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National Medical Products Administration (NMPA)

National Medical Products Administration (NMPA)

Federal regulatory agency

Appears in 2 stories

Stories

Hansoh's B7-H3 ADC wins China breakthrough status for esophageal cancer

New Capabilities

Granted HS-20093 breakthrough therapy designation

Patients with advanced esophageal squamous cell carcinoma who fail both chemotherapy and immunotherapy have almost no good options. On May 11, China's drug regulator granted breakthrough status to Hansoh Pharmaceutical's HS-20093, a targeted cancer drug built around a protein called B7-H3.

Updated 5 days ago

Tarlatamab rewrites treatment for small-cell lung cancer as approvals spread worldwide

New Capabilities

Approved tarlatamab through priority review pathway

For decades, patients with extensive-stage small-cell lung cancer who relapsed after chemotherapy had almost nowhere to turn — five-year survival rates sat around 3%. Now a drug that physically bridges the patient's own immune cells to their tumor cells has been approved in both the United States and China, opening a new treatment class for one of the deadliest cancers. Tarlatamab, sold as Imdelltra, reduced the risk of death by 40% compared to standard chemotherapy in a confirmatory trial of 509 patients.

Updated Apr 13