China Approval Lifts AstraZeneca Stock 5%
AstraZeneca's US-listed shares climbed 5% on March 27 after the company announced a significant regulatory victory in China. The country's National Medical Products Administration granted approval for Enhertu (trastuzumab deruxtecan), an advanced cancer therapy co-developed with Japan's Daiichi Sankyo. This decision provides AstraZeneca access to the vast Chinese market for one of its key oncology assets, driving immediate investor confidence.
Enhertu Secures World-First Indication in China
This approval marks a strategic milestone, as China is the first country globally to approve Enhertu as a neoadjuvant (pre-operative) treatment for patients with early-stage breast cancer. The move highlights China's accelerating drug approval reforms and its growing role as a crucial primary market for global pharmaceutical innovations. The therapy is designed to reduce the risk of disease recurrence and improve the potential for a cure.
The approval of this innovative injection offers a new treatment option and hope for clinical cure to more early-stage breast cancer patients in the country.
— Wu Jiong, Party secretary of Fudan University Shanghai Cancer Center.
Global Momentum Builds with Japanese Regulatory Wins
The Chinese market entry is part of a broader pattern of success for Enhertu, which has secured multiple approvals globally. In Japan, the drug was recently approved as the first tumor-agnostic HER2-directed medicine, its sixth approved indication in the country. Clinical data from the HERALD trial supporting this showed a confirmed objective response rate (ORR) of 56.5% across a range of solid cancers. Separately, Japanese regulators expanded Enhertu's use for second-line gastric cancer after a Phase 3 trial demonstrated a 30% reduction in the risk of death versus standard care. These consistent wins validate Enhertu's efficacy and underpin its importance as a major growth driver for AstraZeneca.