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Novatim’s KQ-2003 and KY-0118 Advance with Clinical Trial Approvals in China
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China-based cancer immunotherapy specialist Novatim Immune Therapeutics (Zhejiang) Co., Ltd has recently obtained clinical trial clearances for two of its products in China. The products are KQ-2003, an autologous chimeric antigen receptor (CAR) T cell therapy for the fourth-line treatment of recurrent/refractory multiple myeloma, and KY-0118, a therapy aimed at…
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Hainan Huluwa Pharmaceutical Gets NMPA Approval for Generic Briviact Clinical Study
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China-based Hainan Huluwa Pharmaceutical Group Co., Ltd (SHA: 605199) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its generic version of UCB Pharma’s Briviact (brivaracetam). The Category III injectable is in development for use as an adjuvant treatment…
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Auzone Biological Technology Gets FDA Approval for Edaravone Oral Preparations in ALS
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Suzhou Auzone Biological Technology Co., Ltd. has received approval from the US Food and Drug Administration (FDA) to initiate a pivotal clinical study for its edaravone oral preparations in the treatment of amyotrophic lateral sclerosis (ALS). The Chinese company, which has a wholly owned subsidiary in Australia, is planning to…
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Grand Pharmaceutical Group Initiates Phase I Study for Sepsis Treatment APAD
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the enrollment and dosing of the first subject in a Phase I study for APAD, a small-molecule compound targeting sepsis with a novel mechanism of action. The study is a randomized, double-blind, dosage escalation, placebo-controlled trial designed to assess the safety,…
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Humanwell Healthcare Initiates Phase IIa Clinical Study for IPF Drug HW021199
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China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced the commencement of a Phase IIa clinical study for its Category 1 chemical drug, HW021199, in the treatment of idiopathic pulmonary fibrosis (IPF). The drug’s target has not been disclosed, other than to note that there is no market-approved product…
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CSPC Pharmaceutical Group Receives FDA Approval for NBL-028 Bispecific Antibody Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received the green light from the US FDA to conduct a clinical study for its bispecific antibody (BsAb), NBL-028, which targets CLDN6 and CD137. The initial focus of the study will be on advanced tumors with CLDN6 expression,…
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Inmagene Biopharmaceuticals Initiates Global Study for IMG-007 in Atopic Dermatitis
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China-based Inmagene Biopharmaceuticals has announced the first patient dosing in a global, multi-center, proof-of-concept study assessing the safety, pharmacokinetics, and efficacy of its pipeline candidate IMG-007. The molecule is being evaluated as a treatment for moderate-to-severe atopic dermatitis (AD), a condition that affects a significant patient population worldwide. IMG-007: An…
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SinoMab BioScience Receives NMPA Approval for Phase I Clinical Study of SM17 Asthma Therapy
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Hong Kong-based biotech company SinoMab BioScience Ltd (HKG: 3681) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study assessing the safety of SM17, a first-in-class asthma therapy, in the Chinese population. The study will also explore the clinical…
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CanSino BiologicsLaunches Phase III Trial for DTcP Vaccine in Infants and Young Children
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CanSino Biologics Inc. a leading China-based vaccines specialist (HKG: 6185), has announced the initiation of a Phase III clinical study for its DTcP vaccine, targeting infants and young children under 2 years old. This development is accompanied by the enrollment of the first subjects in the trial. Quality Consistency and…
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NMPA Greenlights Oricell Therapeutics’ OriCAR-017 for Clinical Trials in Multiple Myeloma
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The National Medical Products Administration (NMPA) has indicated on its website that Oricell Therapeutics Co., Ltd’s GPRC5D-targeted chimeric antigen receptor (CAR)-T cell therapy, OriCAR-017, has been granted approval for clinical trials. The therapy is intended for the treatment of recurrent refractory multiple myeloma (R/R MM). GPRC5D as a Therapeutic Target…
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Lee’s Pharmaceutical’s Subsidiary Completes Phase III Study for Myopia Treatment NVK002
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced the completion of the last patient visit in the one-year Phase III bridging study, Mini-CHAMP, for its NVK002—an atropine external use eye solution for myopia progression. Parallel Phase III Clinical Trials for NVK002In addition to…
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BioCity Biopharma Receives FDA IND Approval for CD3-EGFR BsAb BC3448
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China-based biotechnology company BioCity Biopharma has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its cluster of differentiation-3 (CD3) epidermal growth factor receptor (EGFR)-targeted bispecific antibody (BsAb), BC3448. With this approval, the company will now initiate a Phase I…
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Ascentage Pharma’s Lisaftoclax (APG-2575) Gets FDA Green Light for Phase III Study
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China-based Ascentage Pharma (HKG: 6855) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a regulatory Phase III clinical study for its novel Bcl-2 inhibitor, lisaftoclax (APG-2575). The study will evaluate the efficacy of lisaftoclax in combination with a Bruton’s tyrosine kinase…
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Venus Medtech Receives FDA IDE Approval for VenusP-Valve, a Milestone for Chinese Heart Valve Technology
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Venus Medtech (Hangzhou) Inc. (HKG: 2500) has announced obtaining Investigational Device Exemption (IDE) approval from the US FDA for its VenusP-Valve, marking a significant step as the first China-developed heart valvular system to be approved by the FDA for clinical trial. IDE approval is a critical exemption that allows medical…
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DaVinci Single Port System Launches in Hainan with Successful Surgeries
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The DaVinci Single Port robot-assisted surgical system technology has been successfully implemented in Boao, Hainan province, marking a significant milestone for minimally invasive surgery in the region. Physicians from Ruijin Hospital have successfully carried out two urology procedures and one nasopharyngeal surgery using the advanced system. First Real-World Study and…
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Abbisko Therapeutics Initiates Phase II Clinical Trial for Pimicotinib in Tendon Sheath Giant Cell Tumor
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the dosing of the first patient in a Phase II clinical study for its Category 1 drug ABSK021 (pimicotinib) in tendon sheath giant cell tumor (TGCT) in the United States. Phase III Study Design and ObjectivesThe upcoming randomized, double-blind, placebo-controlled…
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Peijia Medical Commences Clinical Study for Taurus Trio TAVR System with First Patient Enrollment
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Peijia Medical Ltd (HKG: 9996) has announced the enrollment of the first patient in a multi-center regulatory clinical study for its transcatheter aortic valve replacement (TAVR) system, Taurus Trio. This marks a significant milestone in the development and regulatory approval process for the company’s innovative cardiac device. Study Design and…
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RemeGen’s Novel Bispecific Antibody RC148 Receives Clinical Trial Approval
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China-based RemeGen Ltd (SHA: 688331, HKG: 9995) has announced that it has received clinical trial approval for its novel bispecific antibody (BsAb), RC148. This development marks a significant step forward in the company’s efforts to address the complex challenges of treating multiple solid tumors. RC148 Development and Phase I Study…
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Everest Medicines Completes Enrollment for Nefecon’s Phase III Extension Study in China
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China-based Everest Medicines (HKG: 1952) has announced the completion of patient enrollment for the China open-label extension (cOLE) of the Phase III NefIgArd study. This cOLE study provides an additional 9 months of treatment with Nefecon to all qualifying patients who have completed the NefIgArd study, aiming to evaluate the…
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Transcenta Holdings Gets CDE Approval for Phase II Study of TST002 for Bone Density
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China-based biotech company Transcenta Holdings Ltd (HKG: 6628) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a Phase II clinical study. The study will assess the safety, tolerability, and pharmacokinetics of its drug TST002 (blosozumab) in Chinese patients with decreased bone density.…
