The National Medical Products Administration (NMPA) in China has recently approved Sichuan Kelun Biotech Biopharmaceutical’s Sutaray (trastuzumab botidotin) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer (BC). The move marks a pivotal advance in the nation’s oncology market as domestic innovation accelerates in high-need breast cancer segments, says GlobalData, a leading data and analytics company.

Reportedly, Sutaray is the country’s second domestically developed HER2-targeted antibody-drug conjugate (ADC). It binds to HER2 receptor inhibiting the signaling pathway and it has antibody-dependent cell-mediated cytotoxicity (ADCC) activity.

The approval was supported by the results from the Phase III KL166-III-06 trial, which demonstrated that Sutaray monotherapy significantly improved progression-free survival (PFS), and overall survival (OS) as compared to T-DM1(trastuzumab emtansine).

According to GlobalData’s Pharmaceutical Intelligence Center, the incident cases of breast cancer are in China expected to increase at an annual growth rate of 2.40% from 300,489 in 2025 to 338,291 in 2030, making it the leading country across the five major markets (5MM*) in the Asia-Pacific (APAC) region.

Currently three other HER2 targeted ADC drugs: T-DM1(trastuzumab emtansine) from Genentech/Roche (second line of treatment), T-DXd (trastuzumab deruxtecan) from Daiichi Sankyo (second line of treatment) and RemGen’s Edici (disitamab vedotin, third line of treatment), are available for breast cancer in China.

Bobbili Stella Catherin, Pharma Analyst at GlobalData, comments: “Sutaray faces competition from both domestic and western companies ADCs. However, it has the potential for greater accessibility with more favorable pricing and broader reimbursement compared to western ADCs.”

According to GlobalData, there are currently 13 approved ADC drugs across all indications in China, with 157 drugs in clinical development, including 40 ADCs in Phase III. Notably, seven ADC drugs (four from domestic companies and three from Western companies) are approved for breast cancer, with 66 ADC drugs in clinical development, including 15 in Phase III. The recent approval of Sutaray makes it the seventh ADC drug for breast cancer in China.

Catherin concludes: “Sutaray addresses the significant unmet medical needs in patients whose tumors have become resistant to prior HER2-targeted therapies, positioning it as a new therapeutic option in the post-trastuzumab treatment setting. Kelun Biotech already has four approved therapies in Oncology. With its unique auristatin-based payload (Duostatin-5), Sutaray will strengthen Kelun Biotech’s oncology’s position in next-generation antibody-drug conjugates (ADCs).”

*5MM: India, China, Australia, South Korea, Japan.