According to Allist Pharmaceuticals' announcement on June 30, Allist intends to enter into an agreement with ArriVent Biopharma (hereinafter referred to as "ArriVent") to authorize ArriVent the right to exclusively develop (including R&D, production, import, export, use, sales, etc.) Furmonertinib outside Greater China, and Allist will receive a down payment of 40 million US dollars, and an accumulative amount of no more than 765 million US dollars, including R&D and sales milestone payments (after reaching the agreed R&D or sales milestone event), sales commission fees, and some shares of ArriVent.
Furmonertinib is a highly selective and irreversible third-generation EGFR-TKI independently developed by Allist. In March 2021, it was approved for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults with disease progression during or after treatment with EGFR-TKI and positive EGFR T790M mutation confirmed by detection. Furmonertinib's trade name is Ivesa.
Furmonertinib marks the third 3G EGFR-TKI and the second domestic EGFR-TKI approved in China. The Phase 2b clinical data published in The Lancet Respiratory Medicine revealed that Furmonertinib came with an ORR of 74%, mPFS of 9.6 months, and DCR of 94% in the treatment of patients with EGFR T790M mutation-positive locally advanced or advanced NSCLC; In terms with patients with brain metastases, according to the data disclosed in the WCLC 2020, the 160 mg subgroup of the Phase 2a dose extension study suggested Furmonertinib proved central nervous system (CNS) ORR of 84.6 %, CNS mPFS of 19.3 months, and CNS DCR of up to 100%.
Moreover, the production application of Furmonertinib for the first-line treatment of NSCLC (i.e. the treatment of locally advanced or metastatic NSCLC adult patients with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation) are expected to be filed this year. Meanwhile, this drug for adjuvant therapy of the indication (of patients with EGFR mutation-positive stage II-IIIA NSCLC after radical resection with or without adjuvant chemotherapy) is currently subject to Phase 3 clinical trials. Furmonertinib for indications for insertion mutation of exon 20 (of locally advanced or metastatic NSCLC adult patients with EGFR 20 exon insertion mutations) is reported to be in Phase 1b clinical trials.
Avitinib and Furmonertinib going abroad one after another
So far, three 3G EGFR-TKI inhibitors have been permitted in China, details of which are listed in the following table. Therein, AstraZeneca's Osimertinib has been authorized for second-line treatment, first-line treatment, and postoperative adjuvant therapy for patients with EGFR mutation-positive NSCLC, and yet Almonertinib and Alflutinib are only allowed for second-line treatment. Simultaneously, marketing application of Almonertinib for the first-line treatment of new indications of adult EGFR exon 19 deletion or exon 21 (L858R) substitution mutations of locally advanced or metastatic NSCLC (the relevant acceptance number is CXHS2101017) has been brought into the priority review by CDE.
Furthermore, the production application of 4 another third-generation EGFR-TKIs have been submitted, including 4 domestic new drugs and 1 generic drug.
It can be perceived from the approval and production applications of the third-generation EGFR-TKIs that the R&D strength of Chinese pharmaceutical companies shouldn't be belittled, and they have been accredited and favored by overseas pharmaceutical companies. thereinto, Avitinib and Almonertinib have gone global. In May ...
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