Pharmaceutical Executive Daily: Hanmi Licenses HM17321 to Genentech

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In today's Pharmaceutical Executive Daily, Hanmi Pharm licenses its investigational obesity candidate HM17321 to Genentech in a deal worth up to $2.3 billion including a $190 million upfront payment, James LaValle, chair of the International Peptide Society, speaks with Pharmaceutical Executive on what FDA's advisory committee vote recommending six peptides for the Section 503A Bulks List means for the market, and Pharmaceutical Executive examines how tau- and microglia-targeted therapies are redefining the Alzheimer's drug pipeline beyond amyloid.

Hanmi Pharm has entered an exclusive worldwide licensing agreement with Genentech, a member of the Roche Group, for HM17321, a proprietary urocortin-2 analog designed to reduce adiposity while preserving muscle mass through a non-GLP-1 mechanism. The deal is worth up to $2.3 billion, including a $190 million upfront payment plus development, regulatory, and commercial milestones and tiered royalties. Hanmi is completing the ongoing Phase I trial evaluating HM17321 in healthy volunteers and people with obesity, after which Genentech assumes responsibility for Phase II development and beyond.

Pharmaceutical Executive speaks with James LaValle, chair of the International Peptide Society and chief science officer at Life Time, on what FDA's Pharmacy Compounding Advisory Committee's vote recommending six of the seven nominated peptides for the Section 503A Bulks List means for the market. The committee backs BPC-157, TB-500, and Epitalon among others, while declining to recommend Emideltide/DSIP, and LaValle notes the outcome is advisory and does not change the compounds' legal status. He argues the evidence base remains uneven for several of the peptides and calls for "evidence triangulation," including registries and standardized outcome measures, rather than dismissing compounds that haven't gone through traditional pharmaceutical development.

Finally, Ivo Carre examines how Alzheimer's drug development is moving beyond amyloid toward tau and microglia-targeted mechanisms, following the modest clinical impact of approved anti-amyloid therapies Leqembi and Kisunla. On the tau side, newer antibodies like Merck's MK-2214 aim to selectively target pathological forms of the protein, while Biogen and Ionis's antisense therapy diranersen reduced tau pathology in the Phase II CELIA study, though a clinical benefit emerged only in the lowest-dose group. On the microglia side, TREM2 agonists including Sanofi's SAR448851 and Novartis's VHB937 have entered Phase II development, aiming to strengthen the brain's immune response rather than broadly suppress inflammation.

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