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Shandong Buchang Pharmaceuticals Gets NMPA Greenlight for Phase I Study of BC001 in Solid Tumors
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Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a Chinese pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I study for its investigational biologic product BC001. The study will assess the safety, tolerability, efficacy, and pharmacokinetics of BC001, a…
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Haisco Pharmaceutical Gets NMPA Greenlight for HSK39775 Solid Tumor Drug Candidate
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), 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 HSK39775, intended for the treatment of advanced solid tumors. Preclinical study results have demonstrated HSK39775’s potential efficacy across…
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Everest Medicines Gets CDE Approval for Global Phase IIb Study of Zetomipzomib in Lupus Nephritis
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that it has received approval from the Center for Drug Evaluation (CDE) to proceed with the global, placebo-controlled Phase IIb PALIZADE study. The study aims to assess the efficacy and safety of zetomipzomib in patients with active lupus nephritis (LN).…
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Kelun-Biotech Launches Clinical Trials for SKB264, Triggering $75 Million Milestone Payment from MSD
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) has announced the initiation of clinical trials for SKB264 (MK-2870), an antibody-drug conjugate (ADC) co-developed with Merck, Sharp & Dohme (MSD, NYSE: MRK) for the treatment of non-small cell lung cancer (NSCLC) and endometrial carcinoma (EC). This development triggers a clinical milestone payment…
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AstraZeneca Launches Phase I Trial for siRNA Therapy in Collaboration with Silence Therapeutics
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AstraZeneca (AZ; NASDAQ: AZN) has commenced a Phase I trial for a short interfering RNA (siRNA) therapy targeting an undisclosed disease, marking the first clinical candidate to emerge from its 2020 collaboration with UK-based Silence Therapeutics (NASDAQ: SLN). This partnership aims to develop up to ten siRNA therapeutics across cardiovascular,…
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Jiangsu Hengrui Receives NMPA Approval for Adjuvant Therapy Clinical Study of Adebrelimab in NSCLC
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its PD-L1 monoclonal antibody (mAb) adebrelimab (SHR-1316) in combination with chemotherapy as adjuvant therapy for patients with resectable stage II or III…
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Livzon Pharmaceutical Gets CDE Green Light for JP-1366 Reflux Esophagitis Clinical Study
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Livzon Pharmaceutical Group Inc. (HKG: 1513), a leading Chinese pharmaceutical company, has announced that its drug candidate JP-1366 has received clearance from the Center for Drug Evaluation (CDE) to proceed with clinical studies for reflux esophagitis. JP-1366, also known as zastaprazan, is a potassium-competitive acid-blocking (P-CAB) class drug originally developed…
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Hinova Pharmaceuticals’ HP537 Receives CDE Approval for Clinical Study in Hematologic Malignancies
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Hinova Pharmaceuticals Inc. (SHA: 688302), a biotech company based in Chengdu, has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for its Category 1 chemical drug HP537, targeting hematologic malignancies. This development marks a significant step for Hinova Pharmaceuticals as…
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Zhongsheng Pharmaceutical Initiates Phase II Trials for Polypeptide Drug RAY1225 in Diabetes and Obesity
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Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a Chinese pharmaceutical company, has announced the initiation of two Phase II clinical studies, SHINING and REBUILDING, for its Category 1 innovative polypeptide drug candidate RAY1225. These studies aim to assess the efficacy of RAY1225 as a treatment for type 2 diabetes and…
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Bayer Advances BAY3018250 into Phase II Trial Following Successful Phase I Completion
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Germany’s Bayer (ETR: BAYN) has launched a double-blind, placebo-controlled mid-stage trial for its potential first-in-class anti-alpha2 antiplasmin (anti-α2ap) drug, BAY3018250, aimed at treating symptomatic proximal deep vein thrombosis (DVT). This advancement comes on the heels of a successful Phase I study. The investigational antibody works by modulating the breakdown of…
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Mabwell Bioscience Receives FDA Green Light for B7-H3 Targeting ADC 7MW3711
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its antibody drug conjugate (ADC) 7MW3711, which targets B7-H3. The molecule is intended to be assessed…
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Jacobio Pharma Gets CDE Green Light for Phase III Study Combining Gleevec Inhibitors in NSCLC
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Jacobio Pharma (HKG: 1167), a China-based pharmaceutical company, has announced that it has received approval from the Center for Drug Evaluation (CDE) in China to initiate a regulatory Phase III clinical study. The study will assess the combination of its KRAS G12C inhibitor glecirasib with pipeline SHP2 inhibitor JAB-3312 for…
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Phanes Therapeutics’ PT886 Receives CDE Approval for Clinical Trials in Advanced Solid Tumors
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Sino-US biotechnology company Phanes Therapeutics Inc. has announced that it has received clinical trial approval from China’s Center for Drug Evaluation (CDE) for its first-in-class claudin 18.2/CD47 bispecific antibody (BsAb) PT886, intended for the treatment of advanced solid tumors including gastric cancer, gastroesophageal junction cancer, and pancreatic cancer. PT886, a…
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ImmunoTech Biopharm Gets NMPA Green Light for Clinical Study of aT19 Injection for B-ALL
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ImmunoTech Biopharm Ltd (HKG: 6978), a specialist in chimeric antigen receptor T-cell (CAR-T) therapies based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its aT19 injection. The treatment is designed as a sequential therapy for patients…
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CMS Secures NMPA Approval for Clinical Trials of TYK2 Inhibitor CMS-D001 and GnRH Antagonist CMS-D002
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China Medical System Holdings Ltd (CMS, HKG: 0867) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for two of its drug candidates: CMS-D001 and CMS-D002. CMS-D001 is a highly selective TYK2 (tyrosine kinase 2) inhibitor aimed at treating immune inflammatory diseases, including…
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Evopoint Biosciences Enrolls First Patient in Phase III Trial for Gout Drug XNW3009
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Suzhou-based Evopoint Biosciences Co., Ltd. has announced the enrollment of its first patient in a Phase III clinical study for XNW3009, a novel gout drug candidate designed to inhibit the human urate transporter 1 (URAT1) and address gout-related hyperuricemia. Founded in 2016, Sinovent operates across multiple locations, including Beijing, Shanghai,…
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ChinaGene Secures CDE Approval for ZVS101e Gene Therapy Targeting Retinitis Pigmentosa
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Beijing-based ChinaGene Technology Co., Ltd. has announced that it has received tacit clinical approval from the Center for Drug Evaluation (CDE) for its ophthalmic gene therapy ZVS101e, designed to treat retinitis pigmentosa (RP) patients with the RHO-R135W (RHO c.403C>T) mutation. This follows a tacit trial approval granted in the United…
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Jiangsu Hengrui Receives NMPA Approval for Phase II Study of GLP-1 Agonist for Weight Loss
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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 proceed with a Phase II clinical study for its small molecule GLP-1 receptor agonist, HRS-7535, for weight loss treatment. This development marks…
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Konruns Pharmaceutical Commences Phase III Clinical Trial for KC1036 in Esophageal Cancer
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Konruns Pharmaceutical Co., Ltd (SHA: 603590), a Beijing-based pharmaceutical company, has announced the first patient dosing in a Phase III clinical study for its drug candidate KC1036, which is aimed at treating patients with advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This marks a significant milestone in the…
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Joincare Pharmaceuticals Gets Green Light for Semaglutide Biosimilar Clinical Trial
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Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380), a Chinese pharmaceutical entity, has announced that it has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for its biosimilar version of Denmark’s major pharmaceutical company, Novo Nordisk’s semaglutide. Joincare is progressing with the development of this product candidate,…
