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Zelgen Biopharmaceuticals’ ZG006 Earns NMPA Approval for Clinical Trials in Solid Tumors
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a China-based biopharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its pipeline candidate, ZG006. The molecule is set to enter trials targeting general advanced solid tumors. ZG006: A Pioneering Tri-Specific AntibodyZG006 is…
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Nanjing Leads Biolabs’ LBL-034 Secures Clinical Trial Approvals from NMPA and FDA
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Nanjing Leads Biolabs Co., Ltd, a China-based biopharmaceutical company, has announced receiving clinical trial approvals from both the National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb), LBL-034. The drug targets GPRC5D and CD3 and is intended to treat recurrent/refractory (r/r)…
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Huadong Medicine Receives NMPA Approval for Phase I Clinical Trial of DR10624 for Weight Management
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its Category 1 biologic preparation, DR10624, aimed at weight management for overweight or obese populations. DR10624: A Novel Agonist for Weight…
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Jiangsu Simcere Pharmaceutical Receives NMPA Approval for Atopic Dermatitis Drug SIM0278
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China’s Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate SIM0278, which is intended to treat moderate to severe atopic dermatitis (AD). This development marks a significant step forward in addressing the…
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CanSino Biotechnology Receives NMPA Approval for Tetanus Vaccine CS-2047
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China-based vaccines specialist CanSino Biotechnology Inc., (HKG: 6185) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its adsorbed tetanus vaccine, CS-2047, aimed at preventing tetanus in adults. Emphasis on Tetanus Prevention in Adult ImmunizationThe National Health Commission (NHC) has previously released…
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BRL Medicine Inc. Receives IND Approval for CD19-Targeted CAR-T Therapy BRL-301 from CDE
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Shanghai-based BRL Medicine Inc. has announced that it has received Investigational New Drug (IND) approval from China’s Center for Drug Evaluation (CDE) for its CD19-targeted chimeric antigen receptor (CAR)-T cell therapy, BRL-301. The therapy is set to be assessed as a treatment for acute lymphocytic leukemia (ALL). BRL-301: A Universal…
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AstraZeneca’s Eplontersen Gains Tacit Approval from CDE for ATTR-CM Clinical Study
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The Center for Drug Evaluation (CDE) website indicates that UK pharmaceutical major AstraZeneca’s (AZ, NASDAQ: AZN) injectable eplontersen has been tacitly approved for clinical study in hereditary and wild-type transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), aiming to reduce cardiovascular mortality and cardiovascular-related hospitalizations. Eplontersen: An Antisense Oligonucleotide Therapy for ATTR-CMEplontersen, an antisense…
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Boehringer Ingelheim Gets NMPA Approval for Phase II Study of BI 764532 in SCLC
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Boehringer Ingelheim (BI) has announced that it has received approval from the National Medical Products Administration (NMPA) in China to conduct an open, multi-center Phase II dose-setting study. The study will assess the efficacy and safety of BI 764532 in patients with recurrent/refractory extensive-stage small cell lung cancer (ES-SCLC) and…
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HanchorBio’s HCB101 Receives WFDA Approval for Multi-Region Clinical Study
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Taiwan-based HanchorBio has announced that it has received approval from the Taiwan Food and Drug Administration (WFDA) to conduct a multi-region, multi-center clinical study for its innovative fusion protein, HCB101. HCB101: A Promising Fusion Protein for Cancer TreatmentHCB101 is an engineered SIRP linked to IgG4-Fc α fusion proteins that can…
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InnoCare Pharma’s ICP-723 Receives NMPA Approval for Pediatric Clinical Study
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Beijing InnoCare Pharma (HKG: 9969), a China-based biotech company specializing in cancer and autoimmune diseases, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its second-generation pan-TRK inhibitor, ICP-723, in pediatric patients aged 2 to 12 years. This follows…
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Jiangsu Hengrui Pharmaceuticals and Hansoh Pharmaceutical Group Get NMPA Approval for Solid Tumor Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for a combination therapy involving its adebrelimab (SHR-1316) with Hansoh Pharmaceutical Group Co., Ltd’s (HKG: 3692) Ameile (almonertinib) or SHR-A2009, with or without chemotherapy, for the treatment…
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CanSino Biologics Granted Approval by Health Canada for Zoster Vaccine Candidate CS-2032
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China-based vaccines specialist CanSino Biologics Inc., (HKG: 6185) has announced receiving approval from Health Canada to conduct a Phase I clinical study assessing the safety and preliminary immunogenicity of CS-2032, a recombinant vaccine candidate for the zoster virus. This adenovirus vector-based vaccine is co-developed with UK firm Vaccitech Ltd under…
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Jiangsu Simcere Pharmaceutical Gets NMPA Approval for Quviviq, Anti-Insomnia Drug
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced the receipt of clinical trial approval from the National Medical Products Administration (NMPA) for its anti-insomnia drug, Quviviq (daridorexant), co-developed with Swiss firm Idorsia Pharmaceuticals Ltd. The dual orexin receptor antagonist (DORA) is now cleared for testing in the treatment of…
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Merck and Telix Pharmaceuticals Initiate Phase I Study for CAIX-Expressing Tumors Therapy
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A Phase I study assessing the combination of German-major Merck’s (NYSE: MRK) DNA-PK inhibitor, peposertib, and Australia-based Telix Pharmaceuticals’s (ASX: TLX) targeted radiation therapy, TLX250 (177Lu-DOTA-girentuximab), has enrolled its first participant. This open-label dose escalation and dose expansion trial is designed to evaluate the safety profile, dosing, and activity of…
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Chongqing Zhifei Biological Launches Phase I Clinical Trial for Group B Meningococcal Vaccine
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Chongqing Zhifei Biological Co., Ltd (SHE: 300122) has announced the commencement of a Phase I clinical study for its recombinant Group B meningococcal vaccine (Escherichia coli), marking a significant step in assessing the vaccine’s safety, tolerability, and preliminary immunogenicity. This product is the first of its kind to enter clinical…
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Kintor Pharmaceutical Initiates Long-Term Safety Trial for Androgenetic Alopecia Treatment KX-826
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced the start of the long-term safety trial for KX-826, a potential first-in-class androgen receptor (AR) antagonist for the treatment of androgenetic alopecia (AGA). This in-house developed treatment has completed its first patient enrollment in China. Phase III Clinical Trial Design and ObjectivesThe…
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Antengene Initiates Phase I ERASER Study for ATG-017 in Combination with Nivolumab
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China-based biopharmaceutical company Antengene Corp., Ltd (HKG: 6996) has announced the first patient dosing in its Phase I ERASER study. The study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ATG-017 in combination with nivolumab for the treatment of advanced solid tumors. The trial is conducted…
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Mabwell Bioscience’s 7MW3711 ADC for B7-H3 Gets Clinical Trial Approval in China
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced receiving clinical trial approval in China for its antibody drug conjugate (ADC), 7MW3711, which targets B7-H3. This ADC is set to be assessed as a potential treatment for advanced solid tumors. B7-H3’s Role in Cancer and 7MW3711’s…
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Shenzhen Salubris Pharmaceuticals Receives FDA Clearance for SAL0119 Clinical Trial
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Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294), a Chinese pharmaceutical company, has announced that it has received clinical clearance from the US Food and Drug Administration (FDA) for its small molecule pipeline candidate, SAL0119. The upcoming trial will evaluate SAL0119 as a potential treatment for rheumatoid arthritis, ankylosing spondylitis (AS),…
