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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced the efficacy interim results of a Phase III clinical study for its RQ3013, a bivalent mRNA vaccine based on the S protein chimera of Alpha/Beta SARS-CoV-2 variants. The study provides crucial data on the vaccine’s performance as a sequential booster in…
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Biosyngen Pte Ltd, a cell and gene therapy (CGT) biotech with operations in Singapore and Guangzhou, China, has announced receiving Investigational New Drug (IND) approval from the US FDA for its second pipeline product, a T-cell redirection therapy designed for the treatment of EBV-positive lymphoma. This approval follows closely on…
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Shandong Jincheng Pharmaceutical Group Co., Ltd. (SHE: 300233), China’s largest cephalosporin manufacturer, has announced receiving ethical approval to initiate a Phase II clinical study for its LT-01 (litazolid dry suspension). This development marks a significant step in the advancement of the company’s pipeline. LT-01: A Promising Oxazolidone Antibacterial DrugThe Category…
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China-based Innovent Biologics (HKG: 1801) has published the results of a Phase I clinical study for its IBI351 monotherapy in advanced solid tumors at the American Association for Cancer Research (AACR) annual meeting. IBI351: A KRAS G12C Inhibitor Under AssessmentIBI351 (GFH925), a KRAS G12C inhibitor originated by GenFleet Therapeutics Inc.,…
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XZenith Biopharm, a Chinese company with minority ownership by Sihuan Pharma, has completed patient enrollment in a Phase II clinical study for its in-house developed proton pump inhibitor (PPI). The study focuses on the treatment of adult reflux esophagitis (RE) and the control of related symptoms, such as acid reflux,…
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China-based Adagene Inc. (NASDAQ: ADAG) has announced interim results from its combination dose escalation studies of the masked, anti-CTLA-4 SAFEbody, ADG126, at the AACR Annual Meeting in Orlando, Florida, from April 14-19, 2023. The studies include a Phase Ib/II study for ADG126 as a monotherapy and in combination with toripalimab…
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China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) and SpringWorks Therapeutics Inc., (NASDAQ: SWTX) have published the latest data from a Phase Ib clinical study assessing the combination of BeiGene’s RAF dimer inhibitor lifirafenib and SpringWorks’ MEK inhibitor mirdametinib in advanced or refractory solid tumors carrying RAS mutations, RAF mutations,…
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Taiwan-based HanchorBio has announced receiving the green light from the US FDA to conduct a multi-region, multi-center clinical study for its innovative fusion protein, HCB101. The non-blind, dose exploration first-in-human trial will be conducted in the US and Taiwan, focusing on assessing the safety, tolerability, pharmacokinetics, and preliminary clinical anti-tumor…
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China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced that the National Medical Products Administration (NMPA) has accepted a market approval filing for the VEGFR inhibitor Elunate (fruquintinib) in China. The filing focuses on the use of Elunate in combination with paclitaxel as a second-line treatment for advanced gastric or gastroesophageal…
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China-based HuidaGene (Shanghai) Biotechnology Co., Ltd has announced receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) in China for its ophthalmology gene therapy, HG004. This gene replacement therapy drug utilizes a recombinant non-adeno-associated virus serotype 2 (non-AAV2) vector to deliver a functional human RPE65 gene…
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China-based cell therapy specialist Cellular Biomedicine Group Inc. (CBMG) has published the results of the Phase I clinical study for its C-CAR031 at the American Association for Cancer Research (AACR) annual meeting 2023. The open Phase I study was designed to assess the safety and tolerability of C-CAR031, featuring a…
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Neurophth Biotechnology Ltd, a leading gene therapy specialist based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Sino-US multi-center Phase I/II study. The study will assess the safety, efficacy, and tolerability of its gene therapy NFS-02 (rAAV2-ND1) for ND1…
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a China-based pharmaceutical company, has announced that it has received marketing approval from Health Canada for its generic version of Roche’s Cytovene-IV (ganciclovir). This development marks a significant step for the company as it expands its international footprint in the generic drugs market.…
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CanSino Biologics Inc., a leading Chinese vaccines specialist, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative bivalent COVID-19 mRNA vaccine. This development signifies a significant step forward in the company’s efforts to combat the evolving SARS-CoV-2 virus. Preclinical Study…
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JS InnoPharm Ltd, a Shanghai-based pharmaceutical company, announced that the first patient has been dosed in a Phase Ib clinical study for its small-molecule aurora A kinase (AURKA) inhibitor, VIC-1911. This trial marks a significant step in the development of the drug, which is being investigated for its potential in…
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China-based Minghui Pharmaceutical has unveiled positive top-line data from a Phase II trial of its MH004 cream, which is being evaluated as a treatment for adolescents and adults with mild-to-moderate atopic dermatitis (AD). The cream, a pan-JAK inhibitor, successfully met its primary endpoint and all key secondary endpoints, demonstrating its…
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China-based AffaMed Therapeutics has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase III regulatory study. The study will assess the efficacy and safety of Dextenza in subjects following ophthalmic surgery, marking a significant step forward for the company. Dextenza’s Development and…
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China-based Harbour Biomed (HKG: 2142) is set to release early clinical data for its CTLA-4 antibody in combination with Junshi Biosciences’ (HKG: 1877, SHA: 688180) programmed death-1 (PD-1) inhibitor toripalimab as a treatment for neuroendocrine neoplasms (NENs). The findings will be presented via a poster at the upcoming American Association…
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48). This single-arm, open, single-center study aims to evaluate the safety and maximum tolerable…
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Junshi Biosciences (HKG: 1877, SHA: 688180), a leading China-based biopharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for JS401, an injectable co-developed with Risen Pharma, for the treatment of hyperlipidemia. JS401’s Mechanism of ActionJS401 is an innovative angiopoietin-like 3 (ANGPTL3)…