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BeiGene’s Tislelizumab Receives 11th NMPA Filing for First-Line Esophageal Cancer
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BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) announced that the National Medical Products Administration (NMPA) has accepted a supplementary Biologic License Application (sBLA) for its PD-1 inhibitor tislelizumab, seeking approval for first-line treatment of unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). This marks the 11th market…
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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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Supreme People’s Court Rules Against Chugai in China’s First Patent Linkage Case
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China’s Supreme People’s Court has delivered its verdict in the nation’s first patent linkage dispute, ruling against Japan’s Chugai Pharmaceutical Co., Ltd and in favor of generic drugmaker Wenzhou Haihe Pharmaceutical Co., Ltd. The case, involving osteoporosis drug eldecalcitol, marks a milestone under China’s Drug Patent Early Dispute Resolution Mechanism,…
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Viatris Pharmaceuticals’ HIV/AIDS Drug Prioritized for CDE Review
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The Center for Drug Evaluation (CDE) has indicated that Viatris Pharmaceuticals Co., Ltd’s efavirenz/lamivudine/tenofovir is set for prioritized review. The drug is used to treat HIV/AIDS, combining three active ingredients to target viral replication. Drug Profile Global ApprovalsThe compound is marketed abroad under two single-dose regimes:
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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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CSPC Pharmaceutical’s DBPR108 Hits Endpoints in Type 2 Diabetes Trials
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its Category 1 drug DBPR108 has achieved endpoints in two Phase III clinical studies for type 2 diabetes. The oral dipeptidyl peptidase-IV (DPP-4) inhibitor demonstrated efficacy both as a monotherapy and in combination with other drugs, recruiting over 1,000 patients in…
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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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Scitop Bio-tech’s KEX02 Live Bacteria Therapy Gets FDA IND Approval for NSCLC
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Beijing Scitop Bio-tech Co., Ltd (SHE: 300858) announced that the US Food and Drug Administration (FDA) has granted Investigational New Drug (IND) approval for its live bacteria therapeutic candidate KEX02, to be tested in combination with a PD-1 inhibitor for the treatment of non-small cell lung cancer (NSCLC). About KEX02KEX02…
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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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Daiichi Sankyo’s Enhertu Accepted for Review in China for HER2-Low Breast Cancer
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Japan-based Daiichi Sankyo Inc. (TYO: 4568) announced that its market approval filing for Enhertu (T-DXd, trastuzumab deruxtecan), a HER2 antibody drug conjugate (ADC), has been accepted for review by the Center for Drug Evaluation (CDE) in China. The filing seeks approval for the treatment of adult patients with unresectable or…
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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…
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Sirnaomics Initiates Phase I/II Trial for STP705 in Facial Squamous Cell Carcinoma
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) announced the first subject systemic dosing in a Phase I/II clinical study for its therapeutic candidate STP705 in facial squamous cell carcinoma in situ (isSCC). The study is expected to be completed during Q1 2023. Study Design and ObjectivesThe open-label, dosage escalation…
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CSPC Pharmaceutical’s Mitoxantrone Liposome Approved for NMOSD Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its mitoxantrone hydrochloride liposome has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for neuromyelitis optica spectrum disorders (NMOSD). This follows the product’s initial approval in January this year for the treatment of relapsed…
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Spinraza’s NRDL Inclusion Boosts SMA Patient Treatment in China
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The Meier Advocacy & Support Center for Spinal Muscular Atrophy (SMA) and the Shenzhen Research Institute of the Chinese University of Hong Kong jointly released a report titled “Research on the Quality of Life of Chinese SMA Patients.” The report indicates that among patients treated with Biogen’s Spinraza (nusinersen), 76.4%…
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ICT’s GCC19CART Enters US Phase I Study for Colorectal Cancer
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Sino-US firm Innovative Cellular Therapeutics (ICT) announced the involvement of the first subject in a US-based Phase I clinical study for its GCC19CART, a CoupledCAR-based cell therapy, in relapsed / refractory metastatic colorectal cancer (R / R mCRC). The subject has completed apheresis, with cells successfully produced. Study DetailsThe open-label,…
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BRL Medicine’s BRL-101 Receives Clinical Trial Approval for Beta-Thalassemia
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Shanghai-based BRL Medicine Inc. has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its BRL-101. The therapy is an autologous hematopoietic stem progenitor cell treatment for transfusion-dependent beta-thalassemia. Drug DetailsBRL-101 is a gene therapy developed through BRL’s in-house developed hematopoietic stem cell…
