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Ascletis Pharma Receives USPTO Notice for ASC10 Patent
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced receiving the Notice of Issuance from the United States Patent and Trademark Office (USPTO) for the patent application of oral viral polymerase inhibitor ASC10 and its derivatives, and their uses to treat multiple virus infections including SARS-CoV-2, monkeypox virus, and respiratory syncytial…
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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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Simcere Pharmaceutical Completes Enrollment for SIM0417 COVID-19 Drug Trial
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the completion of enrollment of 1,208 patients in a Phase II/III clinical study for its SIM0417, an oral COVID-19 drug candidate being co-developed with the Chinese Academy of Science’s Shanghai Institute of Materia Medica (SIMM) and the Wuhan Institute of Virology. Study…
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Neurophth’s NFS-02 Gene Therapy Gets FDA IND Approval for LHON Treatment
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China-based gene therapy specialist Neurophth Biotechnology Ltd has announced obtaining Investigational New Drug (IND) approval from the US FDA for its second ophthalmology gene therapy, NFS-02 (rAAV2-ND1). The intended indication is Leber’s hereditary optic neuropathy (LHON) caused by the ND1 mutation. NFS-02: A Promising Gene Therapy for LHONNFS-02, a recombinant…
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TG ImmunoPharma Gains FDA Approval for Phase I Study of Anti-PVRIG Antibody
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China-based TG ImmunoPharma Co., Ltd has announced receiving the go-ahead from the US FDA to carry out a Phase I clinical study for its TGI-2/NM1F, a novel anti-PVRIG therapeutic antibody, in patients with advanced solid tumors. Currently, no drugs targeting PVRIG have been approved globally. TGI-2/NM1F: A Promising Anti-PVRIG Therapeutic…
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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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Jiangsu Recbio’s Herpes Zoster Vaccine REC610 Gets Clinical Trial Approval in Philippines
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China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) has announced receiving clinical trial approval for its new adjuvant recombinant herpes zoster vaccine, REC610, in the Philippines. The randomized, observer-blinded, Shingrix-positive controlled Phase I study is designed to assess the safety and immunogenicity of REC610 in healthy subjects aged…
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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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Boehringer Ingelheim’s Spevigo Approved by NMPA for Generalized Pustular Psoriasis
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German giant Boehringer Ingelheim announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Spevigo (spesolimab) to treat generalized pustular psoriasis (GPP) in adults. Notably, the drug, previously awarded breakthrough therapy and priority review statuses in China, took a mere three months after gaining approval in 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…
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Everest Medicines Achieves Preclinical Milestone for mRNA Rabies Vaccine
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China-based Everest Medicines (HKG: 1952) has announced that the company has achieved the preclinical proof-of-concept milestone for its mRNA rabies vaccine program. This new vaccine candidate for rabies post-exposure prophylactic was developed in partnership with Providence Therapeutics Holdings Inc., using a clinically validated mRNA technology platform. It can be used…
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111 Inc. Begins Online Sales of Pfizer’s Paxlovid in China
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China-based online pharmacy 111 Inc. (NASDAQ: YI) reportedly initiated online retail sales of Pfizer Inc.’s oral COVID-19 therapy Paxlovid (nirmatrelvir, ritonavir) in China. The price for one box covering a single course of treatment was set at RMB 2,980 (USD 428.23). 111 later released a statement noting that the drug…
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Ascentage Pharma’s APG-2575 Shows Promising Results in Global Phase II Study
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Suzhou-based Ascentage Pharma (HKG: 6855) unveiled preliminary data from the global Phase II clinical study for its APG-2575, alone or combined with Calquence (acalabrutinib) plus rituximab, in recurrent/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The results were released at the 64th American Society of Hematology (ASH) annual meeting this…
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ImmuneOnco’s IMM2520 Receives FDA Clinical Trial Approval
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd announced receiving clinical trial approval from the US FDA for its IMM2520, a bispecific antibody (BsAb) targeting CD47 and PD-L1 in solid tumors. Mechanism of Action and Preclinical ResultsIMM2520, featuring functional IgG1 Fc, can activate macrophages and T cells simultaneously by targeting CD47 and PD-L1…
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Jiangsu Recbio’s COVID-19 Vaccine ReCOV Shows Superiority in Phase II Trial
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China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) announced the positive results of a Phase II clinical study for its recombinant COVID-19 vaccine ReCOV in the Philippines as a sequential booster shot. The results showed that ReCOV as a sequential booster shot was superior to mRNA vaccine in…
