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IASO Biotherapeutics’ RD118 CAR-T Therapy Receives Clinical Trial Approval for Multiple Myeloma
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IASO Biotherapeutics, a biopharmaceutical company based in China, has announced that it has received tacit clinical trial approval from the National Medical Products Administration (NMPA) for its investigational therapy, RD118. RD118 is a fully human GPRC5D-targeted chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of relapsed/refractory multiple myeloma (r/r…
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CSPC Pharmaceutical’s Enronsubaimab Gets NMPA Nod for Recurrent Cervical Cancer
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) of China has approved its market approval filing for enronsubaimab, a programmed-death 1 (PD-1) monoclonal antibody (mAb). The drug is indicated for the treatment of recurrent or metastatic…
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Genmab and AbbVie’s Epcoritamab Earns FDA Accelerated Approval for Follicular Lymphoma
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Genmab A/S (NASDAQ: GMAB), a Danish biotechnology company, and its co-development partner AbbVie (NYSE: ABBV), have announced that the U.S. Food and Drug Administration (FDA) has granted the first approval for Tepkinly/Epkinly (epcoritamab), an off-the-shelf T-cell engaging CD3xCD20-targeted bispecific antibody (BsAb). The molecule has received accelerated approval for the treatment…
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Novo Nordisk Moves to Acquire 2seventy bio’s Hemophilia A Program and Gene-Editing Technology
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Novo Nordisk (NYSE: NVO; CPH: NOVO-B), a leading Danish biopharmaceutical company, is transitioning from a partnership to an acquisition deal with U.S. biotech firm 2seventy bio Inc. (NASDAQ: TSVT) for the development of a hemophilia A drug candidate. The companies have entered into an asset purchase agreement that will see…
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Abbisko Therapeutics Presents Positive Phase II Results for HCC Treatment at ESMO-GI
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotech company, has announced the presentation of Phase II study results for its irpagratinib in combination with atezolizumab for the treatment of advanced hepatocellular carcinoma (HCC) at the 2024 ESMO-GI annual meeting. Irpagratinib, a novel FGFR4 inhibitor discovered and developed by Abbisko,…
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Dizal Pharmaceutical’s Golidocitinib Breaks Record with Rapid Market Launch in China
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has seen its drug golidocitinib go from marketing approval to first prescriptions in a record time of just two days in China. This marks a significant milestone, as golidocitinib is the first and only approved Janus kinase 1…
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Amoy Diagnostics Partners with Servier to Develop Companion Diagnostic Reagent for IDH Mutations in China
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China-based Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685) has entered into a partnership with French pharmaceutical company Servier to co-develop a companion diagnostic (CDx) reagent in China. This reagent is designed for detecting mutations in the isocitrate dehydrogenase (IDH) 1 and 2 genes. The product will complement Servier’s vorasidenib, which…
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Shanghai Junshi Biosciences’ Toripalimab Gains NMPA Nod for First-Line TNBC Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received an additional indication approval from China’s National Medical Products Administration (NMPA) for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The drug can now be used in combination with Paclitaxel (Albumin bound) for the first-line treatment…
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Antengene’s Xpovio Included in South Korea’s NHIS Reimbursement Drug List
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that South Korea’s National Health Insurance Service (NHIS) has included its drug Xpovio (selinexor) in the medical insurance reimbursement drug list, effective from July 1, 2024. The drug is indicated for the treatment of adult patients with…
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Novartis’s Scemblix STAMP Inhibitor for CML Accepted for Review by China’s NMPA
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Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has had its market filing for Scemblix (asciminib) accepted for review by China’s National Medical Products Administration (NMPA). Scemblix is a Specifically Targeting the ABL Myristoyl Pocket (STAMP) inhibitor, which is filed for the treatment of chronic myeloid leukemia (CML). As the world’s…
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Merck’s HER3-Targeted ADC Patritumab Deruxtecan Faces FDA Complete Response Letter
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Merck, Sharp & Dohme Inc. (NYSE: MRK), a leading U.S. pharmaceutical company, has announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for patritumab deruxtecan, a first-in-class HER3-targeted antibody-drug conjugate (ADC) discovered by Daiichi Sankyo…
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AstraZeneca’s Tagrisso Wins NMPA Approval for First-Line EGFR-mutated NSCLC Treatment
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its drug Tagrisso (osimertinib), an EGFR-tyrosine kinase inhibitor (EGFR-TKI). The drug is now approved for use in combination with chemotherapy as a first-line treatment for…
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CSPC Pharmaceutical’s BCMA-Targeted CAR-T Therapy SYS6020 Receives NMPA Clinical Trial Approval
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for SYS6020, a BCMA-targeted chimeric antigen receptor (CAR)-T cell therapy. This marks a significant milestone for the company as SYS6020 is…
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Jiangsu Simcere Pharmaceutical Wins NMPA Nod for Biosimilar Version of Erbitux
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), a Chinese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for CMAB009, a biosimilar of Merck KGaA/Bristol-Myers Squibb’s (BMS) cetuximab, which is marketed under the trade name Erbitux. The EGFR-targeted monoclonal antibody (mAb) was…
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J&J’s Tecvayli Earns NMPA Approval for Relapsed or Refractory Multiple Myeloma
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Johnson & Johnson (J&J; NYSE: JNJ), a leading U.S. healthcare company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its bispecific antibody (BsAb) Tecvayli (teclistamab) for the treatment of relapsed or refractory multiple myeloma (r/rMM) in patients who have received three or…
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Staidson Pharmaceutical Gets FDA Clearance for TNFR2-Targeted mAb SBT-1901
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Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a biopharmaceutical company based in China, has announced that it has received clinical clearance from the U.S. Food and Drug Administration (FDA) for its TNFR2-targeted monoclonal antibody (mAb), SBT-1901, for the treatment of locally advanced or metastatic solid tumors. Preclinical studies have demonstrated…
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Shanghai Haihe Pharmaceutical’s Glumetinib Earns Marketing Approval in Japan for NSCLC Treatment
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Shanghai Haihe Pharmaceutical Co., Ltd, a Chinese pharmaceutical company, has announced that it has received marketing approval in Japan for its MET targeted tyrosine kinase inhibitor (TKI), glumetinib, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with a MET 14 exon mutation. The approval is…
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Takeda’s Fruquintinib for Metastatic Colorectal Cancer Receives European Commission Marketing Approval
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its partner Takeda (TYO: 4502, NYSE: TAK) has received marketing approval from the European Commission for fruquintinib, a treatment for adult patients with metastatic colorectal cancer (CRC) who have previously been treated with chemotherapy regimens based on fluorouracil, oxaliplatin, and…
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Shanghai Pharmaceuticals’ Subsidiary Shaphar Med Collaborates with Magic Med to Enter Oncology
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Shanghai Pharmaceuticals Holding Co., Ltd (SPH, SHA: 601607; HKG: 2607), a leading pharmaceutical company in China, has announced that its subsidiary, Shaphar Medical Instruments (Shanghai) Co., Ltd, has entered into a partnership with Magic Med, a Chinese firm. This strategic collaboration signifies Shaphar Med’s inaugural venture into the oncology sector.…
