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China-based gene therapy specialist Neurophth Biotechnology Ltd has announced that it has received clinical trial approval from the Therapeutic Goods Administration of Australia for its candidate drug NFS-05. The therapy is set to be assessed as a treatment for autosomal dominant optic atrophy (ADOA), an inherited optic neuropathy. Understanding Autosomal…
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China-based Harbin Gloria Pharmaceuticals Co., Ltd (SHE: 002437) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its programmed cell death-1 (PD-1) monoclonal antibody (mAb) zimberelimab. The drug is indicated for the treatment of recurrent or metastatic cervical cancer patients with positive PD-L1…
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Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), and its partner Genmab (NASDAQ: GMAB), have announced the achievement of the primary endpoint in a Phase III trial for their antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin). The trial focuses on patients with recurrent or metastatic…
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Hong Kong-based biotech company SinoMab BioScience Ltd (HKG: 3681) has announced that a market approval filing has been submitted for its suciraslimab (SM03) to the National Medical Products Administration (NMPA) in China. The CD22 monoclonal antibody (mAb) is seeking its first indication approval as a treatment for rheumatoid arthritis (RA).…
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Researchers at US Columbia University have published the results of a study estimating the cost-effectiveness of Novo Nordisk’s (NYSE: NVO) injections Wegovy (semaglutide) and Saxenda (liraglutide), as well as Vivus’s (NASDAQ: VVUS) pill Qsymia (phentermine + topiramate) for weight-loss interventions in adolescents. The study utilized a simulated cohort of 100,000…
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Gene therapy specialist Shanghai BDgene Technology Co., Ltd has announced the conclusion of three clinical research treatments using its HELP technology, based on the CRISPR-Cas9 gene editing tool, for herpes simplex keratitis (HSK). Preliminary positive results have been published in the journal Molecular Therapy, in an article titled “In Vivo…
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China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for birociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, for review. The drug is intended for the treatment of HR+/HER2- advanced breast cancer in patients who have…
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China-based Jointown Medical Devices Group Co., Ltd (SHA: 600998) has announced that its clinical trial filing for the Category 1 COVID-19 drug candidate, SHEN211, has been accepted for review by China’s National Medical Products Administration (NMPA). SHEN211 is an oral broad-spectrum anti-novel coronavirus non-peptide 3CL protease inhibitor, co-developed by a…
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Boehringer-Ingelheim’s Ofev (nintedanib). This development marks a significant step for the company in expanding its portfolio of generic drugs. Nintedanib’s Approval History…
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The National Medical Products Administration (NMPA) website has indicated that Chia Tai Tianqing’s generic version of Swiss pharmaceutical giant Novartis’s heart failure therapy Entresto (sacubitril, valsartan) has been approved for marketing. However, the generic version will not be launched until 2026 when the originator’s patent expires. This follows the approval…
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The Center for Drug Evaluation (CDE) website has indicated that Denmark-based Novo Nordisk’s (NYSE: NVO) Esperoct (turoctocog alfa pegol) is on track for priority review for the treatment of hemophilia A in adults and children. The drug is indicated for on-demand treatment and control of bleeding events, perioperative management, and…
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Germany-based Bayer (ETR: BAYN) has announced that its subsidiary BlueRock Therapeutics’ open-label Phase I study for cell therapy bemdaneprocel in Parkinson’s disease has successfully met the safety and tolerability primary endpoint. After one year, no bemdaneprocel-related serious adverse events (SAEs) were reported. Additionally, dose-dependent improvement in motor symptoms and evidence…
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib). The drug is now approved for use in adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic…
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Switzerland-based pharmaceutical giant Roche (SWX: ROG) has released an update from an interim analysis of a late-stage trial for its ALK inhibitor Alecensa (alectinib) as adjuvant therapy in the early setting for resected non-small cell lung cancer (NSCLC) with ALK mutations. These mutations are present in approximately 5% of NSCLC…
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The Ministry of Health, Labour and Welfare (MHLW) in Japan has begun the review process for an indication extension filing submitted by the UK pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK). The filing seeks to expand the use of GSK’s anti-IL-5 biologic Nucala (mepolizumab) as a treatment for adults with chronic…
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US pharmaceutical major Eli Lilly & Co., (NYSE: LLY) has announced that the National Medical Products Administration (NMPA) has approved an indication extension for its Verzenios (abemaciclib). The drug is now indicated as adjuvant therapy for hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, and lymph…
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) in China has approved a clinical trial filing for its bispecific antibody (BsAb) JS207. The drug is under development to target PD-1 and VEGF for the treatment of advanced malignant tumors. Pre-Clinical…
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Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) has announced that its Category 1 drug candidate, UBT251, has been tacitly approved in China for a clinical study to assess its effectiveness against overweight and obesity conditions. UBT251: A Triple Agonist for Metabolic ConditionsUBT251 is a long-acting GLP-1 (glucagon-like peptide-1)/GIP…
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The National Medical Products Administration (NMPA) website has indicated that Zai Lab Ltd’s (NASDAQ: ZLAB, HKG: 9688) Margenza (margetuximab), an Fc-engineered monoclonal antibody (mAb) targeting HER2 and developed by MacroGenics Inc., has been approved for the China market. The drug is indicated for the treatment of metastatic HER2-positive breast cancer…
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Sino-US firm MicuRx Pharmaceuticals Inc. has announced the initiation of a Phase III clinical study for its drug candidate MRX-4, focusing on the treatment of complex skin and soft tissue infections in China. The multi-center, randomized, double-blind, double-simulation Phase III trial aims to assess the safety and efficacy of MRX-4…