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Betta Pharmaceuticals’ MCLA-129 Combo Therapy for NSCLC Gets NMPA Clinical Approval
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its bispecific antibody, MCLA-129, in combination with befotertinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The treatment…
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Pfizer Launches Phase III Trial for Quadrivalent Influenza modRNA Vaccine in Argentina
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Global pharmaceutical giant Pfizer (NYSE: PFE) has commenced recruitment in Argentina for a Phase III clinical trial evaluating the efficacy of its quadrivalent influenza modified RNA (modRNA) vaccine in comparison to a conventional quadrivalent influenza vaccine. This double-blind study aims to recruit between 1,500 to 2,000 participants who are above…
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Zai Lab Initiates Phase III Trial for Bemarituzumab in First-Line Gastric Cancer Treatment
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China-based biopharmaceutical company Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced the first patient dosing in the global regulatory Phase III FORTITUDE-101 trial for its drug candidate bemarituzumab, which is being studied for the treatment of first-line gastric cancer in China. Bemarituzumab’s Mechanism and Potential ImpactBemarituzumab is a potential…
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Chile Expands Financial Coverage for AbbVie’s RSV Prophylaxis Synagis
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Chile’s Ministry of Health (MINSAL) has announced an immediate expansion in the coverage under its Financial Protection System for High-Cost Diagnosis and Treatments for AbbVie’s (NYSE: ABBV) respiratory syncytial virus (RSV) prophylaxis, Synagis (palivizumab). The biologic drug is now provided free of charge to families of infants weighing under 2.5…
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GSK’s Cabotegravir Receives NMPA Approval for HIV Treatment in China
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The National Medical Products Administration (NMPA) has granted marketing approval for GlaxoSmithKline’s (GSK, NYSE: GSK) cabotegravir, a significant development in HIV treatment options. Both the injection and tablet dosage forms of the drug have been approved for use in China. Cabotegravir: An Innovative INSTI for HIV TreatmentCabotegravir is an integrase…
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BeiGene’s Brukinsa Receives US FDA Review for Relapsed/Refractory Follicular Lymphoma sNDA
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China-based biotechnology company BeiGene (NASDAQ: BGNE) has announced that the US Food and Drug Administration (FDA) has accepted for review a new supplemental new drug application (sNDA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The application seeks to add a new indication for the treatment of adults with…
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AstraZeneca and Daiichi Sankyo’s Enhertu Gains New Indication Approval in China for HER2-Low Breast Cancer
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Partners AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have announced that their co-developed antibody drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), has been granted a new indication approval in China. This marks the drug’s second approval in the country and is specifically for use as a monotherapy in treating…
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Shanghai Fosun Pharmaceutical Submits Tenapanor Approval Application to China’s NMPA
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196), a China-based pharmaceutical company, has announced a market approval filing to the National Medical Products Administration (NMPA) in China for its in-licensed tenapanor. The drug is indicated for the control of hyperphosphatemia in adult patients with chronic kidney disease (CKD) who are…
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Kedrion Biopharma Achieves First Product Approval in China for Human Albumin
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Italy-headquartered blood products specialist Kedrion Biopharma has announced that its subsidiary, Bio Products Laboratory (BPL), has received approval from China’s National Institutes for Food and Drug Control (NIFDC) to release human albumin into the Chinese market for the first time. This milestone follows a 2022 partnership established between Kedrion and…
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GRIT Biotechnology’s GT201 TIL Therapy Approved for Clinical Studies by China’s CDE
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The Center for Drug Evaluation (CDE) website has indicated that GRIT Biotechnology, a China-based cell therapy specialist, has received approval for its in-house developed gene engineered tumor-infiltrating lymphocyte (TIL) therapy, GT201, for clinical studies in patients with recurrent or metastatic solid tumors. Optimal Structural Design and Custom Retroviral System for…
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Jiangsu Hengrui Pharmaceuticals’ Irinotecan and Bupivacaine Liposome Injections Get Clinical Trial Green Light in China
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving separate clinical trial approvals in China for its irinotecan liposome injection and bupivacaine liposome injection. These approvals mark a significant step forward in the development of these targeted therapies. Irinotecan Liposome Injection for Advanced Colorectal Cancer…
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Shanghai Junshi Biosciences’ Tuoyi Files for 9th Indication in China for RCC Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted for review an additional indication approval filing for its Tuoyi (toripalimab), a programmed death-1 (PD-1) inhibitor, in combination with axitinib for first-line unresectable or metastatic renal cell carcinoma (RCC). This…
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Jiangsu Hengrui Pharmaceuticals Receives Clinical Trial Approvals for Irinotecan and Bupivacaine Liposome Injections
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving separate clinical trial approvals in China for its irinotecan liposome injection and bupivacaine liposome injection. These approvals mark significant steps in advancing the company’s pipeline in oncology and pain management. Irinotecan Liposome Injection for Advanced Colorectal…
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Shanghai Junshi Biosciences’ Tuoyi Files for 9th Indication in China for RCC Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted for review an additional indication approval filing for its Tuoyi (toripalimab), a programmed death-1 (PD-1) inhibitor, in combination with axitinib for first-line unresectable or metastatic renal cell carcinoma (RCC). This…
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Hrain Biotechnology’s Anti-CD70 T Cell Therapy HR010 Gets Tacit Approval for Renal Cancer Trial
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Shanghai-based Hrain Biotechnology Co., Ltd. has announced receiving tacit clinical trial approval from the Center for Drug Evaluation (CDE) for its anti-CD70 T cell therapy, HR010. The therapy is intended for the treatment of advanced or metastatic renal cancer. CD70 as a Potential Target for Kidney Cancer TreatmentCD70, a member…
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Huadong Medicine’s Elahere Receives Approval for FRα Positive Cancer Treatment in China
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving approval to introduce Elahere (mirvetuximab soravtansine), an antibody drug conjugate (ADC) targeting folate receptor α (FRα), at Ruijin Hospital’s Hainan branch. The treatment is indicated for FRα positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in…
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Jiangxi Jemincare Group Launches Omalizumab Biosimilar CMAB007 in China for Asthma and Dermatology
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Jiangxi Jemincare Group has overseen the official launch and first prescription of its omalizumab biosimilar, CMAB007, a version of Roche/Genentech’s (SWX: ROG) anti-IgE dermatology and asthma therapy Xolair, in Beijing. The drug’s launch comes less than two months after it received market approval. Therapeutic Applications of OmalizumabOmalizumab is utilized to…
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C4 Therapeutics’ CFT8919 Earns FDA Approval for Clinical Trials Targeting EGFR L858R Mutations
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US-based C4 Therapeutics Inc., (NASDAQ: CCCC) has announced receiving clinical trial approval from the US FDA for its pipeline candidate, CFT8919. This orally bioavailable BiDAC degrader is designed to target EGFR L858R mutations and has demonstrated good activity and selectivity against solid tumors carrying these mutations. Pre-Clinical Success and Potential…
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Zai Lab’s Vyvgart Receives NMPA Review for Subcutaneous Injection Form in gMG Treatment
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China-based Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced that the National Medical Products Administration (NMPA) has accepted for review a Biologics License Application (BLA) for Vyvgart (efgartigimod alfa) in subcutaneous injection form. The intended indication is for adult patients with generalized myasthenia gravis (gMG). Exclusive Rights and Prior…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for HRS-9815 Radiodiagnostic Drug Clinical Study
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its injectable HRS-9815 and the accompanying preparatory kit. The product candidate is an in-house developed Category 1 radiodiagnostic drug. HRS-9815: A Radiodiagnostic…
