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Harbour BioMed’s Anti-CCR8 Monoclonal Antibody HBM1022 Receives FDA IND Approval
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Harbour BioMed (HBM), which operates out of the Netherlands, the United States, and Suzhou, China, has announced receiving Investigational New Drug (IND) approval from the US FDA for its in-house developed HBM1022, a novel anti-C-C chemokine receptor type 8 (CCR8) monoclonal antibody (mAb). This marks a significant milestone in the…
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Eli Lilly’s Tirzepatide Achieves Primary Endpoints in Chinese Obesity Study
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US major Eli Lilly (NYSE: LLY) has announced that the Phase III SURMOUNT-CN study for its glucose-dependent insulinotropic polyptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide has reached the primary endpoint and all pivotal secondary endpoints in obese or overweight Chinese adults. The study demonstrated that the overall safety profile was…
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Gracell’s CAR-T Therapy GC012F Receives FDA IND Approval
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Shanghai-based biotech Gracell Biotechnologies has reported receiving Investigational New Drug (IND) approval from the US FDA for its chimeric antigen receptor (CAR) T cell candidate GC012F. This dual BCMA/CD19-targeted therapy is set to be assessed in treating relapsed/refractory multiple myeloma (r/r MM), marking a significant step forward in the development…
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Sanofi Reports Strong Q4 and Full-Year 2022 Financials with 7% Growth
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France’s Sanofi (EPA: SAN) released its financial report last week, showing turnover during Q4 and full-year 2022 at EUR 10.7 billion (USD 11.6 billion) and EUR 43.0 billion (USD 46.4 billion) respectively. This represents year-on-year (YOY) growth of 2.6% and 7.0% at constant exchange rates (CER). The results highlight Sanofi’s…
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Grand Pharma’s TLX101 Accepted for NMPA Review for Glioblastoma Treatment
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that an Investigational New Drug (IND) filing for its TLX101, a radionuclide drug conjugate (RDC) being developed to treat glioblastoma multiforme, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development…
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BDgene’s CRISPR-Cas9 Therapy BD111 Accepted for CDE Review
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Shanghai BDgene Technology Co., Ltd has announced that a clinical trial filing for its BD111, a CRISPR-Cas9 in vivo-based therapy for herpes simplex virus (HSV)-related keratitis (HSK), has been accepted for review by the Center for Drug Evaluation (CDE). This marks a significant step forward in the development of innovative…
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JunTop Biosciences’ COVID-19 Therapy Mindewei Priced at RMB 795 per Course
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Sichuan’s provincial Healthcare Security Administration bureau has notified that Shanghai JunTop Biosciences Co., Ltd’s COVID-19 therapy Mindewei (deuremidevir) is to be initially quoted at RMB 795 (USD 117.23) per treatment course. This pricing announcement marks the entry of Mindewei into the market, offering a new treatment option for mild to…
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Mabwell’s Novel ADC 9MW2921 Accepted for NMPA Review
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that a clinical trial filing for its novel antibody-drug conjugate (ADC) 9MW2921 has been accepted for review by the National Medical Products Administration (NMPA). The firm is seeking to assess the ADC as a treatment for general solid tumors, marking…
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Bristol-Myers Squibb’s Ozanimod Approved in China for Multiple Sclerosis
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Bristol-Myers Squibb (BMS, NYSE: BMY) has announced receiving marketing approval from China’s National Medical Products Administration (NMPA) for its ozanimod, a novel selective sphingosine-1-phosphate (S1P) receptor modulator. The drug is now approved to treat recurrent multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple…
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GenScript’s CAR-T Therapy Carvykti Achieves $55M in Sales, Awaits China Approval
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China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that sales of its subsidiary company Legend Biotech Corporation’s (NASDAQ: LEGN) BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), reached USD 55 million as of December 31, 2022. This figure, yet to be independently audited,…
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OcuMension’s Phase I Study for Dry Eye Treatment OT-202 Concludes
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Chinese ophthalmology specialist OcuMension Therapeutics (HKG: 1477) has announced the conclusion of a Phase I clinical study for its OT-202, a tyrosine kinase inhibitor (TKI) being developed to treat dry eye. This marks a significant step in the development of innovative treatments for this common condition. Study Design and ResultsThe…
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Antengene Launches Phase I CLINCH Study for ATG-022 in Australia
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China-based Antengene Corporation Ltd (HKG: 6996) has received approval from Australia’s Therapeutic Goods Administration (TGA) to commence the Phase I CLINCH study for its antibody-drug conjugate (ADC) ATG-022. The study targets advanced or metastatic solid tumors, with a focus on gastric cancer patients expressing Claudin 18.2. ATG-022: Mechanism and Preclinical…
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Henlius Begins Phase I Trial for Biosimilar HLX15 Targeting Multiple Myeloma
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Shanghai Henlius Biotech (HKG: 2696) has announced the dosing of the first subject in a Phase I clinical study for its biosimilar candidate HLX15, targeting Johnson & Johnson’s (J&J, NYSE: JNJ) blockbuster drug Darzalex (daratumumab). The study aims to evaluate the pharmacokinetics, safety, and immunogenicity of HLX15 in healthy male…
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Jiangsu Hengrui’s SHR8058 Accepted for Review by China’s NMPA for Dry Eye Disease
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced that its market filing for the drug candidate SHR8058 has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is dry eye disease associated with meibomian gland dysfunction. SHR8058: Mechanism and DevelopmentSHR8058 is NOV03 (perfluorohexyl octane), a…
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Nanjing-Based Frontier Biotechnologies Secures Full Approval for Albuvirtide in China
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Nanjing-based Frontier Biotechnologies Inc. has announced that its supplementary approval filing for albuvirtide, China’s first domestically developed innovative HIV therapy, has been fully approved by regulators. The approval upgrades the drug’s status from “conditionally” approved to fully approved for marketing. Albuvirtide: A First-of-Its-Kind HIV TherapyAlbuvirtide is described as the world’s…
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Junshi Biosciences’ JS401 Accepted for Review by China’s NMPA for Hyperlipidemia
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for JS401, an injectable co-developed with partner Risen Pharma. The product is an ANGPTL3 mRNA-targeted small interfering RNA (siRNA) designed to treat hyperlipidemia. JS401: Mechanism and DevelopmentJS401 targets…
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Junshi Biosciences Partners with Huahai for Production of COVID-19 Drug VV116
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced a production and supply agreement between its subsidiary, Shanghai JunTop Biosciences Co., Ltd, and Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521). Under the deal, Huahai will provide manufacturing and supply services for Junshi’s oral nucleoside analog drug JT001 (VV116), which is…
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Ocumension Completes Enrollment for Global Phase III Study of Myopia Treatment OT-101
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Chinese ophthalmology specialist Ocumension Therapeutics (HKG: 1477) has announced the completion of enrollment for a global Phase III study of its pipeline candidate OT-101. The randomized, double-blind, placebo-controlled, multi-center trial aims to assess the efficacy and safety of OT-101 in treating myopia in children. The study has enrolled 170 subjects,…
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Hengrui’s HER2-Targeted ADC SHR-A1811 Gains NMPA Clearance for Clinical Trial
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China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving clearance from the National Medical Products Administration (NMPA) to conduct an open, multi-center Phase Ib/II clinical study for its investigational HER2-targeted antibody-drug conjugate (ADC), SHR-A1811. The study will evaluate the drug in patients with unresectable or metastatic breast cancer with low…
