Zhong Nanshan: Origin of SARS-CoV-2 Remains Unclear; South Korea Sees Sixfold Surge in Online Mask Prices Amid Pandemic

Zhong Nanshan: The Origin of the Novel Coronavirus Remains Unclear

On February 27, Zhong Nanshan stated that there have been three coronavirus outbreaks in this century; therefore, any detected coronavirus infection, particularly those showing clustering patterns, must be addressed with immediate and stringent measures. The exact origin of the current novel coronavirus remains unclear. It is also unknown whether the virus had been present earlier. Pangolins are likely not the sole intermediate host.

Russia Has Developed Five Prototype Vaccines Against the Novel Coronavirus

On February 26, according to Russia’s TASS news agency, Russian Deputy Prime Minister Tatyana Golikova stated that Russia had developed five prototype vaccines against the novel coronavirus, but they were still in the early stages of research. At a press conference held in Moscow, Golikova announced that Russia had obtained the viral strain and developed five prototype vaccines, though this work remained in its preliminary phase. She emphasized that staff members were actively working on this effort and that further information would be released once more concrete results became available.

Clinical Study of China Biopharmaceutical’s Drug for the Treatment of COVID-19 Has Completed Filing and Registration

On February 26, 2020, China Biopharmaceutical Holdings Limited issued an announcement stating that the clinical trial registration for a study on the efficacy and safety of combining Diammonium Glycyrrhizinate Enteric-coated Capsules with Vitamin C tablets in the treatment of novel coronavirus pneumonia (COVID-19) had been completed. The announcement indicated that the Group has been committed to the research of glycyrrhizin compounds, having obtained multiple domestic patents in this field, and was honored with the National Gold Award for Patents as well as support from the National Major Science and Technology Project for Significant New Drugs Development.

Gilead Initiates Two Phase III Clinical Trials of Remdesivir for the Treatment of Novel Coronavirus Pneumonia

On February 26, 2020, Gilead Sciences announced the initiation of two Phase III clinical studies to evaluate the safety and efficacy of remdesivir in adult patients with novel coronavirus pneumonia (COVID-19). Beginning in March of this year, these randomized, open-label, multicenter trials will be conducted primarily at medical centers in Asia and other countries worldwide with high numbers of confirmed cases, enrolling approximately 1,000 patients. The studies will assess two intravenous dosing regimens of remdesivir. Gilead submitted Investigational New Drug (IND) applications for the use of remdesivir in the treatment of novel coronavirus pneumonia, and the U.S. Food and Drug Administration (FDA), following an expedited review, approved Gilead to commence these clinical trials.

Amid the COVID-19 Pandemic, Online Mask Prices in South Korea Surge Sixfold

On February 27, Yonhap News Agency reported that as the novel coronavirus (COVID-19) outbreak continued to spread within South Korea, online prices for face masks surged, with individual units now selling for over 4,000 Korean won (approximately RMB 23). According to data released by Statistics Korea on the 27th, the recent online price of KF94 masks exceeded 4,000 Korean won, representing a six- to eight-fold increase compared to pre-outbreak levels (700–800 Korean won), while prices at brick-and-mortar stores such as pharmacies and supermarkets remained stable at around 2,000 Korean won.

Beikang Medical Announces Approval for Market Launch of Preimplantation Chromosomal Aneuploidy Testing Kit

On February 26, 2020, the official website of the National Medical Products Administration (NMPA) announced the recent approval of the registration for an innovative product, the “Preimplantation Chromosomal Aneuploidy Detection Kit (Semiconductor Sequencing Method),” manufactured by Suzhou Beikang Medical Device Co., Ltd. Reportedly, this product establishes a method for detecting preimplantation chromosomal abnormalities using cells from blastocyst-stage embryos. It employs single-cell amplification technology to improve the alignment rate, uniformity, and coverage of sequencing results. Furthermore, by developing a data analysis model for embryonic chromosomal aneuploidy detection, it reduces analytical biases between samples caused by amplification bias, shortening the testing cycle to one day.

Biopharmaceutical Company Puma Announces FDA Approval of Targeted Drug Nerlynx for Third-Line Treatment of HER2-Positive Metastatic Breast Cancer

Recently, biopharmaceutical company Puma Biotechnology announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the targeted anticancer drug Nerlynx (neratinib) in combination with capecitabine. This approval is for patients with HER2-positive metastatic breast cancer who have previously failed two or more prior HER2-targeted therapies (third-line setting). Results from a Phase III study demonstrated that the Nerlynx plus capecitabine regimen significantly prolonged progression-free survival compared to the Tykerb (lapatinib) plus capecitabine combination in the third-line treatment of HER2-positive metastatic breast cancer.

FDA Advisory Committee Backs Approval of Eli Lilly’s Cyramza Combined with Erlotinib as First-Line Treatment for EGFR-Mutant Lung Cancer

Recently, Eli Lilly announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 6 in favor and 5 against to support a favorable benefit/risk profile for Cyramza (ramucirumab), an anti-VEGFR monoclonal antibody, in combination with erlotinib as first-line treatment for patients with epidermal growth factor receptor (EGFR) mutation-positive metastatic non-small cell lung cancer (NSCLC), based on results from the Phase III RELAY study.

Esperion’s Novel Mechanism Cholesterol-Lowering Drug Nexlizet Approved by FDA

Recently, biopharmaceutical company Esperion Therapeutics announced that the FDA has approved Nexlizet (bempedoic acid/ezetimibe, 180 mg/10 mg, tablets). This is the second cholesterol-lowering drug approved by the FDA for the company. Both drugs are oral, once-daily, non-statin LDL-C–lowering agents with the same indication: as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) and adults with atherosclerotic cardiovascular disease (ASCVD) who require further reduction of low-density lipoprotein cholesterol (LDL-C) levels. Both drugs will be launched in the United States on March 30, 2020.

FDA Issues Warning: Weight-Loss Drug Lorcaserin May Increase Cancer Risk; Recalled from U.S. Market

Recently, the FDA issued a warning that the weight-loss drug lorcaserin (Belviq) may increase the risk of cancer. Consequently, the agency has required manufacturers to withdraw the drug from the U.S. market. Eisai Co., Ltd. has voluntarily recalled lorcaserin from the U.S. market. Lorcaserin (lorcaserin hydrochloride) is a serotonin 2C receptor agonist that was approved by the FDA in 2012 for adult patients with obesity or overweight having a body mass index (BMI) ≥27 kg/m².

Jianyou Shares’ Heparin Sodium Injection USP Approved by FDA for Anticoagulant and Antithrombotic Indications

On February 27, 2020, Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (“King-Friend”) issued an announcement stating that it had recently received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Heparin Sodium Injection USP. Heparin Sodium Injection USP is primarily indicated for the treatment of conditions requiring anticoagulation and antithrombotic therapy. All nine specifications of the company’s Heparin Sodium Injection USP (in vials) have now obtained FDA approval. The eight previously approved specifications are already marketed and generating sales in the United States, and the newly approved specification is scheduled for launch and sale in the U.S. market in the near term, which is expected to have a positive impact on the company’s operating performance this year. It is reported that, to date, the company has incurred approximately RMB 26.4421 million in research and development expenses for the Heparin Sodium Injection USP project.

CTTQ’s Budesonide Suspension, the First Generic Version, Approved for Market Launch

On February 26, 2020, Chia Tai Tianqing’s Budesonide Suspension for Inhalation (brand name: Tianqing Suchang) officially received drug registration approval from the National Medical Products Administration (NMPA), granting it market authorization. Budesonide is a classic inhaled corticosteroid (ICS) used clinically for the treatment of glucocorticoid-dependent bronchial asthma or as an alternative to oral steroid therapy, allowing for dose reduction or substitution. Budesonide Suspension for Inhalation is one of the top-selling single products in China, with AstraZeneca’s originator product currently being the only option available on the market.

Dongyangguang Pharmaceutical’s Fingolimod Hydrochloride Capsules, the First Domestic Generic Version, Submitted for Market Approval in China for the Treatment of Multiple Sclerosis

On February 26, the Center for Drug Evaluation (CDE) accepted Dongyangguang Pharmaceutical’s marketing application for Fingolimod Hydrochloride Capsules for the treatment of multiple sclerosis (Acceptance Number: CYHS2000114). Fingolimod is a sphingosine-1-phosphate receptor modulator. The originator product is Novartis’s Gilenya, which was approved by the U.S. Food and Drug Administration (FDA) on September 21, 2010, for the treatment of patients with relapsing forms of multiple sclerosis (MS). According to Novartis’s 2019 financial report, global sales of fingolimod reached $3.223 billion, representing a slight year-on-year decline from $3.341 billion in 2018.

Sanofi’s Oral Selective Estrogen Receptor Degrader SAR439859 Capsules Submitted for Clinical Trial Approval in China

On February 26, Sanofi submitted an Investigational New Drug (IND) application in China for SAR439859 capsules, a selective estrogen receptor degrader (SERD). This drug has been positioned by Sanofi’s new CEO, Paul Hudson, as one of the group’s six key growth drivers. Phase II clinical data for SAR439859 as a second-line treatment for patients with ER+/HER2- breast cancer are expected to be released by the end of 2020; if successful, these results will support Sanofi’s submission of a New Drug Application (NDA) in 2021.

JAMA: Statins May Help Reduce the Risk of Ovarian Cancer in Women

A recent genetics study funded by Cancer Research UK has found that women who take statins long-term have a lower risk of developing ovarian cancer. The same result was observed in women carrying BRCA1/2 gene mutations (who are at higher risk for ovarian cancer). Published in the Journal of the American Medical Association (JAMA), the study analyzed genes and their degree of inhibition of HMG-CoA reductase, the enzyme responsible for regulating cholesterol levels in the body and the target through which statins lower cholesterol.

Cell Host & Microbe: Study Finds Enteritis Linked to Gut Microbiota Depletion

A recent study conducted by researchers at Stanford University School of Medicine has linked this condition to the absence of a specific gut microbe. The study suggests that supplementing missing bacterial metabolites in patients with ulcerative colitis, or helping to restore gut bacterial populations, could effectively treat these patients as well as those suffering from related intestinal inflammation.