SKB BIO-B

The FDA granted sacituzumab tirumotecan (SKB264/MK-2870) breakthrough therapy designation for advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) with EGFR mutations, post-TKI and platinum-based chemotherapy progression. This decision is supported by phase 2 study data, marking the first BTD for the agent in the US.

The FDA granted breakthrough therapy designation to sacituzumab tirumotecan for treating advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) with EGFR mutations, following TKI and platinum-based chemotherapy. The decision is based on phase 2 study findings showing promising objective response rates and disease control rates, with ongoing clinical trials exploring its combination with pembrolizumab. Additionally, the drug is under review by the NMPA for EGFR-mutant NSCLC and has been approved for triple-negative breast cancer.

The FDA granted breakthrough therapy designation to sacituzumab tirumotecan (SKB264/MK-2870) for advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) with EGFR mutations, following TKI and platinum-based chemotherapy progression. The decision is based on phase 2 study findings showing potential benefits in EGFR-mutated NSCLC patients who received at least 2 lines of therapy. Merck emphasizes the importance of ADCs in cancer treatment and aims to improve current standards of care.

Kelun-Biotech received NMPA approval for sacituzumab tirumotecan (sac-TMT), the first domestically developed TROP2 ADC for treating advanced TNBC in China, based on positive phase 3 OptiTROP-Breast01 study results.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced the marketing authorization of sacituzumab tirumotecan (sac-TMT), the first domestically developed TROP2 ADC for treating unresectable locally advanced or metastatic TNBC in China.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HK:6990) received marketing approval in China for sacituzumab tirumotecan (sac-TMT), targeting advanced triple negative breast cancer, following a phase 3 study showing improved patient survival rates compared to standard chemotherapy.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HK:6990) received approval for clinical trials of novel drug SKB571 targeting solid tumors, secured $37.5 million from Merck & Co., with potential milestone payments and royalties, retaining commercialization rights in China, Hong Kong, and Macau. Investors advised caution.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HK:6990) announced the approval of its ADC drug, SKB535, by the National Medical Products Administration for clinical trials. Developed using the OptiDC platform, SKB535 targets advanced solid tumors and has shown promising preclinical results. The company has partnered with Merck & Co., Inc. for further development, with potential milestone payments and royalties upon commercialization.