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Astellas Pharma’s Zolbetuximab BLA Accepted by China’s CDE for Gastric Cancer Treatment
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the Center for Drug Evaluation (CDE) in China has accepted the Biologics License Application (BLA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody (mAb), for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or…
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GSK’s Jemperli Receives FDA Approval for First-Line Treatment of Advanced Endometrial Cancer
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GSK plc (NYSE: GSK), a major UK pharmaceutical company, has announced that the US Food and Drug Administration (FDA) has granted market approval for its programmed death-1 (PD-1) inhibitor, Jemperli (dostarlimab), as a first-line treatment for advanced or recurrent endometrial cancer. This indication is for patients who are to first…
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RemeGen’s Novel Bispecific Antibody RC148 Receives Clinical Trial Approval
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China-based RemeGen Ltd (SHA: 688331, HKG: 9995) has announced that it has received clinical trial approval for its novel bispecific antibody (BsAb), RC148. This development marks a significant step forward in the company’s efforts to address the complex challenges of treating multiple solid tumors. RC148 Development and Phase I Study…
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Jiangsu Hengrui’s Camrelizumab and Apatinib Combo Accepted for FDA Review for HCC Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that the US Food and Drug Administration (FDA) has accepted for review the Biologic License Application (BLA) for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, combined with the small-molecule targeted cancer therapy apatinib, as a first-line treatment for unresectable or…
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Jacobio Pharma’s Glecirasib Enters Breakthrough Therapy Review for Pancreatic Cancer Treatment
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China-based Jacobio Pharma (HKG: 1167) has announced that its novel KRAS G12C inhibitor, glecirasib, has entered into the breakthrough therapy review process for the treatment of locally advanced or metastatic pancreatic cancer with the KRAS G12C mutation. The drug is being developed as a second-line treatment in combination with gemcitabine…
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Lucence and Innovent Biologics Partner to Enhance Access to Cholangiocarcinoma Treatment in Hong Kong
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Singapore-based precision medicine specialist Lucence, with a presence in Suzhou, Hong Kong, and Palo Alto (California, US), has entered into a partnership with China-based Innovent Biologics Inc., (HKG: 1801). This collaboration aims to enhance patient access to Innovent’s Pemazyre (pemigatinib), the world’s first targeted therapy for cholangiocarcinoma (bile duct cancer),…
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Mirxes Holding Company Secures USD 50 Million in Series D Financing for RNA Technology
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Mirxes Holding Company Ltd, a Singapore-headquartered RNA technology company specializing in blood-based miRNA test kit products, has successfully closed a Series D financing round, raising USD 50 million. The funding round was supported by a consortium of existing and new investors, including Beijing Fupu, in which the Zhejiang Anji Economic…
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HanchorBio’s HCB101 Receives WFDA Approval for Multi-Region Clinical Study
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Taiwan-based HanchorBio has announced that it has received approval from the Taiwan Food and Drug Administration (WFDA) to conduct a multi-region, multi-center clinical study for its innovative fusion protein, HCB101. HCB101: A Promising Fusion Protein for Cancer TreatmentHCB101 is an engineered SIRP linked to IgG4-Fc α fusion proteins that can…
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InnoCare Pharma’s ICP-723 Receives NMPA Approval for Pediatric Clinical Study
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Beijing InnoCare Pharma (HKG: 9969), a China-based biotech company specializing in cancer and autoimmune diseases, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its second-generation pan-TRK inhibitor, ICP-723, in pediatric patients aged 2 to 12 years. This follows…
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FDA Approves Daiichi Sankyo’s Vanflyta for FLT3-ITD Positive AML Maintenance Treatment
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The US Food and Drug Administration (FDA) has granted clearance to Japan-based Daiichi Sankyo (TYO: 4568) for its type II FLT3 inhibitor, Vanflyta (quizartinib), as a maintenance treatment following consolidation chemotherapy for newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive in adult patients. Phase III Study Results and…
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Gilead Sciences Halts Development of Magrolimab for HR-MDS Following Phase III Trial Results
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Gilead Sciences (NASDAQ: GILD) has decided to stop pursuing the potential first-in-class immunotherapy, magrolimab, for higher-risk myelodysplastic syndromes (HR-MDS) after obtaining disappointing efficacy data from a Phase III trial. Although the company has not yet released the results, it has confirmed that the study’s primary endpoints included complete response (CR)…
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AbbVie’s Aquipta and Novartis’s Piqray Receive Regulatory Approvals in Mexico
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Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS) has granted registration approvals to two innovative drugs: AbbVie’s (NYSE: ABBV) analgesic Aquipta (atogepant) and Novartis’ (NYSE: NVS) cancer therapy Piqray (alpelisib). This marks a significant milestone for both companies, expanding access to these treatments in the Mexican market. Aquipta: A…
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Jiangsu Hengrui Pharmaceuticals and Hansoh Pharmaceutical Group Get NMPA Approval for Solid Tumor Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for a combination therapy involving its adebrelimab (SHR-1316) with Hansoh Pharmaceutical Group Co., Ltd’s (HKG: 3692) Ameile (almonertinib) or SHR-A2009, with or without chemotherapy, for the treatment…
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BeiGene’s Tislelizumab Receives Positive CHMP Opinion for Esophageal Cancer Treatment
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BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending a first market approval. The regulatory decision on whether to approve tislelizumab monotherapy for unresectable, locally…
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Biotherus Inc. and BioNTech SE Enter Global License Agreement for Cancer Therapies
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China-based biotech company Biotheus Inc. has announced a strategic research collaboration, option, and worldwide license agreement with Germany’s BioNTech SE (NASDAQ: BNTX). The deal grants BioNTech exclusive worldwide options to a preclinical-stage bispecific antibody and a clinical-stage monoclonal antibody for cancer therapy. Additionally, Biotheus will provide BioNTech with exclusive licenses…
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Antengene Corp. Receives FDA Fast-Track Designation for Xpovio in Myelofibrosis Treatment
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China-based biopharma Antengene Corp., Ltd (HKG: 6996) has announced receiving fast-track designation from the US Food and Drug Administration (FDA) for its drug Xpovio (selinexor) in the treatment of myelofibrosis (MF), an indication that covers primary myelofibrosis, myelofibrosis after primary thrombocytosis, and myelofibrosis after polycythemia vera. Background on Xpovio and…
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Merck and Telix Pharmaceuticals Initiate Phase I Study for CAIX-Expressing Tumors Therapy
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A Phase I study assessing the combination of German-major Merck’s (NYSE: MRK) DNA-PK inhibitor, peposertib, and Australia-based Telix Pharmaceuticals’s (ASX: TLX) targeted radiation therapy, TLX250 (177Lu-DOTA-girentuximab), has enrolled its first participant. This open-label dose escalation and dose expansion trial is designed to evaluate the safety profile, dosing, and activity of…
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Chipscreen Pharmaceutical’s Epidaza Granted Priority Status for DLBCL Treatment in China
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The Center for Drug Evaluation (CDE) website has announced that Shenzhen Chipscreen Biosciences Co., Ltd’s (SHA: 688321) Epidaza (chidamide) has been granted priority status for the treatment of treatment-naïve diffuse large B-cell lymphoma (DLBCL) patients with positive MYC and BCL2 expression when used in combination with R-CHOP (rituximab, cyclophosphamide, adriamycin,…
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HutchMed’s Elunate-Tyvyt Combo Receives Breakthrough Therapy Designation in China for Endometrial Cancer
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HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) has announced that the combination of Elunate (fruquintinib) and Tyvyt (sintilimab) has been granted Breakthrough Therapy Designation (BTD) in China for the treatment of patients with mismatch repair normal (pMMR) advanced endometrial cancer. These patients have previously failed at least one line of…
