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Walvax Biotech Wins NMPA Approval for mRNA and Recombinant COVID-19 Vaccines
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has received clinical trial approvals from the National Medical Products Administration (NMPA) for two novel coronavirus vaccines: an mRNA vaccine co-developed with Fudan University and Shanghai RNACure Biopharma, and a recombinant vaccine developed in-house by its subsidiary Shanghai Zerun Biotech. Vaccine Details Strategic…
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Hengrui Medicine’s HRG2101 Inhaler Wins NMPA Approval for IPF Clinical Trial
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China’s Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical trial of its HRG2101 inhaler for idiopathic pulmonary fibrosis (IPF). The drug, with no similar marketed products in China, targets fibroblast activity and inflammatory pathways to address the…
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Henlius Biotech Plans US Bridging Study for Serplulimab in ES-SCLC
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Shanghai Henlius Biotech (HKG: 2696) is advancing its checkpoint inhibitor serplulimab toward the U.S. market, with plans to launch a bridging study in H2 2022 for extensive-stage small-cell lung cancer (ES-SCLC). The decision follows a meeting with the U.S. FDA, as the firm seeks to replicate its Phase III success…
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Jacobio Pharmaceuticals Doses First Patient in JAB-21822 Phase IIa Trial for KRAS G12C NSCLC
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China’s Jacobio Pharmaceuticals Group Co., Ltd (HKG: 1167) announced the first patient dosed in a Phase IIa trial of its KRAS G12C inhibitor, JAB-21822, for first-line non-small cell lung cancer (NSCLC) with KRAS G12C and STK11 co-mutations. The study follows a Phase I trial that showed a 56.3% objective response…
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Biocytogen and Tracon Pharmaceuticals Gain FDA IND Approval for Sarcoma Trial
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China-based Biocytogen (Beijing) Co., Ltd and US-based Tracon Pharmaceuticals Inc. (Nasdaq: TCON) announced that the US FDA has approved an IND application to conduct a clinical trial of YH001 in combination with envafolimab or doxorubicin for sarcoma patients, including those who have not been previously treated. Trial DesignThe Phase I/II…
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ImmuneOnco’s IMM40H Receives NMPA Clinical Trial Approval for CD70 Antibody
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its anti-CD70 antibody IMM40H, following a previous US clinical nod. The drug is designed to target CD70, a protein found in highly activated lymphocytes and a viable target for…
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Junshi Biosciences’ TAB009/JS009 and JS110 Advance in Cancer Trials
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Junshi Biosciences (HKG: 1877, SHA: 688180) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical trial for its injectable monoclonal antibody TAB009/JS009, targeting CD112R, as a monotherapy for advanced solid tumors. The company also plans to initiate a US trial for its XPO1 inhibitor JS110…
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Junshi Biosciences Gets NMPA Go-Ahead for TAB009/JS009 Cancer Study
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Junshi Biosciences (HKG: 1877, SHA: 688180) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical trial for its injectable monoclonal antibody TAB009/JS009, targeting CD112R, in advanced solid tumors. The company also plans to initiate a US trial for its XPO1 inhibitor JS110 after gaining FDA…
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Ranok Therapeutics Doses First Patient in RNK05047 Study for BRD4-Targeted Cancers
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Ranok Therapeutics Co., Ltd, a Hangzhou-based biotech firm, announced that the first patient has been dosed in the Phase I/II CHAMP-1 study (NCT05487170) of its lead drug candidate RNK05047 in the United States. The trial will evaluate the safety and optimal dosage of the potential first-in-class small-molecule degrader targeting BRD4…
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SinoMab Bioscience’s SN1011 Gets NMPA Nod for NMOSD Trial
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Hong Kong-based SinoMab Bioscience Ltd (HKG: 3681) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II/III study of its tyrosine kinase (BTK) inhibitor SN1011 for neuromyelitis optica spectrum disorders (NMOSD). The trial is expected to enroll its first patient in Q1 2023. Drug ProfileSN1011…
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Mabwell Bioscience Receives NMPA Approval for 6MW3511 Clinical Trial in Solid Tumors
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that the National Medical Products Administration (NMPA) has approved a clinical trial for its drug candidate 6MW3511, targeting advanced solid tumors. The trial will evaluate the drug’s efficacy and safety in patients with advanced solid tumors. Drug Profile6MW3511 is a bifunctional…
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Bio-Thera Solutions Receives NMPA Approval for BAT8008 Clinical Trial in Solid Tumors
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Bio-Thera Solutions (SHA: 688177), a Guangzhou-based biotech firm, has received approval from the National Medical Products Administration (NMPA) to conduct a clinical trial for BAT8008, its antibody-drug conjugate (ADC) targeting solid tumors. This marks the fourth product from Bio-Thera’s pipeline to advance into clinical trials. Drug ProfileBAT8008 combines a recombinant…
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Innovent Biologics Doses First Patient in Australia Trial for PD-1/IL-2 Bispecific Antibody IBI363
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China-based Innovent Biologics, Inc. (HKG: 1801) announced that the first patient has been dosed in a Phase I clinical trial of IBI363, an in-house developed PD-1/IL-2 bispecific antibody (BsAb) fusion protein, in Australia. The trial will evaluate the safety, tolerability, and preliminary efficacy of IBI363 in patients with advanced solid…
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Anhui Anke’s HK010 Bispecific Antibody Receives NMPA Review for Cancer Trials
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Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009) announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for HK010, a bispecific antibody (BsAb) targeting PD-L1 and 4-1BB, for the treatment of advanced malignant tumors. Drug ProfileHK010 is designed to block the PD-L1/PD-1 pathway while conditionally…
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Shanghai Pharmaceuticals Gets NMPA Approval for B013 in Triple-Negative Breast Cancer
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Shanghai Pharmaceuticals (HKG: 2607, SHA: 601607) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II/III clinical trial of its Category 1 biologic B013, combined with albumin paclitaxel, for first-line treatment of locally advanced or metastatic triple-negative breast cancer (TNBC). Drug ProfileB013, a potential first-in-class…
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Nuance Pharma Gets NMPA Green Light for Ensifentrine COPD Trials in China
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China-based Nuance Pharma has secured approval from the National Medical Products Administration (NMPA) to conduct both Phase I and Phase III clinical trials for ensifentrine, a dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4), as a maintenance treatment for chronic obstructive pulmonary disease (COPD). Partnership and DevelopmentThe drug…
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IASO Biotherapeutics’ BCMA CAR-T Therapy Approved for NMOSD in China
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China-based IASO Biotherapeutics announced that the National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application for equecabtagene autoleucel (CT103A), a BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy, for the treatment of neuromyelitis optica spectrum disorder (NMOSD). This marks the first global trial of a BCMA…
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Allist Pharmaceuticals Receives NMPA Approval for Furmonertinib in Exon 20 Insertion NSCLC
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Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) announced that the National Medical Products Administration (NMPA) has approved a clinical trial for its furmonertinib, a third-generation epidermal growth factor receptor (EGFR) inhibitor, targeting exon 20 insertion mutated non-small cell lung cancer (NSCLC). Drug ProfileFurmonertinib received conditional market approval from the NMPA in…
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Fosun Kite’s Yescarta CAR-T Therapy Secures New Clinical Trial Approval in China
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Fosun Kite Biotechnology Co., Ltd, a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) and Gilead’s Kite Pharma, has received another clinical trial approval for its anti-CD19 chimeric antigen receptor (CAR) T therapy Yescarta (axicabtagene ciloleucel). The new indication targets adult large B-cell lymphoma (r/r LBCL) that…
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Recbio Completes Phase II Trial Enrollment for ReCOV COVID-19 Vaccine
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China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) announced the completion of enrollment and dosing of all subjects in a Phase II clinical study for its ReCOV, a recombinant protein COVID-19 vaccine, with Pfizer’s mRNA vaccine Comirnaty as a control. The study, approved in the Philippines on August…
