Expert Reports: 83% of Clustered Outbreaks Occur in Households; National Epidemic Trending Downward

Chinese Center for Disease Control and PreventionExpert: 83% of Cluster Outbreaks Occur in Households

On February 11, at a press conference held by the Joint Prevention and Control Mechanism of the State Council, Wu Zunyou, Chief Epidemiologist at the Chinese Center for Disease Control and Prevention, stated that more than 83% of cluster outbreaks occurred in households, with the remaining cases reported in medical institutions, supermarkets and shopping malls, enterprises, and public institutions. He further noted that the occurrence of cluster outbreaks indicated that the virus had not spread widely into the general community, reflecting the effectiveness of preventive and control measures.

President of Jinyintan Hospital: COVID-19 Is a Self-Limiting Disease with a High Cure Rate

On February 10, the Hubei Provincial Command Center for COVID-19 Prevention and Control held a press conference. At the conference, Zhang Dingyu, Deputy Secretary of the Party Committee and President of Jinyintan Hospital, stated that COVID-19 is a self-limiting disease; although there is no specific cure, the recovery rate at his hospital remains high.

National Health Commission: The national epidemic situation is generally showing a downward trend

On February 11, 2020, He Qinghua, head of the Disease Control and Prevention Bureau under the National Health Commission, stated that the epidemic situation in China, excluding Hubei Province, was generally showing a downward trend. From 0:00 to 24:00 on February 10, there were 381 newly confirmed cases in areas outside Hubei, marking the seventh consecutive day of decline. Even including Wuhan, Hubei Province, the national epidemic situation was also generally trending downward.

Biopharmaceutical Technology Company Kite Announces CAR-T Therapy Receives FDA Priority Review Designation

On February 11, 2020, Kite, a Gilead Sciences company, announced that the U.S. Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for KTE-X19, a CAR-T cell therapy, for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL). The FDA also granted Priority Review designation to the therapy, with a decision expected by August 10 of this year. The press release noted that, if approved, Kite would become the first company to have multiple commercialized CAR-T therapies.

Johnson & Johnson’s IL-12/23 Inhibitor Stelara Approved in the EU for Pediatric Patients with Plaque Psoriasis

Recently, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), announced that the European Commission (EC) has approved an expansion of the indications for Stelara (Chinese brand name: Xidano; generic name: ustekinumab injection) to include the treatment of pediatric patients aged 6–11 years with moderate-to-severe plaque psoriasis. Previously, Stelara was approved for adolescent and adult patients aged 12 years and older with plaque psoriasis. Stelara is now the first selective IL-23/IL-12 biologic agent indicated for pediatric patients aged 6–11 years, targeting the IL-23/IL-12 pathway, which plays a critical role in the pathogenesis of this disease.

Precision Medicine Company Blueprint Announces FDA Extends Review of Targeted Cancer Drug Ayvakit by Three Months

Recently, precision medicine company Blueprint Medicines announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target date for a New Drug Application (NDA) for its targeted anticancer drug Ayvakit (avapritinib). The NDA seeks accelerated approval of avapritinib as a fourth-line treatment for patients with gastrointestinal stromal tumors (GIST). The FDA has extended the PDUFA target date from February 14, 2020, to May 14, 2020.

Taiji Group’s Subsidiary Southwest Pharmaceutical’s “Acetaminophen Tablets” Pass Consistency Evaluation

On February 10, Taiji Group announced that its controlled subsidiary, Southwest Pharmaceutical, had received the "Drug Supplemental Application Approval" (Approval No. 2020B02183) from the National Medical Products Administration (NMPA) regarding "Acetaminophen Tablets." Upon review, the drug has passed the consistency evaluation of quality and efficacy for generic drugs. According to available information, Acetaminophen Tablets are indicated for fever caused by the common cold or influenza, as well as for the relief of mild to moderate pain such as headache, joint pain, and toothache.

Biopharmaceutical Company Inovio Receives FDA Authorization to Initiate Phase 1/2 Clinical Trial of INO-3107

On February 11, 2020, biopharmaceutical company Inovio Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) had accepted its Investigational New Drug (IND) application to evaluate the efficacy of its DNA-based therapeutic candidate INO-3107 for recurrent respiratory papillomatosis (RRP) in a Phase 1/2 clinical trial. In addition to initiating this efficacy trial, Inovio also plans to seek orphan drug designation from the FDA’s Office of Orphan Products Development (OOPD).

Cain Technology’s Class 1 New Drug KW-136 Capsules Are Set for Approval

On February 5, the review and approval status of KW-136 capsules, a Class 1 new drug submitted for marketing by Cayan Technology, was updated to “Under Approval.” Used in combination with sofosbuvir, this product is poised to become China’s first all-oral, pan-genotypic curative regimen for hepatitis C.

Biopharmaceutical Company Myovant Sciences’ Innovative Therapy for Uterine Fibroids Meets Phase 3 Clinical Endpoints

On February 11, 2020, Myovant Sciences announced that its investigational relugolix combination therapy met the primary efficacy endpoint in the LIBERTY Phase 3 extension clinical trial for the treatment of patients with uterine fibroids. Results from the LIBERTY extension study demonstrated that the relugolix combination therapy achieved an 87.7% response rate within one year while maintaining patients’ bone mineral density (response was defined as menstrual blood loss of less than 80 mL, or a reduction of more than 50% in menstrual blood loss during the last 35 days of the treatment cycle compared with baseline). These data further support the New Drug Application (NDA) scheduled for submission this April.

Lilly and Roche’s Antibody Drugs Fail in Phase II/III Alzheimer’s Disease Studies

On February 10, Eli Lilly and Roche separately announced that solanezumab and gantenerumab failed to meet the primary endpoint in a study aimed at improving symptoms in patients with autosomal dominant Alzheimer’s disease (ADAD). The study, named DIAN-TU, was a Phase II/III randomized, double-blind, placebo-controlled trial. It evaluated whether Eli Lilly’s solanezumab and Roche’s gantenerumab, compared with placebo, could slow the rate of cognitive decline and improve disease-related biomarkers in patients with known hereditary Alzheimer’s disease.

DIAN-TU Misses Primary Endpoints in Both Phase II and Phase III Clinical Trials for Alzheimer’s Disease

On February 11, 2020, scientists at Washington University in St. Louis (WashU) released top-line data from the DIAN-TU Phase II/III clinical trial for Alzheimer’s disease. The trial enrolled 490 patients with dominantly inherited Alzheimer’s disease (ADAD), who were treated with Eli Lilly’s anti-amyloid antibody solanezumab, Roche’s anti-amyloid antibody gantenerumab, or placebo. The reported data were derived from observations of 194 patients with a mean follow-up of 5 years and a maximum of 7 years. The results showed that neither drug improved cognitive function, failing to meet the primary endpoint of the trial.

Zhongsheng Pharmaceutical’s Chloroquine Phosphate Tablets Receive Approval for Supplemental Drug Application and Resume Production

On February 11, Zhongsheng Pharmaceutical issued an announcement stating that its application to resume production of the drug “Chloroquine Phosphate Tablets” had been approved. The company has received the “Approval Document for Supplementary Drug Application” issued by the Guangdong Provincial Medical Products Administration (NMPA), thereby completing all necessary procedures for resuming production of “Chloroquine Phosphate Tablets.” Zhongsheng Pharmaceutical noted that although it held the manufacturing approval for “Chloroquine Phosphate Tablets,” the product had not been manufactured or marketed for many years. Upon learning that chloroquine exhibited certain in vitro inhibitory activity against the novel coronavirus, the company, under the guidance of the Guangdong Provincial NMPA and other relevant authorities, organized efforts to resume production of “Chloroquine Phosphate Tablets” and promptly obtained the “Approval Document for Supplementary Drug Application” for the product.

Pfizer’s Crisaborole Ointment, Acquired for $5.2 Billion, Files for Market Approval in China

On February 10, the Center for Drug Evaluation (CDE) accepted Pfizer’s marketing application for crisaborole ointment in China. Crisaborole is a non-steroidal phosphodiesterase-4 (PDE4) inhibitor that Pfizer acquired in May 2016 through its $5.2 billion purchase of Anacor Pharmaceuticals. On December 14, 2016, the U.S. Food and Drug Administration (FDA) approved the drug, marketed under the brand name Eucrisa, for the treatment of mild-to-moderate atopic dermatitis in pediatric and adult patients. The drug has also been approved in Canada, Australia, and Israel. In 2019, Eucrisa generated $138 million in sales.

Regeneron’s Eylea (Aflibercept) Reduces Risk of Vision-Threatening Events by 75% Over Two Years of Treatment

Recently, Regeneron announced positive two-year data from the Phase III PANORAMA trial, which evaluated the ophthalmic drug Eylea (aflibercept)^®, aflibercept intravitreal injection solution) 2 mg (0.5 mL) for the treatment of patients with moderate to severe non-proliferative diabetic retinopathy (NPDR). According to Kaplan-Meier analysis, more than half (58%) of untreated sham-injection group patients developed vision-threatening complications (VTC) or center-involved diabetic macular edema (CI-DME) within 2 years after entering the trial. In contrast, treatment with Eylea demonstrated at least a 75% reduction in the likelihood of these vision-threatening events (nominal p < 0.0001).

Menovo and Simcere Collaborate to Develop the Antiviral Active Pharmaceutical Ingredient Arbidol Hydrochloride

On February 10, Menovo issued an announcement stating that on February 2, 2020, the company convened the 18th meeting of its third Board of Directors, which reviewed and approved the “Proposal on Cooperative Research and Development with Nanjing Simcere Dongyuan Pharmaceutical Co., Ltd. and Related-Party Transactions.” The proposal approved the cooperation between Xuancheng Menovo, a controlling subsidiary of the company, and Nanjing Simcere Pharmaceutical to jointly develop the antiviral active pharmaceutical ingredient (API) arbidol hydrochloride and various other antiviral APIs.

FDA Releases Latest Report: No Link Between Cell Phone Radiation and Cancer

On February 11, according to foreign media reports, a latest report from the U.S. Food and Drug Administration (FDA) reviewed relevant scientific studies published over the past 11 years and maintained that exposure to radiofrequency radiation from mobile phones does not pose significant health risks. The report did not provide a definitive conclusion. In fact, the FDA continues to urge researchers to further investigate the effects of mobile phones on humans, shifting the research focus from the general population to individuals predisposed to tumors.

Nature: Scientific Team Completes Most Comprehensive Cancer Genome Analysis to Date

Recently, the Wellcome Sanger Institute in the United Kingdom announced that an international team had completed the most comprehensive whole-genome analysis of cancer to date. This project, known as the “Pan-Cancer Project,” was carried out through collaboration among more than 1,300 scientists from 37 countries, aiming to investigate genetic variants that can lead to cancer and to map a complete atlas of these genes. The Sanger Institute is one of its key members. The team analyzed 2,658 whole genomes across 38 different types of tumors, generating rich genomic data for cancer research. The related findings were published on the same day as a series of more than 20 papers in Nature and its subsidiary journals.