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 patients with HER2-low and HR-positive breast cancer in the second-line...

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

Ascentage Broadens Horizons As Pipeline Shows Renewed Promise

 
• By 

Ascentage will share at ASCO new clinical data on its Bcl-2 inhibitor lisaftoclax, part of the Chinese firm's novel pipeline, on which its CEO shared with Scrip plans and strategy, along with some views on the use of RWD in China.

Strong Data For CARsgen’s CAR-T In Late-Line Gastric Cancer

 

In first confirmatory randomized controlled trial of any CAR-T therapy in solid tumors, CARsgen’s Claudin 18.2-targeting satri-cel reduced risk of death or disease progression by 63% in Chinese patients with gastric/gastroesophageal junction cancer.

Hengrui Set For Biggest Biopharma IPO So Far This Year

 

Jiangsu Hengrui Pharmaceuticals is gearing up for what will be 2025's biggest biopharma IPO so far, hoping to raise up to $1.27bn on the Hong Kong Stock Exchange. China's top drug maker by pipeline size plans to use part of the proceeds to reboot its overseas clinical trials ambitions.

China Biopharma Podcast

 
• By 

Join our China-based editors Dexter Yan and Xu Hu in this Chinese-language podcast looking at some of their recent interviews and other key coverage.

More from Focus On Asia

Ascentage Broadens Horizons As Pipeline Shows Renewed Promise

 
• By 

Ascentage will share at ASCO new clinical data on its Bcl-2 inhibitor lisaftoclax, part of the Chinese firm's novel pipeline, on which its CEO shared with Scrip plans and strategy, along with some views on the use of RWD in China.

Tech Convergence, Quality Data Needed To Accelerate Korea’s AI-Powered R&D

 
• By 

AI-powered drug development was a major topic at the recent Bio Korea meeting, where experts discussed how the technology is changing R&D activities and the challenges being faced by Korean firms as they look to catch up with their global competitors.

Strong Data For CARsgen’s CAR-T In Late-Line Gastric Cancer

 

In first confirmatory randomized controlled trial of any CAR-T therapy in solid tumors, CARsgen’s Claudin 18.2-targeting satri-cel reduced risk of death or disease progression by 63% in Chinese patients with gastric/gastroesophageal junction cancer.