All News
46 articles in total
Next-Generation ALK Inhibitor Dirozalkib Gets Approval in China, Offering New Hope for ALK-Positive Lung Cancer Patients
On August 22, 2025, the National Medical Products Administration (NMPA) officially approved the marketing of dirozalkib tablets, a Class 1 innovative drug independently developed by Xuanzhu Biopharmaceutical. This drug brings a breakthrough treatment option for patients with ALK-positive non-small cell lung cancer.
World's First DPP1 Inhibitor Approved, Creating a New Hotspot in Respiratory Disease Treatment
On August 12, 2025, Insmed announced that the FDA formally approved its DPP1 inhibitor brensocatib for marketing for the treatment of non-cystic fibrosis bronchiectasis in children aged 12 years and above and adults.
Chinese API Companies Accelerate Global Expansion, with Efficiency as a Key Challenge
The latest data shows that between 2022 and 2025, the number of Chinese API companies submitting DMFs to the US FDA surged, surpassing both the US and India in total, demonstrating strong expansion momentum. However, compared with India and the US, the average number of DMFs held by Chinese companies is lower, reflecting a structural problem of increasing quantity but not quality.
EU Approves First Neurofibromatosis Drug, Marking a Breakthrough in NF1-PN Treatment
On July 18, 2025, the European Commission (EC) granted conditional marketing authorization for EZMEKLY (mirdametinib) to SpringWorks Therapeutics, Inc. (a Merck & Co., Inc. healthcare company) for the treatment of adult and pediatric patients (2 years and older) with neurofibromatosis type 1 (NF1) with symptomatic, inoperable plexiform neurofibromas (PN).
BTK Inhibitor Tolebrutinib: Breaking the Silent Progression of Multiple Sclerosis
The BTK inhibitor tolebrutinib is a breakthrough that fills the treatment gap for non-relapsing secondary progressive multiple sclerosis (SPMS).
New Breakthrough in ROS1-Positive NSCLC: Ibtrozi Emerges as a New Force in Targeted Therapy
Recently, Ibtrozi (taletrectinib) developed by Nuvation Bio was approved by the US FDA for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).