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InnoCare Pharma and CStone Pharmaceuticals’ Drugs Receive Prioritized CDE Review
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The Center for Drug Evaluation (CDE) has granted prioritized review status to InnoCare Pharma’s (HKG: 9969) orelabrutinib (a Bruton’s tyrosine kinase, BTK inhibitor) and CStone Pharmaceuticals’ (HKG: 2616) sugemalimab (a PD-L1 inhibitor, Cejemly). Orelabrutinib is filed for marginal zone lymphoma (MZL), while sugemalimab seeks approval for relapsed/refractory extranodal NK/T-cell lymphoma…
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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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Hengrui Medicine’s Dalpiciclib Hits Superiority Criteria in Phase III Study
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that its Phase III SHR6390-III-302 study for dalpiciclib, a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor, has met pre-set superiority criteria. The drug, combined with letrozole or anastrozole, significantly prolonged progression-free survival (PFS) in patients with HR-positive, HER2-negative advanced breast…
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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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Sirnaomics’ STP705 Achieves 100% Complete Remission in Basal Cell Carcinoma Study
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) announced positive results from a Phase II study of STP705 for basal cell carcinoma (BCC). The open-label, dosage escalation trial showed 100% complete remission (CR) in the 180 μg dose cohort, with stable or improved cosmetic outcomes in all subjects. The treatment…
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Henlius Biotech’s PD-1 Inhibitor Serplulimab Secures NMPA Review for Esophageal Cancer
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the National Medical Products Administration (NMPA) has accepted a supplementary Biologic License Application (BLA) for its PD-1 inhibitor Serplulimab (HaiSiZhuang) in combination with cisplatin and fluorouracil (5-FU) for first-line treatment of locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). Additionally,…
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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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Clover Biopharmaceuticals’ SCB-2019 Vaccine Proves Effective in Teenagers
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China-based Clover Biopharmaceuticals Ltd (HKG: 2197) announced positive results from a global Phase II/III trial of its SCB-2019 (CpG 1018/Alum) COVID-19 vaccine in adolescents aged 12 to 17. The study demonstrated superior immune response in teenagers compared to young adults, reinforcing the vaccine’s efficacy. Study Highlights Global Regulatory StrategyClover Bio…
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Alpha Biopharma Completes EVEREST Trial for Zorifertinib in EGFR+ NSCLC with CNS Metastases
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Shanghai-based Alpha Biopharma announced the completion of the last patient visit in the Phase II/III EVEREST study for its next-generation EGFR inhibitor zorifertinib, targeting EGFR mutation-positive non-small cell lung cancer (NSCLC) patients with central nervous system (CNS) metastases. Topline data is expected by the end of 2022. Study DetailsThe multi-regional…
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Sorrento Therapeutics’ Abivertinib Shows Positive Long-Term Data in NSCLC Trial
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Sorrento Therapeutics Inc. (OTCMKTS: SRNE) announced positive long-term results for its third-generation EGFR inhibitor abivertinib in a pivotal trial for advanced non-small cell lung cancer (NSCLC). The study, conducted exclusively in China, enrolled 209 patients with EGFR-mutated lung cancer previously treated with first-generation EGFR inhibitors. Trial Results The data is…
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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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CSPC Pharmaceutical’s SYS6006 mRNA Vaccine Shows Strong Safety and Efficacy in Trials
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has provided updates on its in-house COVID-19 mRNA vaccine SYS6006, which has completed six clinical trials demonstrating safety and efficacy across different age groups and vaccination scenarios. Trial Highlights Vaccine ProfileSYS6006 is designed with antigenic mutations targeting prevalent strains. Preclinical data show efficacy…
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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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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:
