Akeso Biopharma has successfully raised approximately $250 million through a share placement, drawing significant recognition from international investment firms. The placement saw a majority of subscribers from long-term and healthcare-focused funds, highlighting Akeso’s strong appeal in the global investment landscape. This substantial capital influx serves as a testament to Akeso’s impressive track record in drug […]
Summit Therapeutics Inc. has announced a significant milestone in its oncology development efforts, completing patient enrollment for the HARMONi Phase III clinical trial. This pivotal study seeks to evaluate the efficacy of Ivonescimab, a novel bispecific antibody, in combination with platinum-doublet chemotherapy as a second-line treatment for patients with epidermal growth factor receptor-mutated (EGFRm) non-squamous […]
China’s National Medical Products Administration (NMPA) has approved AstraZeneca’s Forxiga (dapagliflozin) for diminishing the risk of cardiovascular fatalities and hospitalizations in adults diagnosed with symptomatic chronic heart failure (HF). This follows an earlier authorization for patients suffering from heart failure with reduced ejection fraction (HFrEF). Now, Forxiga’s capabilities extend to all adults with symptomatic chronic […]
The National Medical Products Administration (NMPA) of China has granted approval to AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for use as a monotherapy in adult patients with unresectable or metastatic HER2-low breast cancer. The approval applies to patients who have undergone prior systemic therapy in a metastatic setting or experienced disease recurrence within six […]
Gufic Biosciences has received approval from the National Medical Products Administration (NMPA) in China for its product, Prilocaine (API), an amide-type local anesthetic. The approval will aid in the commercialization of Prilocaine in China, opening up new opportunities in the Chinese market for Gufic. Prilocaine, which shares a similar clinical profile to lidocaine, is used […]
Innovent Biologics has been granted breakthrough therapy designation (BTD) for olverembatinib from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The breakthrough therapy designation has been given to olverembatinib as a treatment for succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) patients who have received first-line treatment. The designation was based […]
AstraZeneca has announced that its drug, Forxiga (dapagliflozin), has received approval from the Chinese National Medical Products Administration (NMPA) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) and reduced ejection fraction (HFrEF). This marks a significant step forward in the treatment options available […]
Amgen said that sotorasib, an investigational KRASG12C inhibitor, has been given breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. The Chinese breakthrough therapy designation for sotorasib is for the treatment of patients having KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer […]
Antengene has been given approval from China’s National Medical Products Administration (NMPA) for a phase 1/2 clinical trial of ATG-016 (eltanexor) in myelodysplastic syndrome (MDS). The Chinese biopharma company will enroll patients having intermediate and higher risk myelodysplastic syndrome as determined by the Revised International Prognostic Scoring System (IPSS-R) after the failure of hypomethylating agents […]