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China-based China Medical System Holdings Ltd (CMS; HKG: 0867) has announced receiving New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) for its diazepam nasal spray. This dosage form is the first of its kind to gain approval in China and is set for use as a…
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) presented updates on the clinical development of its JAK1 inhibitor golidocitinib (DZD4205) and DZD8586 at the 17th International Conference on Malignant Lymphoma (ICML) annual meeting. Golidocitinib: A Promising Treatment for PTCLGolidocitinib, the world’s first and only JAK1 inhibitor in regulatory trial stages, received…
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UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has announced that its Soliris (eculizumab), a first-in-class C5 complement inhibitor, has obtained its third indication approval from the National Medical Products Administration (NMPA) in China. This approval allows the use of Soliris to treat adult patients with refractory generalized Myasthenia gravis (gMG)…
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Shanghai-based biotech firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the first patient dosing in a Phase II clinical study for its Category 1 drug ABSK021 (pimicotinib), which is aimed at treating chronic graft versus host disease (cGVHD). Understanding cGVHD and the Role of CSF-1R InhibitionThe pathological and physiological…
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China’s Genor Biopharma Co., Ltd (HKG: 6998) has announced that the National Medical Products Administration (NMPA) has declined its New Drug Application (NDA) for geptanolimab, a programmed-death 1 (PD-1) inhibitor, for the treatment of recurrent/refractory peripheral T-cell lymphoma (PTCL). The drug, which was under development to treat a range of…
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its best-in-class antibody drug conjugate (ADC), CPO301, has received fast-track status for the treatment of recurrent/refractory (R/R) or EGFR targeted therapy ineffective metastatic EGFR mutant non-small cell lung cancer (NSCLC). Preclinical Efficacy and Safety of CPO301Preclinical studies have demonstrated that…
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China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced receiving market approval from the National Medical Products Administration (NMPA) for enarodustat, a novel drug candidate specifically targeting renal anemia. Enarodustat is a hypoxia-inducible factor proline hydroxylase inhibitor (HIF-PHI) developed for anemia in non-dialysis adult chronic kidney disease (CKD) patients.…
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China-based Keymed Biosciences Inc., (HKG: 2162) has announced that the latest results from a Phase I clinical study for its Category 1 drug CM313, a monoclonal antibody (mAb) targeting CD38, have been presented at the 28th European Hematology Association (EHA) annual meeting. The trial focuses on the molecule’s potential use…
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HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) has announced that new and updated clinical data related to two novel investigational therapies for hematological malignancies, HMPL-306 and amdizalisib, will be presented at the European Hematology Association (EHA) Annual Meeting and the 17th International Conference on Malignant Lymphoma (ICML). HMPL-306: A Dual…
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Reistone Biopharma Co., Ltd, a company incubated by Hengrui Pharmaceuticals (SHA: 600276) with an investment of USD 100 million in 2018, has announced that the market filing for its JAK1 inhibitor, ivarmacitinib, for the treatment of moderate to severe atopic dermatitis (AD) has been accepted for review by the Center…
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The Center for Drug Evaluation (CDE) in China has indicated that Overland ADCT BioPharma (CY) Ltd’s Zynlonta (loncastuximab tesirine), an antibody-drug conjugate (ADC) targeting CD19, and BeiGene Ltd’s (NASDAQ: BGNE, HKG: 6160, SHA: 688235) Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) are on track to receive priority review statuses. Both…
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The National Medical Products Administration (NMPA) has granted approval for Betta Pharmaceuticals Co., Ltd’s (SHE: 300558) Category 1 drug vorolanib to be used in combination with everolimus for the second-line treatment of advanced renal cell carcinoma (RCC). This approval follows the market filing submitted in January last year and marks…
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received clinical trial approval from the US FDA for its bispecific antibody (BsAb), ZGGS15, which targets LAG-3 and TIGIT in advanced solid tumors. This marks ZGGS15 as the world’s first BsAb of its kind to reach the clinical…
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received the green light from Health Canada to initiate a Phase I clinical study. The study will assess the safety, pharmacokinetics, and preliminary efficacy of its in-house developed antibody-drug conjugate (ADC), CPO301, in patients with advanced solid tumors,…
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China-based Jacobio Pharma (HKG: 1167) has announced receiving approval in China to initiate a Phase I/IIa clinical study for its in-house developed PARP7 inhibitor, JAB-26766, targeting advanced solid tumors. JAB-26766: A Potential Treatment for Squamous CancersThe oral small molecule PARP7 inhibitor is under development for the treatment of squamous non-small…
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced receiving clinical trial approvals from the National Medical Products Administration (NMPA) for its VUM02, a human umbilical cord-derived mesenchymal stem cell therapy. The Category 1 therapeutic biologic product is set to be assessed in acute-on-chronic liver failure (ACLF)…
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) presented updates on the clinical development of its next-generation epidermal growth factor receptor (EGFR) inhibitor sunvozertinib (DZD9008) and JAK1 inhibitor golidocitinib (DZD4205) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. Sunvozertinib: A Promising EGFR Inhibitor for NSCLCSunvozertinib, under development for…
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that its Category 1 drug ABSK021 (pimicotinib) has received Priority Medicine (PRIME) status from the European Medicines Agency (EMA) for the treatment of inoperable tenosynovial giant cell tumor (TGCT). This decision comes on the heels of positive results from an…
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CStone Pharmaceuticals’ (HKG: 2616) French partner, Servier, has published the latest results of the global Phase III AGILE study for Tibsovo (ivosidenib) combined with azacitidine in newly diagnosed acute myeloid leukemia (AML) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. Phase III AGILE Study Design and FindingsThe…
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Germany’s BioNTech (NASDAQ: BNTX) has released preliminary data from a Phase I/IIa trial for DB-1303, a DNA topoisomerase I-inhibiting antibody-drug conjugate (ADC) licensed from China-based Duality Biologics. The trial focused on patients with solid tumors, and the results indicated that 44.2% of patients exhibited an objective partial tumor response. Notably,…