In Part 1 of our feature, we explored Enhertu’s groundbreaking pharmacological profile and its role in launching the second ADC boom. In this concluding part, we shift focus to intellectual property strategies, patent lifespans, and the intensifying global race for HER2 ADC dominance. Finally, I share my perspective on where this high-stakes battle is headed.
Intellectual Property: The Hidden Battleground
Beyond clinical efficacy, intellectual property (IP) defines market power in the ADC space. Enhertu is strongly protected through patents on its DXd payload and linker technology, securing exclusivity well into the 2030s. Further extensions may be achieved through indication-specific method patents.
By contrast, Kadcyla faces waning protection as key patents expire, opening the door for biosimilars and eroding its market share. This stark contrast underlines why patent strategy is as crucial as clinical differentiation.
Rising Challengers and Their IP Play
BioNTech and DualityBio’s BNT323/DB-1303 has demonstrated superiority over Kadcyla in Phase 3 trials, combining trastuzumab with a novel linker and payload. Its patent estate may extend into the mid-2030s, offering a foothold as a “second-generation” HER2 ADC.
Meanwhile, biotech innovators in Europe and the U.S. are designing ADCs with immune-stimulating payloads and DNA-damaging agents, aiming for IP protection that stretches into the 2040s.
The Reality of Global Overcompetition
More than 20 HER2 ADC programs are now active worldwide. Chinese companies are moving rapidly, targeting windows created by patent expirations and seeking domestic dominance with cost-competitive products. In contrast, Western players are leveraging strong patent portfolios to defend global markets.
The key differentiators now are safety (especially managing ILD risk) and combination strategies. The race has shifted from standalone efficacy to redefining treatment paradigms through synergy with checkpoint inhibitors, VEGF blockade, and beyond.
My Perspective: Looking Ahead
The HER2 ADC market stands at a turning point. Enhertu will likely hold its dominance in the near term, but challengers armed with new payloads and extended patents are gaining momentum. The race is evolving from a “one-horse show” to a dynamic battlefield of multiple contenders.
In my view, the future will hinge on three fronts:
- Expanding beyond HER2-low into tumors with heterogeneous HER2 expression
- Balancing potency with safety through next-gen payload design
- Shaping new treatment paradigms via rational combinations
This emerging “Warring States era” of HER2 ADCs will ultimately benefit patients, offering more diverse and powerful treatment options. Each clinical readout now represents not just a data point, but a pivotal moment in the future of oncology.
As we conclude this two-part feature, one thing is clear: HER2 ADCs are no longer an extension of antibody therapy—they are the central battlefield shaping the future of cancer care.
This article was edited by the Morningglorysciences team.
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