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Luye Pharma’s LY03020 Receives NMPA Approval for Schizophrenia and Alzheimer’s Psychosis Treatment
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Luye Pharma Group (HKG: 2186), a China-based pharmaceutical company, has announced that it has received clinical approval from the National Medical Products Administration (NMPA) for its Category 1 drug candidate LY03020, intended for the treatment of schizophrenia and Alzheimer’s disease psychosis (ADP). LY03020 is developed using Luye’s innovative New Molecular…
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Degen Biopharmaceutical’s DG01 PROTAC Drug Receives NMPA Clearance for Solid Tumor Studies
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Suzhou Degen Biopharmaceutical Co., Ltd, a leading specialist in PROteolysis TArgeting Chimeras (PROTAC) technology in China, has announced that its oral dual-targeted PROTAC drug, DG01, has been granted approval by the National Medical Products Administration (NMPA) to proceed with clinical studies for advanced or metastatic castration-resistant prostate cancer and liver…
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Yantai Dongcheng Pharmaceutical Secures NMPA Nod for PSMA-Targeted Radiotherapeutic Drug
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug, 177LuLNC1011. This novel therapeutic is a prostate specific membrane antigen (PSMA)-targeted radioactive in vivo treatment…
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Innovent Biologics and Sanegene Bio Commence Phase I Clinical Trial for Hypertension siRNA Drug
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, in collaboration with Sanegene Bio USA Inc., has announced the dosing of the first patient in a Phase I First-in-Human (FIH) clinical trial for their siRNA drug candidate, IBI3016. This investigational therapy targets angiotensinogen (AGT) and is being…
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Akeso Biopharma Initiates Phase II Global Study for Ligafulimab in High-Risk MDS
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China-based Akeso Biopharma (HKG: 9926) has reached a clinical milestone with the dosing of the first patient in a Phase II study for its investigational drug ligufalimab (AK117) in the United States. The study is a randomized, placebo-controlled, global multi-center trial that combines ligufalimab with azacitidine for the treatment of…
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Lee’s Pharmaceutical Commences Phase I Clinical Trial for AI-Discovered HCC Drug AU409
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a leading biopharmaceutical company based in China, has announced the first dosing in a Phase I clinical study for AU409, an oral small molecule drug. The drug was discovered by Auransa Inc. using the AI platform SMarTR Engine and will be manufactured by Lee’s…
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Tonghua Dongbao Pharmaceuticals Launches Phase III Clinical Trial for Semaglutide Biosimilar in China
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Tonghua Dongbao Pharmaceuticals (SHA: 600867), a Chinese pharmaceutical company, has announced the commencement of a Phase III clinical study for its drug candidate THDB0225, a biosimilar to Novo Nordisk’s semaglutide and Ozempic, used for the treatment of type 2 diabetes patients with inadequate glycemic control following metformin therapy. The multi-center,…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for SHR-A1921 Clinical Study in Advanced Solid Tumors
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its innovative antibody drug conjugate (ADC), SHR-A1921. The study will evaluate the efficacy and safety of SHR-A1921…
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Sinqi Pharmaceutical Gets NMPA Green Light for SQ-22031 Eye Drops to Treat Dry Eye Syndrome and Neurotrophic Keratitis
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Shenyang Sinqi Pharmaceutical Co., Ltd (SHE: 300573), a pharmaceutical company based in China, has received clinical trial approval from the National Medical Products Administration (NMPA) for its therapeutic biologic, SQ-22031 eye drops. This Category 1 therapeutic biologic is intended for the treatment of dry eye syndrome and neurotrophic keratitis, with…
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China’s NMPA Gives Tacit Nod to IASO Biotechnology’s IASO-782 for SLE Clinical Trials
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IASO Biotherapeutics, a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has granted tacit approval for its Investigational New Drug (IND) application for IASO-782. The company’s injectable drug candidate is slated for clinical trials in China to evaluate its efficacy in treating systemic lupus…
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Luye Pharma’s Subsidiary Gets NMPA Go-Ahead for First CD228-Targeted ADC BA1302
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Shandong Boan Biotechnology Co., Ltd (HKG: 6955), a subsidiary of China-based Luye Pharma Group (HKG: 2186), has received approval from the National Medical Products Administration (NMPA) to commence a Phase I clinical trial for its proprietary antibody-drug conjugate (ADC), BA1302. The trial, which is multi-center, open-label, and involves multiple dosages…
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Hainan Poly Pharm’s Novel Nanomedicine PLAT001 Cleared for Clinical Trial by NMPA
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug candidate, PLAT001. This novel injectable drug is under evaluation for the treatment of general advanced or metastatic solid tumors.…
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Hinova Pharmaceuticals Receives NMPA Approval to Test Myelofibrosis Drug Candidate HP560
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Hinova Pharmaceuticals Inc. (SHA: 688302), a biopharmaceutical company based in Chengdu, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 chemical drug candidate, HP560. The molecule is being evaluated as a potential treatment for myelofibrosis,…
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IASO Biotherapeutics’ CAR-T Therapy Fucaso Receives FDA IND Approval for Multiple Sclerosis
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China-based IASO Biotherapeutics has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) to explore the potential of its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Fucaso (equecabtagene autoleucel), in treating multiple sclerosis (MS). This marks the second IND nod…
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ST Phi Therapeutics’ Universal Cell Therapy for Solid Tumors Gets Green Light for Clinical Trial in China
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ST Phi Therapeutics, a Hangzhou-based cell therapy specialist, has secured tacit approval from China’s National Medical Products Administration (NMPA) to initiate a clinical trial for its innovative cell therapy, CNK-UT002. This marks a significant milestone, as CNK-UT002 is the first universal cell therapy for solid tumors to be approved for…
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Innorna’s Herpes Zoster mRNA Vaccine IN001 Receives Clinical Trial Approval in China
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Shenzhen-based Innorna Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to commence clinical trials for its proprietary IN001, a novel mRNA vaccine designed to combat herpes zoster. This marks a significant milestone for the company, as IN001 is the first mRNA-based herpes…
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Bayer’s BAY 3375968 Receives NMPA Approval for Clinical Trial in Advanced Solid Tumors
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Bayer AG (ETR: BAYN), a multinational pharmaceutical giant based in Germany, has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its Category 1 drug BAY 3375968. This novel Fc optimized anti-CCR8 antibody is currently the subject of a Phase I clinical study globally. BAY 3375968 has…
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Chipscreen’s HDAC Inhibitor Chidamide to be Tested in Combination Therapy for CRC by NMPA
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Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical trial. The trial is designed to evaluate the efficacy and safety of Epidaza (chidamide) in combination with the PD-1 inhibitor sintilimab…
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RemeGen’s Telitacicept Earns Full NMPA Approval for RA Treatment and PMN Clinical Study Green Light
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RemeGen (HKG: 9995), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has granted full approval for its drug telitacicept, which is used in combination with methotrexate for the treatment of moderate to severe rheumatoid arthritis (RA) patients who have not responded well to…
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AccurEdit Therapeutics Receives CDE Approval for Gene Editing Drug ART001 Targeting Amyloidosis
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AccurEdit Therapeutics (Suzhou) Co., Ltd, a leading specialist in gene editing therapies based in China, has received approval from the Center for Drug Evaluation (CDE) for its investigational drug ART001. This drug is designed to target transthyroxine protein amyloidosis, a severe genetic disorder. ART001 marks a significant advancement in China’s…
