Amunix Secures $73 Million Series A Financing to Advance Oncology Pipeline; China's Pandemic Measures Prevented Over 100,000 Cases

National Health Commission: To recommend relevant Chinese institutions to serve as WHO reference laboratories for novel coronavirus surveillance

On March 5, Zeng Yixin, Deputy Director of the National Health Commission, stated at a press conference held by the State Council Information Office that China is preparing to nominate relevant Chinese institutions to serve as WHO Reference Laboratories for Novel Coronavirus Surveillance. China will share its technical protocols for diagnosis, treatment, and prevention and control with the World Health Organization (WHO), promote deeper participation of Chinese research institutions and scientists in international scientific collaborations led by the WHO, and actively recommend experts to provide technical support to affected countries through the WHO platform.

China’s Prevention and Control Measures Successfully Averted or Prevented at Least 100,000 Cases

On March 5, the State Council Information Office held a press conference. Zeng Yixin, Deputy Director of the National Health Commission, stated that diseases know no borders, and the COVID-19 pandemic is a common challenge facing humanity. The investigation report released by the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19) noted that China had adopted the most courageous, flexible, and proactive containment measures in history against this previously unknown virus, successfully avoiding or at least preventing 100,000 cases, and establishing a strong first line of defense against the international spread of the disease.

bioRxiv: Study Reveals Replication Characteristics of SARS-CoV-2 in the United States

On March 3, researchers from the U.S. Centers for Disease Control and Prevention (CDC) and other institutions published a paper on bioRxiv describing the virus isolated from the first confirmed COVID-19 patient in the United States, along with its genomic sequence and replication characteristics. The researchers stated that the unprecedented speed of the outbreak’s spread has created an urgent need for reference reagents to facilitate further research on SARS-CoV-2. The public health community requires viral lysates as diagnostic references, while the research community needs viral isolates to test antiviral compounds, develop new vaccines, and conduct fundamental research.

Biotech Startup Amunix Completes $73 Million Series A Financing to Advance Corporate Transformation

On March 5, biopharmaceutical startup Amunix announced the completion of a $73 million Series A financing round. The round was led by Omega Funds, with participation from Longitude Capital, Redmile Group, Polaris Partners, Casdin Capital, Two River, Venrock, and Delian Capital. Existing investor Frazier Healthcare Partners also continued its support. This funding will help Amunix transition from a technology platform company to an oncology drug development company.

Roche’s GALAD Blood Test Receives FDA Breakthrough Device Designation

On March 5, Roche announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its Elecsys GALAD score assay to support the early diagnosis of hepatocellular carcinoma (HCC). The algorithm underlying the Elecsys GALAD test integrates patient sex and age with biomarker levels of alpha-fetoprotein (AFP), AFP-L3 (a subtype of AFP), and des-gamma-carboxy prothrombin (PIVKA-II), facilitating earlier diagnosis of HCC. As a blood-based diagnostic tool, it offers a minimally invasive approach for patients.

Kanghong Pharmaceutical's Sedative-Hypnotic Drug Eszopiclone Tablets Pass Consistency Evaluation

On March 2, Kanghong Pharmaceutical’s eszopiclone tablets, a sedative-hypnotic agent, passed the consistency evaluation. Eszopiclone tablets are a new generation of non-benzodiazepine sedative-hypnotics. They exhibit high selectivity for γ-aminobutyric acid (GABA) receptors and possess pharmacokinetic characteristics including a time to peak concentration (Tmax) of 1 hour and a half-life (t1/2) of 6 hours. These properties enable rapid absorption and onset of action to induce sleep, sustain effects for 7–8 hours to maintain intact sleep, and result in minimal next-day residual effects.

Shanghai Pharmaceuticals’ Sedative-Hypnotic Drug Eszopiclone Tablets Pass Consistency Evaluation

On March 2, Shanghai Pharma’s Zhongxi Pharmaceutical obtained approval for the bioequivalence evaluation of its eszopiclone tablets. Eszopiclone tablets are a new generation of non-benzodiazepine sedative-hypnotic agents. They exhibit high selectivity for γ-aminobutyric acid (GABA) receptors and possess pharmacokinetic characteristics including a time to peak concentration (Tmax) of 1 hour and a half-life (t1/2) of 6 hours. These properties enable rapid absorption and onset of action to induce sleep, sustain effects for 7–8 hours to maintain uninterrupted sleep, and minimize residual effects the following morning.

CSPC Ouyi Rivaroxaban Tablets Pass Consistency Evaluation

On March 5, CSPC Ouyi’s rivaroxaban tablets, submitted under the new Class 4 application pathway, received approval from the National Medical Products Administration (NMPA) and were deemed to have passed the consistency evaluation. This makes CSPC Ouyi the second company in China to achieve consistency evaluation for this product, following Chia Tai Tianqing. Rivaroxaban is a novel oral anticoagulant that exerts its anticoagulant effect primarily by inhibiting the activity of coagulation factor Xa, thereby reducing the generation of thrombin (coagulation factor IIa), without affecting the activity of already formed thrombin. Currently, rivaroxaban is widely used for the prevention and treatment of venous thromboembolism, as well as for stroke prevention in patients with non-valvular atrial fibrillation.

Kura Oncology’s Anti-Tumor Drug Tipifarnib Receives FDA Fast Track Designation

Recently, biopharmaceutical company Kura Oncology announced that the FDA has granted Fast Track Designation (FTD) to its lead candidate drug tipifarnib for the treatment of adult patients with relapsed or refractory angioimmunoblastic T-cell lymphoma (AITL), follicular T-cell lymphoma (FTCL), and nodal peripheral T-cell lymphoma with T-follicular helper phenotype (TFH).

Sanofi’s Cablivi Approved in Canada for the Treatment of Acquired Thrombotic Thrombocytopenic Purpura

Recently, Sanofi announced that Health Canada has approved the nanobody drug Cablivi (caplacizumab) through its Priority Review pathway. In combination with plasma exchange and immunosuppressive therapy, Cablivi is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP). aTTP is a rare blood disorder characterized by the formation of blood clots in small vessels throughout the body, which can lead to damage to vital organs and potentially fatal complications. Cablivi is the first medication specifically approved in Canada for the treatment of aTTP.

GlaxoSmithKline Plans to Sell Its Antibiotics Business

On March 2, British pharmaceutical company GlaxoSmithKline (GSK) announced plans to divest part of its antibiotics business. According to insiders, the purpose of this divestiture is to allow GSK to focus on core businesses, including oncology immunotherapy. Bloomberg further reported that the assets slated for divestment include the franchise rights for cephalosporin prescription drugs, such as Zinnat and Fortum. Given that these drugs generate approximately $200 million in annual revenue for GSK, Bloomberg expects the sale to bring in hundreds of millions of dollars for the company.

Johnson & Johnson Submits Marketing Authorization Application for S1P1 Modulator Ponesimod to the European Medicines Agency

Recently, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), seeking approval for ponesimod for the treatment of adult patients with relapsing multiple sclerosis (RMS). Ponesimod is a novel, oral, selective sphingosine-1-phosphate receptor 1 (S1P1) modulator that functionally inhibits S1P protein activity and sequesters lymphocytes within lymph nodes, thereby reducing the number of circulating lymphocytes capable of crossing the blood-brain barrier.

Pfizer’s Potent “Last-Resort” Drug Lorlatinib Launches in Hong Kong, China for the Treatment of Non-Small Cell Lung Cancer

Currently, Pfizer’s third-generation ALK inhibitor lorlatinib is marketed in Hong Kong, China, and has been approved for the treatment of patients with ALK-positive advanced non-small cell lung cancer (NSCLC) who have experienced disease progression after crizotinib therapy or after treatment with at least one other ALK inhibitor. The advantage of lorlatinib lies in its potential efficacy even after resistance has developed to multiple other ALK inhibitors, earning it the reputation as a potent “last-resort” medication.

NMPA: Overuse of Immediate-Release and Extended-Release Acetaminophen Preparations Can Cause Severe Liver Injury

On March 3, the National Medical Products Administration (NMPA) issued an announcement on its official website titled “Announcement on Revising the Package Inserts of Immediate-Release and Extended-Release Acetaminophen Preparations,” stating that, to further ensure public medication safety, the NMPA has decided to revise sections such as [Adverse Reactions] and [Precautions] in the package inserts for immediate-release and extended-release acetaminophen preparations. The revision requirements released alongside the announcement indicate that immediate-release acetaminophen prescription and over-the-counter drugs should be used with caution in patients with hypersensitivity, and that overdose of immediate-release and extended-release acetaminophen preparations may cause severe liver injury.

《PLOS Genet》: Low-dose radiation used in medical imaging causes mutations in cell cultures

Recently, a new study found that these doses cause DNA breaks in human cell cultures, leading to the integration of extra DNA fragments into chromosomes. Roland Kanaar and Alex Zelensky from Erasmus University Medical Center, along with their colleagues, reported these new findings in the recently published issue of *PLOS Genetics*.