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Biogen’s Felzartamab Demonstrates Promising Results in Phase II Study for IgA Nephropathy
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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 Receives NMPA Approval for Chemically Synthesized Semaglutide Clinical Trial
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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’ Circular RNA Therapy RXRG001 Gets FDA Green Light for Dry Mouth Clinical Trial
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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’s Zoladex Receives NMPA Approval for Higher Dosage Form in Breast Cancer Treatment
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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’ Antibiotic MRX-5 Completes Successful Phase I Clinical Trial in Australia
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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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Wantai Biological’s P85 Ab Detection Kit Receives NMPA Approval for Nasopharyngeal Carcinoma Screening
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Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392), a Chinese pharmaceutical company, announced last week that it has received marketing approval from the National Medical Products Administration for its EB virus BNLF2b antibody (P85 Ab) detection kit, which utilizes the magnetic particle chemiluminescence method. This product is a collaborative…
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Chinese ADCs from Escugen, Hansoh, and MediLink Therapeutics Eye Breakthrough Designations in China
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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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GSK Commits USD 800 Million to New State-of-the-Art Manufacturing Facility in Pennsylvania
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GSK plc (NYSE: GSK), a leading UK pharmaceutical company, has announced a significant investment in the United States with the establishment of a multi-purpose facility in Marietta, Pennsylvania. The company will invest USD 800 million to develop a state-of-the-art drug substance manufacturing facility and additional drug product manufacturing capabilities, creating…
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ImmuneOnco Biopharmaceuticals Partners with Yangtze River Pharmaceutical to Boost Pipeline Development
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541), a biopharmaceutical company based in China, has entered into a strategic partnership with fellow Chinese firm Yangtze River Pharmaceutical (Group) Co., Ltd. This collaboration aims to strengthen and enhance the development of ImmuneOnco’s investigational pipeline programs. The partnership encompasses a wide range of…
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LaNova Medicines Regains Rights to Claudin 18.2 Targeting ADC LM-302 from BMS
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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’s Beizary Receives FDA Clearance for Multiple Cancer Indications
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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’s PD-1 Inhibitor Tevimbra Scores First US Prescription, Offers More Affordable Option
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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’s Telitacicept Receives Priority Review Status from China’s CDE for gMG Treatment
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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’s Taitaxipu Receives CDE Acceptance for New Indication Application in China
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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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Shanghai MicroPort Initiates Pre-Marketing Clinical Study for Embolic Microspheres in Liver Cancer Treatment
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a Chinese medical technology company, has announced the commencement of a pre-marketing clinical study for its polyvinyl alcohol embolic microspheres. The company has completed the first pre-marketing clinical implantation in transcatheter arterial chemoembolization (TACE) surgery for left lobe lesions in patients with…
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Chongqing Zhifei Biological’s Influenza Vaccine Application Accepted by China’s Drug Evaluation Center
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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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TheDerma’s Series A+ Round to Fund R&D and Commercialization of AhR Targeted Drugs
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TheDerma, a Shanghai-based pharmaceutical company, has announced the completion of a nearly CNY 100 million Series A+ financing round. The round was led by Qingdao Guoxin, with existing shareholders Baino Capital, Han Kang Capital, and Beta Fund continuing to add investments. Kaicheng Capital once again served as the exclusive financial…
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BMS Launches Cardiac Myosin Inhibitor Camzyos in China for Obstructive Hypertrophic Cardiomyopathy
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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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Boston Scientific Reports 19.5% YOY Increase in Q3 Net Sales, Driven by New Product Launches and Market Expansion
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Boston Scientific Corporation (NYSE: BSX), a leading medical device manufacturer in the U.S., has announced its financial results for the third quarter of 2024, highlighting a robust 19.5% year-on-year (YOY) increase in net sales, which reached USD 4.209 billion. The company’s business units reported significant growth, with MedSurg contributing USD…
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Hengrui Pharmaceuticals Considers HKEX Secondary Listing Amid Financing Challenges in Mainland China
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, is reportedly planning a secondary listing on the Hong Kong Stock Exchange, according to multiple media sources. The move is anticipated to raise approximately USD 2 billion (RMB 14 billion) and comes amidst concerns regarding “difficulty in financing…
