Sichuan Kelun-Biotech Biopharmaceutical (HKG:6990) said its sacituzumab tirumotecan (sac-TMT) in combination with tagitanlimab has received a breakthrough therapy designation in China for lung cancer, according to a Wednesday Hong Kong bourse filing.
The designation, granted by China's National Medical Products Administration (NMPA), covers first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer in patients without actionable genomic alterations.
Kelun-Biotech said this marks the fifth breakthrough tag for sac-TMT granted by the NMPA.
Sac-TMT is already approved in China for multiple indications and is being developed globally with Germany's Merck, which is leading 14 Phase 3 trials outside Greater China, the filing said.
Shares of the biopharmaceutical firm were down about 3% in recent trade.
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