Recently (November 7th), the official website of the China National Center for Drug Evaluation (CDE) showed that Chengdu Yuandong Biopharmaceutical Co., Ltd.’s application for the marketing of injection grade naprolimus mesylate, classified as Class 3, has been accepted. According to public information, the indications of this product are for the treatment of acute pancreatitis, chronic pancreatitis with acute exacerbation, postoperative acute pancreatitis, acute pancreatitis after pancreatography, and acute traumatic pancreatitis; Used for the treatment of disseminated intravascular coagulation (DIC); 3. Used to prevent blood clotting during extracorporeal circulation. Naprolimus mesylate is a strong and broad-spectrum serine protease inhibitor. This product was first launched in Japan for the prevention and treatment of disseminated intravascular coagulation (DIC), improvement of acute symptoms of pancreatitis, and anticoagulation during extracorporeal circulation. In March 2020, according to overseas media reports, Professor Junichiro Inoue of the Medical Research Institute of the University of Tokyo and others issued ...
On the evening of October 23, Heyuan Biotechnology released its third-quarter report for 2024. In the third quarter, the company achieved a revenue of 70.81 million yuan, a year-on-year increase of 32.99%, but realized a net profit attributable to shareholders of -76.42 million yuan. For the first three quarters of this year, the company recorded a total revenue of 184 million yuan, marking a year-on-year growth of 34.22%, with a net profit attributable to shareholders of -190 million yuan. Improved Industry Environment Provides Growth Opportunities According to public data, Heyuan Biotechnology’s main business includes providing Contract Research Organization (CRO) services such as the development of gene therapy vectors and gene function research for cellular and gene therapy foundational research. It also offers Contract Development and Manufacturing Organization (CDMO) services, including application for Investigational New Drug-Chemistry, Manufacturing, and Controls (IND-CMC) pharmaceutical research and GMP production of clinical samples for the development ...
Motefutide Macau officially approvedOn September 20, 2024, Guangzhou Yuheng Biotechnology Co., Ltd. (referred to as “Yuheng Biotechnology”) announced the world’s first peptide drug, Mortifutide (APHEXDA), targeting the chemokine receptor 4 (CXC chemokine receptor 4, CXCR4) ®, Motixafortide has recently been officially approved for marketing by the Drug Administration of the Macao Special Administrative Region of China. According to the WHO ATC (Anatomical Therapeutic Chemical Classification System) drug classification management system, it has been approved as immune enhancer L03AX23, which is used in combination with granulocyte colony-stimulating factor (G-CSF) to mobilize hematopoietic stem cells for peripheral blood stem cell collection and subsequent autologous transplantation in patients with multiple myeloma (MM). After Boao, Hainan, Macau has become the second region within Yuheng Biotech’s Asia authorized area to receive approval for Motefutide. Motefutide has obtained new drug approval in the United States in September 2023. It is the first approved innovative drug for ...
LY-M003 Disclaimer: Due to limited proficiency, errors are inevitable, or some information may not be timely. Please feel free to leave a message to indicate. This article only provides an introduction to medical and health-related drugs, and does not recommend treatment plans (if applicable); This article does not constitute any investment advice. Recently, a prospective, single center, open label, single arm, single dose clinical study evaluating the safety, tolerability, and efficacy of LY-M003 injection in the treatment of adult patients with Wilson’s disease was launched at the First Affiliated Hospital of Zhejiang University School of Medicine (hereinafter referred to as “Zhejiang First Hospital”). The project was led by Professor Yu Chaohui, the leader of the Gastroenterology Department, as the main researcher. LY-M003 injection is an innovative gene therapy drug developed by Lingyi (Hangzhou) Biotechnology Co., Ltd. (hereinafter referred to as “Lingyi Biotechnology”). The Department of Gastroenterology at Zhejiang First Hospital ...
SHANGHAI, July 26, 2024 /PRNewswire/ — On July 15, Eluminex Biosciences announced that their tri-specific fusion antibody drug, EB-105, has administered its first dose to a diabetic macular edema patient in the United States. This clinical trial, known as LOTUS, is an open-label, multicenter, single-dose, dose-escalation clinical trial via intravitreal injection, currently being conducted in four hospitals across the United States. On July 22, 2024, Foreseen Biotechnology announced the exclusive global licensing of their ADC targeted drug, FS001, to Ipsen Pharma SAS of France. Ipsen will have exclusive rights to develop, manufacture, and commercialize FS001 worldwide. The total licensing fee, including upfront payments, milestone payments, and sales royalties, amounts to US$1.03 billion. Eluminex Biosciences’s preclinical studies have shown that EB-105 can effectively inhibit signal transduction pathways such as VEGF-A/VEGFR-2, Ang-2/Tie-2, and IL-6/IL-6R. In addition to targeting vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2), EB-105 also inhibits intracellular inflammation-related signal ...
Vaccine immunization has dramatically reduced the morbidity and mortality of invasive bacterial infectious diseases such as bloodstream infections. Although a large number of studies have demonstrated that immune protection requires vaccine-induced antibody production, human beings still lack a clear understanding of the cellular and molecular mechanisms of how vaccines provide immune protection. The current international consensus is that vaccines provide immune protection by activating phagocytes in the spleen and blood circulation to remove pathogens that invade the bloodstream. Recently, Jingren Zhang’s group and Linqi Zhang’s group at Tsinghua University School of Medicine, together with Haifa Zheng’s group at Beijing Minhai Biotechnology Co., Ltd, published a paper in Science Translational Medicine titled “Liver macrophages and sinusoidal endothelial cells The research paper, entitled Liver macrophages and sinusoidal endothelial cells execute vaccine-elicited capture of invasive bacteria, reveals that the liver is the main organ that executes vaccine-elicited immunoprotection, and elucidates the molecular mechanism ...
According to the announcement from Anke Biotechnology’s joint venture company, Yuan Song Biotechnology: Shanghai Yuan Song Biotechnology Co., Ltd. (hereinafter referred to as “Yuan Song Biotech”) announced that its independently developed oncolytic virus anticancer drug, “Recombinant L-IFN Adenovirus Injection,” obtained the Investigational New Drug (IND) approval from the United States Food and Drug Administration (FDA) on December 21, 2023. Dr. Zhang Kangjian, Co-founder and General Manager of Yuan Song Biotech, stated that the successful completion of the IND in the United States is a significant milestone for Yuan Song Biotech, a company dedicated to the development of oncolytic virus anticancer clinical drugs. This achievement not only validates our research and development strategy and technological platform for industrialization but also demonstrates Yuan Song Biotech’s clinical development capabilities in the field of targeted gene-virus therapy. This includes oncolytic adenovirus process development, quality method research, high-quality preclinical studies, and clinical research. With the ...
Important Notice: Changchun BCHT Biotechnology Co. (hereinafter referred to as the “Company”) has recently received the Notice of Approval of Drug Clinical Trial from the State Drug Administration. 2, the freeze-dried human rabies vaccine (human diploid cells) subsequent clinical trials are uncertain, and there is a certain degree of uncertainty whether the commercial purpose can ultimately be achieved. Investors are kindly advised to make decisions with caution and pay attention to the prevention of investment risks. The relevant information is announced as follows: I. Main information of the Notice of Approval of Drug Clinical Trial Acceptance No.: CXSL2300615 Notification No.: 2023LP02456 Drug Name: Lyophilized Human Rabies Vaccine (Human Diploid Cells) Conclusion: Agree to carry out clinical trials for the prevention of rabies. Approval date: December 6, 2023 The freeze-dried human rabies vaccine (human diploid cell) approved by the Company this time is freeze-dried human rabies vaccine (MRC-5 cell). II. Introduction ...
Recently, Zhejiang Pukang Biotechnology Co., Ltd. has completed the Phase IV clinical trial titled “Single-Arm, Multi-Center Evaluation of the Safety and Immunogenicity of Freeze-Dried Live Attenuated Hepatitis A Vaccine in Chinese Children Aged 18-24 Months” and received the final report. This Phase IV clinical study, involving a large sample size of 10,000 cases across multiple centers, aimed to observe the safety and immunogenicity of the freeze-dried live attenuated Hepatitis A vaccine in the real world. The study results show that after a single dose of the vaccine, the AEFI incidence rate in the 18-24 month-old children was 0.34%, with no serious AEFI reported, and an antibody seroconversion rate of 98.91%. This confirms the vaccine’s good safety and immunogenicity profile, providing richer data support for its widespread application. The freeze-dried live attenuated Hepatitis A vaccine (H2 strain), developed and produced by Zhejiang Pukang Biotechnology Co., Ltd., simulates ...
According to reports, the biotechnology company Abpro has rescheduled its $96 million IPO, delaying a capital infusion it hoped would support the first clinical trials of its lead product candidates over the next year.
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