Zhong Nanshan: Relevant Vaccines Still Require Time Before Clinical Application; Adjuvanted Monovalent Influenza A Vaccine Audenz Approved by FDA

Zhong Nanshan: It Will Take Time for Relevant Vaccines to Reach Clinical Application

On February 2, Zhong Nanshan, an academician of the Chinese Academy of Engineering and head of the expert group for scientific research under the joint prevention and control mechanism for the novel coronavirus (2019-nCoV) outbreak, stated in an interview that a scientific understanding of the 2019-nCoV epidemic is essential to implement effective containment measures and avoid unnecessary panic. Zhong noted that, to date, there are no specific antiviral drugs targeting 2019-nCoV. The efficacy of therapeutic agents reported in individual case studies still requires further validation through clinical trials. At least seven small-molecule drugs targeting viral RNA polymerase or proteases, including the CR3022 antibody therapy, are currently at various stages of clinical investigation. Related vaccine development is also underway, but it will take time before they are ready for clinical application.

Expert Briefing: Latest Updates on Pandemic Drug Development

On February 4, Sun Yanrong, Deputy Director of the Biotechnology Development Center of the Ministry of Science and Technology, stated that in drug development, increasing cure rates and reducing mortality rates are the top priorities for emergency research efforts. The development of new drugs is typically a lengthy process; however, the sudden outbreak has made it impossible to follow traditional pathways for new drug development. In response, the Ministry of Science and Technology promptly mobilized relevant experts to conduct targeted research, achieving certain progress by identifying a number of already-approved drugs with antiviral activity, including chloroquine phosphate, favipiravir, and several proprietary Chinese medicines.

Zhongsheng Quantai Opens Its Ultra-Large Peptide Library for Free to Accelerate R&D of Novel Drugs Against 2019-nCoV

Currently, Zhongsheng Quantai has completed the preparation of a peptide entity library containing approximately 500 million peptide sequences and operates a high-throughput new drug screening platform with a dedicated screening team. The company is actively negotiating with multiple parties, including the State Key Laboratory for Diagnosis and Treatment of Infectious Diseases at Zhejiang University and the State Key Laboratory of Applied Organic Chemistry at Lanzhou University, to form joint R&D teams for the urgent development of anti-2019-nCoV drugs. To accelerate the R&D process, Zhongsheng Quantai invites global teams and enterprises with new drug development capabilities to collaborate, offering free access to the world’s largest peptide entity library. It is committed to comprehensive and open domestic and international R&D cooperation to jointly overcome challenges and defeat the virus.

National Health Commission: Lopinavir/ritonavir and other drugs are undergoing clinical trials

On February 4, 2020, the National Health Commission held a press conference. Song Shuli, spokesperson for the National Health Commission, revealed that clinical trial data on lopinavir/ritonavir and certain traditional Chinese medicines were being collected. Ms. Song further disclosed that in addition to the clinical trials of lopinavir/ritonavir and some traditional Chinese medicines, another drug called remdesivir had recently emerged, with multiple medical institutions organizing clinical trials to evaluate its safety and efficacy.

On February 4, 2020, gene therapy company Passage Bio announced plans to raise $125 million through an initial public offering (IPO). The previous year, the company completed two rounds of financing totaling $225 million to develop therapeutics for rare monogenic central nervous system disorders. Among Passage Bio’s pipeline candidates, three leading gene therapies are being developed for the treatment of patients with GM1 gangliosidosis (GM1), frontotemporal dementia (FTD), and Krabbe disease.

Seqirus’s Adjuvanted Monovalent Influenza A Vaccine, Audenz, Approved by FDA for Market Launch

On February 4, 2020, Seqirus announced that the U.S. Food and Drug Administration (FDA) had approved its adjuvanted monovalent influenza A (H5N1) vaccine, Audenz, for the prevention of influenza A (H5N1) infection in individuals aged six months and older. The company’s press release noted that Audenz is the first FDA-approved cell-based, adjuvanted influenza A (H5N1) vaccine, designed to enhance protection against this strain of influenza in the event of a pandemic.

Aimmune’s First Peanut Allergy Treatment Approved by the FDA

For millions of people with peanut allergies, a new, first-of-its-kind treatment is now available. Recently, the U.S. Food and Drug Administration (FDA) approved Aimmune Therapeutics’ oral immunotherapy AR101, which will be marketed under the brand name Palforzia.

Biopharmaceutical Company Epizyme Announces FDA Approval of EZH2 Inhibitor TazemetostatListing

Recently, the FDA approved the marketing of Tazemetostat, a “first-in-class” EZH2 inhibitor developed by the biopharmaceutical company Epizyme, for the treatment of unresectable, metastatic or locally advanced epithelioid sarcoma. Tazemetostat is a highly active and selective epigenetic drug. EZH2 is a histone methyltransferase; its abnormal activation can lead to dysregulation of genes controlling cell proliferation, thereby causing unrestricted and rapid growth of cells in non-Hodgkin lymphoma and various other solid tumors. The drug exerts its antitumor effects by inhibiting EZH2 enzymatic activity.

Biopharmaceutical Company Resverlogix’s New Drug Apabetalone Receives FDA Breakthrough Therapy Designation

On February 4, 2020, the biopharmaceutical company Resverlogix announced that the U.S. FDA had granted Breakthrough Therapy Designation to its drug apabetalone (RVX-208). This designation is for use in combination with standard of care, including high-intensity statins, as a secondary prevention therapy for major adverse cardiovascular events caused by type 2 diabetes and acute coronary syndrome.

Bio-Thera Solutions’ BAT1706 Achieves Primary Endpoint in International Multicenter Phase III Clinical Study

On February 4, 2020, Bio-Thera Solutions, Ltd. announced that the international multicenter Phase III clinical study of BAT1706 (bevacizumab injection) had met its primary clinical endpoint. This international, multicenter, randomized, double-blind Phase III clinical study was designed to compare the efficacy and safety of BAT1706 with Avastin® in patients with advanced non-squamous non-small cell lung cancer. Trial data demonstrated that BAT1706 was equivalent to Avastin® in terms of clinical efficacy and safety.

AstraZeneca Announces That Brilinta Combined with Aspirin Significantly Reduces the Risk of Acute Ischemic Stroke

Recently, AstraZeneca announced that the Phase III THALES trial, which evaluated the cardiovascular outcomes of the anticoagulant Brilinta (ticagrelor), had met its primary endpoint. The results showed that initiating treatment within 24 hours after an acute ischemic stroke or transient ischemic attack (TIA) reduced the composite risk of stroke and death with Brilinta plus aspirin compared to aspirin alone.

Samsung Biologics Reports 64% Revenue Growth in FY2019, Eyes Global Expansion in 2020

INCHEON, South Korea, Feb. 4, 2020 /PRNewswire/ -- Samsung Biologics, a contract manufacturing organization (CMO) in the pharmaceutical industry, achieved record-high results in fiscal year 2019, reporting a 30.9% increase in sales to KRW 701.6 billion and a 64.6% surge in operating profit, which rose by KRW 91.7 billion from the previous year. The strong performance was driven by increased operations across all three of its manufacturing plants.

Robotic Pill Developer Rani Therapeutics Announces Potential IPO Within a Year

On February 4, 2020, Rani Therapeutics, a company headquartered in California, USA, announced that its investigational biologic delivery capsule, RaniPill, had performed better than expected in a trial involving 58 participants. In an interview, the company’s CEO, Mr. Mir Imran, stated that as clinical development of RaniPill accelerates, Rani requires financial support and is highly likely to conduct an initial public offering (IPO) within the next year.

Trefoil Selects AGC Biologics as Primary Manufacturer for TTHX1114, a Therapy for Corneal Diseases

On February 4, 2020, AGC Biologics, a global contract development and manufacturing organization (CDMO) for biopharmaceuticals, and Trefoil Therapeutics announced the execution of a manufacturing agreement to supply Trefoil’s lead product candidate, TTHX1114. Trefoil is developing this engineered form of fibroblast growth factor-1 (FGF-1) to restore vision in patients with corneal diseases by regenerating corneal tissue.