinib has higher cytogenetic and molecular reaction rates in the first-line treatment of chronic myeloid leukemia in chronic phase (CML-CP), and can achieve faster and deeper molecular reaction;
▪ The adverse event types of Flumatinib are similar to those of Imatinib, and some of them have been improved, while no other specific adverse events of second-generation TKI have been observed.
To "create excellence in pharmaceuticals, enhance innovation in China" is Hansoh Pharma’s corporate mission. Since its establishment more than twenty years ago, the company has been striving to solve the unsatisfied clinical needs in China’s major disease fields through continuous innovation while adhering to the national strategy of "Healthy China 2030". Hansoh Xinfu is the third independent innovative drug of Hansoh Pharma after Mailingda (morpholinazole and sodium chloride injection, a new generation of anti-anaerobe drugs) and Fulaimei (polyethylene glycol loxenatide injection, the first independently developed hypoglycemic drug injected once a week in China).
Hematologic oncology is a top priority field of Hansoh Pharma. In addition to Hansoh Xinfu, a series of high-end first generic drugs have been put on the market in recent years, covering a number of diseases in the field of hematological oncology, which have largely solved the problem of drug accessibility in this field, including Xinwei (Imatinib mesylate tablets for the treatment of chronic myelogenous leukemia), Xintai (Bortezomib for injection for the treatment of multiple myeloma) and Xinmei (Decitabine for injection for the treatment of myelodysplastic syndrome). In the future, Hansoh Pharma will further introduce more innovative drugs in the pipeline to benefit the vast number of patients.