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RemeGen’s RC118 Receives Orphan Drug Designations for Gastric and Pancreatic Cancers
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China-based RemeGen Ltd announced that its antibody drug conjugate (ADC) drug candidate RC118 has obtained two orphan drug designations (ODD) from the US FDA, for the therapy’s potential use against gastric and pancreatic cancers. RC118: Mechanism and DevelopmentRC118, a novel ADC drug candidate co-developed with contract research organization (CRO) Biocytogen,…
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Innovent Biologics Presents Clinical Study Results at ESMO-IO 2022
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China-based Innovent Biologics Inc. (HKG: 1801) announced the presentation of two clinical studies at the 2022 European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO). IBI939 Phase Ib Study ResultsA Phase Ib study to evaluate the safety, tolerability, and efficacy of anti-TIGIT candidate IBI939 in combination with sintilimab in patients with…
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Harbour BioMed Concludes Phase I Study for HBM4003 in Advanced Melanoma
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Harbour BioMed (HBM; HKG: 2142), a biotech operating out of the United States, the Netherlands, and Suzhou (China), announced the conclusion of a Phase I clinical study for its anti-CTLA-4 antibody HBM4003 combined with Junshi Bio’s programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) in advanced melanoma. The study has shown that…
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Jacobio’s KRAS G12C Inhibitor JAB-21822 Receives Breakthrough Therapy Designation
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The Center for Drug Evaluation (CDE) website indicates that China-based Jacobio Pharmaceuticals Group Co., Ltd’s (HKG: 1167) KRAS G12C inhibitor JAB-21822 has received breakthrough therapy designation (BTD) status for its potential as a treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS p.G12C mutation. The…
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CSPC and Ascletis Get NMPA Approval for COVID-19 Drug Clinical Trials
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China-based firms CSPC Pharmaceutical Group Ltd (HKG: 1093) and Ascletis Pharma Inc. (HKG: 1672) both announced receiving the green light from the National Medical Products Administration (NMPA) to carry out clinical trials for their respective SYH2055 and ASC11, both inhibitor drugs targeting 3-chymotrypsin like protease (3CLpro) for COVID-19. Market Landscape…
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Hansoh’s Generic Firazyr Approved for Marketing in China by NMPA
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The National Medical Products Administration (NMPA) website indicates that China-based Hansoh Pharmaceutical Group Co., Ltd’s (HKG: 3692) generic version of Japan firm Takeda Pharmaceutical Co., Ltd’s Firazyr (icatibant) has been approved for marketing in China. Firazyr: Mechanism and Approval HistoryFirazyr, a selective bradykinin B2 receptor antagonist developed by Shire Pharmaceuticals,…
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NMPA Approves Viatris’ Symfi Lo for HIV-1 Treatment in China
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The National Medical Products Administration (NMPA) website indicates that US-based Viatris Inc.’s (NASDAQ: VTRS) Symfi Lo (efavirenz, lamivudine, tenofovir) has been approved for marketing in China. The drug was awarded priority review status in May 2020 for use in human immunodeficiency virus type 1 (HIV-1) infection in adults and children…
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SciClone’s Danyelza Approved for Marketing in China by NMPA
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The National Medical Products Administration (NMPA) website indicates that SciClone Pharmaceuticals Inc’s (Nasdaq: SCLN) Danyelza (naxitamab) has been approved for marketing in China. Danyelza is a GD2-targeted monoclonal antibody originated by Y-mAbs Therapeutics Inc., and was fast-tracked for marketing approval in November 2020. SciClone struck a licensing deal with Y-mAbs…
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Enhertu Confirmed as New Standard of Care for Breast Cancer in Phase III Study
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AstraZeneca PLC (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) released the latest data supporting the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) as a new standard of care for breast cancer. An update from the DESTINY-Breast03 Phase III study assessing Enhertu head-to-head against Roche’s Kadcyla (trastuzumab emtansine, TDM-1) in patients with…
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MicuRx Pharmaceuticals Gains Clinical Trial Approvals for MRX-4 in Europe
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Sino-US firm MicuRx Pharmaceuticals Inc. announced receiving clinical trial approvals in France, Greece, Hungary, Italy, Latvia, Lithuania, Portugal, Spain, and Estonia for its novel anti-microbial agent MRX-4 combined with contezolid (MRX-I) as a sequential treatment for diabetic foot infection. Drug Overview and DevelopmentBoth drugs are in-house developed new-generation oxazolidinone antibiotics.…
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Beijing Wantai’s Nasal Spray COVID-19 Vaccine Approved for Emergency Use in China
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China-based Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392) announced the inclusion of its nasal spray influenza virus vector SARS-CoV-2 vaccine co-developed by Xiamen University and Hong Kong University, in the emergency use program in China. Vaccine Development and MechanismThe vaccine, produced by inoculating Madin-Darby Canine Kidney (MDCK) cells…
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Junshi Biosciences Files for EMA Approval of Tuoyi for Nasopharyngeal and Esophageal Cancers
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that a market approval filing has been made for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) with the European Medicines Agency (EMA). The biotech is seeking approval for the checkpoint inhibitor in combination with chemotherapy as a first-line treatment for locally recurrent…
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WestVac Biopharma’s Recombinant COVID-19 Vaccine Approved for Emergency Use in China
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Chengdu-based WestVac Biopharma Co., Ltd announced the inclusion of its recombinant COVID-19 vaccine (Sf9 cells) in the emergency use program in China. It is the first recombinant protein novel coronavirus vaccine produced by the insect cell technology platform approved for emergency use in China. Vaccine Efficacy and TechnologyThe data shows…
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Qilu Pharmaceutical’s QL1604 Plus Chemotherapy Shows Promise in Phase II Study
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China-based Qilu Pharmaceutical announced that the results of the Phase II study assessing its QL1604 plus chemotherapy as a first-line treatment for patients with recurrent or metastatic (R/M) cervical cancer were released on December 4, 2022, in an oral presentation (Proffered Paper, 179O) at the European Society for Medical Oncology…
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Hybio Receives Ethical Approval for HY3000 COVID-19 Nasal Spray Phase II Study
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) announced receiving ethical approval for a Phase II clinical study protocol for its Category 1.1 chemical drug HY3000 nasal spray targeting COVID-19. The clinical filing for the product was accepted for review by the National Medical Products Administration (NMPA) in August 2022. Study…
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Clover Biopharmaceuticals’ COVID-19 Vaccine SCB-2019 Included in China’s Emergency Use Program
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China-based vaccine specialist Clover Biopharmaceuticals, Ltd (HKG: 2197) announced the inclusion of its COVID-19 vaccine SCB-2019 (CpG 1018/Alum) in the emergency use program in China. The protein vaccine was developed using Clover’s proprietary Trimer-Tag (protein trimerization) technology, a drug development platform which allows the production of novel, covalently-trimerized fusion proteins.…
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Henlius Biotech Doses First Patient in Phase I Study for HLX60 in China
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced the first patient dosing of a Phase I clinical study for its HLX60 in solid tumors and lymphomas in mainland China. Study Design and ObjectivesThe open, dose escalation, first-in-human Phase I study is designed to assess the safety and tolerability of the drug…
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Fudan Team Presents Ribociclib Phase II Bridging Study Results at ESMO Asia
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A Fudan University Shanghai Cancer Center team led by Shao Zhimin made an oral presentation of results from a Phase II bridging study for ribociclib at the European Society for Medical Oncology (ESMO) Asia Congress 2022. Ribociclib (trade name: Kisqali) is a cyclin-dependent kinases 4/6 (CDK4/6) inhibitor developed by Swiss…
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Hansoh’s EGFR Inhibitor Ameile Filed for EMA Review by Partner EQRx
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that a market filing for its epidermal growth factor receptor (EGFR) inhibitor Ameile (almonertinib) has been filed for review with the European Medicines Agency (EMA) by US-based partner EQRx Inc. Hansoh/EQRx’s targeted indication is as a first-line treatment of locally advanced…
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Sinocelltech’s SCTV01C Vaccine Included in China’s Emergency Use Program
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China-based Sinocelltech Group Ltd (SHA: 688520) announced the inclusion of its recombinant novel coronavirus alpha+beta mutant S-trimer protein vaccine SCTV01C in the emergency use program in China. SCTV01C is a next-generation bivalent mutant recombinant protein vaccine being developed to prevent diseases caused by COVID-19. The active ingredient of SCTV01C contains…
