On September 9, the House of Representatives of the United States Congress returned from a summer break and immediately scheduled a series of legislative votes, including the draft Biosafety Act (H.R. 8333). The draft biosecurity law passed the House of Representatives with 306 votes in favor and 81 votes against, but the 70% support rate made it the most divisive draft bill in the same batch, and even narrowly fell below the “bottom line” of more than two-thirds of the votes to pass the bill. The draft Biosafety Act places five companies, including WuXi AppTec and WuXi Biologics, on the list of “biotechnology companies of concern” on the grounds of “national security”, and intends to restrict the use of funds, loans or subsidies from the United States government to cooperate with these companies. Unlike previous committees that voted in small groups, this time there were several members of the House ...
In September, several domestic companies focused on the field of cell and gene therapy (CGT) announced progress in financing. This article will share basic information about its 7 companies based on publicly available materials. Xingsairui has successfully completed tens of millions of yuan in angel round financing On September 14th, Hangzhou Xingsai Ruizhen Biotechnology Co., Ltd. (hereinafter referred to as “Xingsai Ruizhen”) announced the completion of tens of millions of yuan in angel round financing and officially launched the angel+round financing plan! This round of financing is jointly invested by Fosun Pharma’s Rehabilitation Capital New Drug Innovation Fund and Chuangrui Investment Jiaxing Chuangyan Fund. This round of financing will be used for the continuous promotion of core pipelines and platforms, as well as the construction of the company’s team and research and development laboratories. Xingsai Ruizhen was founded in July 2022 and incubated by the New Drug Innovation ...
The long-term existence of CAR T is closely related to its clinical treatment efficacy, and long-life memory CAR T provides continuous immune monitoring to prevent tumor recurrence [1,2]. Model animal studies have found that asymmetric cell division (ACD) is one of the important mechanisms for memory formation in CD8+T cells [3,4]. The daughter cells derived from parental cell division, which are close to antigen-presenting cells (APCs), inherit immune synapses and are more likely to differentiate into short-lived effector T cells (Teff). In contrast, distal terminal cells differentiate into long-lived memory T cells with unique transcriptional, epigenetic, and metabolic characteristics (see BioArt report: Expert review of epigenetic strategies for improving T cell function by Guo Ao/Huang Hongling/Chi Hongbo/Douglas Green, etc.) [4-6]. Given the broad prospects of CAR T for cancer treatment, researchers have maintained a strong interest in the phenotype and memory formation of CAR T over the past decade. However, ...
Immune escape is one of the important features of cancer progression and a core challenge that affects the effectiveness of immunotherapy. Although immune checkpoint inhibitors (ICI) have achieved significant success in certain cancers, the overall response rate in solid tumors is still very limited. Exploring the mechanism of tumor immune escape in depth, discovering new targets, and improving ICI efficacy through combination therapy have become one of the key directions of current tumor immune research. On September 19, 2024, Professor Jiang Kuirong and Professor Feng Xu from the First Affiliated Hospital of Nanjing Medical University, together with Professor Chen Junjie and Professor Jiang Dadi from the MD Anderson Cancer Center of the University of Texas in the United States, published a research paper entitled In vivo CRISPR screens identify Mga as an immune target in triple negative breast cancer online on PNAS magazine, systematically expounded the core route of immune ...
Cancer is one of the major public health problems facing China and the world. With the aging of China’s population and changes in lifestyle, the incidence of malignant tumors continues to increase. According to the latest data from the National Cancer Center based on tumor registration and follow-up monitoring, there will be 4.8247 million new cases of malignant tumors in China in 2022, and the total number of deaths will reach 2.5742 million1. Malignant tumors are one of the major diseases that threaten the health of Chinese residents. The lifetime risk of cancer among Chinese people is 28.9%2. China has been on the road to fighting cancer. The “Healthy China 2030” Planning Outline clearly states that by 2030, chronic disease health management will be achieved for the entire population and throughout the life cycle, and the overall 5-year cancer survival rate will increase by 15%3; the Cancer Prevention and ...
Drugdu.com expert’s response: FIC (First-in-class) drugs, as their name implies, are the first medications of their kind with entirely novel and unique mechanisms of action, pioneering the treatment of specific diseases. Their latest advancements can be outlined from several perspectives: Ⅰ. Overview of FIC Drugs Globally and in China Global Scope: According to publicly available information, the FDA approved a total of 55 new drugs in 2023, among which 20 were FIC drugs, accounting for 36% of the total. This underscores the pivotal role of FIC drugs in the global drug discovery and development landscape. Chinese Scope: Chinese enterprises are increasingly focusing on innovative drugs. In 2023, 30 of the newly approved drugs in China were developed domestically, constituting 37% of the overall approvals. Furthermore, Chinese scholars’ publications in authoritative journals indicate a significant increase in the total number of innovative products in China’s pipeline, with FIC products growing from ...
Recently, according to publicly available information from the Center for Drug Evaluation (CDE) of the National Medical Products Administration, the technetium-99m ([99mTc]) hydrazinonicotinamide polyethylene glycol RGD peptide injection (referred to as “99mTc-3PRGD2”) developed by Ruidiao Pharmaceuticals has been included in the priority review list. This also applies to the injection of toluenesulfonate hydrazone nicotinamide polyethylene glycol RGD peptide. 99mTc-3PRGD2 is a radiolabeled drug conjugate (RDC) independently developed by Ruidiao Pharmaceuticals. It is the first class I new drug for radiologic diagnosis in nuclear medicine in China and the world’s first broad-spectrum tumor imaging agent for SPECT imaging. Notably, the success of this drug’s development will change the current technical status and conventional understanding that SPECT/CT imaging technology in nuclear medicine cannot be used for tumor diagnosis, staging, and efficacy evaluation. According to Ruidiao Pharmaceuticals, 99mTc-3PRGD2 targets integrin and specifically binds to the integrin αvβ3 receptor on tumor neovascularization, demonstrating high ...
Recently, Astellas announced that Japan’s MHLW has approved its ADC drug ennozumab PADCEV and Merck’s K drug as a first-line combination therapy for adult patients with fundamentally unresectable urothelial cancer. With excellent data, this combination treatment regimen was approved by the Japanese MHLW in such a short time after Merck announced on September 4 that it had been approved by the European Commission (EC) as a first-line therapy. However, sporadic victories cannot conceal the plight of K-drugs. For the pharmaceutical industry, the biggest hot spot in the past two weeks is definitely the announcement by Kangfang Biologics on September 8 that ivocilimab has become the world’s first and only single-drug head-to-head phase III clinical study to prove that its efficacy is significantly better than that of pabrolib. The drug Zizumab. On the day the results were announced, Merck’s stock price fell in response, and the dilemma was obvious. Under the ...
Public information shows that this is a subcutaneous administration fixed combination of the EGFR/MET bispecific antibody amivantamab developed by Johnson&Johnson and recombinant human hyaluronidase. In June of this year, Johnson&Johnson submitted a biopharmaceutical approval application for subcutaneous injection of bevacizumab to the US FDA, for all indications of approved or submitted intravenous bevacizumab preparations, covering different types of non-small cell lung cancer (NSCLC). According to Johnson&Johnson’s previous press release, patients were able to complete the injection of the subcutaneous formulation within 5 minutes. Evantomab is a humanized EGFR/MET bispecific antibody. It has multiple anti-cancer mechanisms, not only blocking EGFR and MET mediated signaling, but also guiding immune cells to target tumors carrying activating and drug-resistant EGFR/MET mutations and amplifications. The intravenous formulation of this product was first granted accelerated approval by the FDA in May 2021, and has since been approved for multiple indications, including: Adult patients with locally ...
Today (September 24), CDE plans to include Novartis’ Lutetium [177Lu] Texivirpitide Injection and Radioactive Drug Gallium [68Ga] Gozertide Injection Preparation Kit in the priority review. According to the CDE official website, both drugs are based on the “Opinions of the National Medical Products Administration on Reforming and Improving the Management System for the Review and Approval of Radioactive Drugs” (National Medical Products Administration Drug Note [2023] No. 20) and the “Medium- and Long-Term Development Plan for Medical Isotopes (2021-2035)”. After review, they comply with the “Drug Registration Management Measures” and the “Announcement of the National Medical Products Administration on the Release of the “Breakthrough Therapeutic Drug Review Work Procedures (Trial)” and other three documents (No. 82 of 2020). The requirements are agreed to be included in the priority review and approval procedure according to the priority review scope “(VI) Other circumstances prescribed by the National Medical Products Administration for priority ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.