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BeiGene’s Tevimbra Receives CHMP Recommendation for Expanded Use in G/GEJ and ESCC Cancers in EU
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading China-based biotechnology company, has received notification that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an extension of authorization for its programmed death-1 (PD-1) inhibitor Tevimbra (tislelizumab). The expanded authorization covers…
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Sino Biopharmaceutical’s Anlotinib Receives Ninth Indication Approval from China’s CDE for Soft-Tissue Sarcoma
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading pharmaceutical company in China, has announced that it has received another indication approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its oral multi-target kinase inhibitor, anlotinib. The request is for anlotinib to be used in…
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Johnson & Johnson’s Akeega Approved in China as First Dual Action Tablet for mCRPC
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Johnson & Johnson (J&J, NYSE: JNJ), a leading US pharmaceutical company, has announced that China’s National Medical Products Administration (NMPA) has granted indication approval for Akeega (niraparib and abiraterone acetate), to be taken with prednisone or prednisolone, for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2…
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BeiGene’s Tevimbra Approved in China for NSCLC Patients as Neoadjuvant and Adjuvant Therapy
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading China-based biotechnology company, has announced that it has received market approval in China for its programmed death-1 (PD-1) inhibitor Tevimbra (tislelizumab). The National Medical Products Administration (NMPA) has granted approval for tislelizumab in combination with platinum-containing chemotherapy as both neoadjuvant…
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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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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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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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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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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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Pfizer Partners with TRIANA Biomedicines to Develop Molecular Glue Degraders for Oncology and Other Diseases
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Pfizer (NSE: PFIZER), a leading US pharmaceutical company, has entered into a strategic partnership and licensing agreement with Massachusetts-based biotech firm TRIANA Biomedicines. The collaboration aims to develop innovative molecular glue degraders targeting a variety of diseases, with a focus on oncology, according to a press release from TRIANA. Under…
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Tencent Invests USD 30 Million in Early Cancer Detection Firm Insighta, Backed by Prenetics
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Prenetics Global Limited (NASDAQ: PRE), a prominent health sciences company with operations in the US and Hong Kong, China, has announced a significant investment of USD 30 million by Chinese internet conglomerate Tencent into Insighta, a Hong Kong-based company specializing in early cancer detection. Insighta represents a substantial joint venture…
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Chengdu Baiyu Pharmaceutical Strikes Licensing Deal with Novartis for Unannounced Anti-Tumor Asset
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Chengdu Baiyu Pharmaceutical Co., Ltd., a Chinese pharmaceutical company, has entered into a licensing agreement with Swiss pharmaceutical giant Novartis (NYSE: NVS), according to the Xinhua News Agency. Under this deal, Novartis will acquire the global exclusive rights to develop and commercialize one of Baiyu’s small molecule anti-tumor assets, the…
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Novocure’s Optune Lua Wins FDA Approval for mNSCLC Treatment in Combination with Immunotherapies
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Novocure (NASDAQ: NVCR), a Swiss firm renowned for its pioneering Tumor Treating Fields (TTFields) cancer therapy, has received marketing approval from the US Food and Drug Administration (FDA) for its Optune Lua device. This portable device is now cleared for use in combination with PD-1/PD-L1 inhibitors or docetaxel to treat…
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Alphamab Oncology and CSPC Pharma’s KN026 Phase III Trial for Breast Cancer Gets NMPA Approval
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Alphamab Oncology (HKG: 9966) and CSPC Pharma (HKG: 1093) have jointly announced that their Phase III clinical study application for the combination of HER2 bispecific antibody KN026 and nab-paclitaxel HB1801 (Study Protocol Number: KN026-004) has received approval from the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) for neoadjuvant…
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Shanghai Junshi Biosciences’ Toripalimab Wins Marketing Approvals in India and Hong Kong for Nasopharyngeal Carcinoma
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biotech company based in China, has announced that it has received marketing approvals in India and Hong Kong for its drug toripalimab, used for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The drug will be marketed under…
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Jiangsu Hengrui Resubmits Application for Camrelizumab Combo in HCC to FDA
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent pharmaceutical company based in China, has announced a new attempt at a market filing with the US Food and Drug Administration (FDA) for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, in combination with the small-molecule targeted cancer therapy apatinib, as…
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Boehringer Ingelheim Partners with Circle Pharma to Develop First-in-Class Cyclin Inhibitor
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Boehringer Ingelheim (BI), a leading German pharmaceutical company, has announced a research collaboration and license agreement with Circle Pharma, a US-based firm. This strategic partnership aims to develop a first-in-class cyclin inhibitor, a novel approach that could halt the growth of cancer cells and offer new hope for patients struggling…
