BRIEF: Everest Medicines advances with major licensing deal, new drug application approval

Everest Medicines Ltd. (1952.HK) last Thursday announced an exclusive licensing agreement to commercialize Micot’s MT1013 for the treatment of secondary hyperparathyroidism (SHPT), worth up to 1.24 billion yuan ($179 million). It also announced an important advance for its Velsipity drug a day later, as China’s National Medical Products Administration (NMPA) approved its new drug application (NDA) for the treatment of moderately to severely active ulcerative colitis (UC).

The licensing deal will see Everest Medicines work exclusively with Shaanxi Micot Pharmaceutical Technology Co. Ltd. to commercialize MT1013, which is the world’s first-in-class dual-targeting receptor agonist polypeptide that simultaneously targets the Calcium-Sensing Receptor (CaSR) and the Osteogenic Growth Peptide (OGP) receptor. The drug is primarily being developed to treat SHPT.

According to the agreement, Everest Medicines will make an upfront payment of 200 million yuan to Micot, as well as potential regulatory and commercial milestone payments of up to 1.04 billion yuan. Micot will cover relevant development costs going forward for MT1013, which is currently in its Phase 3 clinical trials in China.

Separately, Everest Medicines said last Friday that the NMPA had granted Velsipity an NDA to treat adults suffering from moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

Velsipity, or etrasimod arginine tablets, is a next-generation selective sphingosine 1-phosphate receptor modulator. Its NDA approval by the NMPA was based on two Phase 3 studies showing the drug “demonstrated statistically significant and clinically meaningful improvements across all primary and secondary efficacy endpoints” over the course of the studies, Everest Medicines said.

Everest’s stock rose 5.5% over the two trading days on Thursday and Friday last week after the announcements, bringing their gains for this year to 7.2%.

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