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US-based medical technology major Boston Scientific Corporation (NYSE: BSX) has announced the initiation of the real-world REPLACE study for its pulsed field ablation (PFA) system, FARAPULSE, in Chinese patients with paroxysmal atrial fibrillation (PAF). The study is being conducted at the Boao Lecheng Medical Tourism Pilot Zone of Hainan Province,…
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Shanghai Haihe Pharmaceutical Co., Ltd has announced the first patient dosing of a global multi-center Phase I clinical study for its in-house developed BET-BD2 inhibitor, HH3806, in Australia. This marks a significant milestone in the development of the drug, which targets the bromo and extra terminal (BET) binding domain 2…
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China-based vaccines specialist CanSino Biologics Inc. has announced the initiation and first subject enrollment of a Phase Ib clinical study for its in-house developed protein-based pneumococcal vaccine (PBPV). This marks a significant step forward in the development of a globally innovative vaccine. Innovation and AdvantagesCanSino’s PBPV represents the third generation…
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the first patient in (FPI) a clinical study for its SIM0237, a bispecific antibody (BsAb) targeting PD-L1 and IL-15 in advanced solid tumors. The global multi-center, open-label Phase I study is designed to assess the safety, efficacy, and pharmacokinetics/pharmacodynamics of the drug.…
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China-based Bio-Thera Solutions, Ltd (SHA: 688177) has announced the first patient dosing in a multi-center, open Phase I study to assess the safety, tolerability, and preliminary efficacy of BAT8008, an antibody-drug conjugate (ADC) targeting Trop2 in advanced solid tumors. The study will also help determine the recommended Phase II dosage.…
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced the first subject dosing in a clinical study for its B-cell lymphoma-2 (BCL2) inhibitor ICP-248. The study, approved in China in September last year, marks a significant step in the development of this novel therapy. Drug Profile and IndicationsICP-248 is a…
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the first patient in (FPI) a clinical study for its bispecific antibody (BsAb) SIM0237, targeting PD-L1 and IL-15 in advanced solid tumors. The global multi-center, open-label Phase I study is designed to assess the safety, efficacy, and pharmacokinetics/pharmacodynamics of the drug. The…
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China-based Bio-Thera Solutions, Ltd (SHA: 688177) has announced the first patient dosing in a multi-center, open Phase I study to assess the safety, tolerability, and preliminary efficacy of BAT8008, an antibody-drug conjugate (ADC) targeting Trop2 in advanced solid tumors. The study will also help determine the recommended Phase II dosage.…
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced the first subject dosing in a clinical study for its B-cell lymphoma-2 (BCL2) inhibitor, ICP-248. The study was approved in China in September last year. This marks a significant milestone in the development of the drug, which is designed to treat…
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China-based JW Therapeutics (HKG: 2126) has announced the initiation of a clinical study for its Carteyva (relmacabtagene autoleucel injection) in the treatment of first-line high-risk large B-cell lymphoma. A significant milestone was reached with the completion of reinfusion therapy for the first patient. Previous Study Outcomes and Current Trial DesignThe…
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China-based JW Therapeutics (HKG: 2126) has announced the initiation of a clinical study for its Carteyva (relmacabtagene autoleucel injection) in first-line high-risk large B-cell lymphoma. The first patient has already completed reinfusion therapy, marking a significant step in the study’s progress. Previous Study ResultsThe pivotal RELIANCE study previously demonstrated that…
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China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd has announced receiving approval from the China National Medical Products Administration (NMPA) to conduct an open-label Phase I dosage escalation study. The study will assess the safety, tolerability, and preliminary anti-tumor activity of YH008, an internally developed first-in-class PD-1 x CD40 bispecific antibody (BsAb)…
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for HB0025, an in-house developed bispecific antibody (BsAb) targeting programmed-death ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF). The BsAb will be assessed in combination…
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AffaMed Technologies, a joint venture between AffaMed Therapeutics and SIFI S.p.A., has announced the completion of the first patient implantation in the regulatory clinical trial for its MINI WELL progressive Extended Depth-of-Focus (EDOF) intraocular lens (IOL). The procedure was successfully conducted at the EYE & ENT Hospital of Fudan University…
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced the first patient dosing in a randomized, open, positive controlled, multi-center Phase III study. The study is designed to assess the efficacy and safety of its mitoxantrone hydrochloride liposome in patients with recurrent and metastatic nasopharyngeal carcinoma (NPC) when combined with…
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Chinese ophthalmology specialist OcuMension Therapeutics (HKG: 1477) has announced the initiation of a randomized, double-blind, placebo-controlled Phase II clinical study. The study is designed to assess the safety and efficacy of its Category 1 drug OT-202, a tyrosine kinase inhibitor (TKI) intended for the treatment of dry eyes. This marks…
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Shanghai-based Kinnjiu Biopharma Inc. has announced the first subject dosing in the global multi-center Phase I study ‘KN-8701’, focusing on its Category 1 drug exarafenib (KIN-2787) in the Chinese mainland. This milestone comes shortly after Kinnate Biopharma Inc. (Nasdaq: KNTE) acquired an ownership stake in Kinnjiu Bio, previously held by…
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced the first subject dosing in a Phase I clinical study assessing the safety and tolerability of intravitreal injection of IBI333. This recombinant anti-VEGF-A and anti-VEGF-C bispecific antibody (BsAb) was independently developed by Innovent and is being evaluated for the treatment of neovascular…
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced receiving tacit clinical trial approval from the US FDA for its Category 1.1 chemical drug HY3000 nasal spray targeting COVID-19. This approval marks a significant step forward in the development of novel treatments for the virus, offering a new approach to…
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New Jersey-based Accutar Biotechnology Inc., which is heavily backed by Chinese funds, has announced the first patient dosing in a Phase I trial for AC0176, an orally bioavailable chimeric degrader molecule targeting the androgen receptor protein. This marks a significant milestone in the development of innovative treatments for prostate cancer.…