Innovent Receives Second Fast Track Designation from the U.S. FDA for IBI363 in Squamous Non-Small Cell Lung Cancer
Innovent Receives FDA for IBI363 in Squamous Non-Small Cell Lung Cancer
February 17, 2025
by PR Newswire
US FDA accepts Spectrum Pharmaceuticals’ poziotinib NDA for review
The US Food and Drug Administration (FDA) has accepted for review Spectrum Pharmaceuticals’ New Drug Application (NDA) for its therapy poziotinib.
February 14, 2022
by pharmaceutical-business-review
CStone announces the clinical data from registrational study of Sugemalimab in stage III non-small cell lung cancer published in The Lancet Oncology
CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology therapies and precision medicines...
January 17, 2022
by prnasia
Fierce Competition of R&D of KRAS G12C Inhibitors
Recently, the class 1 new drug "ZG19018 Tablets" of Suzhou Zelgen Biopharmaceuticals Co., Ltd. is approved for clinical use in China and the indications are: advanced malignant solid tumors with KRAS G12C mutation.
January 13, 2022
by PharmaSources/Yi
FDA grants Fast Track status to Genprex’s drug for NSCLC treatment
In preclinical studies, Reqorsa plus Keytruda were found to be efficient versus Keytruda alone in boosting survival.
January 5, 2022
by Pharmaceutical-Technology
Closely following Pralsetinib, the second RET inhibitor in China was applied for production
On November 9, according to the CDE official website, the listing application of Eli Lilly's RET inhibitor "Selpercatinib Capsule" was accepted.
December 2, 2021
by PharmaSources/Yi
BerGenBio Receives FDA Fast Track Designation For Bemcentinib In STK11-mutated Advanced/Metastatic Non-small Lung Cancer (NSCLC)
BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL inhibitors for severe unmet medical needs, today announces that the U.S. Food...
November 10, 2021
by prnewswire
PD-1/VEGF Bi-Specific Antibody (AK112) Obtained Approval to Initiate a Phase II Clinical Trial for Monotherapy or Combined Chemotherapy Neoadjuvant/Adjuvant Therapy of Resectable Non-Small Cell Lung C
Akeso, Inc. (the Company, 9926.HK) announces that AK112 (PD-1/VEGF bi-specific antibody), the novel immuno-oncology drug independently developed by the Company, obtained approval from the Center for Drug Evaluation...
November 2, 2021
by prnasia
Alphamab Oncology Announces First Patient Dosed in the Pivotal Clinical Study of KN046 for the Treatment of PD-(L)1 Refractory Advanced NSCLC
Alphamab Oncology (stock code: 9966.HK) announced, a pivotal clinical study of PD-L1/CTLA-4 bispecific antibody KN046 in China (ENREACH-LUNG-02) recently completed the first drug administration.
October 29, 2021
by prnasia
CStone presents updated data from registrational clinical study of sugemalimab in patients with stage IV NSCLC in an oral presentation at IASLC 2021 WCLC
CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focus on researching, developing and commercializing innovative immuno-oncology therapies and precision medicines...
September 28, 2021
by prnasia
WCLC 2021 | Mini Oral - Ascentage Pharma Announces Latest Data of Its Investigational Bcl-2/Bcl-xL Inhibitor Pelcitoclax (APG-1252) Combined with Osimertinib in Patients with EGFR TKI-Resistant Non-Sm
Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today reported the Phase Ib results of the dual Bcl-2/Bcl-xL inhibitor...
September 13, 2021
by prnasia
CStone presents registrational bridging study data for GAVRETO® (pralsetinib) highlighting efficacy and safety in Chinese patients with advanced RET fusion-positive non-small cell lung cancer at IASLC
CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on researching, developing and commercializing innovative immuno-oncology therapies and precision medicines...
September 13, 2021
by prnasia