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Zai Lab and argenx Report Positive Preliminary Results from Vyvgart Hytrulo CIDP Study
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China-based Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) and its Netherlands-based partner argenx SE (NASDAQ: ARGX) have announced preliminary positive results from the ADHERE study. The study assessed the effects of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The ADHERE trial is the…
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Janssen’s Rybrevant Meets Primary Endpoint in Phase III NSCLC Study
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has announced positive results from a Phase III confirmatory study for the bispecific antibody Rybrevant (amivantamab). The study focused on patients with newly diagnosed advanced or metastatic non-small cell lung cancer (NSCLC) that harbor epidermal growth factor receptor (EGFR) exon…
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Antengene Corp., Ltd Receives Hong Kong NDA Approval for Xpovio in Relapsed Multiple Myeloma
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China-based biopharmaceutical company Antengene Corp., Ltd (HKG: 6996) has announced receiving New Drug Application (NDA) approval from the Department of Health of Hong Kong. The approval is for the use of Xpovio in adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for SHR-A1811 and Pyrotinib Combo Study
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study. The study will assess the safety, tolerability, and efficacy of SHR-A1811 in combination with the small-molecule HER2 inhibitor pyrotinib for the treatment…
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Mabwell Bioscience Receives NMPA Approval to Launch 9MW2921 Clinical Study
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its novel antibody-drug conjugate (ADC), 9MW2921. Next-Generation ADC Based on Mabwell’s IDDC Platform9MW2921 is a next-generation ADC that leverages…
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TransThera Sciences’ TT-00420 Receives Breakthrough Designation for Cholangiocarcinoma Treatment
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The Center for Drug Evaluation (CDE) website has indicated that Nanjing-based TransThera Sciences (Nanjing), Inc.’s candidate TT-00420 is set to receive breakthrough therapy designation (BTD) for the treatment of unresectable advanced or metastatic cholangiocarcinoma. This designation is for patients whose disease recurs after previous systemic chemotherapy and/or FGFR inhibitor treatment.…
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Shenzhen Salubris Pharmaceuticals’ SAL0120 for IgA Nephropathy Accepted for NMPA Review
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Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced that the National Medical Products Administration (NMPA) has accepted its clinical trial filing for the small molecule SAL0120, which is indicated for the treatment of IgA nephropathy. SAL0120: An Endothelin Receptor Antagonist for Chronic Kidney Disease and HypertensionSAL0120, an in-house developed…
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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…
