•
China-based biopharmaceutical company Ascentage Pharma (HKG: 6855) has announced that it has received approval from the Center for Drug Evaluation of the National Medical Products Administration (NMPA) to conduct two separate Phase III clinical studies assessing its investigational drug APG-2449. The trials will evaluate the FAK/ALK/ROS1 tyrosine kinase inhibitor (TKI)…
•
China-based Innovent Biologics Inc. (HKG: 1801) and Jiangsu Aosaikang Pharmaceutical Co., Ltd (ASK Pharma, SHE: 002755) have announced a strategic collaboration and licensing agreement focused on ASK’s limertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) designed for lung cancer treatment. Under the terms of the deal,…
•
Suzhou-based biotech MediLink Therapeutics (Suzhou) Co., Ltd has announced a partnership with US pharmaceutical giant Amgen Inc. (NASDAQ: AMGN). The collaboration will see the two companies conduct a global clinical trial combining MediLink’s B7-H3-targeting antibody-drug conjugate (ADC) YL201 with Amgen’s DLL3- and CD3-targeting bispecific T-cell engager (BiTE) IMDELLTRA for the…
•
BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the commercial availability of TEVIMBRA (Tislelizumab) in the United States following its approval by the FDA for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy. The drug received FDA approval in March…
•
The U.S. Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS, NYSE: BMY) Opdivo (nivolumab) for use in combination with platinum-based chemotherapy as a neoadjuvant treatment for adult patients with resectable non-small cell lung cancer (NSCLC), followed by Opdivo as an adjuvant treatment post-surgery. This decision…
•
On October 4, 2024, Summit Therapeutics (referred to as “Summit”), a partner of Akeso Biopharma (HKG: 9926), announced the completion of subject enrollment for the HARMONi study, which evaluates the PD-1/VEGF bispecific antibody, Ivociclib (also known as AK112). The international Phase III clinical study is led by Summit and investigates…
•
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, 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…
•
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…
•
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).…
•
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…
•
Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm CSPC Pharmaceutical Group Ltd (HKG: 1093). The deal grants CSPC exclusive license and sub-license rights to Alphamab’s JSKN003 in mainland China for development, sales, and commercialization related to oncology indications.…
•
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has announced that its U.S. partner Bristol-Myers Squibb has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I/IIa study for BL-B01D1, an in-house developed bispecific antibody drug conjugate (ADC), in patients with advanced…
•
Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its combination drug QL1706, comprising iparomlimab and tuvonralimab, has received conditional marketing approval from the National Medical Products Administration (NMPA) for the treatment of recurrent or metastatic cervical cancer. QL1706 (PSB205), originally developed by the U.S. biotech Qilu Puget Sound Biotherapeutic…
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a prominent pharmaceutical company based in China, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its investigational drug XS-04 for the treatment of hematologic malignancies. XS-04, an innovative small molecule drug developed…
•
Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its investigational drug JAB-23E73, a pan-KRAS inhibitor developed in-house. This follows prior clearance from U.S. authorities to initiate a Phase I/IIa study for…
•
AstraZeneca (NASDAQ: AZN, LON: AZN), a UK-based pharmaceutical giant, has announced that it has received a new indication approval from the US Food and Drug Administration (FDA) for its non-small cell lung cancer (NSCLC) drug Tagrisso (osimertinib). The FDA has approved Tagrisso for the treatment of adult patients with unresectable,…
•
The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) convened on September 26 to scrutinize the application of PD-1 inhibitors in oncology, particularly focusing on Bristol Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab) and Merck, Sharp & Dohme’s (NYSE: MRK) Keytruda (pembrolizumab). The committee evaluated the risk-benefit profile of these drugs for…
•
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase I/II clinical study for its pipeline drug candidate, ZG005, aimed at treating advanced solid tumors. ZG005 is an…
•
Johnson & Johnson (J&J; NYSE: JNJ), a healthcare giant in the U.S., is reportedly winding down its cardiovascular and metabolic pharmaceutical unit, as reported by Endpoints News. Insiders have indicated that J&J has issued notices to its sales, marketing, and medical affairs teams this week. The company has acknowledged the…