-
FRα ADC Rina-S by Genmab Enters Late-Stage Clinical Trial Following ProfoundBio Acquisition
•
Genmab A/S (NASDAQ: GMAB) has initiated a Phase III clinical trial for its FRα ADC candidate, Rina-S, as registered on ClinicalTrials.gov on October 1, 2024. The trial aims to enroll 530 patients with platinum-resistant advanced ovarian cancer to compare Rina-S head-to-head with chemotherapy, with an anticipated preliminary completion date in…
-
Dizal Pharmaceutical’s Surufatinib Earns CDE Consideration for Breakthrough Therapy in EGFR exon20ins NSCLC
•
Dizal Pharmaceutical, a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China is considering its drug candidate DZD9008 for breakthrough therapy status. The drug is designed to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received…
-
Hengrui Medicine’s HR19042 Capsules Designated as Breakthrough Therapy for Autoimmune Hepatitis by China NMPA
•
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has recently announced that Hengrui Medicine (SHA: 600276)’s Class 2.2 improved drug, HR19042 capsule, is planned to be included in the breakthrough therapy category, targeting active autoimmune hepatitis. According to previous announcements by Hengrui Medicine, HR19042 is…
-
NMPA Clears AbbVie’s ABBV-706 for Clinical Trials Targeting SCLC and Neuroendocrine Tumors
•
The China National Medical Products Administration (NMPA) has granted clinical trial approval to ABBV-706, a novel antibody-drug conjugate (ADC) developed by AbbVie (NYSE: ABBV), for the treatment of relapsed/refractory small cell lung cancer (SCLC) and other neuroendocrine tumors . ABBV-706 is a targeted therapy that binds to SEZ6, a protein…
-
Jiangsu Alphamab Biopharmaceuticals Partners with Shanghai Jinmant Biotech for JSKN003 ADC
•
Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has announced that its wholly-owned subsidiary, Jiangsu Alphamab Biopharmaceuticals Co. Ltd, has entered into a licensing agreement with Shanghai Jinmant Biotech Co., Ltd, a subsidiary of CSPC Pharmaceutical Group Co., Ltd (HKG: 1093), for the development and commercialization of its…
-
CStone Pharmaceuticals’ Partner HengRui Medicine Launches Phase III Trial for CTLA-4 Antibody in HCC
•
CStone Pharmaceuticals (HKG: 2616), an innovation-driven biopharmaceutical company focused on the development of oncology drugs, announced today that its partner, HengRui Medicine, has initiated a Phase III clinical study for CS1002/SHR-8068 (an anti-CTLA-4 monoclonal antibody) in combination with adebrelimab and bevacizumab for the first-line treatment of advanced hepatocellular carcinoma (HCC).…
-
Zephyrm Biotechnologies Aims for HKEX Main Board with Innovative Cell Therapy Products
•
Zephyrm Biotechnologies Co., Ltd. (hereinafter referred to as “Zephyrm Bio”) officially submitted its prospectus to the Hong Kong Stock Exchange (HKEX) on September 30, 2024, with the intention to list on the Main Board, with CICC acting as the sole sponsor. Established in 2017, Zephyrm Bio, a clinical-stage biopharmaceutical company,…
-
Akeso Biopharma’s Cadonilimab Secures NMPA Approval for Gastric Cancer Indication
•
Akeso Biopharma Inc. (HKG: 9926) announced that its self-developed PD-1/CTLA-4 bispecific antibody, Cadonilimab injection (AK104), has been approved by the National Medical Products Administration (NMPA) in China for a new indication. This is the second indication for the product in China and is for the first-line treatment of patients with…
