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Haihe Pharma’s Glumetinib Gains Conditional NMPA Approval for NSCLC
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Shanghai Haihe Pharmaceutical Co., Ltd’s Category 1 product, glumetinib, has received conditional market approval from the National Medical Products Administration (NMPA). This small-molecule MET inhibitor is now approved for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET14 exon hopping, marking a significant advancement in…
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JW Therapeutics Launches Carteyva Clinical Study for High-Risk Lymphoma
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China-based JW Therapeutics (HKG: 2126) has announced the initiation of a clinical study for its Carteyva (relmacabtagene autoleucel injection) in the treatment of first-line high-risk large B-cell lymphoma. A significant milestone was reached with the completion of reinfusion therapy for the first patient. Previous Study Outcomes and Current Trial DesignThe…
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Haihe Pharma’s Glumetinib Receives Conditional Approval for NSCLC Treatment
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Shanghai Haihe Pharmaceutical Co., Ltd’s Category 1 product, glumetinib, has obtained conditional market approval from the National Medical Products Administration (NMPA). The small-molecule MET inhibitor is now approved for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET14 exon hopping. Development and Clinical FindingsGlumetinib, co-developed…
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JW Therapeutics Initiates Clinical Study for Carteyva in First-Line High-Risk Large B-Cell Lymphoma
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China-based JW Therapeutics (HKG: 2126) has announced the initiation of a clinical study for its Carteyva (relmacabtagene autoleucel injection) in first-line high-risk large B-cell lymphoma. The first patient has already completed reinfusion therapy, marking a significant step in the study’s progress. Previous Study ResultsThe pivotal RELIANCE study previously demonstrated that…
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Biocytogen’s YH008 Gets NMPA Approval for Phase I Study
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China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd has announced receiving approval from the China National Medical Products Administration (NMPA) to conduct an open-label Phase I dosage escalation study. The study will assess the safety, tolerability, and preliminary anti-tumor activity of YH008, an internally developed first-in-class PD-1 x CD40 bispecific antibody (BsAb)…
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Inmagene’s Tavalisse First Prescribed in China for ITP Treatment
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China-based Inmagene Biopharmaceuticals has announced that its in-licensed drug Tavalisse (fostamatinib) has been first prescribed at the Hainan branch of Shanghai’s Ruijin Hospital. This marks a significant milestone in the availability of the oral spleen tyrosine kinase (SYK) inhibitor for the treatment of immunization thrombocytopenia (ITP) in China. Background and…
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BrightGene’s Generic Halaven Approved for Marketing in China
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China-based BrightGene Bio-Medical Technology Co., Ltd (SHA: 688166) has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Japan-based Eisai’s (TYO: 4523) cancer therapy Halaven (eribulin). The approval signifies that BrightGene’s product, trade-named BoLiNing, has passed the generic quality consistency evaluation (GQCE). BoLiNing is…
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Inovio and ApolloBio Announce Positive Phase III Data for VGX-3100 Vaccine
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US-based Inovio Pharmaceuticals (NASDAQ: INO) and China-based ApolloBio Corp. (NEEQ:430187) have announced positive data from the Phase III Reveal 2 study for the DNA therapeutic vaccine VGX-3100 (known as ABC-3100 in China). The two firms are co-developing VGX-3100 under a 2018 licensing deal, with ApolloBio holding development and commercialization rights…
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Takeda’s Exkivity Receives First Prescription in China with Innovative Payment Solutions
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Takeda Pharmaceutical Co., Ltd has announced the first prescription of its lung cancer therapy Exkivity (mobocertinib) in China. The Japanese pharmaceutical giant will partner with China-based health platform MediTrust Health to launch innovative payment solutions for the drug in China, making this advanced therapy more accessible to patients. Clinical Need…
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Harbour BioMed’s Batoclimab Shows Positive Results in gMG Phase III Trial
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Harbour BioMed (HKG: 2142), a biotech company operating out of the United States, the Netherlands, and Suzhou (China), has announced positive topline results from its phase III clinical trial of batoclimab (HBM9161) for the treatment of generalized myasthenia gravis (gMG). The pivotal clinical study, designed to confirm the efficacy and…
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Sanofi’s Dupixent Receives Priority Review for Prurigo Nodosa Treatment
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French pharmaceutical major Sanofi (NASDAQ: SNY) has announced that it has received priority review status from the Center for Drug Evaluation (CDE) for its Dupixent (dupilumab) to treat prurigo nodosa (PN) in adults. This marks another significant breakthrough in the type 2 inflammation field, following the drug’s indication approval for…
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Eli Lilly’s Retevmo Launched in China by Innovent Biologics
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Eli Lilly & Co’s (NYSE: LLY) Retevmo (selpercatinib) has been officially launched in the Chinese market. The drug is being commercialized by domestic firm Innovent Biologics Inc. (HKEX: 01801) under a partnership deal signed between the two companies in March last year. This collaboration aims to bring innovative treatments to…
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Huahai Pharma’s HB0025 Receives NMPA Approval for Clinical Trials
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for HB0025, an in-house developed bispecific antibody (BsAb) targeting programmed-death ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF). The BsAb will be assessed in combination…
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Hengrui’s Adebrelimab Receives NMPA Approval for Lung Cancer Treatment
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Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its adebrelimab (SHR-1316), a programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb). The molecule is now approved for use in combination with chemotherapy to treat first-line extensive stage small-cell lung…
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Sino Biopharmaceutical’s Bevacizumab Biosimilar Approved by NMPA
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Sino Biopharmaceutical Ltd (HKG: 1177) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its bevacizumab biosimilar. The approved indications for the biosimilar include the treatment of metastatic colorectal cancer (CRC), recurrent glioblastoma, and advanced metastatic or recurrent non-small cell lung cancer (NSCLC).…
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Mabwell’s 9MW3911 Monoclonal Antibody Accepted for NMPA Review
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that a clinical trial filing for its 9MW3911, a non-IL-2 blocking CD25 monoclonal antibody (mAb) developed via the high-efficiency B lymphocyte screening platform, has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication for this…
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Venus Medtech Completes Patient Enrollment for Liwen RF Ablation System Study
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China-based Venus Medtech (Hangzhou) Inc. (HKG: 2500) has announced that all patients have been successfully enrolled in a confirmatory study in China for its Liwen RF ablation system, designed for the treatment of hypertrophic cardiomyopathy (HCM). This marks a significant step forward in the clinical development of this innovative device.…
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Atom Bioscience’s ABP-671 Shows Positive Phase IIa Results in Gout Treatment
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China-based Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd) has announced positive results from a Phase IIa clinical study for its lead product, ABP-671. The randomized, double-blind, placebo-controlled trial enrolled 54 patients with gout or hyperuricemia across six cohorts, with 7 randomized to ABP-671 and 2 to placebo per…
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CSPC Pharmaceutical Initiates Phase III Study for Mitoxantrone Liposome in Nasopharyngeal Carcinoma
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced the first patient dosing in a randomized, open, positive controlled, multi-center Phase III study. The study is designed to assess the efficacy and safety of its mitoxantrone hydrochloride liposome in patients with recurrent and metastatic nasopharyngeal carcinoma (NPC) when combined with…
