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China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Carvykti (ciltacabtagene autoleucel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adults with relapsed or refractory multiple myeloma. The approval is limited to…
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The National Medical Products Administration (NMPA) has released the 59th batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes a total of 67 new specifications, among which 15 are injectables. The update aims to further standardize and improve the quality of generic drugs in the…
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China-based Harbour BioMed (HKG: 2142) has announced the completion of the first subject dosing in a Phase I clinical study for HBM9378 (SKB378), a next-generation fully human antibody targeting thymic stromal lymphopoietin (TSLP), in patients with moderate-to-severe asthma. The study is being conducted in China and marks a significant step…
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Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) has announced that it has received Investigational New Drug (IND) approval from China’s Center for Drug Evaluation (CDE). The company will now commence a pivotal Phase III registration study in China for its TLX250-CDx (89Zr-girentuximab), an imaging agent used to support positron emission tomography…
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Shanghai Fosun Pharma (Group) Co., Ltd (SHA: 600196, HKG: 2196) has reported the market launch in the US of its sodium phenylacetate and sodium benzoate (SPSB) liquid product, the only 20ml version available on the market. The product is being launched by its partner MAIA Pharmaceuticals Inc. (MAIA), a specialty…
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The Center for Drug Evaluation (CDE) has indicated that the methylphenidate hydrochloride oral sustained-release dry suspension, developed by US firms Tris Pharma and Pediatrix Therapeutics, has been awarded priority review status for use in attention deficit hyperactivity disorder (ADHD). The drug falls into the category of “new varieties, dosage forms,…
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China-based Angel Pharmaceuticals Ltd has announced that it has received approval from the Center for Drug Evaluation (CDE) to initiate a Phase I/Ib clinical study in China for its mupadolimab (formerly CPI-006) in advanced solid tumors. Angel Pharma owns the rights to mupadolimab in Greater China. Drug Overview and MechanismMupadolimab…
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Gluetacs Therapeutics has reported filing an Investigational New Drug (IND) application for its first molecular glue degrading agent with the Center for Drug Evaluation in China. The company, which specializes in the development of small molecule drugs via protein degradation technology, has also secured an undisclosed amount of investment from…
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China-based Brii Biosciences Limited (HKG: 2137) has published the top-line results from a Phase I study for its long-acting, single-injection therapy for postpartum depression (PPD), BRII-296. The open-label, single ascending dose Phase I study assessed the safety, tolerability, and pharmacokinetics (PK) of BRII-296 as a single-injection treatment option for PPD…
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China’s Sino Biopharmaceutical Ltd (HKG: 1177) has announced that its subsidiary, Beijing Tide Pharmaceutical Co. Ltd, has received clinical trial approval from the National Medical Products Administration (NMPA) for its in-house developed Category 1 drug TDI01. The targeted indication for the drug is COVID-19. TDI01: Unique Mechanism and DevelopmentTDI01 stands…
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China-based ophthalmic therapies developer Arctic Vision has announced the first injection of triamcinolone acetonide suprachoroidal injection suspension (ARVN001) in a patient with uveitis macular edema (UME) at the Boao Super Hospital in Hainan’s medical pilot zone. This marks the first application of suprachoroidal injection therapy in Lecheng, facilitated by the…
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 drug candidate, GST-HG171, in adult patients with mild/common COVID-19. This marks a significant step forward in the development of…
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China-based biotech Everest Medicines (HKG: 1952) has announced that it has received approval from the Center for Drug Evaluation (CDE) in China to conduct a Phase Ib clinical study assessing the safety, efficacy, pharmacokinetics, and pharmacodynamics of its EVER001. The drug candidate, a next-generation covalent reversible Bruton’s tyrosine kinase (BTK)…
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China-based generics firm HEC Pharma has managed to overturn a previous final decision in a patent dispute with Swiss pharmaceutical giant Novartis AG (NYSE: NVS) over the multiple sclerosis blockbuster drug Gilenya (fingolimod). In January 2022, the US Court of Appeals for the Federal Circuit (CAFC) had dismissed an appeal…
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Swiss pharmaceutical giant Novartis AG (SWX: NOVN) has encountered its latest and potentially final setback in the fight to maintain a key patent covering the multiple sclerosis drug Gilenya (fingolimod) in the United States. The company announced that the US Court of Appeals for the Federal Circuit (CAFC) had denied…
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China’s Center for Drug Evaluation (CDE) has indicated that Hengrui Medicine Co., Ltd’s (SHA: 600276) dexmedetomidine hydrochloride nasal spray has been awarded priority review status. The drug is filed for approval as a preoperative sedation in children, such as for general anesthesia in pediatric patients. Drug Overview and Market ContextDexmedetomidine,…
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China-based Yichang Humanwell Pharmaceutical Co., Ltd’s generic version of Sanofi’s clobazam (trade name: Frisium) has been approved by the National Medical Products Administration (NMPA) for use as a combination therapy for seizures in patients with Lennox-Gastaut syndrome (LGS) aged two years and older. This marks the first availability of this…
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UK-based AstraZeneca (NASDAQ: AZN) and US-based Merck, Sharp & Dohme (MSD, NYSE: MRK) have announced that they have received another indication approval from the National Medical Products Administration (NMPA) for Lynparza (olaparib). The poly (ADP-ribose) polymerase (PARP) inhibitor is now approved as a maintenance therapy for homologous recombination repair deficiency…
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Janus kinase (JAK) inhibitor, jacktinib, in systemic lupus erythematosus (SLE). This marks a significant milestone in the development of this innovative therapy for autoimmune diseases.…
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China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received orphan drug designation (ODD) status from the US FDA for its core product MRG003, an epidermal growth factor receptor targeted antibody drug conjugate (ADC) for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). Drug Mechanism and DevelopmentMRG003…