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Innovent Biologics Announces Strategic Partnerships to Form Tumor Diagnosis and Treatment Alliance
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China-based Innovent Biologics (HKG: 1801) has announced a series of strategic partnerships with compatriot firms Xinyi Biology, LBP Medicine, Xiangxin Biotechnology, Wuhan HealthCare Biotechnology Co., Ltd, Amoy Diagnostics Co., Ltd, and Shanghai OrigiMed Co., Ltd. The aim is to jointly establish a tumor diagnosis and treatment biosphere alliance. Financial details…
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Hinova’s PROTAC Drug HP518 Accepted for FDA Review in mCRPC
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China-based biopharma Hinova Pharmaceuticals has announced that a clinical trial filing for its androgen receptor (AR) targeted proteolysis-targeting chimeric (PROTAC) drug HP518 in metastatic castration-resistant prostate cancer (mCRPC) has been accepted for review by the US FDA. The study in question is an open-label study assessing the safety, pharmacokinetics, and…
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Fosun Kite’s CAR-T Therapy FKC889 Approved for Clinical Trials in China
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its subsidiary Fosun Kite Biotechnology Co., Ltd’s chimeric antigen receptor (CAR)-T cell therapy FKC889 has obtained clinical trial approval in mainland China to treat adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL).…
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Yantai Dongcheng Receives NMPA Approval for F18 PET Imaging Study
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for an F18 product for use in positron emission tomography (PET) imaging of fibroblast activating protein (FAP)-positive lesions. This marks a significant step forward in…
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InnoCare Receives CDE Approval for Phase II Trial of Orelabrutinib Combination
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China-based biopharma InnoCare Pharma (HKG: 9969, SHA: 688428) has announced receiving approval from China’s Center for Drug Evaluation (CDE) to start a Phase II clinical trial assessing a combination of orelabrutinib with tafasitamab and lenalidomide in patients with relapsed/refractory (r/r) non-Hodgkin’s lymphoma (nHL). This approval marks a significant step in…
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JW Therapeutics Collaborates with Juno for DLL3 CAR-T Therapy Development
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China-based JW Therapeutics Co., Ltd (HKG: 2126) has issued a stock exchange announcement revealing a strategic collaboration with its major shareholder Juno. The deal sees Juno grant licenses to patents and know-how in order to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T cell therapy targeting the solid…
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Mabwell Bioscience Licenses Biosimilars to Russian Firm Binnopharm
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China-based Mabwell Bioscience (SHA: 688062) has announced the establishment of a licensing agreement with the Russian pharmaceutical company Binnopharm Group, focused on 9MW0113, 9MW0321, and 9MW0311, Mabwell’s biosimilar versions of adalimumab and denosumab. Binnopharm will have exclusive rights to develop, register, manufacture, and market the drugs with a status of…
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Sirnaomics’ Lead Candidate STP707 Shows Promising Phase I Data
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Sino-US small interfering RNA (siRNA) specialist Sirnaomics (HKG: 2257) has revealed that its lead pipeline candidate STP707 has produced strong early safety and efficacy data in a Phase I clinical trial. STP707, which is comprised of two siRNA oligonucleotides targeting TGF-β1 and COX-2 mRNA and formulated in a peptide nanoparticle…
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Aosaikang Receives FDA Approval for ASKG915 Clinical Trial
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced receiving clinical trial approval for its Category 1 biologic product ASKG915 from the US FDA. The intended indication is advanced solid tumors, marking a significant step forward in the development of innovative therapies for this condition. Drug Profile and DevelopmentASKG915 is…
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XtalPi Partners with Singapore’s EDDC to Develop Lung Cancer Treatments
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Sino-US artificial intelligence (AI) firm XtalPi Inc. has struck a partnership with the Experimental Drug Development Centre (EDDC) of Singapore. The aim is to provide new drug candidates for lung cancer precision treatment, driven by a research and development model integrating artificial intelligence (AI), automation experimentation, and expert expertise. No…
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CStone’s Sugemalimab MAA Accepted by UK MHRA for NSCLC Treatment
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has accepted the marketing authorization application (MAA) submitted by its US-based partner EQRx for sugemalimab in combination with chemotherapy as a first-line treatment of patients with metastatic non-small cell lung…
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HutchMed Initiates Rolling NDA Submission for Elunate to US FDA
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Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has announced the initiation of a rolling submission of a New Drug Application (NDA) to the US FDA for Elunate (fruquintinib) for the treatment of refractory metastatic colorectal cancer (CRC). HutchMed plans to complete the NDA submission in the first half of…
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Adagene Initiates International Study for ADG126 in Hepatocellular Carcinoma
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China-based biotech Adagene Inc. (NASDAQ: ADAG), which also operates out of San Diego, California, has announced the initiation of a randomized, international, multi-center clinical study to assess the effects of its anti-CTLA-4 monoclonal antibody (mAb) ADG126, combined with Roche’s Tecentriq (atezolizumab) and Avastin (bevacizumab), in first-line advanced hepatocellular carcinoma (HCC).…
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GenFleet and Merck KGaA Partner on European Clinical Study for KRAS G12C Inhibitor
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China-based GenFleet Therapeutics Inc. has announced a European multi-center clinical study and drug supply agreement with Germany’s Merck KGaA. The collaboration will conduct an open, multi-center, Phase Ib/II clinical study to assess the efficacy of combining GenFleet’s KRAS G12C inhibitor, GFH925, with Merck’s Erbitux (cetuximab) in treatment-naïve advanced non-small cell…
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Henlius’ Serplulimab Receives Orphan Drug Designation in Europe for SCLC
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Shanghai Henlius Biotech (HKG: 2696) has announced receiving orphan drug designation (ODD) status from the European Committee for its HanSiZhuang (serplulimab) for the treatment of small-cell lung cancer (SCLC). The programmed death-1 (PD-1) inhibitor, previously awarded ODD status in the US for the same indication, is expected to become the…
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Doer Bio and MSD Collaborate on Clinical Trial for Anti-Claudin18.2 Antibody DR30303
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China-based Zhejiang Doer Biologics Co., Ltd has announced a clinical trial collaboration agreement with US major Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) to investigate Doer Bio’s anti-Claudin18.2 antibody DR30303 in combination with MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) in patients with gastric or gastroesophageal junction cancer (GC/GEJ). Under the…
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Cosmo Pharmaceuticals’ Lumeblue Completes Phase III Trial in China
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Ireland-based Cosmo Pharmaceuticals N.V. (OTCMKTS: CMOPF) revealed that its Lumeblue (methylthioninium chloride) diagnostic agent has successfully completed a Phase III clinical trial in China. The trial was carried out by Cosmo’s partner, China Medical System Holdings Ltd (CMS; HKG: 0867). Trial Design and ResultsThe randomized, double-blind, placebo-controlled trial compared Lumeblue…
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Tracon Pharmaceuticals Provides Positive Update on Envafolimab Phase II Trial
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China-based Alphamab Oncology (HKG: 9966)’s US partner Tracon Pharmaceuticals (NASDAQ: TCON) has provided an early positive update from a Phase II trial underway for envafolimab, the Alphamab-discovered programmed death-ligand 1 (PD-L1) antibody capable of subcutaneous injection. The pivotal ENVASARC trial, being conducted by Tracon in the US and UK, is…
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Sirnaomics Announces Interim Results for STP705 in Phase IIb Study for isSCC
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) has announced the interim results of part one of a Phase IIb clinical study for STP705, a therapeutic that combines TGF-β1/COX-2 with histidine-lysine polypeptide (siRNA/HKP) nanoparticle silencing. The trial is assessing the therapy as a treatment for cutaneous squamous cell carcinoma in…
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Henlius Biotech Initiates Phase I Trial for HLX60 in Australia
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Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the first subject dosed in a Phase I clinical trial in Australia for its independently developed HLX60 (recombinant anti-GARP humanized monoclonal antibody injection) in combination with Henlius’s innovative in-house anti-PD-1 mAb serplulimab. The trial is assessing the combination in treating general advanced…
