DualityBio/BioNTech’s ADC Takes on Enhertu In Chemo-Naive HER2-Low Breast Cancer

The Sino-German partnership is betting that the Phase III DYNASTY-Breast02 trial with the HER2-targeting antibody-drug conjugate DB-1303 will produce a rival to AstraZeneca/Daiichi Sankyo’s Enhertu in the US market.

narrowing window of time
time running out for fast-followers of Enhertu to prove themselves in chemo-free HER2-low breast cancer • Source: Shutterstock

The Chinese antibody-drug conjugate specialist Duality Biologics (DualityBio), together with partner BioNTech SE, are racing against a narrowing window of opportunity to exploit the HER2-low breast cancer field, which was first kicked into high gear by Daiichi Sankyo Co., Ltd. and AstraZeneca PLC’s ADC Enhertu (trastuzumab deruxtecan).

Key Takeaways
  • DualityBio and BioNTech will initiate the US-only Phase III DYNASTY-Breast02 of their HER2-targeting ADC DB-1303 in chemotherapy-naive patients with HER2-low and HR-positive breast cancer.

The Sino-German alliance is planning to initiate the US-only Phase III DYNASTY-Breast02 trial with its HER2-targeting ADC DB-1303 in chemotherapy-naive...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from China

More from Focus On Asia

Torrent Acquires JB Chem In 2025’s Biggest Deal For Indian Pharma

 
• By 

Torrent Pharma’s JB Chemicals acquisition follows the Curatio deal and Boehringer brands buyout. The second-biggest deal ever and the largest in 2025 among domestic pharma companies helps Torrent fill white spaces in areas like nephrology and gives an entry into the CDMO segment

Snapshot Of India’s Pharma Manufacturing Network Amid ‘Trumponomics’

 

Scrip collates data on the global manufacturing network of leading Indian drug makers, the markets serviced and production hubs for active pharmaceutical ingredients. Will ongoing geopolitical tensions and policy shifts have a bearing on some of these down the line?

GSK, Bharat On Shigella Vaccine Phase II Data Timelines, Malaria Vaccine Price Halving

 
• By 

GSK tells Scrip about timelines for data expected from two Phase II trials for its Bharat Biotech-partnered shigella vaccine candidate, which puts it ahead of Limmatech/Valneva. Meanwhile, a global-first malaria vaccine, also partnered with Bharat, sees an over 50% price cut