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InnoCare Pharma’s Orelabrutinib Gains NMPA Approval for Recurrent/Refractory MZL Treatment
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, orelabrutinib. The drug can now be used to treat recurrent/refractory marginal zone lymphoma (MZL), marking it as the first BTK inhibitor for that…
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Biosyngen Receives US FDA IND Approval for T-Cell Redirection Therapy for EBV-Positive Lymphoma
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Biosyngen Pte Ltd, a cell and gene therapy (CGT) biotech with operations in Singapore and Guangzhou, China, has announced receiving Investigational New Drug (IND) approval from the US FDA for its second pipeline product, a T-cell redirection therapy designed for the treatment of EBV-positive lymphoma. This approval follows closely on…
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RemeGen Ltd Partners with Shandong Cancer Hospital for ADC Development and Integrated System
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RemeGen Ltd (HKG: 9995) has announced a strategic partnership with Shandong Cancer Hospital to establish a clinics-centered integrated system that spans the pharmaceutical industry, academia, and research fields, with a focus on antibody-drug conjugate (ADC) development. RemeGen’s ADC Achievements and PipelineRemeGen’s disitamab vedotin marked a significant milestone as the first…
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Innovent Biologics Presents IBI351 Phase I Results at AACR Annual Meeting
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China-based Innovent Biologics (HKG: 1801) has published the results of a Phase I clinical study for its IBI351 monotherapy in advanced solid tumors at the American Association for Cancer Research (AACR) annual meeting. IBI351: A KRAS G12C Inhibitor Under AssessmentIBI351 (GFH925), a KRAS G12C inhibitor originated by GenFleet Therapeutics Inc.,…
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Adagene Inc. Presents Positive Interim Results for ADG126 at AACR Annual Meeting
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China-based Adagene Inc. (NASDAQ: ADAG) has announced interim results from its combination dose escalation studies of the masked, anti-CTLA-4 SAFEbody, ADG126, at the AACR Annual Meeting in Orlando, Florida, from April 14-19, 2023. The studies include a Phase Ib/II study for ADG126 as a monotherapy and in combination with toripalimab…
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BeiGene and SpringWorks Therapeutics Report Positive Phase Ib Results for Lifirafenib and Mirdametinib Combination
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China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) and SpringWorks Therapeutics Inc., (NASDAQ: SWTX) have published the latest data from a Phase Ib clinical study assessing the combination of BeiGene’s RAF dimer inhibitor lifirafenib and SpringWorks’ MEK inhibitor mirdametinib in advanced or refractory solid tumors carrying RAS mutations, RAF mutations,…
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HanchorBio Receives FDA Approval for Multi-Region Clinical Study of HCB101 Fusion Protein
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Taiwan-based HanchorBio has announced receiving the green light from the US FDA to conduct a multi-region, multi-center clinical study for its innovative fusion protein, HCB101. The non-blind, dose exploration first-in-human trial will be conducted in the US and Taiwan, focusing on assessing the safety, tolerability, pharmacokinetics, and preliminary clinical anti-tumor…
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HutchMed’s Elunate Receives NMPA Review for Second-Line Gastric Cancer Treatment
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China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced that the National Medical Products Administration (NMPA) has accepted a market approval filing for the VEGFR inhibitor Elunate (fruquintinib) in China. The filing focuses on the use of Elunate in combination with paclitaxel as a second-line treatment for advanced gastric or gastroesophageal…
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CBMG’s C-CAR031 Shows Promising Results in Phase I Study for Hepatocellular Carcinoma
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China-based cell therapy specialist Cellular Biomedicine Group Inc. (CBMG) has published the results of the Phase I clinical study for its C-CAR031 at the American Association for Cancer Research (AACR) annual meeting 2023. The open Phase I study was designed to assess the safety and tolerability of C-CAR031, featuring a…
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JS InnoPharm Initiates Phase Ib Study of AURKA Inhibitor VIC-1911 for EGFR-TKI Resistant NSCLC
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JS InnoPharm Ltd, a Shanghai-based pharmaceutical company, announced that the first patient has been dosed in a Phase Ib clinical study for its small-molecule aurora A kinase (AURKA) inhibitor, VIC-1911. This trial marks a significant step in the development of the drug, which is being investigated for its potential in…
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Harbour Biomed to Present Early Clinical Data for CTLA-4 Antibody Combo at AACR 2023
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China-based Harbour Biomed (HKG: 2142) is set to release early clinical data for its CTLA-4 antibody in combination with Junshi Biosciences’ (HKG: 1877, SHA: 688180) programmed death-1 (PD-1) inhibitor toripalimab as a treatment for neuroendocrine neoplasms (NENs). The findings will be presented via a poster at the upcoming American Association…
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RemeGen’s Disitamab Vedotin (RC48) Clears for Phase I Study in HER2-Positive Tumors
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48). This single-arm, open, single-center study aims to evaluate the safety and maximum tolerable…
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Fosun Pharmaceutical’s FCN-159 Earns Breakthrough Therapy Designation for Histiocyte Tumors
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The Center for Drug Evaluation (CDE) website has announced that Shanghai Fosun Pharmaceutical (Group) Co., Ltd’s (SHA: 600196, HKG: 2196) novel small-molecule chemical drug FCN-159 has been granted breakthrough therapy designation (BTD) status for the treatment of histiocyte tumors. FCN-159’s Mechanism and ImpactFCN-159 is a highly selective MEK1/2 inhibitor with…
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Huadong Medicine Reports 9.12% YOY Revenue Growth and 13.24% Increase in Net Profits for 2022
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Huadong Medicine Co., Ltd (SHE: 000963), a leading China-based pharmaceutical company, has released its 2022 financial report, demonstrating robust growth with revenues of RMB 37.715 billion (USD 5.5 billion), an increase of 9.12% year-on-year (YOY), and net profits of RMB 2.598 billion (USD 379.3 million), marking a 13.24% YOY increase.…
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Convalife Pharmaceuticals’ Mefuparib Earns Orphan Drug Designation for Cholangiocarcinoma
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Shanghai-based Convalife Pharmaceuticals has announced that it has received orphan drug designation (ODD) status from the US FDA for its second-generation PARP inhibitor, mefuparib (CVL218). The designation is in recognition of the drug’s potential as a treatment for cholangiocarcinoma, a rare and aggressive form of cancer. Advantages of CVL218 Over…
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Overland ADCT BioPharma Achieves Primary Endpoint in Zynlonta Phase II Study for R/R DLBCL
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Joint venture Overland ADCT BioPharma (CY) Ltd, a partnership between China’s Overland Pharmaceuticals and Swiss firm ADC Therapeutics SA (NYSE: ADCT), announced that the primary endpoint has been reached in a Phase II regulatory study. The study assessed the efficacy and safety of Zynlonta (loncastuximab tesirine), an antibody-drug conjugate (ADC)…
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Junshi Biosciences’ Senaparib Meets Primary Endpoint in Phase III Ovarian Cancer Study
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China’s Junshi Biosciences (HKG: 1877, SHA: 688180) has declared that the Phase III FLAMES study for senaparib (JS109/IMP4297), a PARP inhibitor co-developed with Impact Therapeutics Inc., has achieved the pre-set optimal efficiency threshold, marking the trial’s primary endpoint. The study targets the first-line maintenance treatment for stage III/IV ovarian cancer,…
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Specialised Therapeutics to Commercialize Akeso’s PD-1 Inhibitor Penpulimab in APAC
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Singapore-based Specialised Therapeutics Asia Pte Ltd (ST) has been appointed to handle the commercialization of the programmed death-1 (PD-1) inhibitor, Anniko (penpulimab), in Australia, Singapore, and South-East Asia. The drug is developed by the joint venture (JV) CTTQ-Akeso (Shanghai) Biomed Tech Co., Ltd, a partnership between Akeso Inc. (HKG: 9926)…
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Luye Pharma’s Bevacizumab Biosimilar Accepted for Review in Brazil by ANVISA
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China-based Luye Pharma Group (HKG: 2186) has announced that the market approval filing for its biosimilar version of Roche’s Avastin (bevacizumab) has been accepted for review by Brazil’s National Health Surveillance Agency (ANVISA). Luye’s Biosimilar Approval and Global OutlookLuye’s biosimilar bevacizumab was approved in China in 2021 to treat indications…
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Zelgen Biopharmaceuticals’ ZG006 Earns FDA Approval for Small-Cell Lung Cancer Trial
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced receiving clinical trial approval from the US FDA for its investigational drug ZG006, intended to treat small-cell lung cancer and other solid tumors. ZG006: A Tri-Specific Antibody Targeting CD3 and DLL3 EpitopesZG006 is a tri-specific antibody developed through the company’s…
