On September 29, Shi Pharma Group signed an exclusive licensing agreement with Jiangsu Conri Pharma on the development and commercialization of JSKN003 in mainland China. JSKN003 is a HER2-targeting bispecific antibody-drug conjugate (ADC) with dual HER2 targeting, giving it stronger internalization induction and bystander killing effects, making it highly active against HER2-expressing tumors. Currently, JSKN003 is undergoing Phase I clinical trials in Australia and Phase I/II and Phase III clinical trials in China. Next, Jinmant Bio (a wholly-owned subsidiary of Chiatai Tianqing Pharmaceutical Group) will be granted exclusive license and sublicensing rights for the development, sales, promised sales, and commercialization of the product. They will bear all clinical development costs and become the sole marketing authorization holder for JSKN003 in Mainland China for that field. According to the agreement, Corning Jerry has the right to receive a total of up to 3.08 billion RMB in upfront and milestone payments, including ...
Recently, the combination antibody of apalutamide toripalimab (QL1706, trade name: Qilu’an, hereinafter referred to as “etuo combination antibody”) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of recurrent or metastatic (R/M) cervical cancer patients who have failed platinum-based therapy. This milestone development not only signifies a major breakthrough in the treatment of advanced cervical cancer in China, but also heralds a new stage of development for cancer immunotherapy.It is reported that the Etu combination antibody is the first dual-function combination antibody targeting PD-1 and CTLA-4 designed and produced by Qilu Pharmaceutical through its self-developed MabPair®️ technology platform. It has shown great potential in the treatment of solid tumors such as cervical cancer, lung cancer, and liver cancer, demonstrating both efficacy and safety. With its unique mechanism, it is at the forefront of the journey of tumor dual immunotherapy strategy!Cervical cancer is the ...
Mammalian sleep includes rapid eye movement sleep (REMS) and non rapid eye movement sleep (NREM). REMS is also known as paradoxical sleep. The characteristic of NREM is the high amplitude slow wave oscillation of the electroencephalogram, which reflects the synchronous transition of cortical neurons between depolarization rising state and hyperpolarization falling state. In contrast, REM is characterized by an increase in the average firing rate of cortical neurons, rapid oscillations and theta waves in the electroencephalogram, and loss of skeletal muscle activity (muscle tone imbalance). The brainstem’s brainstem is a key structure regulating REMS. Research on cats has shown that the perifocal coeruleus (LC) – α is a crucial region within the pontine tegmentum for inducing REM. Subsequent analysis showed that the subthalatoral nucleus (SLD) of rodents is homologous to LC – α in cats [6,7]. In SLD, inhibiting glutamatergic neurotransmission can reduce REMS levels and alleviate muscle tone ...
The analysis of pathogenic genetic variations has always been an important challenge in the field of human genetics. Single nucleotide mutations in genes related to Mendelian genetic diseases should be the easiest type of mutation to study in human genetics. However, for many disease genes, the clinical importance of at least half of single nucleotide mutations has not been determined, seriously affecting the diagnostic efficiency of genetic diseases, especially rare genetic diseases. Deep mutational screening (DMS) refers to a research method that generates large-scale gene variations through saturation mutagenesis and then studies genetic variations in cell lines through high-throughput methods. This method can greatly accelerate the diagnosis of genetic diseases and deepen our understanding of the clinical importance of single nucleotide mutations. However, the cost and complexity of current deep mutation screening methods hinder their widespread application in clinical research. On September 25, 2024, Monkol Lek’s team from Yale ...
Drugdu.com expert’s response: FDA medical device consensus standards play a pivotal role in the medical device industry. Ⅰ. The Role of FDA Medical Device Consensus Standards Ensuring Safety and Effectiveness: These standards assist manufacturers in ensuring that their medical devices meet safety and effectiveness requirements during design, manufacturing, and usage, thereby safeguarding the health of patients and users. Streamlining Regulatory Processes: Manufacturers can leverage these consensus standards to fulfill FDA regulatory requirements, reducing the need for redundant testing and evaluations, which accelerates pre-market approval timelines. Enhancing Transparency: Consensus standards provide clear benchmarks for medical device performance and safety, contributing to increased industry transparency and fostering fair competition. Facilitating International Harmonization: Many FDA-recognized medical device consensus standards are international, simplifying international trade and market access, thereby promoting coordinated development of the global medical device market. Ⅱ. Definition of FDA Medical Device Consensus Standards FDA medical device consensus standards refer to a ...
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 ...
So far, a large number of pharmacies have withdrawn from medical insurance. In September alone, Inner Mongolia has inspected 636 designated medical institutions and 1,661 retail pharmacies, imposed administrative penalties on 34, and suspended or terminated medical insurance agreements for 1,023; Xinjiang terminated the medical insurance service agreements of 162 designated medical institutions; 3 retail pharmacies in Tongling, Anhui terminated the medical insurance service agreements, and 1 medical institution in Yongxin, Jiangxi cancelled its medical insurance designated qualification… Earlier, similar situations also occurred in pharmacies in Zhoukou, Henan, Heyuan, Guangdong, Dezhou, Shandong, Fangshan, Beijing, Shaoyang, Hunan, Kunshan, Jiangsu, etc. The reasons for pharmacies to withdraw from the medical insurance service agreement vary, most of which are “actively applying”, “due to their own business reasons”, “illegal and irregular”, “due to failure to handle relevant procedures, no incurrence or approval of settlement expenses for more than six months”, etc. Pharmacies have ...
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 ...
Recently, Ascletis announced that its independently developed small molecule GLP-1R agonist ASC30 is undergoing two Phase I clinical trials in the United States for the treatment of obesity with monthly subcutaneous injections and daily oral tablets. With the launch of these two Phase I clinical trials, Ascletis has officially entered the field of weight loss drugs. This is another highlight of the pipeline after Ascletis announced in April this year that it would focus on the development of core non-alcoholic steatohepatitis (NASH) drugs. Urgent need for a new engine Like most biotechs, Ascletis has also been moving forward by trial and error. However, Ascletis is luckier than most biotechs. It has become famous for its first local original hepatitis C drug Ganovo, which not only broke the monopoly of multinational companies such as Gilead, AbbVie, Bristol-Myers Squibb, and Merck in the domestic hepatitis C drug market, ...
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