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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its SYS6020. This investigational treatment is a BCMA-targeted chimeric antigen receptor (CAR)-T cell therapy intended for myasthenia gravis (MG). Notably,…
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Eli Lilly & Co. (NYSE: LLY), a leading U.S. pharmaceutical company, has announced the results of the Phase III Adapt study for its interleukin-13 (IL-13) inhibitor, Ebglyss (lebrikizumab). The study demonstrated that Ebglyss improved skin conditions, including on the hands and face, and reduced itch in patients with moderate-to-severe atopic…
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Biogen Inc. (NASDAQ: BIIB), a prominent biopharmaceutical company based in the U.S., has announced comprehensive results from the Phase II IGNAZ study for felzartamab in the treatment of IgA nephropathy. The findings were showcased at Kidney Week 2024, the annual meeting of the American Society of Nephrology. The study demonstrated…
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Humanwell Healthcare (Group) Co., Ltd (SHA: 600079), a leading healthcare company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 2.2 chemically synthesized semaglutide injection, intended for the treatment of type 2 diabetes. Semaglutide, a glucagon-like peptide-1…
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RiboX Therapeutics, a Shanghai-based developer of circular RNA (circRNA) therapies, has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate the Phase I/IIa clinical study SPRINX-1 for its candidate RXRG001. This study will evaluate the efficacy and safety of RXRG001 in patients suffering…
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AstraZeneca Inc., (AZ, NASDAQ: AZN), a UK-based pharmaceutical giant, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its Zoladex (goserelin sustain-released implant) 10.8mg. This new dosage form is intended for use in premenopausal and perimenopausal women with breast cancer who can be…
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MicuRx Pharmaceuticals Inc. (SHA: 688373), a Sino-US pharmaceutical company, has announced the successful completion of a Phase I clinical study for its in-house developed antibiotic, MRX-5, in Australia. This new benzodiazole antibiotic is designed to treat infections caused by Mycobacterium, with a particular focus on non-tuberculosis Mycobacterium (NTM). The Phase…
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The Center for Drug Evaluation of the National Medical Products Administration (NMPA) has indicated on its website that three antibody drug conjugates (ADCs) from Chinese pharmaceutical companies are on track to receive breakthrough therapy designations (BTDs) in China. These include Shanghai Escugen’s ESG401, Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692)’s…
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LaNova Medicines Ltd, a Shanghai-based developer of cancer therapies, has announced the reclamation of control over LM-302, an antibody drug conjugate (ADC) targeting Claudin 18.2, from US pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY). LaNova had previously signed an agreement with Turning Point Therapeutics, Inc. (TPTX.US) in May 2022 to…
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Zhuhai Beihai Biotech Co., Ltd has announced that it has received marketing clearance from the US Food and Drug Administration (FDA) for its in-house developed drug, Beizary, a modified version of docetaxel, which is indicated for the treatment of various cancers including breast cancer, non-small cell lung cancer, head and…
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BeiGene Ltd, a leading China-based biotechnology company (NASDAQ: BGNE; HKG: 6160; SHA: 688235), has announced the first prescription of its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab), in the United States. This marks a significant milestone for the company as it expands its global reach. Tislelizumab received approval in the US…
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RemeGen (HKG: 9995), a China-based pharmaceutical company, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted another market filing for its drug telitacicept with priority review status. The filing seeks approval for the treatment of generalized myasthenia gravis (gMG), a serious…
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RemeGen Co., Ltd. (HKG: 9995, SHA: 688331) has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted a new indication application for its Claudin18.2-targeted antibody, Taitaxipu (Telitacicept), in combination with tislelizumab and chemotherapy as a first-line treatment for advanced gastric cancer. This…
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On October 24, 2024, the Center for Drug Evaluation of the National Medical Products Administration indicated that the influenza virus split vaccine marketing application from Chongqing Zhifei Biological Products Co., Ltd. (SHE: 300122)’s wholly-owned subsidiary, Zhifei Longkoma, has been accepted, with the acceptance number CXSS2400114. Currently, Chongqing Zhifei Biological has…
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced the official market launch of its cardiac myosin inhibitor Camzyos (mavacamten) in China. The drug is indicated for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) graded II to III under the New York Heart Association (NYHA) functional classification, aiming to improve…
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that it has received approval in the Greater Bay Area (GBA) for its drug Velsipity (etrasimod) to be used in Foshan Fosun Chancheng Hospital and the First Affiliated Hospital of Sun Yat-sen University. These medical institutions are part of the…
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The official website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has indicated that Daiichi Sankyo (TYO: 4568)’s pexidartinib (PLX3397) is on track to receive priority review status for the treatment of symptomatic giant cell tumor of the tendon sheath (TGCT) in adult patients…
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Asieris Pharmaceuticals (SHA: 688176), a China-based specialist in urogenital cancer treatments, has announced that it has received clinical clearance from the U.S. Food and Drug Administration (FDA) for its in-house developed ubiquitin specific peptidase 1 (USP1) inhibitor, APL-2302, for the treatment of advanced solid tumors. Preclinical studies have indicated that…
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced the dosing of the first patient in a global, multi-center Phase III study for its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab, HLX10). The study combines serplulimab with bevacizumab and chemotherapy for the first-line treatment of…
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541), a Chinese biopharmaceutical company, has announced the first patient in (FPI) for a Phase Ib clinical study of its dual-target macromolecular drug amulirafusp alfa (IMM0306) in the treatment of moderate to severe systemic lupus erythematosus (SLE). This marks a significant advancement in the…