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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…
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Moderna Initiates Construction of First China-Based Pharmaceutical Plant in Shanghai
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S-based mRNA specialist, Moderna (NASDAQ: MRNA), has commenced construction on its inaugural pharmaceutical facility in China, as reported by Xinhua. The new plant, situated in Shanghai’s Minhang District at the Xinzhuang Industry Park, is set to serve as Moderna’s China R&D and production headquarters. The project has attracted an investment…
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Pfizer Inc. Reports Q3 2023 Revenue Contraction and Launches Cost Realignment Program
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US pharmaceutical giant Pfizer Inc., (NYSE: PFE) has released its financial results for the third quarter of 2023, reporting a contraction of -41% year-on-year (YOY) in operational terms to USD 13.2 billion, excluding foreign currency fluctuations. The quarter was marked by a net loss of USD 2.38 billion, the company’s…
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CSPC Pharmaceutical Group Gains NMPA Approval for Bivalent COVID-19 mRNA Vaccine Study
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a prominent pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its bivalent COVID-19 mRNA vaccine SYS6006.32, targeting the XBB.1.5 and BQ.1 variants. Vaccine Development and ImmunogenicitySYS6006.32 is…
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Dr. Reddy’s Laboratories Reports 9% YOY Revenue Growth in Q2 2024 Fiscal Year
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India-based generics giant Dr. Reddy’s Laboratories Ltd (NYSE: RDY) has released its financial report for the Q2 2024 fiscal year ended September 30, 2023. The company reported consolidated revenues of USD 828 million for the quarter, marking a 9% year-on-year (YOY) increase. This growth was primarily driven by robust generic…
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Roche’s Q3 2023 Report Shows 1% Global Growth Amid Lower COVID-19 Product Demand
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Swiss pharmaceutical giant Roche (SWX: ROG) released its Q3 2023 report, indicating that a reduced demand for COVID-19 products impacted global growth, resulting in a 1% year-on-year (YOY) increase at constant exchange rates over the first nine months, with total sales amounting to CHF 44.1 billion (USD 49.4 billion). Excluding…
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Guangdong Zhongsheng Launches AI Q&A Bot for Leritrelvir Drug Support
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the innovative launch of a smart Artificial Intelligence (AI) Q&A bot for its antiviral drug Yueruiling (leritrelvir). This AI-driven platform is designed to enhance patient support by providing smart Q&A services, an offline drug purchase map guide, and a comprehensive…
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Vcanbio Receives NMPA Approval for Stem Cell Therapy VUM02 Clinical Trial
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China-based biotechnology firm Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, double-blind, placebo-controlled Phase I/II study. The study will assess the efficacy and safety of its innovative product VUM02, a…
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SciClone Pharmaceuticals Gains FDA Nod for Thymalfasin COVID-19 Vaccine Booster Study
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SciClone Pharmaceuticals Inc. (HKG: 6600), formerly a US-based and Nasdaq-listed company, has announced that it has received approval from the US FDA to conduct a clinical study for its drug thymalfasin as a booster for COVID-19 mRNA vaccines. This marks a significant step in exploring new ways to enhance the…
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Pfizer Adjusts 2023 Revenue Projections Amidst Decreased COVID-19 Solution Demand
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Pharmaceutical giant Pfizer Inc. (NYSE: PFE) has revised its projected 2023 revenues downward, reflecting a decrease in demand for COVID-19 solutions. The new revenue projection falls between USD 58.0 billion and 61.0 billion, a significant adjustment from the previously anticipated range of USD 67.0 billion to 70.0 billion as reported…
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Jiangsu Recbio Forms Strategic Cooperation for Vaccine Production in Zimbabwe
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China-based Jiangsu Recbio Technology Co., Ltd (HKG: 2179) has announced a tripartite strategic cooperation agreement with the Zimbabwe National Biotechnology Authority (Zimbabwe NBA) and the International Centre for Genetic Engineering and Biotechnology China Regional Research Centre (ICGEB). This collaboration aims to enhance vaccine production capabilities in Zimbabwe, starting with the…
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Hybio Pharmaceutical Gets NMPA Approval for COVID-19 Nasal Spray HY3000
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its Category 1.1 chemical drug, HY3000, a nasal spray designed to target COVID-19. Mechanism of Action and EfficacyHY3000 is a new type of polypeptide membrane…
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EMA’s CHMP Supports Gilead’s Veklury for COVID-19 Patients with Hepatic Impairment
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The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recently endorsed the potential approval of Gilead’s (NASDAQ: GILD) repurposed antiviral Veklury (remdesivir) for the treatment of COVID-19 patients with mild-to-severe hepatic impairment. This milestone could position the nucleotide analog as the first COVID-19 treatment authorized…
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Sinovac Biotech Advances SA55 COVID-19 Neutralizing Antibody into Phase II Trials
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China-based vaccines firm Sinovac Biotech Ltd (NASDAQ: SVA) has announced the completion of a Phase I trial and the immediate initiation of a Phase II study for its broad-spectrum COVID-19 neutralizing antibody, SA55. The molecule, which was first approved to enter clinical trials in China on May 24 this year,…
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Jointown Medical’s COVID-19 Drug Candidate SHEN211 Accepted for Review by NMPA
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China-based Jointown Medical Devices Group Co., Ltd (SHA: 600998) has announced that its clinical trial filing for the Category 1 COVID-19 drug candidate, SHEN211, has been accepted for review by China’s National Medical Products Administration (NMPA). SHEN211 is an oral broad-spectrum anti-novel coronavirus non-peptide 3CL protease inhibitor, co-developed by a…
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Pfizer and BioNTech Receive Positive CHMP Opinion for Comirnaty Vaccine
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on the Omicron XBB.1.5-adapted monovalent version of the SARS-CoV-2 vaccine Comirnaty, developed in partnership by Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX). The vaccine is intended for use in children…
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Youcare Pharmaceutical’s YKYYO17 Receives Ethical Approval for COVID-19 Treatment Study
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China-based Youcare Pharmaceutical Group (SHA: 688658) has received ethical approval from the China-Japan Friendship Hospital to conduct a Phase II/III study assessing the efficacy and safety of its YKYYO17 aerosol inhalation agent as a potential treatment for mild-to-moderate COVID-19. The drug candidate is a broad-spectrum coronavirus membrane fusion inhibitor polypeptide…
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Latin America Accelerates COVID-19 Fight with Vaccine and Treatment Initiatives Across the Region
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Latin America is ramping up its contributions to the worldwide race for COVID-19 vaccines and treatments. Cuba’s state-owned BioCubaFarma, through its Center for Genetic Engineering and Biotechnology (CIGB), has designed a vaccine candidate and is advancing its development in collaboration with China’s Research and Development Center in Yongzhou, Hunan’s Industrial…
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Thermo Fisher Scientific Develops Serology Test to Detect COVID-19 Antibodies in Collaboration with WuXi Diagnostics and Mayo Clinic
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Thermo Fisher Scientific Inc., a titan in the US device industry and listed on the NYSE under the ticker (TMO), has unveiled the development of a serology test designed to detect the SARS-CoV-2 coronavirus. This collaborative effort with China’s WuXi Diagnostics and the prestigious US medical institution, Mayo Clinic, is…
