NMPA Grants Emergency Approval to Three Novel Coronavirus Diagnostic Products from Three Companies

Hubei Provincial Health Commission: Chloroquine Phosphate, a Specific Drug for COVID-19, Carries Risk of Fatality

Recently, the Hubei Provincial Health Commission issued the "Notice on Closely Monitoring Adverse Reactions to Chloroquine Phosphate" to health commissions of all cities, prefectures, and directly administered cities in Hubei Province, as well as medical institutions under the ministry and provincial governments. The notice stated that chloroquine phosphate has been included as a recommended medication for COVID-19. "According to information released by the Wuhan Institute of Virology, Chinese Academy of Sciences, the lethal dose in adults is 2–4 g, causing acute fatality. All designated medical institutions are requested to closely monitor patients during the use of this drug and promptly report any cases of adverse reactions to the Provincial Health Commission."

NMPA Grants Emergency Approval for Three Novel Coronavirus Detection Products from Three Companies

On February 22, the National Medical Products Administration (NMPA) granted emergency approval for three novel coronavirus testing products from three companies, including two colloidal gold-based antibody test kits and one isothermal amplification chip-based nucleic acid test kit. This expansion of detection methods and capabilities aims to fully support the needs of epidemic prevention and control.

JAMA: First Report of an Asymptomatic Carrier with Negative CT Scan and Single Negative Nucleic Acid Test

On February 21, a letter published in JAMA reported a transmission event in Anyang City, Henan Province, attributed to a presumed asymptomatic carrier. The presumed asymptomatic carrier returned from Wuhan and transmitted the virus to five relatives; however, two CT scans and the initial nucleic acid test yielded normal results, and other laboratory tests showed no abnormalities. The second nucleic acid test was positive, but subsequent multiple tests were negative. As of the time of manuscript submission, the asymptomatic carrier had not developed any symptoms.

Hybribio Successfully Develops Combined Test Kit for COVID-19, Influenza A, and Influenza B

On February 24, Hybribio issued an announcement stating that its wholly-owned subsidiary, Guangzhou Hybribio Medical Technology Co., Ltd., had recently developed the “COVID-19, Influenza A (FluA), and Influenza B (FluB) Combined Nucleic Acid Detection Kit (Fluorescent PCR Method)” based on a quantitative fluorescent PCR platform. This kit utilizes a closed, automated, high-throughput nucleic acid extraction and amplification system. It is primarily used for the detection of Influenza A virus, Influenza B virus, and the novel coronavirus (COVID-19). The kit offers safe and rapid operation, thereby reducing the risk of infection for laboratory personnel. It not only meets the clinical need for rapid testing but also helps monitor the co-circulation effects of seasonal influenza while combating the COVID-19 epidemic.

Adalimumab Registered in Clinical Trials for COVID-19 to Treat Critically Ill Patients

On February 22, the Chinese Clinical Trial Registry listed a clinical study on the safety and efficacy of adalimumab (brand name: Geleli) in treating patients with severe and critical COVID-19. The drug used in the study was donated by Bio-Thera Solutions, Ltd.

BioCapital’s Six-Item Respiratory Virus Nucleic Acid Detection Kit Approved

On February 22, the “Six-Item Respiratory Virus Nucleic Acid Detection Kit (Isothermal Amplification Chip Method),” which includes detection for the novel coronavirus (2019-nCoV) and was jointly designed and developed by CapitalBio Corporation, Tsinghua University, and West China Hospital of Sichuan University, received emergency approval from the National Medical Products Administration (NMPA) as a medical device for combating the novel coronavirus. It will be rapidly deployed to the front lines of epidemic prevention and control, providing rapid, precise, and effective diagnosis for numerous patients and frontline healthcare workers. This emergency-approved “Six-Item Respiratory Virus Nucleic Acid Detection Kit (Isothermal Amplification Chip Method)” is the world’s first chip-based nucleic acid detection kit capable of testing for six respiratory viruses, including the novel coronavirus (2019-nCoV), within 1.5 hours.

Dirui Medical Cytokeratin 19 Fragment Assay Kit Receives Medical Device Registration Certificate

On February 24, Dirui Medical Technology Co., Ltd. announced that its Cytokeratin 19 Fragment Assay Kit (Chemiluminescent Immunoassay) had obtained the Medical Device Registration Certificate issued by the National Medical Products Administration. The kit is intended for the in vitro quantitative determination of cytokeratin 19 fragments (CYFRA21-1) in human serum or plasma. It is primarily used for dynamic monitoring of patients with malignant tumors to assist in assessing disease progression or treatment efficacy. It shall not be used as a basis for early diagnosis or confirmed diagnosis of malignant tumors, nor shall it be used for tumor screening in the general population.

Dirui Medical’s Neuron-Specific Enolase Assay Kit Receives Medical Registration Certificate

On February 24, Dirui Medical Technology Co., Ltd. announced that its Neuron-Specific Enolase (NSE) Assay Kit (Chemiluminescent Immunoassay) had obtained the Medical Device Registration Certificate issued by the National Medical Products Administration. The kit is used for the in vitro quantitative determination of neuron-specific enolase (NSE) levels in human serum. It is primarily intended for dynamic monitoring of patients with malignant tumors to assist in assessing disease progression or treatment efficacy. It shall not be used as a basis for early diagnosis or definitive diagnosis of malignant tumors, nor for cancer screening in the general population.

Kadmon Reports Positive Results for Oral ROCK2 Inhibitor KD025

Recently, Kadmon Holdings announced the latest data from its pivotal ROCKstar clinical trial evaluating KD025, an oral selective Rho-associated coiled-coil containing protein kinase 2 (ROCK2) inhibitor, for the treatment of chronic graft-versus-host disease (cGVHD). The results showed that an interim analysis conducted two months after completion of patient enrollment (October 2019) had met the objective response rate (ORR) endpoint. Data indicated that the ORRs were 64% and 67% in the groups receiving KD025 200 mg once daily and 200 mg twice daily, respectively, with both results being statistically and clinically significant.

Hengrui Medicine’s Oral A2AR Antagonist SHR5126 Approved for Clinical Trials

On February 24, Hengrui Medicine announced that SHR5126 tablets had received approval for clinical trials, with the intended use being the treatment of patients with solid tumors; specific indications are to be determined through clinical trials. SHR5126 is a novel, potent, and highly selective oral A2AR antagonist that significantly inhibits human A2AR activity and reduces intranuclear pCREB levels. It further enhances the activation of tumor-infiltrating CD8+ T cells by immune checkpoint inhibitors, thereby exerting anti-tumor effects through the secretion of IFN-γ and other mechanisms. It is intended for the treatment of patients with solid tumors.

Unimed Pharma Releases 2019 Financial Results: Revenue of RMB 611 Million, Down 9.39% Year-on-Year

On February 24, Unimed Pharmaceuticals released its preliminary earnings report. The company reported operating revenue of RMB 611 million for the period from January to December 2019, representing a year-on-year decrease of 9.39%, compared with an average operating revenue growth rate of 18.43% in the biological products industry. Net profit attributable to shareholders of the listed company amounted to RMB 37.7545 million, marking a year-on-year increase of 139.87%, while the average net profit growth rate in the biological products industry was 17.88%.

Xintong Pharmaceutical Plans to Invest RMB 300 Million in Building an R&D and Industrialization Base for Liver-Targeted Innovative Drug Series

On February 22, the online signing ceremony for a series of projects under Xi’an’s biomedical industry cluster was held in the Xi’an High-Tech Industries Development Zone. Xi’an Xintong Pharmaceutical Research Co., Ltd. announced its plan to invest RMB 300 million in establishing an R&D and industrialization base for liver-targeted innovative drugs. Currently, five innovative drug candidates are at various stages of development, with three expected to receive marketing approval between 2021 and 2024. Upon reaching full production capacity, the project is projected to generate annual sales revenue of RMB 6 billion.

“Cancer Cell”: Circular RNAs Restrict Metastasis of Skin Cancer

Recently, a new study has found that a mysterious genetic material can inhibit the spread of skin cancer cells, but this substance is often lost as they mature. This new research was recently published in "Cancer Cell". Typically, DNA is converted into RNA, which is then translated into proteins with cellular functions. While most RNAs are linear molecules, some form circles when their ends loop and attach to each other. This new study shows that when the interaction between CDR1as and the RNA-binding protein IGF2BP3 is disrupted, melanoma metastasis begins.

*Nature*: Novel Immune Cells Aid Cancer Immunotherapy

Recently, a research team from MSK discovered a group of immune cells known as innate lymphoid cells (ILCs). These cells are present in many different tissues and appear to exert mild anti-tumor effects under normal, quiescent conditions. The researchers demonstrated that pharmacological activation of ILCs can mobilize T cells to reduce the volume of pancreatic cancer tumors. Vinod Balachandran, a surgical scientist affiliated with the Pancreatic Cancer Research Center and an author of the study, stated, “We believe this represents an important discovery for both pancreatic cancer research and cancer immunotherapy as a whole. We are learning how to harness multiple components of the immune system to combat cancer. We think this signals the imminent emergence of new immunotherapies.” The relevant findings were published in the recent issue of Nature.