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Sichuan Biokin’s Multi-Specific Antibody GNC-077 Gets NMPA Nod for Advanced Solid Tumor Clinical Trial
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to advance its drug candidate, GNC-077, into clinical trials for the treatment of advanced solid tumors. GNC-077 is a multi-specific antibody developed on…
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SciClone Pharmaceuticals Gets NMPA Approval for Phase III Study of First-in-Class SERD Orserdu
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SciClone Pharmaceuticals Inc. (HKG: 6600), a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III bridging study for its drug Orserdu (elacestrant), the world’s first selective estrogen receptor degrader (SERD) originally developed by Eisai. The Phase III study, which is randomized,…
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ApolloBio’s HPV Therapeutic Vaccine VGX-3100 Gets NMPA Green Light for Clinical Trial
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ApolloBio Corp., a joint stock company of China’s leading cephalosporin manufacturer Jincheng Pharmaceutical Group Co., Ltd. (SHE: 300233), has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for VGX-3100. This drug, hailed as the world’s first therapeutic vaccine for human papillomavirus (HPV), is…
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Jacobio Pharma’s Pan-KRAS Inhibitor JAB-23E73 Clears FDA Hurdle for Clinical Trials
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Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, has received the green light from the U.S. Food and Drug Administration (FDA) to commence a Phase I/IIa clinical study for its investigational new drug, JAB-23E73. This in-house developed pan-KRAS inhibitor has shown promise in simultaneously inhibiting both active and…
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Hybribio’s Chloroquine Phosphate Gel Cleared for Clinical Trial on High-Risk HPV Infections
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Hybribio Limited (SHE: 300639), a Guangdong-based pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its chloroquine phosphate gel, a patented pharmaceutical preparation in China. The gel, designed for topical administration, is intended to reduce systemic exposure and is formulated…
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Yantai Dongcheng Pharmaceutical’s 18F-LNC1007 Receives Clinical Clearance for Solid Tumor Diagnostics
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has received clinical trial approval from the National Medical Products Administration (NMPA) for its 18F-LNC1007 injection, a novel radioactive diagnostic drug. This drug is designed to target fibroblast activating protein (FAP) and integrin alpha-v beta-3, which are biomarkers…
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Beijing’s Apollobio Receives NMPA Approval for HPV Therapeutic Vaccine VGX-3100
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Beijing’s Apollobio, has announced that the National Medical Products Administration (NMPA) has granted market approval for its innovative therapeutic vaccine VGX-3100. This vaccine, which targets HPV-16/18 related anal precancerous lesions, is a significant advancement in the treatment landscape for conditions associated with Human Papillomavirus (HPV). The vaccine’s approval follows a…
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Ascletis Pharma Initiates Phase I Trials for Monthly Subcutaneous and Daily Oral Obesity Treatment ASC30 in the US
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Ascletis Pharma Inc. (HKG: 1672), a biopharmaceutical company based in China, has announced the dosing of the first batch of patients in two Phase I clinical studies for its investigational drug ASC30 in the United States. ASC30 is positioned as the world’s first and only small molecule glucagon-like peptide-1 receptor…
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Shanghai Pharmaceuticals’ Dual-Targeting CAR-T Therapy Advances with IND Re-Acceptance
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Shanghai Pharmaceuticals Group Co., Ltd. (SHA: 601607)’s biotech subsidiary has announced that its investigational ‘CD19 and CD22 targeting chimeric antigen receptor T cell injection’ has received renewed acceptance for its Investigational New Drug (IND) application by the relevant authorities. Known under the development code B019, this cellular therapy candidate has…
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Innovent Biologics Launches Phase I Clinical Trial for IBR822 Cell Injection Solution in Solid Tumors
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Innovent Biologics (Hangzhou) Co., Ltd (HKG: 1801, OTCMKTS: IVBXF), a biopharmaceutical company based in China, has announced the successful initiation of a Phase I clinical trial for its proprietary IBR822 cell injection solution at Zhejiang Cancer Hospital. The trial, led by Professor Song Zhengbo from Zhejiang Cancer Hospital, is conducted…
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Suzhou GenAssist Launches First-of-Its-Kind Base Editing Drug Trial for Duchenne Muscular Dystrophy
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Suzhou GenAssist Therapeutic Co., Ltd, a biopharmaceutical company based in China, has announced the commencement of an investigator-initiated-trial (ITT) for its base editing drug candidate, GEN6050X, in patients afflicted with Duchenne muscular dystrophy (DMD). DMD is a rare genetic disorder linked to the X-chromosome, typically caused by mutations in the…
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Nuance Pharma Completes Enrollment for Phase III COPD Trial of Ohtuvayre in China
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Nuance Pharma, a China-based pharmaceutical company, has announced the completion of patient enrollment for the Phase III ENHANCE-CHINA study (NCT05743075) for its drug Ohtuvayre (ensifentrine). This Phase III trial is a randomized, double-blind, placebo-controlled investigation assessing the efficacy and safety of Ohtuvayre over a 24-week period in adult patients diagnosed…
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Duality Biologics Initiates Global Clinical Trial for DB-1419 in Advanced Solid Tumors
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Duality Biologics, Inc., a biopharmaceutical company based in China, has reached a significant milestone with the dosing of the first patient in its Phase I/IIa clinical study for the in-house developed antibody drug conjugate (ADC) DB-1419. The study is aimed at evaluating the safety and efficacy of DB-1419 in patients…
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Vcanbio’s Stem Cell Therapy VUM02 Gets NMPA Approval for Systemic Sclerosis Clinical Trial
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Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645), a biotechnology company based in China, has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 therapeutic biologic product, VUM02. This product, derived from human umbilical cord mesenchymal stem cells, is designed…
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Akeso’s Ivonescimab Shows Promising Results in Phase III Clinical Trial for Hepatocellular Carcinoma
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Akeso Inc. (HKG: 9926), a biopharmaceutical company based in China, has announced that its first-in-class bispecific antibody, ivonescimab, in combination with lenvatinib and transcatheter arterial chemoembolization (TACE), has reached a significant milestone in its Phase III clinical trial for unresectable, non-metastatic hepatocellular carcinoma (HCC). The drug has demonstrated promising results…
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Sinocelltech’s Herpes Zoster Vaccine SCTV04C Clears NMPA for Clinical Trial
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Sinocelltech Group Ltd (SHA: 688520), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to commence clinical trials for SCTV04C, its proprietary recombinant herpes zoster vaccine. Herpes zoster, commonly known as shingles, is an infectious skin condition that results from the reactivation of…
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Jiangsu Kanion Pharmaceutical Gets NMPA Go-Ahead for Psoriasis Drug Clinical Trial
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Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557), a prominent pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to commence clinical studies for its investigational drug KYS202004A for the treatment of psoriasis. This Category 1 biologic is a novel, dual-targeted…
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Venus Medtech Initiates Global Study with Venus Vitae TAVR System Implantations
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Venus Medtech (Hangzhou) Inc., listed on the Hong Kong Stock Exchange as HKG: 2500, has reached a significant milestone with the implantation of its next-generation transcatheter aortic valve replacement (TAVR) system, Venus Vitae, in two patients as part of the global, multi-center pivotal SMART-ALIGN study. This prospective, randomized, interventional study…
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Hanx Biopharmaceuticals Receives NMPA Approval for HX009 Combination Therapy Phase II Trial
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On September 5, 2024, China-based Hanx Biopharmaceuticals Co., Ltd announced that it has received approval from the National Medical Products Administration (NMPA) for the Phase II clinical trial of its investigational drug HX009 in combination therapy for biliary tract cancer (BTC). The application met the relevant requirements for drug registration,…
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Humanwell Healthcare’s Innovative Drug for Solid Tumors Gets Green Light from NMPA
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Humanwell Healthcare (Group) Co., Ltd (SHA: 600079), a leading pharmaceutical entity in China, has received a significant boost with the clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug, HW071021. This novel drug, designed to combat advanced solid tumors, stands as a unique…
