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Junshi Biosciences’ Mindewei Receives Full Approval in China
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that the conditional approval in China for its COVID-19 therapy Mindewei (deuremidevir) has been converted to full approval by the National Medical Products Administration (NMPA). This approval is for the treatment of adult patients with mild to moderate…
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Merck Initiates Phase III MOVE-NOW Study for Lagevrio COVID-19 Antiviral
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US pharmaceutical giant Merck & Co., Inc. (NYSE: MRK) has announced the commencement of the Phase III MOVE-NOW study for its oral antiviral COVID-19 medicine, Lagevrio (molnupiravir), in adults with COVID-19 who are at high risk for disease progression. This trial marks a significant step in the ongoing development and…
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Shanghai-Based ANEXT Commences Clinical Trials for Exosome Product ANEXT FIT CELL in Respiratory Conditions
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ANEXT, a Shanghai-based exosome specialist, has launched two clinical studies for their product ANEXT FIT CELL, which is derived from mesenchymal stem cells exosomes. One study aims to evaluate the product’s efficacy in treating cough symptoms following infection, while the other is focused on safety and preliminary efficacy in the…
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Simcere Pharmaceutical’s COVID-19 Therapy Xiannuoxin Earns Full Approval in China
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Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that its small-molecule COVID-19 therapy, Xiannuoxin (simnotrelvir, ritonavir), has received regular approval from the Chinese regulatory authorities, converting from its previous conditional approval status. This makes Xiannuoxin the first COVID-19 therapy of its kind to achieve full…
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Moderna Partners with Mitsubishi Tanabe for mRNA Vaccine Promotion in Japan
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Moderna Inc. (NASDAQ: MRNA), a leading mRNA specialist biotechnology company based in the U.S., has selected Japan’s Mitsubishi Tanabe Pharmaceutical Corp. to establish a co-promotion partnership for Moderna’s mRNA respiratory vaccine portfolio in the Japanese market. The agreement will encompass the promotion of Moderna’s COVID-19 vaccine, Spikevax, and aims to…
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GSK Secures Global Rights to CureVac’s mRNA Vaccine Candidates in Expanded Partnership
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GlaxoSmithKline (GSK, NYSE: GSK) , a UK-based pharmaceutical giant, is poised to expand its partnership with CureVac N.V. (Nasdaq: CVAC), a German mRNA specialist. The revised agreement will grant GSK full global rights to develop, manufacture, and commercialize mRNA candidate vaccines for influenza and COVID-19, encompassing related combination regimens. As…
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U.S. Lawmakers Question FDA on Discrepancies in Foreign Inspections of China and India
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U.S. lawmakers have intensified their scrutiny of the FDA’s foreign inspection program, particularly for companies based in China and India. Members of the Energy and Commerce Select Committee have penned a letter to FDA Commissioner Robert Califf, expressing serious concerns over significant variations in inspection outcomes that they believe raise…
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Walvax Biotechnology Halts COVID-19 Vaccine Clinical Trials Citing Low Benefits
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Walvax Biotechnology Co., Ltd (SHE: 300142), a biopharmaceutical company based in China, has announced the termination of clinical studies for its recombinant COVID-19 vaccine (CHO cell) and recombinant COVID-19 variant vaccine (CHO cell), due to the assessment of low economic and social benefits. The vaccines were approved for clinical trials…
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Andon Health’s COVID-19 Trio Test Kit and OTC Antigen Test Win FDA Approval
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Andon Health Co., Ltd (SHE: 002432), a healthcare company based in China, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for two of its COVID-19 testing products. The first is the iHealth COVID-19/Flu A&B Rapid Test Pro, a triple detection point-of-care (POC) kit…
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Sanofi Secures Novavax Vaccine Tech in a Deal Valued at Up to USD 1.2 Billion
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France’s Sanofi (NASDAQ: SNY) has announced a strategic partnership with protein-based vaccines specialist Novavax (NASDAQ: NVAX), aiming to enhance its immunization portfolio. Under the agreement, Sanofi will gain access to Novavax’s Matrix-M adjuvant and secure exclusive rights to combine its influenza vaccines with Novavax’s SARS-CoV-2 vaccine. Sanofi will also co-commercialize…
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Andon Health’s Triplex Virus Test Kit Receives US FDA Emergency Use Authorization
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Andon Health Co., Ltd (SHE: 002432), a leading healthcare company based in China, has announced that it has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its novel triplex test kit, capable of detecting COVID-19, influenza A virus, and influenza B virus. The product…
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Wondfo Biotech’s WELLlife Test Kit Receives FDA Nod for Home Use in the US
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Guangzhou Wondfo Biotech Co., Ltd (SHE: 300482), a leading biotechnology company based in China, has announced that it has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its WELLlife COVID-19/Influenza A&B Home Test. This triplex test kit, available in an over-the-counter (OTC) version, is…
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Bio-Thera Solutions’ BAT1806 Receives Positive CHMP Recommendation for EU Approval
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the market approval filing of BAT1806, a biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab). The CHMP’s recommendation…
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Former Sinopharm Executive Yang Xiaoming Removed from National People’s Congress Over Alleged Serious Violations
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Yang Xiaoming, previously the chief engineer and chief scientist of China National Pharmaceutical Group Corporation (Sinopharm), has been dismissed from his role as a delegate to the 14th National People’s Congress due to suspicions of serious disciplinary and legal violations, as determined by the Standing Committee of the National People’s…
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Walvax Biotechnology’s COVID-19 Variant Vaccine RQ3033 Shows Positive Phase III Results
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China-based Walvax Biotechnology Co., Ltd (SHE: 300142) has announced positive results from a Phase III immunogenic bridge study for its COVID-19 variant mRNA vaccine candidate, RQ3033, co-developed with Fudan University and RNACure. The vaccine is specifically targeting the Omicron XBB.1.5 variant and has demonstrated good efficacy and safety in the…
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Gilead’s 2023 Flat Sales Reflect Stagnation and COVID-19 Demand Decline
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Gilead Sciences Inc. (NASDAQ: GILD) has reported a stagnant performance for the year 2023, with total product sales remaining unchanged at USD 26.9 billion. Amid a broad decline in demand for COVID-19 treatments, the company’s antiviral Veklury (remdesivir) sales could not offset the downturn, although HIV sales increased by 6%…
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Gilead’s 2023 Stagnation Foresees Flat 2024 Sales as Veklury Revenues Dwindle
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Gilead Sciences (NASDAQ: GILD) has reported a stagnant performance for 2023, with product sales remaining flat at USD 26.9 billion. The company’s financials were affected by a widespread downturn in demand for COVID-19 treatments, as its antiviral Veklury (remdesivir) sales offset growth in other areas. HIV sales reached USD 18.2…
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Chinese Firms Secure EUAs for Omicron XBB Vaccines Amid Dominant Variant Surge
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A wave of Chinese pharmaceutical companies has announced the receipt of Emergency Use Authorizations (EUAs) for their COVID-19 vaccines targeting the Omicron XBB variant. Among the notable developments are Lizhu Pharmaceutical’s (HKG: 1513) recombinant bivalent vaccine, which combines the prototype strain with the Omicron XBB variant, and CanSino Biologics’ (SHA:…
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Fujian Cosunter’s Oral COVID-19 Therapy Receives Conditional Approval in China
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Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a Chinese pharmaceutical company, has announced that its Category 1 product, GST-HG171/ritonavir, an oral COVID-19 therapy, has received conditional marketing approval in China. GST-HG171 is a 3CL protease (3CLpro) inhibitor, characterized as having broad-spectrum anti-COVID-19 activity. 3CL protease is an essential protease for…
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Fujian Cosunter’s COVID-19 Therapy GST-HG171/Ritonavir NDA Accepted by NMPA
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Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a China-based pharmaceutical company, has announced that its New Drug Application (NDA) for the Category 1 product GST-HG171/ritonavir, an oral therapy for COVID-19, has been accepted for review by China’s National Medical Products Administration (NMPA). Therapeutic Profile of GST-HG171/RitonavirGST-HG171 is identified as a…
