SHANGHAI, April 19, 2024 /PRNewswire/ — GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced US Food and Drug Administration (FDA) has granted the clinical trial approval for GFH925 (KRAS G12C inhibitor) in a multi-center, open-label, randomized and controlled phase III study treating refractory metastatic colorectal cancer (CRC) patients. It is the first phase III trial of KRAS G12C inhibitor monotherapy targeting CRC patients worldwide, with GFH925 being the first G12C inhibitor that received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for previously treated advanced CRC. GFH925 was also granted BTD and New Drug Application acceptance with Priority Review Designation by NMPA for previously treated advanced non-small cell lung cancer(NSCLC)patients with G12C mutation. The trial (GFH925X0301) will enroll refractory metastatic CRC patients harboring KRAS G12C mutation who have progressed or experienced disease recurrence on or after at least two prior ...
Organiser: Ministry of Health of Vietnam Time:1 – 3 August 2024 address:Lawrence S. Ting Building 801 Nguyen Van Linh Parkway, Dist. 7 Ho Chi Minh City Vietnam Exhibition hall: Saigon Exhibition & Convention Center Product range: Medical products: medical equipment and instruments, medical consumables, medical dressings, surgical equipment, rescue equipment, diagnostic equipment and supplies, ophthalmic equipment and equipment, ENT equipment, dental equipment and supplies, medical reagents and equipment, medical health products and equipment, medical institutions and laboratory technical equipment, medical information and technical exchange, beauty equipment Analytical instruments: Optical analysis instruments, mass spectrometers, spectrometers, chromatographs, spectrometers, electrochemical analysis instruments, X-ray analysis instruments, gas chromatography, liquid chromatography, thermal analysis instruments, all kinds of portable instruments, surface analysis instruments, nuclear analysis instruments, elemental analysis instruments, process analysis instruments, composition analysis instruments, injection analysis instruments and other general analytical instruments Laboratory equipment: Laboratory instruments and equipment, laboratory automation and accessories, optical instruments and equipment, ...
Biopharmaceutical companies are regaining interest in metabolic dysfunction-associated steatohepatitis (MASH) innovator drug development. MASH innovator drugs witnessed over $2.5 billion increase in the total value of partnership deals from 2020 to 2024 year-to-date (YTD), with more than $2 billion forged in Q1 2024 alone, reveals GlobalData. MASH, previously known as nonalcoholic steatohepatitis (NASH), is a disease characteriSed by liver inflammation and damage caused by the accumulation of fat. Madrigal Pharmaceuticals’ Rezdiffra (resmetirom), a small molecule THRB agonist, was the first drug approved by the FDA for MASH in March 2024. Alison Labya, Business Fundamentals Analyst at GlobalData, comments, “Interest in MASH has returned in light of the FDA approval of Madrigal’s Rezdiffra, as well as the success of GLP-1 obesity drugs and their potential efficacy in MASH, as demonstrated by Eli Lilly’s Zepbound (tirzepatide; also known as Mounjaro for type 2 diabetes) in its Phase II SYNERGY-NASH trial readout.” However, ...
Recently, Anhui ANKE Bio Engineering (Group) Co., Ltd (hereinafter referred to as “ANKE Bio”, stock code: 300009) signed a license agreement with Shanghai Shijian Biotechnology Co. (“ANKE Bio”). According to the license agreement, ANKE Bio has formally obtained the license of EZWi-Fit®, the ADC technology platform of SHIJIAN BIOLOGY, to develop ADC products. During the license period, ANKE Bio will be responsible for the preclinical research, clinical development and commercial production and sales of the developed products in Greater China, and will pay equity payments (including down payment and milestone payments) and a sales commission as a percentage of net sales to SHIJIAN BIO. Shijian Bio acquires an overseas interest in the ADC product. Shijian Bio is a clinical-stage ADC new drug discovery and development company with an ADC clinical pipeline and comprehensive new drug discovery and development capabilities, and has established a new-generation ADC technology platform, EZWi-Fit®, with its ...
On April 12, 2024, Shanghai Yuansong Biotechnology Co., Ltd (“Yuansong Biotechnology”) announced that its self-developed lysosomal virus Class I new drug “Recombinant L-IFN Adenovirus Injection (YSCH-01)” has received implied clinical trial approval from the Center for Drug Evaluation of the State Drug Administration (CDE) and has been approved to conduct Class I clinical trials in China. The Center for Drug Evaluation (CDE) of the State Drug Administration has granted implied consent for clinical trials and approved to conduct Phase I clinical trials in China for the indication of advanced solid tumors. The approval of this IND filing by the CDE in China is another important progress made by YuanSong Biotech in exploring the clinical study of YSCH-01, in addition to the clinical approval by the US FDA in December 2023 for two original IIT programs under development, including capsular delivery for recurrent gliomas and lysosomal viral nebulized delivery for the ...
On April 9, 2024, Beijing Sinovac Biotech Ltd., a subsidiary of Sinovac Holdings Biotechnology Ltd. (Sinovac Biotech), obtained the approval for registration of the 5-dose Sabin Strain Inactivated Polio Vaccine (Vero Cells) (hereinafter referred to as the 5-dose sIPV) developed by Sinovac Biotech Ltd. from the National Drug Administration (NDA) for the prevention of polio caused by the poliovirus types I, II and III. (hereinafter referred to as “sIPV”) received the approval of drug registration from the State Drug Administration (NMPA) for the prevention of poliomyelitis caused by poliovirus types I, II and III (commonly known as “polio”), and is suitable for the immunization of children aged 2 months and above. Compared with the single-dose sIPV vaccine, the 5-dose sIPV vaccine can significantly reduce the global immunization cost, and has been listed as an urgently needed variety in the WHO Polio Eradication Action Plan, and the launch of Sinovac Biotech ...
Organiser: KFDA、KPMA Time:23 – 26 April 2024 address:217-59 Kintekseu-ro, Daehwa-dong, Ilsanseo-gu, Goyang-si, Gyeonggi-do,Korea Exhibition hall: KINTEX Product range: Pharmaceutical: Pharmaceutical raw materials, API, pharmaceutical fine chemicals, intermediates, pharmaceutical additives, pharmaceutical agents, natural extracts, biotechnology, pharmaceutical outsourcing and services, laboratory equipment, pharmaceutical equipment, etc Chemical: chemical raw materials, chemical equipment, instrumentation, automatic control technology, heat exchanger, crystallization, gas absorption, drying, filtration, centrifuge, dust removal, chemical reactor, mill, blender, etc Cosmetics: cosmetic raw materials, cosmetic additives, functional materials, natural extracts, etc About KOREA PHARM & BIO: The KOREA PHARM & BIO event includes a variety of events, including a policy briefing on raw materials and pharmaceuticals, an export fair, and a variety of pharmaceutic-related seminars. The broad development space creates good opportunities for companies interested in exploring and developing the Korean market, and will undoubtedly become the best platform for companies to reach deals.
YANTAI, China, April 3, 2024 /PRNewswire/ — RemeGen Co. Ltd. (“RemeGen” or “the Company”) (9995.HK, 688331.SH), a commercial-stage biotechnology company, obtained Fast Track Designation (FTD) by the United States Food and Drug Administration (FDA) recently for its innovative BLyS/APRIL dual-target fusion protein drug, Telitacicept (RC18), independently developed by RemeGen for the treatment of patients with primary Sjögren’s syndrome (pSS). The FDA grants FTD to accelerate the development and review of new drugs that have the potential to treat life-threatening conditions and address unmet medical needs. Primary Sjögren’s syndrome (pSS) is a common rheumatic disease characterized by autoimmune exocrinopathy that clinically manifests as dry eyes and mouth caused by glandular dysfunction as a result of autoimmune damage with multiple organ systems also at risk of being affected. Studies have shown that B-cells are key immune cells involved in the pathogenesis of pSS, and excessive activation of B-cells is a pathogenic indicator ...
CellVoyant – an AI biotechnology spin-out from the University of Bristol – has announced a £7.6 million funding round. Led by Octopus Ventures – with additional participation from Horizons Ventures, Air Street Capital and Verve Ventures – the funding represents the first stage in commercialising CellVoyant’s first of its kind AI and imaging platforms. Meanwhile, the company now aims to enable the rapid development of novel cell therapies. Stem cells unlock a wide range of treatment possibilities that have not historically been available to patients. Indeed, current treatments tend to act on the body’s existing cells, while stem cells have the potential to develop into different cell types in the body – replacing dysfunctional cells or regenerating damaged tissues and organs. CellVoyant’s platform combines advanced AI with live cell imaging to address pain points. The technology can extract spatial and temporal information in real-time from hundreds of millions of cells. ...
Aston University is on course to create the Aston Institute for Membrane Excellence (AIME) – a cross-disciplinary facility to develop novel biomimetic membranes – having received £10m from Research England. The institute will be led by Professor Roslyn Bill, from the School of Biosciences, along with Professor Paul Topham from the department of Chemical Engineering and Applied Chemistry. Both biological and synthetic membranes are significant across several many sectors. Indeed, the world’s top ten selling human medicines all target proteins in biological membranes, while synthetic polymer membranes are commonly used in the water purification industry. The AIME believes that the full potential of membranes will only be realised by an interdisciplinary group which spans biology, physics and chemistry and that can investigate membranes holistically. Professor Bill, a European Research Council (ERC) Advanced grantee leads Aston Membrane Proteins and Lipids (AMPL) research centre of excellence that studies the structure and function ...
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