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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…
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Abbisko Therapeutics’ EGFR Inhibitor ABSK112 Clears FDA for Global Phase I NSCLC Study
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Shanghai-based biotech firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a global Phase I clinical study for its next-generation EGFR inhibitor, ABSK112, in non-small cell lung cancer (NSCLC). This development highlights the company’s progress…
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Jacobio Pharma’s KRAS Inhibitor Glecirasib Advances to Pivotal Pancreatic Cancer Trial
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China-based Jacobio Pharma (HKG: 1167) has announced that it has received the green light from the National Medical Products Administration (NMPA) to initiate a pivotal clinical study for its novel KRAS G12C inhibitor, glecirasib, in pancreatic cancer. This development marks glecirasib as the world’s first KRAS inhibitor to reach the…
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Amoytop Biotech’s Pegfilgrastim (Y Shape) Approved for Marketing by NMPA
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Xiamen-based Amoytop Biotech Co. Ltd (SHA: 688278) has received marketing approval from the National Medical Products Administration (NMPA) for its pegfilgrastim (Y shape) product. This Category 1 biologic is designed for use in patients with non-myeloid malignant tumors to reduce the incidence of infection with febrile neutropenia during treatment with…
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Huadong Medicine’s Mirvetuximab Soravtansine Heads for Priority Review by China’s CDE
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The China’s Center for Drug Evaluation (CDE) website has indicated that Huadong Medicine Co., Ltd (SHE: 000963) is moving forward with a priority review for its mirvetuximab soravtansine, an antibody drug conjugate (ADC), for potential use in folate receptor α (FRα) positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or…
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Transcenta’s Osemitamab Combo Shows Promising PFS Data in Advanced GC/GEJ Cancer Study
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Transcenta Holding Ltd (HKG: 6628), a China-based biopharmaceutical company, has presented progression-free survival (PFS) data based on CLDN18.2 expression levels from a Phase I/II study of osemitamab (TST001) in combination with capecitabine and oxaliplatin (CAPOX) as a first-line treatment for advanced gastric/gastroesophageal junction (GC/GEJ) carcinoma at the ESMO World Congress…
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InnoCare Pharma and Keymed Biosciences Initiate Clinical Trial for ICP-B02 with First Subcutaneous Injection
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InnoCare Pharma (HKG: 9969; SHA: 688428) and Keymed Biosciences Inc., (HKG: 2162) have announced a significant milestone in their joint development of ICP-B02 (CM355), a bispecific antibody (BsAb) targeting CD20 and CD3. The first subcutaneous injection administration has been successfully administered to a Chinese patient, marking a new route of…
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Jiangsu Hengrui Medicine Gets NMPA Approval for HRS-4357 Clinical Study in Prostate Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 radiotherapeutic drug, HRS-4357. This novel molecule is under development for the treatment of prostate specific…
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Sinocelltech Group Receives NMPA Approval for Bevacizumab Biosimilar for Multiple Cancers
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its bevacizumab biosimilar. This biosimilar will be used to treat a range of cancers including metastatic colorectal cancer (CRC), recurrent glioblastoma, advanced metastatic or recurrent non-small cell lung…
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Huadong Medicine Receives NMPA Approval for DR30206 Clinical Study in Advanced Solid Tumors
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its injectable DR30206, a Category 1 biologic product, in the treatment of advanced solid tumors. DR30206: A Promising Antibody Fusion Protein Targeting PD-L1,…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for Phase III Studies of Gallium Edotreotide Injection
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with Phase III clinical studies for its gallium [68Ga] edotreotide injection and gallium [68Ga] edotreotide injection preparation kit. Gallium [68Ga]…
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Jacobio Pharma Reports Promising Clinical Results for KRAS G12C Inhibitor Gecirasib in CRC
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China-based Jacobio Pharma (HKG: 1167) has announced clinical results for its novel KRAS G12C inhibitor, glecirasib, in the treatment of KRAS G12C mutant advanced colorectal cancer (CRC). The findings were presented at the Second JCA-AACR Precision Medicine International Conference, showcasing the potential of glecirasib as both a monotherapy and in…
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Qilu Pharmaceutical’s Iruplinalkib Receives NMPA Approval for ALK+ NSCLC Treatment
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China-based Qilu Pharmaceutical has announced that its Category 1 chemical drug, iruplinalkib, an ALK inhibitor, has obtained marketing approval from the National Medical Products Administration (NMPA). This approval allows the use of iruplinalkib to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that harbor anaplastic lymphoma…
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Shanghai Junshi Biosciences Gets FDA Approval for Phase III Study of Tifcemalimab in Small-Cell Lung Cancer
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877) has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a randomized, double-blind, placebo-controlled, global multi-center Phase III study for its drug tifcemalimab (TAB004/JS004) in combination with Tuoyi (toripalimab). This consolidation therapy is intended for patients with limited-stage small-cell…
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Shandong Buchang Pharmaceuticals’ BC001 Gets Clinical Trial Approval for Solid Tumors
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Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a China-based pharmaceutical company, has announced receiving clinical trial approval for its investigational injectable product BC001. The drug is intended for use in combination with pucotenlimab for the treatment of advanced solid tumors, including first-line HER-2 negative advanced or metastatic gastric cancer/adenocarcinoma at…
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Grand Pharmaceutical Initiates Phase I Study for TLX250-CDx in Renal Mass Imaging
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the first patient dosing in the Phase I clinical study for its TLX250-CDx (89Zr-DFO-girentuximab), an imaging agent licensed from Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) in a deal valued at up to USD 225 million in 2020. Phase I Study Design…
