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Anhui Anke Biotechnology Receives NMPA Clearance for Clinical Trial of mRNA Drug AFN0328 for HPV-Related Cancers
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Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009), a biopharmaceutical company based in China, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its drug candidate AFN0328. The drug is intended for the treatment of malignant tumors associated with HPV16/18 infection, including cervical…
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Roche’s Genentech Terminates Relay Therapeutics Collaboration for SHP2 Inhibitor
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In a recent development, Roche Inc.’s subsidiary Genentech has given notice of termination for a license and collaboration agreement with Relay Therapeutics Inc., affecting the development of an oral small-molecule Src homology region 2 domain-containing phosphatase-2 (SHP2) inhibitor, RLY-1971, now known as migoprotafib or GDC-1971 . The termination, effective 180…
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Sino Biopharmaceutical’s Anlotinib Achieves Milestones in Phase III Trial for Soft-Tissue Sarcoma
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading pharmaceutical company based in China, has announced positive interim data from a Phase III clinical study for its drug anlotinib. The study combines anlotinib with chemotherapy as a first-line treatment for advanced unresectable or metastatic soft-tissue sarcoma. The Independent Data Monitoring Committee (IDMC)…
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Full-Life Technologies Strikes USD 571.5 Million Licensing Deal with SK Biopharmaceuticals for Radiopharmaceutical Asset
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Full-Life Technologies Ltd, a globally integrated radiotherapeutics company with a presence in Belgium, Germany, and China, has entered into a lucrative licensing agreement with South Korea-based SK Biopharmaceuticals, granting the latter exclusive global rights to develop, manufacture, and commercialize the radiopharmaceutical FL-091. The deal is valued at USD 571.5 million…
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MGI Tech Partners with Predica Diagnostics to Advance RNA Sequencing in Cancer Detection
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MGI Tech Co., Ltd, a leading gene sequencing specialist based in China, has announced a strategic collaboration with Predica Diagnostics, a Netherlands-based company. Under this partnership, MGI will provide support to Predica in the development of targeted RNA sequencing tests utilizing MGI’s next-generation sequencing platforms. While the financial details of…
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BeiGene Receives NMPA Greenlight for BG-C9074 Clinical Trial in Advanced Solid Tumors
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the National Medical Products Administration (NMPA) in China has approved its clinical filing for the Category 1 pipeline candidate BG-C9074. The antibody drug conjugate (ADC) is set to be initially assessed for the treatment of general advanced solid tumors, marking…
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Celling Biotechnology’s CEL001 Earns Tacit Approval for Clinical Trials in China
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Celling Biotechnology Co., Ltd, a Guangzhou-based biopharmaceutical company, has announced that its pipeline candidate CEL001 has received tacit clinical trial approval in China. The drug candidate is an antibody fusion protein targeting PD-1, TIGIT, and IL-15, and is intended for the treatment of advanced solid tumors, with a particular focus…
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Shenzhen Tyercan Bio-Pharma’s TYE1001 Earns Tacit IND Approval from FDA for Advanced Solid Tumors
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Shenzhen Tyercan Bio-pharm Co., Ltd, a biopharmaceutical company based in China, has announced that it has received tacit Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its anti-tumor drug TYE1001. The drug is intended for the treatment of advanced solid tumors and lymphomas. TYE1001…
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Eisai’s Next-Gen SERD, Orserdu, Begins Real-World Study in Shanghai Ruijin Hospital’s Hainan Subsidiary
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Shanghai Ruijin Hospital’s Hainan subsidiary has initiated a real-world study for Orserdu (elacestrant), a next-generation selective estrogen receptor degrader (SERD) originally developed by Eisai (TYO: 4523). The drug was transferred to Radius Health for global development back in 2006. In a strategic move in July 2020, the Menarini Group, based…
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Oricell Therapeutics’ GPRC5D-Targeted CAR-T Therapy Earns FDA Fast Track for Multiple Myeloma
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Oricell Therapeutics Co., Ltd, a leading biopharmaceutical company based in China, has announced that it has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its innovative therapy, OriCAR-017. This chimeric antigen receptor (CAR)-T cell therapy is targeted at GPRC5D, aiming to treat recurrent refractory multiple myeloma…
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Shanghai Escugen Initiates Phase III Clinical Trial for Breast Cancer Drug Candidate ESG401
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Shanghai Escugen, a biopharmaceutical company based in China, has announced the dosing of the first patient in a Phase III clinical study for its candidate drug ESG401. The study is assessing the efficacy of ESG401 in patients with hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-)…
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Ipsen Strikes Global Licensing Deal with Foreseen Biotechnology for First-in-Class ADC FS001
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Ipsen (EPA: IPN; OTCMKTS: IPSEY), a French biopharmaceutical company, has announced a global licensing agreement with Chinese startup Foreseen Biotechnology for the latter’s lead pipeline candidate, FS001. This agreement grants Ipsen exclusive rights to develop, manufacture, and commercialize the antibody-drug conjugate (ADC) on a global scale. As per the terms…
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Sichuan Biokin Pharmaceutical Gets NMPA Approval for BL-M14D1 Clinical Trial in Solid Tumors
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its antibody-drug conjugate (ADC), BL-M14D1, intended for the treatment of advanced solid tumors. BL-M14D1 leverages the same…
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Beijing Sun-Novo Gets NMPA Green Light for STC008 Clinical Trial in Tumor Cachexia
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Beijing Sun-Novo Pharmaceutical Research Co., Ltd (SHA: 688621), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its investigational drug candidate STC008. This study will focus on the treatment of tumor cachexia…
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KeChow Pharma’s Keluping, First NRAS Mutant Melanoma Therapy, Hits the Market
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Shanghai-based KeChow Pharma has announced the official market launch of its groundbreaking drug, Keluping (tunlametinib), the world’s first targeted therapy designed specifically for NRAS mutant melanoma. Tunlametinib, a novel ATP noncompetitive MEK inhibitor that targets NRAS mutations, received marketing approval in China in March this year. The drug was granted…
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Allist Pharmaceuticals Faces Arbitration Over Promotion Agreement for Furmonertinib
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Allist Pharmaceuticals Co., Ltd, a Shanghai-based biopharmaceutical company, has announced that it has received a notice of the initiation of arbitration from the Shanghai International Economic and Trade Arbitration Commission. The applicant in this matter is Shanghai Fosun Pharmaceutical Group Co., Ltd (SHA.600196; HKEX.02196), which is seeking the cancellation of…
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Amgen Halts Development of Claudin 6-Targeting BiTE Immune Therapy AMG 794
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Amgen Inc. (NASDAQ: AMGN), a leading biopharmaceutical company based in the U.S., has decided to halt the development of AMG 794, a half-life extended BiTE (bispecific T-cell engager) immune therapy that targets the oncofetal antigen Claudin 6 (CLDN6). This decision was disclosed on the clinicaltrials.gov website under the identifier NCT05317078,…
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Shanghai Junshi Biosciences’ HDAC Inhibitor JS125 Clinical Trial Application Accepted by NMPA
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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 a clinical trial filing for JS125 (WJ47156), a histone deacetylases (HDAC) inhibitor co-developed with Wigen Biomedicine Technology (Shanghai) Co., Ltd. This epigenetic regulator is intended for the treatment…
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GRIT Biotechnology and Quangang Pharmaceutical Co., Ltd Partner to Develop TIL and IL-2 Combination Therapy
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GRIT Biotechnology, a leading cell therapy specialist based in China, has entered into a strategic partnership with compatriot firm Quangang Pharmaceutical Co., Ltd. The collaboration aims to co-develop a combination therapy for solid tumors, leveraging tumor-infiltrating lymphocyte (TIL) therapy and recombination human interleukin-2 (IL-2). Interleukin-2 (IL-2) products, which are already…
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Shandong Buchang Pharmaceuticals Receives NMPA Approval for BC008-1A Biologic Product Clinical Trial
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Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 biologic product BC008-1A. This product is intended for the treatment of glioblastoma and advanced…
