Weekly Digest – October 2025 Weekly Digest – October 2025 20 October 2025: JSKN003 granted another breakthrough therapy designation in China for the treatment of patients with HER2-positive advanced colorectal cancer JSKN003, a biparatopic HER2-targeting antibody-drug conjugate co-developed by CSPC’s […]
Weekly Digest – October 2025 Weekly Digest – October 2025 21 October 2025: Padcev (Enfortumab vedotin) plus Keytruda (Pembrolizumab) sBLA granted FDA priority review for treatment of certain patients with muscle-invasive bladder cancer The FDA has accepted a supplemental Biologics License […]
Weekly Digest – October 2025 Weekly Digest – October 2025 23 October 2025: Heidelberg Pharma’s lead ADC Candidate HDP-101 granted fast track designation by US FDA for the treatment of multiple myeloma The US FDA granted fast track designation to […]
Weekly Digest – October 2025 Weekly Digest – October 2025 30 September 2025: AbbVie submits Biologics License Application (BLA) to U.S. FDA for Pivekimab sunirine (PVEK) an investigational ADC to treat rare cancer with limited treatment options AbbVie has submitted […]
Weekly Digest – October 2025 Weekly Digest – October 2025 01 October 2025: Enhertu followed by THP supplemental biologics license application accepted in the U.S. for patients with high-risk HER2 positive early-stage breast cancer prior to surgery The U.S. FDA […]
Weekly Digest – October 2025 Weekly Digest – October 2025 30 September 2025: Henlius receives the NMPA IND approval for Its PD-L1 targeting ADC HLX43 in combination with novel anti-EGFR mAb HLX07 The China NMPA approved Henlius’ IND application for […]
Weekly Digest – February 2025 Weekly Digest – February 2025 26 Feb 2025: Pyxis Oncology granted FDA fast track designation for PYX-201 monotherapy in patients with recurrent or metastatic head and neck cancer The FDA has granted Fast Track Designation […]
Weekly Digest – February 2025 Weekly Digest – February 2025 25 Feb 2025: Hansoh Pharma’s HS-20093 receives Breakthrough Therapy Designation from NMPA for Osteosarcoma Hansoh Pharma’s B7-H3-targeted ADC, HS-20093, has been granted Breakthrough Therapy Designated Drug status by China’s NMPA […]
ADC Digest – August 2020 ADC Digest – August 2020 Kadcyla approved in Japan for adjuvant therapy of HER2-positive early breast cancer 21 Aug 2020 Kadcyla (Trastuzumab emtansine, Tubulin polymerization inhibitor; Chugai (a Roche subsidiary)/Immunogen) Approval was based on the […]
ADC Digest – August 2020 ADC Digest – August 2020 AstraZeneca in collaboration with Daiichi Sankyo initiated a Phase 3 study evaluating trastuzumab deruxtecan versus chemotherapy in HER2-low, HR+ breast cancer 20 Aug 2020 Enhertu (Trastuzumab deruxtecan, DNA topoisomerase I […]
