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Jiangsu Hengrui Medicine Initiates Phase III Clinical Trial for SHR-A1904 in Gastric Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has filed for a Phase III clinical study of its Claudin18.2-targeted antibody drug conjugate (ADC) SHR-A1904 on Clinicaltrials.gov. The study aims to enroll 524 patients with second-line recurrent or metastatic gastric cancer and is anticipated to…
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MicroPort Sorim CRM’s PLATINIUM Series ICD Receives NMPA Approval, A First for China
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MicroPort Sorim CRM, a Chinese medical device company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its PLATINIUM series implantable cardioverter defibrillator (ICD). This marks a significant milestone as the PLATINIUM series becomes the first domestically developed ICD in China. The approved…
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Jacobio Pharma’s G12C Inhibitor Gecirasib Earns Orphan Drug Designation in Europe for Pancreatic Cancer
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Jacobio Pharma (HKG: 1167), a China-based biopharmaceutical company, has announced that it has received Orphan Drug Designation (ODD) from the European Medicine Agency (EMA) for its KRAS G12C inhibitor, glecirasib, for the treatment of pancreatic cancer. This designation follows previous awards for glecirasib, including ODD in the US and Breakthrough…
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MicroPort NeuroTech’s NUMEN Silk Receives FDA Approval for Embolization Treatment
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MicroPort NeuroTech Limited (HKG: 2172), a Chinese medical device company, has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its product NUMEN Silk, a spring coil embolization system that marks its first international approval. This milestone follows the initial approval of the…
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Astellas Pharma’s Vyloy Receives FDA Approval for CLDN18.2 Positive Gastric Cancer Treatment
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Astellas Pharma (TYO: 4503) has announced that the U.S. Food and Drug Administration (FDA) has granted approval for its Claudin18.2 (CLDN18.2) targeting antibody Vyloy (zolbetuximab) in combination with a fluoropyrimidine- and platinum-based chemotherapy regimen for the first-line treatment of adult patients with locally advanced unresectable or metastatic, HER2-negative gastric or…
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Westgene Biopharma’s Pioneering mRNA Vaccine for EBV-Related Tumors Clears IND Hurdle in China
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Westgene Biopharma has received approval from the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) in China for its new drug research application (IND) for “WGc-043 Injection.” The approval, dated August 6, 2024, grants Westgene Biopharma the green light to initiate Phase I clinical trials. “WGc-043…
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Kanghong Pharmaceutical’s NASH Drug KH629 Receives Clinical Trial Implicit Approval in China
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On October 18th, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China announced that Kanghong Pharmaceutical (SHE: 002773)’s Class 1 new drug, KH629 tablets, has been granted implicit approval for clinical trials for the treatment of adult non-alcoholic steatohepatitis (NASH).…
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Beijing Biostar Pharmaceuticals Set to Go Public on HKEX with Focus on Oncology Innovation
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On October 18, 2024, the Hong Kong Stock Exchange announced that Beijing Biostar Pharmaceuticals Co., Ltd. is set to go public following a successful hearing. CCB International and CITIC Securities International will serve as joint sponsors for the listing. According to the prospectus, Biostar is a biotechnology company driven by…
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