No Data
No Data
Alphamab Oncology Announced Anti-HER2 Bispecific ADC JSKN003 Received Approval From CDE to Initiate a Phase III Clinical Study for Ovarian Cancer
Express News | Alphamab Oncology - Approval From Cde China for Jskn003 to Initiate a Phase III- Clinical Study for Treatment of Oc
The clinical study of Corning Jereh's HER2 bispecific antibody ADC subcutaneous injection compound formulation JSKN033 has been approved for clinical trials.
Suzhou, December 26, 2024 /PR Newswire/ -- Corning Jiere Biotechnology (stock code: 9966.HK) announced that the application for a Phase I/II clinical study (Study No: JSKN033-102) of the high-concentration subcutaneous compound formulation JSKN033, a HER2 bispecific antibody-conjugated drug (ADC) combined with a PD-L1 inhibitor, has been approved by the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE). This study is part of the pilot project for optimizing Innovative Drugs clinical trial review and approval. JSKN033-102 is an open, multi-center...
Alphamab Oncology's Anti-Tumor Drug Gets IND Approval From NMPA
ALPHAMAB-B (09966.HK): The IND application for a Phase I/II clinical trial of JSKN033 has been approved by CDE.
On December 24, Gelonghui announced that ALPHAMAB-B (09966.HK) has received approval from the National Medical Products Administration ("NMPA") Drug Evaluation Center ("CDE") for its new drug clinical trial application ("IND") for JSKN033 (a high concentration subcutaneous combined formulation of HER2 bispecific antibody conjugate drug ("ADC") and PD-L1 immune checkpoint inhibitor). JSKN033-102 is an open-label, multi-center, phase I/II clinical trial.
Highly resilient! Leading CRO companies have stabilized their fundamentals, but the shadow of the biosafety bill may still linger next year | Year-end review.
① In 2024, the USA Biodefense Act will disrupt CROs throughout the year and may continue next year; ② In the first three quarters of this year, over half of listed companies experienced revenue growth, and leading CROs demonstrated resilience; ③ Research on popular targets such as ADC, GLP-1, and bispecific antibodies will continue to be hot; ④ In 2025, the performance of leading CROs and small to medium enterprises may further diverge.