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Nanjing Immunophage Biotech Co., Ltd, a China-based biotechnology company, has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its in-house developed Category 1 pipeline candidate, IPG11406. This small molecule is intended to be assessed as a treatment for systemic lupus erythematosus (SLE)…
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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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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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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 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 (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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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 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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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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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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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’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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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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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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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 (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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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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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 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 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…