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Chengdu-based biotech Hinova Pharmaceuticals Inc., (SHA: 688302) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its drug candidate, HP568. The Chinese firm plans to test HP568 in patients with estrogen receptor (ER) positive, human epidermal growth factor receptor 2 negative…
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China-based CanSino Biologics (HKG: 6185) has received market approval from the Badan Pengawas Obat dan Makanan (BPOM) of Indonesia for its ACYW135 Meningococcal Conjugate Vaccine (CRM197), commercially known as Menhycia. Menhycia: Protection for Infants and Young ChildrenMenhycia is indicated for infants and young children aged between 3 months to 3…
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its GnRH receptor agonist, SYH9016, in the treatment of solid tumors. SYH9016: A Modified Leuprorelin Product for Solid TumorsSYH9016 is a novel modified…
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Sino-US firm MicuRx Pharmaceuticals Inc. has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its in-house developed antibiotic, MRX-5, for the treatment of non-tuberculosis Mycobacterium (NTM) infections. MRX-5: A Promising New Antibiotic for NTMMRX-5 is a novel benzodiazole antibiotic specifically designed to…
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced positive results from its pivotal Phase II CT041-ST-01 study for satricabtagene autoleucel, a chimeric antigen receptor (CAR) T-cell therapy. The study, which is randomized, controlled, and multi-center, aims to evaluate the efficacy and safety of the therapy in patients with CLDN18.2-expressing…
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Holland-based argenx SE (NASDAQ: ARGX) has announced receiving another indication approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). This approval allows the drug to be used for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP), who can…
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Japan-based pharmaceutical company Daiichi Sankyo (TYO: 4568) has announced that it has received marketing approval in Japan for its datopotamab deruxtecan, to be sold under the commercial name Datroway. Datroway is indicated for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative unresectable or recurrent breast cancer,…
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Taizhou-based MabPharm Ltd (HKG: 2181), a specialist in monoclonal antibody (mAb) biosimilars, has announced the receipt of market approval for CMAB807, a biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) Remicade (infliximab), in Indonesia, with a similar approval in Peru in July this year. The approval encompasses all six…
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China-based biopharmaceutical company BeiGene Ltd (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that the US Food and Drug Administration (FDA) has granted another indication approval for its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab). This new approval allows the use of tislelizumab in combination with platinum and fluoropyrimidine-based chemotherapy to…
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Global biopharmaceutical company Bristol-Myers Squibb (BMS, NYSE: BMY) has announced that the US Food and Drug Administration (FDA) has granted marketing approval for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy). This combination product pairs nivolumab with recombinant human hyaluronidase (rHuPH20) and is set to be used in most previously approved adult solid…
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China-based HitGen Inc. (SHA: 688222) has announced the commencement of the first patient enrollment in a Phase II clinical study for its Category 1.1 anti-tumor drug, HG146. This study focuses on the treatment of recurrent or metastatic adenoid cystic carcinoma, a rare and aggressive form of cancer. HG146: A Promising…
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Partners Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) have jointly announced the voluntary withdrawal of the marketing authorization application (MAA) in the European Union for their co-developed drug, datopotamab deruxtecan (Dato-DXd). This decision pertains to the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell…
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The Beijing Municipal Medical Insurance Bureau has released the list of the first batch of novel drugs and technologies that will enjoy payment outside of the China Health-care Security Diagnosis Related Groups (CHS-DRG) payment scheme. A total of 24 payment items are included, featuring small molecule inhibitors such as olaparib,…
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US giant Johnson & Johnson (J&J, NYSE: JNJ) has announced an exclusive licensing agreement with Japan-based Kaken Pharmaceutical Co., Ltd. This agreement grants Johnson & Johnson global development, manufacturing, and commercialization rights for a STAT6 program aimed at treating autoimmune and allergic diseases, including atopic dermatitis (AD). Under the terms…
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Auzone Biological Technology has announced the submission of a New Drug Application (NDA) for its product candidate TTYP01 (edaravone) (Product Name: AUKONTALS)to the US Food and Drug Administration (FDA). The Chinese company is seeking approval for the drug to treat amyotrophic lateral sclerosis (ALS). Notably, the FDA previously awarded an…
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China-based Pediatrix Therapeutics has announced that the New Drug Application (NDA) for its neffy (epinephrine nasal spray) has been accepted for review by the National Medical Products Administration (NMPA). The intended indication for neffy is the emergency treatment of type I allergic reactions, including severe allergic reactions, in adults and…
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China-based biopharma Hinova Pharmaceuticals has announced the enrollment of the first patient in an open, multi-center Phase II study assessing the safety, pharmacokinetics, and anti-tumor activity of its Category 1 chemical drug, HP518, in patients with metastatic castration resistant prostate cancer (mCRPC). Innovative Mechanism of Action for HP518HP518 is an…
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Japan-based Astellas Pharma Inc. (TYO: 4503) has struck an accord with compatriot firm Axcelead Drug Discovery Partners, Inc. (Axcelead DDP) to collaborate on the discovery of new candidate compounds for targeted protein degraders (TPD). Axcelead DDP’s DegLead Platform to Support Astellas’ TPD DiscoveryAxcelead DDP, a company focused on targeted protein…
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China-based vaccine developer Advaccine Biotechnology has announced receiving registration approval from the US Food and Drug Administration (FDA) for its soluble microneedle drug, MICROEPAD. MICROEPAD: A Revolutionary Approach to Skin TreatmentsMICROEPAD, or Dissolvable Microneedle Blemish Patches, is an over-the-counter (OTC) medication designed to treat acne, acne scars, and blackheads, promoting…
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China-based Chia Tai Tianqing Pharmaceutical, a subsidiary of Sino Biopharmaceutical Ltd (HKG: 1177), has announced positive readouts from the Phase III TQB2450-Ⅲ-12 study for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450) combined with the multi-target kinase inhibitor anlotinib. Phase III Study Design and OutcomesThe multi-center, randomized, double-blinded,…