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NMPA Approves Zynlonta for Relapsed or Refractory Large B-Cell Lymphoma Treatment
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The website of China’s National Medical Products Administration (NMPA) has indicated that the marketing filing for Zynlonta (loncastuximab tesirine), a collaboration between China’s Overland Pharmaceuticals and Swiss firm ADC Therapeutics SA (NYSE: ADCT), has been approved. This approval allows the CD19-targeted antibody-drug conjugate (ADC) to be used for treating adult…
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Wuhan YZY Biopharma’s M701 Shows Promise in Phase II Study for Malignant Pleural Effusion at ESMO ASIA 2024
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China-based Wuhan YZY Biopharma Co., Ltd (HKG: 2496) has announced the presentation of results from a Phase II clinical study for its M701, a recombinant anti-EpCAM and CD3 human murine chimeric bispecific antibody (BsAb) injection, at the ESMO ASIA Congress 2024. The study focused on patients with malignant pleural effusion…
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Immunofoco’s IMC002 Earns FDA Fast-Track Designation for CLDN 18.2-Positive Gastric Cancer
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Immunofoco, a leading developer in tumor immunotherapy based in Suzhou, has announced that it has received Fast-Track Designation (FTD) from the US Food and Drug Administration (FDA) for its IMC002. This chimeric antigen receptor (CAR)-T therapy targets CLDN 18.2 and is intended for the treatment of patients with unresectable locally…
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InnoVec Biotherapeutics’ IVB102 Receives FDA IND Approval for X-Linked Retinoschisis Treatment
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Beijing-based gene therapy specialist InnoVec Biotherapeutics Inc. has announced receiving Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its IVB102. This development follows the completion of enrollment in the investigator-initiated trial (ITT) at Peking Union Medical College Hospital. The FDA clearance was granted based…
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Eisai’s Urece (Dotinurad) Approved by China’s NMPA for Gout Treatment with Hyperuricemia
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Eisai’s (TYO: 4523) China unit has announced that it has received marketing approval from the National Medical Products Administration (NMPA) of China for its Urece (dotinurad), a uric acid excretion promoting drug. This approval allows the use of Urece to treat gout patients with hyperuricemia in China. Phase III Study…
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Daiichi Sankyo and AstraZeneca’s Datopotamab Deruxtecan Earns FDA Breakthrough Therapy Designation
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Partners Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) have jointly announced that their co-developed TROP-2-targeted antibody drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd), has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA). The designation is based on the positive results from the Phase II…
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China Medical System’s Methylthioninium Tablets Receive First Prescriptions for Colonoscopy Use
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China Medical System Holdings (CMS; HKG: 0867) has announced that the first prescriptions have been issued in China for its methylthioninium enteric coated sustained-release tablets. These tablets are designed to enhance the visualization of colorectal lesions in adult patients undergoing colonoscopy screening or monitoring. Methylthioninium’s Multi-Matrix Technology and MechanismMethylthioninium utilizes…
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Dizal Pharmaceutical Unveils Promising Data on DZD8586 for B-NHL at ASH Annual Meeting
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has presented new data from a pooled safety and efficacy analysis of DZD8586, a non-covalent blood-brain barrier (BBB) penetrant dual inhibitor targeting LYN and BTK, in patients with B-cell non-Hodgkin lymphoma (B-NHL) at the 66th American Society of Hematology (ASH) Annual Meeting. Clinical…
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AbbVie’s Tavapadon Shows Positive Results in Phase III TEMPO-2 Study for Parkinson’s Disease
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US-based pharmaceutical company AbbVie (NYSE: ABBV) has revealed positive top-line results from the pivotal Phase III TEMPO-2 study for its tavapadon, the world’s first and only D1/D5 partial agonist under investigation as a once-daily treatment for Parkinson’s disease (PD). TEMPO-2 Trial Design and OutcomesThe TEMPO-2 trial assessed the efficacy, safety,…
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Eli Lilly’s Jaypirca Demonstrates Superiority in BRUIN CLL-321 Study for CLL/SLL Treatment
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US pharmaceutical major Eli Lilly and Company (NYSE: LLY) unveiled the latest data from the Phase III BRUIN CLL-321 study for its Jaypirca (pirtobrutinib), an oral, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. BRUIN CLL-321 Study Design and Primary…
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Keymed Biosciences Presents CM336 Data for Relapsed Multiple Myeloma at ASH Annual Meeting
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China-based Keymed Biosciences Inc., (HKG: 2162) has announced the presentation of the latest data from the Phase I/II study for its bispecific antibody (BsAb) CM336, used for treating relapsed or refractory multiple myeloma (R/R M/M), at the 66th American Society of Hematology (ASH) Annual Meeting. Phase I/II Study Design and…
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Antengene’s Xpovio Showcases Positive Results in Phase III BENCH and Phase I/II TOUCH Studies at ASH 2024
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China-based Antengene Corporation Limited (Antengene, HKG: 6996) announced the presentation of the latest results from two clinical studies for its Xpovio (selinexor) at the 2024 American Society of Hematology Annual Meeting (ASH 2024). Phase III BENCH Study ResultsThe Phase III BENCH study evaluated the efficacy and safety of the selinexor,…
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Lee’s Pharmaceutical Receives NMPA Approval for Generic Glaucoma Treatments
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic versions of Pfizer’s Xalatan (latanoprost), Novartis/ Alcon’s Travatan (travoprost), and Novartis/ Alcon’s Duotrav (travoprost, timolol). All three generic drugs…
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CSPC Pharmaceutical Group’s SYHX2011 for Metastatic Breast Cancer Accepted for NMPA Review
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has announced that the National Medical Products Administration (NMPA) of China has accepted a marketing filing for its Category 2.2 chemical drug, SYHX2011. The drug is indicated for the treatment of metastatic breast cancer that has failed combined chemotherapy or has relapsed…
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GSK’s Nucala Receives FDA Review for COPD Indication Based on MATINEE Study Data
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UK-based pharmaceutical giant GSK (NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has accepted for review data from the MATINEE study. The study seeks an indication approval for GSK’s Nucala (mepolizumab) as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) who exhibit…
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HuidaGene Therapeutics Initiates HERO Trial for RNA-Editing Therapy HG204 in MECP2 Duplication Syndrome
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Shanghai-based HuidaGene Therapeutics has announced the first subject dosing of the HERO clinical trial, which is evaluating HG204, an RNA-editing therapy, for the treatment of MECP2 duplication syndrome (MDS). CRISPR RNA-Editing Therapy and Its MechanismThe CRISPR RNA-editing therapy utilizes a single adeno-associated virus vector to deliver HuidaGene’s proprietary high-fidelity RNA…
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Simcere Pharmaceutical’s SIM0508 Reaches First Patient Dosing in Global Clinical Study
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China-based Simcere Pharmaceutical Group Limited’s (HKG: 2096) subsidiary, Simcere Zaiming, has announced the first patient dosing in a global clinical study for its Pol θ inhibitor, SIM0508, which targets advanced solid tumors. Global Phase I Study Design and ApprovalThe global multi-center, open-label Phase I study is designed to assess the…
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TJ Biopharma and Jumpcan Pharmaceutical Announce NMPA Review of Eftansomatropin Alfa BLA
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Chinese partners TJ Biopharma and Jumpcan Pharmaceutical (SHA: 600566) have jointly announced that the National Medical Products Administration (NMPA) of China has accepted a Biologic License Application (BLA) for eftansomatropin alfa (TJ101) for review. This product, the first and currently only fusion protein long-acting growth hormone, is anticipated to offer…
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AstraZeneca’s Imfinzi Receives FDA Priority Review for Muscle-Invasive Bladder Cancer
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UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has announced that the US Food and Drug Administration (FDA) has accepted for review an additional indication filing for its programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab). The filing, which seeks approval for the treatment of muscle-invasive bladder cancer (MIBC), has also been…
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Amgen’s Blincyto Meets Primary Endpoint in Phase III AALL1731 Study for Pediatric B-ALL
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US-based biotechnology company Amgen (NASDAQ: AMGN) has published the results from the Phase III study (AALL1731) for its bispecific T-cell engager (BiTE) Blincyto (blinatumomab) at the 66th American Society of Hematology (ASH) annual meeting. The study assessed the potential of adding Blincyto to chemotherapy to improve disease-free survival (DFS) in…
