Hengrui Pharma (01276) Climbs Nearly 5% After NMPA Accepts Ruikang Trastuzumab Application Under Priority Review

Shares of Jiangsu Hengrui Pharmaceuticals Co., Ltd. climbed nearly 5% on Tuesday, as the Chinese drugmaker secured regulatory acceptance for a new indication of its flagship antibody-drug conjugate targeting breast cancer.

As of press time, Hengrui Pharma (01276.HK) was up 3.59% at HKD 62.05, with turnover reaching HKD 217 million.

The catalyst: the company's subsidiary, Suzhou Shengdia Biopharm Co., Ltd., received an Acceptance Notice from China's National Medical Products Administration (NMPA) for the new drug application of Ruikang trastuzumab for injection (development code: SHR-A1811). The application has been placed under the priority review program.

This marks the third regulatory milestone for the drug in China, which has already secured approval for two indications domestically.

Phase III Trial Design

The new indication submission is based on a Phase III clinical trial featuring a randomized, open-label, active-controlled, multicenter design. The study evaluated the efficacy and safety of SHR-A1811 versus investigator's choice chemotherapy in patients with HER2-low recurrent or metastatic breast cancer.

The trial enrolled patients who had either not received or had received only first-line chemotherapy for metastatic disease.

The control arm included five standard chemotherapy options: paclitaxel, nab-paclitaxel, eribulin, capecitabine, and gemcitabine.

What This Means

Priority review status signals that regulators view the drug as addressing an unmet medical need. If approved, SHR-A1811 would expand Hengrui's footprint in the competitive HER2-targeted therapy space, particularly in the growing HER2-low breast cancer segment.

The HER2-low classification has emerged as a distinct therapeutic category in recent years, representing patients whose tumors express lower levels of the HER2 protein compared to traditional HER2-positive cases. This population has historically had fewer targeted treatment options.

Hengrui Pharma, one of China's largest pharmaceutical companies by market capitalization, has been aggressively expanding its oncology pipeline. The company's push into antibody-drug conjugates reflects a broader industry trend toward more precise, targeted cancer therapies.

Investors will be watching for clinical data readouts and the timeline for the NMPA approval decision.