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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,…
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On December 24, 2024, China Isotope & Radiation Corporation (HKG: 1763) announced that its subsidiary, HTA Co., Ltd., has received approval from the National Medical Products Administration (NMPA) to initiate clinical trials for their Class 1 innovative drug, [18F] Piramide Injection. [18F] Piramide: A PET Imaging Agent for Enhanced Melanoma…
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced receiving official approval from the US Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of its biosimilar version of Denmark firm Novo Nordisk’s (NYSE: NVO) Victoza (liraglutide). Liraglutide: A Crucial Treatment for DiabetesLiraglutide, an analog of human…
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China’s Shanxi C&Y Pharmaceutical Group Co., Ltd (SHE: 300254) has announced the initiation of a clinical study for its generic version of UK firm Shield TX(UK)Limited’s iron supplement ferric maltol, following approval from the National Medical Products Administration (NMPA). The study aims to evaluate the drug’s efficacy in treating iron…
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China-based Clinical Research Organization (CRO) Boji Medical Technology Co., Ltd. (SHE: 300404) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for TBA, a novel treatment for drug-resistant pulmonary tuberculosis. TBA: A New Approach to Combating Drug-Resistant TuberculosisThe Category 1 chemical drug, co-developed…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving separate clinical trial approvals from the National Medical Products Administration (NMPA). One trial will test the combination of HRS-4357 with ADT and a novel androgen receptor pathway inhibitor for prostate cancer. The other trial will assess SHR-4602 in combination with…
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The China’s Center for Drug Evaluation (CDE) website has indicated that China-based Sichuan Biokin Pharmaceutical Co., Ltd’s (SHA: 688506) BL-M08D1 and CSPC Pharmaceutical Group Ltd’s (HKG: 1093) SYS6010 are on track to obtain Breakthrough Therapy Designations (BTDs) from the agency. These designations are for the treatment of recurrent small cell…
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The China’s Center for Drug Evaluation (CDE) website has indicated that several drugs, including German giant Boehringer Ingelheim’s (BI) zongertinib, Visirna Therapeutics’ plozasiran, Chia Tai Tianqing’s anlotinib, and HutchMed (China) Ltd’s (HKG: 0013, NASDAQ: HCM) Orpathys (savolitinib), are on course to obtain priority review statuses. Boehringer Ingelheim’s Zongertinib for HER2-Mutated…