1.Epidemic Update
China CDC: The risk of viral transmission to humans through contaminated clothing is extremely low
On February 20, Feng Luzhao, a researcher at the Chinese Center for Disease Control and Prevention, stated that the likelihood of viral transmission through contaminated clothing is extremely low. Unless individuals have visited specific locations, such as hospitals to visit patients, or have had contact with persons exhibiting suspicious symptoms, there is no need to perform specialized disinfection of their clothing. Additionally, spraying alcohol on clothing poses a fire hazard when exposed to open flames, high temperatures, or static electricity; therefore, it is recommended not to spray alcohol directly onto clothing.
National Healthcare Security Administration: RMB 17.129 billion in special funds has been disbursed in advance
On February 20, Xiong Xianjun, Director of the Department of Pharmaceutical Management under the National Healthcare Security Administration, stated that medical expenses for patients with novel coronavirus pneumonia (COVID-19) would be budgeted separately and would not count against the overall budget targets. As of February 19, healthcare security authorities at all levels had advanced a total of RMB 17.129 billion in special funds specifically designated for the medical treatment of COVID-19. Of this amount, RMB 3.016 billion was pre-allocated to Hubei Province, including RMB 902 million to Wuhan City. Based on the actual medical costs incurred by confirmed and suspected cases to date, the pre-allocated funds are sufficient to meet current needs for medical treatment.
National Healthcare Security Administration: Confirmed or Suspected Patients to Receive Treatment First, Settlement Later
On February 20, Xiong Xianjun, Director of the Department of Pharmaceutical Management under the National Healthcare Security Administration, stated that to effectively carry out medical treatment for COVID-19, two clear guarantees had been put forward: ensuring that patients’ access to care is not hindered by costs, and ensuring that hospitals’ provision of treatment is not affected by payment policies. For patients confirmed or suspected of having COVID-19 as recognized by health authorities, treatment will be provided prior to settlement. After coverage by basic medical insurance, critical illness insurance, and medical assistance according to regulations, the remaining out-of-pocket expenses will be subsidized by government finances.
Hongri Pharmaceutical’s Xuebijing Injection Included in Recommended Medications for COVID-19
On February 20, Chase Sun Pharmaceutical issued a noon announcement stating that its product, Xuebijing Injection, had been included as a recommended medication in the "Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 6)." The previous day, Chase Sun Pharmaceutical also stated on its interactive platform that Xuebijing Injection was being used in more than 1,000 designated hospitals for the treatment of novel coronavirus pneumonia. The scope of its use is continuing to expand, and clinical physicians have reported definitive therapeutic efficacy. Other data are still being compiled. The inclusion is expected to have a positive impact on the market promotion and sales of Xuebijing Injection; however, the impact on the company’s operating performance cannot be estimated at this time.
At the Request of the Guangdong Provincial Government, Bayer Allocated 300,000 Tablets of Chloroquine Phosphate to China to Combat the COVID-19 Pandemic
Recently, Bayer Group announced that its subsidiary in Pakistan, at the request of the Guangdong Provincial Government, urgently allocated 300,000 tablets of Resochin® (chloroquine phosphate tablets) this month and provided them free of charge. The approval for the first batch was expedited and completed within 24 hours, enabling the fastest possible international aid effort encompassing production, stockpiling, and delivery. These supplies are intended for epidemic prevention and control reserves as well as for use in clinical trials. Previous studies have shown that Resochin not only has antimalarial effects but also exhibits broad-spectrum antiviral activity and significant immunomodulatory effects.
Wondfo’s Two COVID-19 Testing Products Enter Emergency Approval Pathway
On February 20, Wondfo Biotech announced that it had recently received the “Letter on Recommending Relevant Products for Detection Reagent Emergency Projects to Enter the Emergency Approval Channel” from the Office of the Joint Prevention and Control Mechanism of the State Council in Response to the Novel Coronavirus Pneumonia Epidemic (Scientific Research Task Force). The company’s two product submissions—namely, a novel coronavirus antigen rapid test kit suitable for point-of-care use during the epidemic, and a novel coronavirus antibody rapid test kit based on fluorescent microsphere/colloidal gold immunochromatography technology—have been recommended for entry into the emergency approval channel.
2.Over the past 24 hours, VCBeat has monitored one financing/investment event and one acquisition in the biopharmaceutical sector.
ImmuneOnco Completes RMB 45 Million Pre-B Financing Round, Deepening Its Focus on the Field of Tumor Immunology
On February 20, ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. announced the completion of a RMB 45 million Pre-B financing round. This round was jointly invested by Shengzhou Minglang Industrial Development Equity Investment Fund Partnership (Limited Partnership) and Shijiazhuang High-Tech Zone Pu’en Guoxin Equity Investment Center (Limited Partnership). The proceeds from this financing will be primarily used for the clinical development and research of the IMM01 and IMM0306 projects.
Pharmaceutical Company Humanetics Acquires Manufacturing Assets for DSM’s Radioprotective Drug BIO 300
On February 19, 2020, clinical-stage pharmaceutical company Humanetics announced that it had entered into a definitive agreement with DSM Nutritional Products Ltd. to acquire all assets related to the production of the active pharmaceutical ingredient (API) for BIO 300. BIO 300 is a clinical-stage drug developed by Humanetics for oncology and biodefense applications. Currently, Humanetics has secured substantial federal funding to advance BIO 300 toward FDA approval.
3.Approval Status: Latest Updates from the FDA, NMPA, and EU
Biopharmaceutical Company Monopar’s Camsirubicin Granted Orphan Drug Designation by the European Commission
On February 20, biopharmaceutical company Monopar Therapeutics announced that the European Commission (EC) has granted orphan drug designation (ODD) to camsirubicin for the treatment of soft tissue sarcoma (STS). Camsirubicin is a novel doxorubicin (adriamycin) analog. Numerous clinical studies have demonstrated the anticancer efficacy of long-term, high-dose doxorubicin therapy; however, its optimal clinical benefit has historically been limited by the risk of irreversible, potentially life-threatening cardiotoxicity in patients.
FDA Grants Fast Track Designation to ALX’s Lead Candidate ALX418 for the Treatment of Head and Neck Cancer and Gastric Cancer
Recently, immuno-oncology company ALX Oncology announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its lead candidate, ALX148, for two indications: first-line treatment of patients with head and neck squamous cell carcinoma (HNSCC), and second-line treatment of patients with HER2-positive gastric or gastroesophageal junction (gastric/GEJ) adenocarcinoma.
Livzon Pharmaceutical’s IL-17A/F Monoclonal Antibody Clinical Trial Application Approved by the National Medical Products Administration
On February 20, Livzon Pharmaceutical Group issued a corporate announcement stating that the clinical trial application for its “Recombinant Humanized Anti-Human IL-17A/F Monoclonal Antibody Injection,” jointly submitted by Zhuhai Livzon Monoclonal Antibody Biotechnology Co., Ltd., a controlled subsidiary of Livzon Pharmaceutical Group Inc., and Beijing Xinkanghe Biopharmaceutical Technology Co., Ltd., has been approved by the National Medical Products Administration. The IL-17A/F monoclonal antibody can promote the expression of other pro-inflammatory cytokines and effector proteins, further leading to the activation of neutrophils, macrophages, epithelial cells, and fibroblasts, playing a significant role in the pathophysiology of many autoimmune diseases.
Seattle Genetics’ ADC Combination Therapy Receives FDA Breakthrough Therapy Designation
On February 20, Seattle Genetics and Astellas jointly announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the combination therapy of the antibody-drug conjugate (ADC) Padcev (enfortumab vedotin-ejfv) and pembrolizumab as a first-line treatment for previously untreated patients with locally advanced or metastatic urothelial carcinoma.
Immutep Announces Positive Phase 2 Clinical Results for Eftilagimod Alpha Combination Therapy
Recently, pharmaceutical company Immutep announced that its soluble LAG-3 fusion protein eftilagimod alpha, in combination with Merck’s PD-1 inhibitor Keytruda, achieved positive interim results in a Phase 2 clinical trial. As a first-line treatment for patients with non-small cell lung cancer (NSCLC), the combination therapy demonstrated an overall response rate (ORR) of 47%. In contrast, Keytruda monotherapy yields an ORR of only 20% in NSCLC patients when not selected for high PD-L1 expression levels. Additionally, the combination therapy achieved an ORR of 33% as a second-line treatment for patients with head and neck squamous cell carcinoma (HNSCC).
Medicinal Cannabis Company Zelira’s Product ZTL-101 Achieves Clinical Success
On February 20, medicinal cannabis company Zelira Therapeutics announced positive results from its Phase Ib/IIa trial evaluating ZLT-101 for the treatment of patients with chronic insomnia. The data showed that ZLT-101 treatment met the primary endpoint, achieving a statistically significant improvement in Insomnia Severity Index scores.
Pharmaceutical Company Incyte’s Topical JAK Inhibitor Ruxolitinib Meets Phase 3 Clinical Endpoints
On the 20th, pharmaceutical company Incyte announced that its topical JAK inhibitor ruxolitinib formulation met the primary endpoint in the second Phase 3 clinical trial, TRuE-AD1, for the treatment of patients with atopic dermatitis. In the TRuE-AD1 Phase 3 trial involving adolescent and adult patients with mild-to-moderate atopic dermatitis, treatment with ruxolitinib for 8 weeks resulted in a significant improvement of ≥2 points from baseline in the Investigator’s Global Assessment (IGA) total score in 50% (0.75% dose) and 53.8% (1.5% dose) of patients, compared with only 15.1% in the placebo group, thereby meeting the trial’s primary endpoint.
Haijieya's Combo Knife, a Minimally Invasive Cryo-Thermal Ablation Device for Tumors, Receives EU CE Certification
Recently, Haijieya Medical’s pioneering combined cryo-thermal ablation device has obtained EU CE certification, granting approval for market launch and formal clinical commercial use in Europe. The Kangbo Knife, independently developed by Haijieya Medical, primarily consists of a main unit, combined cryo-thermal ablation probes, and multi-point temperature probes. Under imaging guidance, ultra-fine probes are percutaneously inserted into the human body to achieve targeted energy release of liquid nitrogen at the probe tip, subjecting tumor tissue to alternating cold and thermal injury ranging from -196°C to 80°C. Compared with pure cryoablation or thermal ablation alone, this alternating cold-thermal cycle induces reperfusion injury, increases vascular permeability, causes more severe endothelial damage, and thereby exacerbates tumor ischemia and necrosis.
Ruikang Pharmaceutical’s Independent Chairman Quan Yuhua Resigns
On February 20, Realcan Medicine announced that its Board of Directors had recently received a written resignation report from Ms. Quan Yuhua, the company’s independent director. Ms. Quan has applied to resign from her positions as independent director and member of relevant specialized committees due to personal reasons. Following her resignation, she will no longer hold any position within the company.
Science Advances: Unveiling a New Mechanism of Multidrug Resistance in Cancer Cells
Recently, researchers at the Korea Advanced Institute of Science and Technology (KAIST) have identified the mechanism by which acquired resistance to first-line chemotherapy transitions to second-line targeted therapy, a process that leads to a “domino effect” in cancer drug resistance. Their study, published in *Science Advances*, proposes a new strategy to improve second-line treatments for patients who have developed resistance to anticancer drugs.