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Jiangsu Hengrui Pharmaceuticals’ Pyrotinib Gains NMPA Approval for HER2+ Breast Cancer Treatment
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Jiangsu Hengrui Pharmaceuticals (SHA: 600276), a leading China-based pharmaceutical company, has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its small-molecule HER2 inhibitor, pyrotinib. The drug is now approved for use in combination with Herceptin (trastuzumab) plus chemotherapy to treat recurrent or metastatic breast cancer…
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Evopoint Biosciences Gets CDE Approval for Phase I/II Study of XNW27011 ADC
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Suzhou Evopoint Biosciences Co., Ltd., a China-based pharmaceutical company, has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a Phase I/II clinical study for its antibody-drug conjugate (ADC), XNW27011. The study will focus on locally advanced unresectable or metastatic malignant solid tumors expressing Claudin 18.2 (CLDN18.2).…
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PharmaEssentia Corporation Completes Secondary Offering of GDR Shares on Luxembourg Exchange
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Taiwan-based PharmaEssentia Corporation (TPE: 6446) has announced the successful closing of a secondary offering of Global Depositary Receipt (GDR) shares. A total of 34 million shares of common stock were offered at a price of USD 13.61 per share, resulting in a capital raise of USD 462.7 million. The shares…
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Neurodawn Pharmaceutical’s Y-1 Receives NMPA Approval for Primary Intracranial Tumor Treatment
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Nanjing-based Neurodawn Pharmaceutical Co., Ltd has announced that its Category 1 drug, injectable Y-1, has obtained clinical trial approval from the National Medical Products Administration (NMPA) for the treatment of primary intracranial malignant tumors. TRPML1 Inhibitor’s Non-Clinical Study ResultsNon-clinical studies have demonstrated that the TRPML1 inhibitor, Y-1, can effectively inhibit…
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AACR 2023 Highlights: CAR-T Therapies and Monoclonal Antibody Combinations in Cancer Research
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The 2023 edition of the American Association for Cancer Research (AACR) annual meeting has concluded, highlighting the latest trends in clinical cancer research. The event featured a range of CAR-T cell therapies under development, including Allogene Therapeutics’ (NASDAQ: ALLO) CD70-targeting allogeneic treatment ALLO-316, as well as anti-CD19/CD20 and anti-TACI/BCMA bispecific…
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BeiGene’s Tislelizumab-Chemo Combo Excels in RATIONALE 305 Trial for Gastric Cancer
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BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235), a China-based biopharmaceutical company, has announced that the global RATIONALE 305 trial has successfully met its primary endpoint of overall survival. The trial demonstrated that tislelizumab, in combination with chemotherapy, showed superior overall survival (OS) compared to chemotherapy alone in patients with advanced…
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Junshi Biosciences’ Tuoyi Combo Shows Promise in Phase III Neotorch Study for NSCLC
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has published the results of the Phase III Neotorch study for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) combined with chemotherapy for the perioperative treatment of resectable non-small cell lung cancer (NSCLC) at the American Society of Clinical Oncology (ASCO) Plenary Series this…
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CSPC Pharmaceutical Group Gets NMPA Approval for SYS6010 ADC Clinical Trial
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC), SYS6010, which is intended for the treatment of advanced solid tumors. Pre-Clinical Studies and Patent Protection for SYS6010Pre-clinical studies have demonstrated that…
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Legend Biotech’s Carvykti Data Boosts Stock Price by 19.64% on Positive Phase III Results
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Shares of Legend Biotech (NASDAQ: LEGN) jumped an impressive 19.64% in a single day, attributed by industry media to the recent leak of positive data from the ongoing Phase III CARTITUDE-4 study. The study is assessing Legend’s BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Carvykti (ciltacabtagene autoleucel), as a…
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CARSgen Therapeutics’ CT041 Receives NMPA Approval for Post-Operative Pancreatic Cancer Therapy
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China-based chimeric antigen receptor (CAR)-T cell specialist, CARSgen Therapeutics Holdings Ltd (HKG: 2171), has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its pipeline candidate, CT041. The therapy will be assessed as a post-operative adjuvant treatment for Claudin18.2 (CLDN18.2)-positive pancreatic cancer. Potential First-In-Class CAR-T Therapy:…
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Zelgen Biopharmaceuticals’ ZG2001 Receives NMPA Approval for Clinical Trials
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 product candidate, ZG2001. ZG2001: An Oral Pan-KRAS Mutation InhibitorZG2001, an in-house developed oral pan-KRAS mutation inhibitor, is under development for the treatment of…
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Beijing Aosaikang’s ASKG915 Receives NMPA Approval for Clinical Trials in Advanced Solid Tumors
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced receiving clinical trial approval for its Category 1 biologic product ASKG915 from the National Medical Products Administration (NMPA). The study will initially assess the therapy in patients with general advanced solid tumors. ASKG915: A Bifunctional Fusion Protein Targeting PD-1 and IL-15ASKG915…
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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…
