On June 24, the CDE official website announced that CSPC Pharmaceutical Group’s Category 1 new drug SYS6043 has been proposed for Breakthrough Therapy designation, with the indication being platinum-resistant ovarian cancer, primary peritoneal cancer, and fallopian tube cancer. SYS6043 is…
On June 24, Astellas announced that the European Commission has approved PADCEV (enfortumab vedotin) in combination with Keytruda (pembrolizumab) as neoadjuvant therapy (pre-surgical treatment), followed by adjuvant therapy after radical cystectomy, for the treatment of adult patients with resectable muscle-invasive…
On June 23, the CDE official website showed that the new drug application (NDA) for Chia Tai Tianqing’s Vitekotuo Biantibody for Injection has been accepted. It is indicated as monotherapy for patients with CLDN18.2-positive, locally advanced or metastatic gastric/gastroesophageal junction…
On June 22 local time, Pfizer announced the top-line results from the Phase III SigVie-002 study (formerly known as Be6A Lung-01) of Sigvotatug vedotin. Sigvotatug vedotin is a potentially first-in-class ADC targeting integrin beta-6 (IB6), which Pfizer obtained through its…
On June 23, Haisco Pharmaceutical Group announced that it has entered into an exclusive licensing agreement with Nuvectis Pharma, Inc. in the United States. Under the agreement, Haisco grants Nuvectis exclusive worldwide rights, excluding Greater China, to develop, manufacture, and…
On June 22, the NMPA official website showed that Takeda Pharmaceutical’s “Apadamtase alfa” has been approved for marketing in China for on-demand or prophylactic enzyme replacement therapy (ERT) in children and adults with congenital thrombotic thrombocytopenic purpura (cTTP) (Acceptance No.:…
On June 22, the NMPA official website showed that AstraZeneca’s Osimertinib has been approved for a new indication in China (Acceptance No.: JXHS2500107/8), in combination with Savolitinib for the treatment of patients with locally advanced or metastatic non-squamous non-small cell…
On June 22, the NMPA official website showed that Biokin Pharmaceutical’s Category 1 new drug “Lunkang Yilong Tuomab” has been approved for marketing in China for the treatment of adult patients with recurrent/metastatic nasopharyngeal carcinoma who have previously failed at…
On June 22, the NMPA announced the approval of CARsgen’s Satricabtagene autoleucel for the treatment of CLDN18.2-positive, HER2-negative advanced gastric/gastroesophageal junction adenocarcinoma in patients who have failed at least two prior lines of therapy. This approval marks a significant breakthrough, as it…
On June 22, the NMPA official website showed that IntellimRNA Biotech’s “GR1801” has been approved for marketing in China for passive immunization of adult rabies virus-exposed individuals. Notably, according to Insight Database statistics, this is the first and currently only…