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CStone Pharmaceuticals’ CS5001 Enters Phase Ib Trial for Diffuse Large B-Cell Lymphoma
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China-based CStone Pharmaceuticals (HKG: 2616) has announced a Phase Ib clinical filing in Australia for its ROR1-targeted antibody-drug conjugate (ADC), CS5001, in combination with first-line standard-of-care (SoC) for diffuse large B-cell lymphoma (DLBCL). The move underscores the company’s commitment to expanding the therapeutic potential of CS5001 across hematologic and solid…
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AIM Vaccine Leverages DeepSeek AI to Optimize mRNA Shingles Vaccine Design
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has filed its mRNA-based shingles vaccine with the U.S. Food and Drug Administration (FDA), marking a milestone for the company’s entry into the global vaccine market. The submission follows promising preclinical data and positions AIM as a pioneer in mRNA shingles vaccine development,…
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CStone Pharmaceuticals Initiates First-in-Human Trial for PD-1/VEGF/CTLA-4 Trispecific Antibody CS2009
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China-based CStone Pharmaceuticals (HKG: 2616) has announced the clinical filing for its CS2009, a PD-1/VEGF/CTLA-4 trispecific antibody, in Australia. This first-in-human study is registered and published on Clinicaltrials.gov with the NCT number: NCT06741644. Innovative Design and Mechanism of CS2009CS2009 boasts an innovative molecular design that simultaneously targets PD-1, VEGFA, and…
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Ascentage Pharma Submits Application for Lisaftoclax, a Novel Oral Bcl-2 Inhibitor
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Ascentage Pharma (HKG: 6855) has announced that its proprietary oral Bcl-2 selective inhibitor, Lisaftoclax (APG-2575), has submitted its market application, which has been officially accepted by regulatory authorities. The formulation is being produced in collaboration with Xuantai Pharmaceutical. This innovative treatment targets patients suffering from refractory or relapsed chronic lymphocytic…
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Bliss Bio Secures NMPA Approval for BB-1712, Pioneering ADC Therapy
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Bliss Bio announced that its Investigational New Drug (IND) application for the innovative antibody-drug conjugate (ADC) BB-1712 has been approved by the National Medical Products Administration (NMPA) of China. BB-1712, a B7-H3 targeted ADC utilizing Eribulin as its cytotoxic agent, has been developed for the treatment of multiple solid tumors,…
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Betta Pharmaceuticals’ MCLA129 for Advanced Solid Tumors Accepted for Review by China’s NMPA
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its clinical filing for MCLA129, a Category 1 biologic product intended for the treatment of advanced solid tumors. The potential indications for MCLA129 include, but…
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Kelun-Biotech’s ADC for Cancer Gets NMPA Review, Expands MSD Collaboration
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has achieved a regulatory milestone with its clinical trial application for SKB571, an innovative antibody-drug conjugate (ADC), being accepted for review by China’s National Medical Products Administration (NMPA). SKB571 is designed to target a spectrum of cancers, including those of the lung and…
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China’s NMPA Approves Pilot Plan to Streamline Clinical Trial Reviews for Innovative Drugs
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In a meeting chaired by Party Secretary and Director of the National Medical Products Administration (NMPA) Li Li on July 30, 2024, the “Pilot Work Plan for Optimizing Clinical Trial Review and Approval of Innovative Drugs” was given the green light. The initiative aims to enhance the quality and efficiency…
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Sichuan Huiyu’s HY07121 Antifungal Protein Earns NMPA Review for Clinical Trials
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Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a Chinese biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted its clinical trial filing for HY07121, an innovative antibody fusion protein targeting PD-1, TIGIT, and IL-15 for the treatment of advanced solid tumors. The drug candidate, classified as…
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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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Medigene AG Secures Chinese Patent for TCR-T Therapy Targeting NY-ESO-1 and LAGE 1a
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Medigene AG (ETR: MDG1), a biopharmaceutical company based in Germany, has announced that it has been granted patent protection in China for its T cell receptor (TCR) technology targeting NY-ESO-1 and LAGE 1a. This development pertains to the company’s lead pipeline candidate, MDG1015, which is a first-in-class, third-generation TCR-T therapy.…
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AIM Vaccine Submits Pre-IND Applications for mRNA Vaccines Targeting RSV and Herpes Zoster to NMPA
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AIM Vaccine Co., Ltd (HKG: 6660), a biopharmaceutical company based in China, has announced the submission of pre-Investigational New Drug (pre-IND) filings to China’s National Medical Products Administration (NMPA) for two of its mRNA vaccine candidates. These candidates target the respiratory syncytial virus (RSV) and herpes zoster, respectively. RSV infection…
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Mabwell’s 9MW2821 ADC for Triple Negative Breast Cancer Accepted for Review by NMPA
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review a clinical trial filing for its pipeline candidate, 9MW2821. This antibody drug conjugate (ADC) targets Nectin-4 and is planned to be assessed in combination…
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InnoCare Pharma Receives IND Approval in China for BCL2 Inhibitor Combo Therapy
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InnoCare Pharma (HKG: 9969; SHA: 688428), a Beijing-based biotech company, has announced that it has received approval for an Investigational New Drug (IND) clinical trial filing in China. The company is set to initiate a clinical trial for its pipeline B-cell lymphoma-2 (BCL2) inhibitor, ICP-248, in combination with its Bruton’s…
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Sino-US Laekna’s LAE102 Clinical Trial Filing Accepted for Review in Obesity and Metabolic Disorders
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Sino-US Laekna (HKG: 2105) has announced that its clinical trial application for LAE102, an antibody targeting adult obesity and metabolic disorders, has been accepted for review by the Center for Drug Evaluation (CDE). LAE102 is a potent and selective monoclonal antibody against ActRIIA, known for its regulatory roles in tumor…
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Phanes Therapeutics’ First-in-Class BsAb PT217 Accepted for Review by China’s CDE
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Sino-US biotechnology company Phanes Therapeutics Inc. has announced that the Investigational New Drug (IND) filing for its potential first-in-class in-house bispecific antibody (BsAb) PT217 has been accepted for review by China’s Center for Drug Evaluation (CDE). PT217 is designed to directly kill tumor cells through the antibody-dependent cellular phagocytosis (ADCP)…
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Everest Medicines Secures IND Review for Zetomipzomib in China
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Everest Medicines (HKG: 1952) has announced that its Investigational New Drug (IND) application for zetomipzomib has been accepted for review by China’s National Medical Products Administration (NMPA). Zetomipzomib is a first-in-class selective immunoproteasome inhibitor currently under development for a variety of autoimmune diseases, including lupus nephritis and systemic lupus erythematosus…
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Acotec Secures FDA IDE Approval for AcoArt Litos Paclitaxel-Coated Balloon Catheter
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Acotec Scientific Holdings Ltd (HKG: 6669), based in China, has received Investigational Device Exemption (IDE) approval from the U.S. FDA for its AcoArt Litos paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter. This IDE approval enables Acotec to commence clinical trials for the device, pending Institutional Review Board (IRB) clearance. The…
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SinoMab BioScience’s Suciraslimab IND Accepted for Review by China’s NMPA
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SinoMab BioScience Ltd (HKG: 3681), a Hong Kong-based biotechnology company, has announced that the National Medical Products Administration (NMPA) in China has accepted its Investigational New Drug (IND) filing for suciraslimab for review. The company anticipates initiating a Phase I clinical study for the drug in the treatment of early…
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Sirius Therapeutics Pursues First-in-Human Trial for SRSD107 in Australia
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Sino-US biotech Sirius Therapeutics has announced its pursuit of Investigational New Drug (IND) approval in Australia to conduct a first-in-human clinical trial for its pipeline candidate, SRSD107. This next-generation small interfering RNA (siRNA) therapeutic is under development for the treatment of thromboembolic disorders and targets coagulation factor XI (FXI). Notably,…
