Recently, Hansen Pharmaceutical announced that the European Medicines Agency (EMA) has officially accepted the marketing application of ametinib mesylate tablets submitted by the company's partner EQRx for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-sensitive mutations, and for the treatment of locally advanced or metastatic NSCLC adult patients
with EGFR T790M mutation-positive.
According to the data, ametinib is a third representative skin growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) developed by Hansen Pharmaceutical, and EQRx has the rights and interests
of the drug outside Greater China.
The marketing application filed in Europe is based on the results of the Phase
3 clinical trial AENEAS.
Trial data showed that the study met the primary endpoint that ametinib significantly prolongs progression-free survival and has a better safety profile
compared with gefitinib.
It is understood that Hansen Pharmaceutical's plan to export innovative drugs to the sea has continued to advance steadily in
recent years.
As early as July 2020, Hansen Pharmaceutical signed an overseas cooperation agreement with EQRx, and EQRx is responsible for the research, development, production and commercialization of ametinib outside the Greater China region, further expanding the therapeutic potential of ametinib and accelerating the international layout
of Hansen Pharmaceutical's innovative achievements.
In June this year, the UK officially accepted the marketing authorization application submitted by Hansen Pharmaceutical's partner EQRx for the joint development and commercialization of a new, third-generation EGFR-TKI ametinib first-line treatment of positive locally advanced or NSCLC with EGFR-sensitive mutations and for the treatment of locally advanced or metastatic NSCLC with positive T790M mutations that have previously progressed through EGFR-TKI treatment
.
Industry analysts believe that the application for ametinib marketing authorization has been officially accepted by the United Kingdom, and with the blessing of the "innovation certificate", it may soon usher in an overseas listing
.
In the future, it may be expected to further play the therapeutic potential of China's original third-generation EGFR inhibitors in the international lung cancer targeted therapy stage, and accelerate the development of innovative drugs in China to occupy a dominant position in the global competitive landscape, so that more patients around the world can benefit from China's high-quality innovation results
faster.
It is worth mentioning that in addition to the acceptance of the first overseas listing application of ametinib, Hansen Pharmaceutical has also recently reached cooperation or expanded cooperation
with the Global Health Drug Research and Development Center (GHDDI), South Korea's biomedical R&D company TiumBio, and Beijing Wangshi Intelligent Technology Co.
, Ltd.
The collaboration includes obtaining global development, production and commercialization rights for the GDI-4405 series; Obtained an exclusive license agreement in China for the oral non-peptide GnRH receptor antagonist TU2670 to develop and commercialize TU2670 for the treatment of endometriosis and uterine fibroids and other potential indications; Carry out strategic cooperation in the field of AI-enabled early drug R&D to help accelerate the early R&D of new drugs, reduce costs and improve the success rate
.
In this regard, industry analysts believe that driven by the BD strategy of globalization and diversification, the pace of international development of new drugs of Hansen Pharmaceutical will become faster
and faster.
At the same time, it is expected that the company's revenue in overseas markets will continue to grow
in the future.
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