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Novo Nordisk’s Alhemo Receives CHMP Recommendation for Haemophilia Prophylaxis in Europe
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Novo Nordisk (NYSE: NVO), a Danish pharmaceutical company, has been notified that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Alhemo (concizumab). This would make Alhemo the first once-daily subcutaneous prophylactic treatment for individuals aged 12 years or…
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Novartis’s Kisqali Receives Positive CHMP Opinion for Early Breast Cancer Treatment in the EU
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Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending the approval of Kisqali (ribociclib), a CDK4/6 inhibitor, for the adjuvant treatment of adults with hormone receptor-positive/human epidermal growth…
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Kanghong Pharmaceutical’s NASH Drug KH629 Approved for Clinical Trials in China
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Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its Category 1 chemical drug KH629, which is intended for the treatment of adult non-alcoholic steatohepatitis (NASH). This development follows the…
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Huadong Medicine Gets Green Light for HPK1 PROTAC Drug HDM2006 in Advanced Solid Tumors
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a study for its Category 1 chemical drug HDM2006, which targets advanced solid tumors. This development marks a significant step for Huadong as it…
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Astellas Pharma’s Vyloy Receives FDA Approval for Gastric Cancer Treatment in CLDN18.2 Positive Tumors
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Astellas Pharma Inc. (TYO: 4503), a Japanese pharmaceutical company, has announced that it has received market approval from the US Food and Drug Administration (FDA) for its drug Vyloy (zolbetuximab-clzb). The approval is for use in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally…
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Gilead Sciences to Withdraw Accelerated Approval of Trodelvy in Urothelial Carcinoma
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Gilead Sciences Inc., (NASDAQ: GILD), a leading US-based biopharmaceutical company, has announced its intention to voluntarily withdraw the accelerated approval of its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who have been previously treated with platinum-based chemotherapy…
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Jiangsu Hengrui Pharmaceuticals Initiates Phase III Clinical Trial for SHR-A1904 in Gastric Cancer
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Jiangsu Hengrui Pharmaceuticals 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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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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Akeso Biopharma Launches Phase Ib/II Trial for Cadonilimab and AK112 in Pancreatic Cancer
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On October 17, ClinicalTrials.gov reported that Akeso Biopharma (HKG: 9926) has initiated a Phase Ib/II clinical study to evaluate the combination of Cadonilimab (CTLA-4/PD-1 dual antibody) and AK112 (Envafolimab, a PD-1/VEGF dual antibody) with chemotherapy as a first-line treatment for pancreatic cancer. The primary endpoints of the study include safety,…
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FDA Extends Review of Amgen’s Lumakras for KRAS G12C mCRC Treatment to January 2025
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On October 18, FirstWord reported that the U.S. FDA has extended the review period for Amgen (NASDAQ: AMGN)’s KRAS G12C inhibitor Lumakras (sotorasib) in combination with the anti-EGFR monoclonal antibody panitumumab for second-line treatment of KRAS G12C-mutated metastatic colorectal cancer (mCRC) by three months, pushing the decision date to January…
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Shenzhen Chipscreen Advances CS231295 for Cancer Treatment as IND Accepted by NMPA
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On October 17, Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced that its innovative Class 1 national drug candidate, CS231295, for cancer treatment has received acceptance for its clinical trial application (IND) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China (Acceptance Numbers:…
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AstraZeneca Files for Market Approval of Tremelimumab in China for Hepatocellular Carcinoma
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The Center for Drug Evaluation (CDE) has indicated on its website that AstraZeneca (NASDAQ: AZN), a leading UK pharmaceutical company, has submitted a market filing for tremelimumab, which is likely intended for the treatment of hepatocellular carcinoma (HCC) in combination with durvalumab. This move suggests a strategic expansion in AstraZeneca’s…
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Changshan Biochemical Pharmaceutical Wins Marketing Approval for Enoxaparin in Niger
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Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255), a Chinese pharmaceutical company, has announced that it has received marketing approval for its enoxaparin in Niger. This development marks an important step for Changshan Bio as it expands the international reach of its pharmaceutical products. Changshan Bio’s enoxaparin is a…
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Huahai Pharmaceutical Gets FDA Nod for Generic Empagliflozin and Metformin ANDA
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Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a prominent Chinese pharmaceutical company, has announced the receipt of Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its generic version of Boehringer Ingelheim’s (BI) empagliflozin and metformin combination therapy. This therapy was originally approved in…
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Laekna Advances Obesity Treatment Candidate LAE102 with Subcutaneous Dosing in Phase I Study
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Laekna, a Sino-US biotech firm, has announced the commencement of a subcutaneous dosing cohort within its Phase I single ascending dose (SAD) study for the monoclonal antibody drug candidate LAE102, which is under investigation for the treatment of obesity. The study, which is randomized, double-blinded, and placebo-controlled, aims to evaluate…
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Antengene’s Xpovio Secures Expanded Access in South Korea for Multiple Myeloma Treatment
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Antengene Corp., Ltd (HKG: 6996), a China-based biopharmaceutical company, has announced that it has received an additional supplementary New Drug Application (sNDA) approval from the National Health Insurance Service (NHIS) of South Korea for its drug Xpovio (selinexor). This marks Xpovio as the world’s first and only FDA-approved oral XPO1…
