Home Pfizer's Revatio and Vyndaqel Approved in China; Zhong Nanshan Predicts COVID-19 Peak in Mid-to-Late February

Pfizer's Revatio and Vyndaqel Approved in China; Zhong Nanshan Predicts COVID-19 Peak in Mid-to-Late February

Feb 12, 2020 18:00 CST Updated 18:00

1.Epidemic Update.


WHO Report: Novel Coronavirus Linked to Rhinolophus Bat Coronaviruses

 

On February 11, a situation report on the novel coronavirus (2019-nCoV) released by the World Health Organization (WHO) indicated that growing evidence points to a link between the novel coronavirus and coronaviruses (CoVs) circulating in bats. More specifically, it is associated with coronaviruses found in bat subspecies of the genus Rhinolophus (horseshoe bats). According to the report, these Rhinolophus subspecies are abundant and widely distributed across southern China, as well as in Asia, the Middle East, Africa, and Europe.

 

Zhong Nanshan: The epidemic peak should occur in mid-to-late February; the inflection point cannot be predicted.

 

On February 11, the front-line ICU team of the Guangdong Medical Team in Wuhan held a remote video case discussion with their counterparts at the First Affiliated Hospital of Guangzhou Medical University in Guangzhou. Academician Zhong Nanshan stated via video link that, based on current data, the inflection point of the epidemic remains unpredictable, but the peak is expected to occur in mid-to-late February. The timing of the epidemic’s inflection point will depend on the effectiveness of containment measures during the peak return-travel period.

 

The World Health Organization named the novel coronavirus pneumonia “COVID-19”

 

On February 11, Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization (WHO), announced in Geneva, Switzerland, that the disease caused by the novel coronavirus would be named “COVID-19.” Tedros explained, “Under the joint guidelines of the WHO, the World Organisation for Animal Health, and the Food and Agriculture Organization of the United Nations, we needed to find a name that does not refer to a geographical location, an animal, an individual, or a group of people, while also being easy to pronounce and related to the disease.” Tedros emphasized the importance of naming the disease, as it helps avoid the use of inaccurate or stigmatizing names and establishes a standard format for future outbreaks of other coronaviruses.

 

National Administration of Traditional Chinese Medicine: Establishing a Collaborative Mechanism Between Traditional Chinese and Western Medicine for the Prevention and Control of Infectious Diseases Such as COVID-19

 

On February 12, the General Office of the National Administration of Traditional Chinese Medicine issued the "Notice on Establishing and Improving a Collaborative Mechanism between Traditional Chinese Medicine and Western Medicine in the Prevention and Control of Infectious Diseases such as Novel Coronavirus Pneumonia." The Notice proposes that health administrative departments at all levels, in conjunction with traditional Chinese medicine authorities, should promote medical institutions treating patients to establish and improve a system of joint consultations involving both traditional Chinese medicine and western medicine, with full-process collaboration, thereby enabling deep integration of traditional Chinese medicine into infectious disease prevention and control as well as clinical treatment. For medical institutions designated for centralized treatment of infectious disease patients, as well as general hospitals and specialized hospitals participating in infectious disease treatment—particularly those equipped with traditional Chinese medicine departments (or integrated traditional Chinese and western medicine departments)—a close and normalized system of joint TCM-Western medicine consultations shall be established, and diagnostic and treatment protocols shall be formulated.


2.Approval Status, Including FDA, NMPA, and the Latest Developments in Germany.


Pfizer’s Upjohn Brand Revatio Approved in China for New Indication: Treatment of Pulmonary Arterial Hypertension

 

On February 12, Pfizer Upjohn announced that Revatio (sildenafil citrate tablets) had been approved by the National Medical Products Administration (NMPA) of China on February 5, 2020, for the treatment of pulmonary arterial hypertension (PAH), a rare disease, to improve exercise capacity and delay clinical worsening. It is also the first phosphodiesterase-5 (PDE-5) inhibitor approved in China for the treatment of PAH.


Pfizer’s Innovative Rare Disease Drug Vyndaqel Approved in China

 

On February 12, Pfizer announced that Vyndaqel (tafamidis meglumine soft capsules, 20 mg), the world’s first oral transthyretin stabilizer, was approved by China’s National Medical Products Administration on February 5 for the treatment of adult patients with stage I symptomatic transthyretin amyloidosis polyneuropathy (ATTR-PN) to delay peripheral neurological impairment.


CTTQ’s Fulvestrant Injection ANDA Approved and Granted Marketing Authorization in Germany

 

On February 11, China Biopharmaceutical announced that its subsidiary, Chia Tai Tianqing, had received approval for an Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) and marketing authorization from the German Federal Institute for Drugs and Medical Devices (BfArM) for its anti-breast cancer drug, Fulvestrant Injection. The drug is currently under application for market approval in China and is considered equivalent to applying for consistency evaluation. Fulvestrant Injection is clinically indicated for postmenopausal women with estrogen receptor-positive breast cancer, including locally advanced or metastatic disease, who have relapsed following adjuvant anti-estrogen therapy or whose disease has progressed during anti-estrogen treatment.


FDA Grants Priority Review to Novartis’ Potent MET Inhibitor Capmatinib for Cancer Treatment

 

Recently, Novartis announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for capmatinib (INC280) and granted it Priority Review, shortening the review timeline from the standard 10 months to 6 months. Capmatinib is a MET inhibitor currently being evaluated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping (METex14) mutations, including both treatment-naïve (first-line) and previously treated patients.


Latest Global Developments in Biomedicine


01
Corporate News


China’s First Authoritative Real-Time Platform for Oncology Consultation Information Goes Live

 

On February 12, the Kapok Project launched a “Real-Time Broadcast Platform for Admission Updates from China’s Leading Oncology Hospitals” designed for cancer patients. By following this platform, patients can stay informed about the real-time status of their chosen oncology hospitals, eliminating the need for arduous travel, reducing the risk of contracting other infections during hospital visits, and alleviating anxiety among cancer patients. The Kapok Project is a brand under QTC CARE, a renowned innovative company led by Tencent in the fields of digital therapeutics R&D, innovative medical insurance services, and global healthcare services.

 

Xinchao Biology Successfully Develops and Produces Two Novel Coronavirus Test Kits

 

Recently, Shanghai ChipBio Technology Co., Ltd., a subsidiary of Shanghai Biochip Co., Ltd. (Shanghai National Engineering Research Center for Biochip), announced the successful development and production of two test kits: the Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR Fluorescent Probe Method); and the Colloidal Gold Immunochromatographic Assay Kits, including the Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Detection Kit and the Novel Coronavirus (2019-nCoV) IgM Antibody Detection Kit.

 

02
Other News


UK Begins Animal Trials for COVID-19 Vaccine: Mice Already Inoculated, with Hopes for Year-End Launch

 

On February 12, a research team at Imperial College London announced that animal trials for a coronavirus vaccine had commenced. Researcher Paul McKay stated that the initial phase involves testing the vaccine in mice, with the aim of evaluating their blood and antibody responses over the coming weeks. If successful, the vaccine could be ready for use by the end of this year.

 

The Lancet Subjournal: Early Administration of Dexamethasone Can Reduce Mortality in Patients with Acute Respiratory Distress Syndrome

 

Recently, in a new clinical study, Spanish researchers aimed to evaluate the role of dexamethasone in acute respiratory distress syndrome (ARDS), which may modulate pulmonary and systemic inflammation, leading to reduced duration of mechanical ventilation and lower mortality. The relevant findings were published online in The Lancet Respiratory Medicine.

 

"Cancer Cell": Study Reveals the Origin of Ovarian Cancer

 

Recently, researchers at the University of Oxford identified the cell of origin for ovarian cancer, facilitating the development of novel ovarian cancer screening tools. This new technology, known as single-cell RNA sequencing, enables the examination of all RNA molecules within individual cells. In this study, the researchers employed single-cell sequencing to analyze RNA in individual normal cells of the fallopian tube lining (epithelium). Through this approach, they were able to identify a new subtype of normal fallopian tube cells. The research paper was published in the journal Cancer Cell.