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Optimization strategy for production process of RNA targeted drugs

RNA targeted drugs are a completely new category of drugs that are completely different from small molecule drugs and antibody drugs. On the one hand, they can target mRNA, ncRNA, and other intracellular proteins through gene silencing to inhibit their expression and achieve the goal of treating diseases; On the other hand, new generation vaccines and protein replacement therapies can also be developed based on mRNA. RNA targeted drugs are undoubtedly a strategic frontier in biopharmaceutical innovation, with broad potential application scenarios in the future. The production process technology of mRNA industrialization is particularly important for the widespread application and industrialization of mRNA. Based on this, this article will focus on the optimization strategies for the production process of RNA targeted drugs. Stability chemical modification enhances drug safety and efficacy For RNA targeted drugs, chemical modification (excluding tissue targeting ligands) mainly has two basic functions: firstly, chemical modification can significantly ...
- Source: drugdu
- 147
- October 3, 2024
Seven domestic companies have completed a new round of financing, focusing on the fields of cell and gene therapy

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 ...
- Source: drugdu
- 182
- October 3, 2024
Record-breaking advance payments for going overseas, and new changes in breast cancer

Since the discovery of cyclin-dependent kinases (CDKs), scientists have been trying to target them to disrupt cancer cell division and proliferation. Breast cancer in particular relies on this process to grow. Because of this, the first-generation CDK inhibitors targeting CDK4 and CDK6 have been very successful. In February 2015, palbociclib, the first CDK4/6 inhibitor developed by Pfizer, was approved for marketing in the United States for the treatment of locally advanced or metastatic breast cancer of HR/HER2-. There are many breast cancer patients, and in 2020, there were more than 2.3 million new breast cancer patients in the world, making it the world’s largest cancer type. Based on the large patient size, the sales scale of palbociclib is also considerable. In 2016, the sales of palbociclib in the first full year of marketing reached 2.135 billion US dollars, becoming a well-deserved blockbuster drug. Since then, CDK4/6 inhibitors of Eli ...
- Source: https://mp.weixin.qq.com
- 147
- October 3, 2024
“The leader of narcotics” in China, the actual controller may change hands

On September 25, Humanwell Pharmaceutical announced that it had received a “Notification Letter on the Company’s Application for Reorganization” from Wuhan Contemporary Technology Industry Group Co., Ltd. (hereinafter referred to as “Modern Technology”), the controlling shareholder of the company, the day before, and Wuhan Credit Risk Management Financing Guarantee Co., Ltd. and Tianjin Shengcao Law Firm had applied to the Intermediate People’s Court of Wuhan City, Hubei Province for the reorganization of Modern Technology. At present, Humanwell Pharma has not received the documents of the Wuhan Intermediate People’s Court on the acceptance of the above-mentioned application for reorganization, and it is not yet known whether the court will accept it and whether Modern Technology will enter the reorganization procedure in the future. In this regard, many investors took the lead in voting in favor, believing that the replacement of the major shareholder of Modern Technology will be more conducive to ...
- Source: https://mp.weixin.qq.com
- 129
- October 3, 2024
Over 3 billion, Stone Pharmaceutical Group reached a major cooperation

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 ...
- Source: https://mp.weixin.qq.com
- 166
- October 2, 2024
Global Leader! Qilu Pharmaceutical’s ATO Combination Antibody Approved for Second-line Treatment of Cervical Cancer

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 ...
- Source: https://mp.weixin.qq.com
- 132
- October 2, 2024
The role of brainstem medullary circuit in rapid eye movement sleep and Parkinson’s disease

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 ...
- Source: drugdu
- 125
- October 2, 2024
Cell | Ma Kaiyue et al. develop a new method for high-throughput functional identification of mutations

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 ...
- Source: BioArt
- 111
- October 2, 2024
【EXPERT Q&A】What is the role, definition, and inquiry of the FDA Consensus Standard for medical devices?

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 ...
- Source: drugdu
- 87
- October 2, 2024
Nature | Fate selection of CD8+CAR T driven by asymmetric division

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, ...
- Source: Wind BioArt
- 98
- October 1, 2024

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