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TransThera Sciences’ TT-00420 Receives Breakthrough Designation for Cholangiocarcinoma Treatment
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The Center for Drug Evaluation (CDE) website has indicated that Nanjing-based TransThera Sciences (Nanjing), Inc.’s candidate TT-00420 is set to receive breakthrough therapy designation (BTD) for the treatment of unresectable advanced or metastatic cholangiocarcinoma. This designation is for patients whose disease recurs after previous systemic chemotherapy and/or FGFR inhibitor treatment.…
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Zai Lab Initiates Phase III Trial for Bemarituzumab in First-Line Gastric Cancer Treatment
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China-based biopharmaceutical company Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced the first patient dosing in the global regulatory Phase III FORTITUDE-101 trial for its drug candidate bemarituzumab, which is being studied for the treatment of first-line gastric cancer in China. Bemarituzumab’s Mechanism and Potential ImpactBemarituzumab is a potential…
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InnoCare Pharma and ArriVent Biopharma Partner on SHP2 Inhibitor and EGFR Inhibitor Combination
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China-based InnoCare Pharma (HKG: 9969; SHA: 688428) has announced a clinical development collaboration with US-based ArriVent Biopharma Inc. The partnership aims to evaluate the combination of InnoCare’s novel SHP2 allosteric inhibitor, ICP-189, with ArriVent’s furmonertinib, a highly brain-penetrant and broadly active mutation-selective EGFR inhibitor. Combining ICP-189 and Furmonertinib for Solid…
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GeneQuantum Healthcare and Aimed Bio Expand Partnership to Develop Five Novel ADC Drugs
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China-based GeneQuantum Healthcare has unveiled a new agreement to expand its existing partnership with South Korea-based biotech firm Aimed Bio. The collaboration will see the two companies jointly develop up to five novel antibody drug conjugate (ADC) drugs, with the specific molecular and disease targets undisclosed. This expansion follows last…
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LianBio Secures Clinical Supply Agreement with AstraZeneca for SHP2 Inhibitor Trial
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Sino-US biotech firm LianBio (OTCMKTS: LIANY) has announced the signing of a clinical supply agreement with UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN). The agreement facilitates LianBio’s plan to test the combination of its pipeline SHP2 inhibitor, BBP-398, with AstraZeneca’s Tagrisso (osimertinib) in a Phase I clinical trial for patients…
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GRIT Biotechnology’s GT201 TIL Therapy Approved for Clinical Studies by China’s CDE
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The Center for Drug Evaluation (CDE) website has indicated that GRIT Biotechnology, a China-based cell therapy specialist, has received approval for its in-house developed gene engineered tumor-infiltrating lymphocyte (TIL) therapy, GT201, for clinical studies in patients with recurrent or metastatic solid tumors. Optimal Structural Design and Custom Retroviral System for…
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Jiangsu Hengrui Pharmaceuticals’ Irinotecan and Bupivacaine Liposome Injections Get Clinical Trial Green Light in China
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving separate clinical trial approvals in China for its irinotecan liposome injection and bupivacaine liposome injection. These approvals mark a significant step forward in the development of these targeted therapies. Irinotecan Liposome Injection for Advanced Colorectal Cancer…
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Shanghai Junshi Biosciences’ Tuoyi Files for 9th Indication in China for RCC Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted for review an additional indication approval filing for its Tuoyi (toripalimab), a programmed death-1 (PD-1) inhibitor, in combination with axitinib for first-line unresectable or metastatic renal cell carcinoma (RCC). This…
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Jiangsu Hengrui Pharmaceuticals Receives Clinical Trial Approvals for Irinotecan and Bupivacaine Liposome Injections
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving separate clinical trial approvals in China for its irinotecan liposome injection and bupivacaine liposome injection. These approvals mark significant steps in advancing the company’s pipeline in oncology and pain management. Irinotecan Liposome Injection for Advanced Colorectal…
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Shanghai Junshi Biosciences’ Tuoyi Files for 9th Indication in China for RCC Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted for review an additional indication approval filing for its Tuoyi (toripalimab), a programmed death-1 (PD-1) inhibitor, in combination with axitinib for first-line unresectable or metastatic renal cell carcinoma (RCC). This…
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Hrain Biotechnology’s Anti-CD70 T Cell Therapy HR010 Gets Tacit Approval for Renal Cancer Trial
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Shanghai-based Hrain Biotechnology Co., Ltd. has announced receiving tacit clinical trial approval from the Center for Drug Evaluation (CDE) for its anti-CD70 T cell therapy, HR010. The therapy is intended for the treatment of advanced or metastatic renal cancer. CD70 as a Potential Target for Kidney Cancer TreatmentCD70, a member…
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Huadong Medicine’s Elahere Receives Approval for FRα Positive Cancer Treatment in China
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving approval to introduce Elahere (mirvetuximab soravtansine), an antibody drug conjugate (ADC) targeting folate receptor α (FRα), at Ruijin Hospital’s Hainan branch. The treatment is indicated for FRα positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in…
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C4 Therapeutics’ CFT8919 Earns FDA Approval for Clinical Trials Targeting EGFR L858R Mutations
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US-based C4 Therapeutics Inc., (NASDAQ: CCCC) has announced receiving clinical trial approval from the US FDA for its pipeline candidate, CFT8919. This orally bioavailable BiDAC degrader is designed to target EGFR L858R mutations and has demonstrated good activity and selectivity against solid tumors carrying these mutations. Pre-Clinical Success and Potential…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for HRS-9815 Radiodiagnostic Drug Clinical Study
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its injectable HRS-9815 and the accompanying preparatory kit. The product candidate is an in-house developed Category 1 radiodiagnostic drug. HRS-9815: A Radiodiagnostic…
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Transcenta Holding Ltd Secures Global Clinical Trial Approvals for Osemitamab in Gastric Cancer
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China-based Transcenta Holding Ltd has reported receiving clinical trial approvals from China’s Center for Drug Evaluation (CDE) and South Korea’s Ministry of Food and Drug Safety (MFDS) for their pipeline candidate osemitamab (TST001), a CLDN18.2-targeted monoclonal antibody. Both regulatory bodies have approved the plan for TranStar 301, a global Phase…
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HutchMed Ltd Initiates Phase I Clinical Study for SHP2 Inhibitor HMPL-415 in Solid Tumors
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China-based HutchMed Ltd (NASDAQ: HCM; HKG: 0013) has announced the initiation of a Phase I clinical study for its investigational novel selective allosteric inhibitor, HMPL-415, which targets Src homology-2 domain-containing protein tyrosine phosphatase-2 (SHP2). The trial, aimed at assessing the molecule in general solid tumors, marked its first patient dosing…
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C-Mer Eye Care Holdings Ltd Partners with Hong Kong Ophthalmologist for Novel Drug Development
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China-based C-Mer Eye Care Holdings Ltd (HKG: 3309) has announced the establishment of a joint venture with Doctor Dennis Lam, a distinguished ophthalmologist in Hong Kong. The joint venture, valued at a market capitalization of HKD 50 million (USD 6.4 million), is aimed at focusing on the development of innovative…
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Chime Biologics, Leads Biolabs, and BeiGene Form Strategic Partnership for LAG-3 mAb LBL-007
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Wuhan-based Contract Development and Manufacturing Organization (CDMO) Chime Biologics has signed a strategic cooperation agreement with Nanjing-based Leads Biolabs and Beijing firm BeiGene Inc., (NASDAQ: BGNE, HKG: 6160). The cooperation focuses on the development and global manufacturing of LBL-007, a LAG-3 monoclonal antibody (mAb). BeiGene’s Acquisition and Global Rights to…
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Genprex Inc. Receives Chinese Patent Protection for Reqorsa Immunogene Therapy
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Texas-based gene therapy company Genprex Inc., (NASDAQ: GNPX), has reported receiving a patent protection award in China for its lead pipeline candidate, Reqorsa (ONC-001/2) immunogene therapy. The China Intellectual Property Administration (CNIPA) has granted patent No: 201780076886.X, which covers the use of the therapy in combination with PD-1 antibodies, providing…
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Luye Pharma’s Goserelin Acetate Microspheres Approved by NMPA for Prostate Cancer Treatment
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Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its injectable goserelin acetate in microsphere form, a treatment for prostate cancer requiring androgen castration therapy. This innovative formulation is designed to provide a smoother drug release during the…
