The kickoff meeting of Flumatinib Mesylate (trade name: Hansoh Xinfu), Hansoh Pharma’s Class 1 innovative drug and China’s first independently developed new second-generation BCR-ABL tyrosine kinase inhibitor (TKI), was held in Shanghai on October 20, 2019. Over 200 experts and scholars in the hematological oncology field attended this meeting to discuss the role of Hansoh Xinfu in improving the treatment of chronic granulocytic leukemia (CML) in China and to figure out the fastest way towards “Functional Cure”.

Hansoh Xinfu is used for the treatment of CML. It was declared for marketing in July 2018 and included in the priority review procedure in September 2018. It has passed the three-in-one comprehensive review and is to be approved for marketing soon. Professor Wang Jianxiang, Deputy Director of the Institute of Hematology of the Chinese Academy of Medical Sciences, said in his speech at the meeting that Hansoh Xinfu is the first new second-generation TKI achieving “both-way optimization” in terms of efficacy and safety, which can allow CML patients to obtain faster and deeper therapeutic response, less progression and significantly improved safety, and will provide doctors and patients with better treatment options after its launch.

CML is the first cancer in human history that can be effectively treated by small molecule targeted drugs. Since the introduction of the first-generation TKI imatinib mesylate targeting CML virulence gene in 2000, the survival period of patients has been prolonged significantly. Professor Wu Depei, Director of the Hematology Department of the First Affiliated Hospital of Soochow University, pointed out that, the emergence of imatinib has turned this malignant disease into a controllable chronic disease, but the “downside” is that some patients are resistant or intolerant to this drug, causing obstacles to the treatment. Even though the second-generation TKI is already available on the market, its side effects still raise concerns. As the newest option for CML treatment in China, flumatinib is expected to fill the gap in unmet treatment needs.

Flumatinib is optimally designed and modified on the basis of the molecule structure of imatinib, and the unique mechanism endows it with strong efficacy and high selectivity. Preclinical studies have shown that, flumatinib has stronger inhibition effect on wild-type and common mutations, and its selectivity for ABL kinase resistant to imatinib is better than that of commonly used TKI, with less “off-target” phenomena.

The result of a multi-center, randomized and controlled Phase III clinical study led by the Institute of Hematology of the Chinese Academy of Medical Sciences shows that, compared with imatinib, flumatinib has significant advantages in both efficacy and safety in the first-line treatment of chronic granulocytic leukemia chronic-phase (CML-CP) patients in China. Professor Wang Jianxiang commented that flumatinib has a higher cytogenetic and molecular response rate for CML-CP, achieving faster and deeper molecular response and excellent curative effect; in addition, it can effectively lower down the incidence rate of adverse events such as neutropenia, anemia, hypophosphatemia, edema, limb pain and rash, with better tolerance, and no other adverse events specific to second-generation TKIs occur, so the high safety can meet the long-term treatment needs of patients. In June this year, the result of the Phase III clinical study of flumatinib was released at the annual meeting of the American Society of Clinical Oncology (ASCO), and the official summary of the ASCO Hematology session accurately summarized the study result as “flumatinib is significantly better than imatinib in treatment of newly diagnosed CML”, indicating that the efficacy and safety of flumatinib are highly recognized by international authoritative experts.

Will there be another major breakthrough in CML treatment to help patients reach the drug discontinuance threshold for a better life? Clinical practice has found that some patients are likely to achieve treatment-free remission, i.e., functional cure, after they have been on TKI for a sufficient period of time and have achieved sustained deep molecular response (MR4.5 is the generally accepted standard). Professor Shen Zhixiang, Director of the Hematology Department of the Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine said that flumatinib has shown significantly better early molecular response, complete cytogenetic response and deep molecular response than imatinib in clinical trials, and is more likely to drive CML treatment to treatment-free remission and turn functional cure into reality. The launch of Hansoh Xinfu will arouse even greater expectations.

Adhering to the original mission of “create excellence in pharmaceuticals；enhance innovation in China.”, Hansoh Pharma broke the technical barrier in 2013 and became the first to manufacture and launch the generic first-generation TKI Xinwei (imatinib mesylate), which greatly improved medication accessibility and affordability, and now the new second-generation TKI Hansoh Xinfu (flumatinib mesylate) is to be launched soon. From generic to innovative, Hansoh Pharma has embarked on a distinctive road of innovation and upgrading while living up to its continuous commitment to CML patients. At the meeting, the head of R&D of Hansoh Pharma declared that the company would focus on major clinical needs, accelerate the pace of scientific and technological innovation, contribute to the society with more, newer and better drugs, and bring health benefits to patients in China and even the world.