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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 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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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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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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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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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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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 (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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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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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 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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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 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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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 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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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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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 (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 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),…