Antengene Corporation Limited, a commercial-stage global biopharmaceutical company, has announced a significant milestone with the China National Medical Products Administration (NMPA) approving a new indication for XPOVIO (selinexor). This approval allows the use of XPOVIO as a monotherapy for adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), one of the most […]
GSK plc (LSE/NYSE: GSK) has reached a pivotal milestone in the prevention of shingles (herpes zoster) in China, with the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) now reviewing the regulatory application for Shingrix (Recombinant Zoster Vaccine or RZV) for adults aged 18 years and over at increased risk. […]
Avistone Biotechnology Co. Ltd., a precision oncology therapeutics company, has announced the conditional approval from the National Medical Products Administration (NMPA) of China for commercializing Vebreltinib to treat patients with MET exon 14 skipping non-small cell lung cancer (NSCLC). Pivotal Phase II Study Results Underpinning Approval The NMPA’s decision was influenced by the positive outcomes […]
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 […]
In a pivotal move, AceLink Therapeutics, Inc., a frontrunner in the biopharmaceutical sector, has inaugurated its first clinical trial site in China. The Phase 2, open-label study aims to gauge the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary physiological efficacy measures of AL01211 for untreated classic Fabry disease males. A vanguard in the field, AceLink […]
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 […]
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 […]
BeiGene said that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a new drug application (NDA) of pamiparib for the treatment of certain ovarian cancer patients. Pamiparib is an investigational inhibitor of PARP1 and PARP2 and its NDA is for patients having deleterious or suspected deleterious germline […]
Genetron Health has been granted approval by China’s National Medical Products Administration (NMPA) for GENETRON S5, its semiconductor-based next-generation sequencing system (NGS system). With the approval, the Chinese precision oncology company can launch the new desktop medium-throughput NGS system for clinical applications. The NGS system has been developed by Genetron Health for the detection of […]