Chinese FDA Swiftly Approves BGI's Diagnostic Kits as They Rush to Defeat Virus
The National Medical Products Administration has announced the ‘emergency approval' of four diagnostic kits for the novel coronavirus, including BGI's.
Four diagnostic products for the new coronavirus have been approved for listing and immediate use by the National Medical Products Administration (NMPA), two of them from the Shenzhen-based giant BGI Genomics (300676: SH).
The kits possess tremendous importance for the afflicted region, considering the symptoms of the new virus are similar to other diseases like flu, further complicating the diagnostic process and creating excess demand among patients who need to be assessed. The claim that the critically short supply of diagnostic equipment has further escalated the crisis is not just a rumor anymore.
"The NMPA immediately started the approval processes for medical devices and approved four products, including the novel coronavirus 2019-nCoV nucleic acid detection kit with fluorescent PCR method and coronavirus nucleic acid sequencing systems," the NMPA – the regulatory head that supervises the CFDA, the China Food and Drug Administration – has announced.
The first batch of 100,000 kits from BGI will assist in the frontline of pathogen detection in Hubei province, the epicenter of the epidemic, and an additional 200,000 kits will be deployed to respond aggressively to the spread of the virus in the rest of the country, BGI announced. The Wuhan Municipal Health Commission has also designated BGI as the authorized institution for the detection of the new pathogen, the statement added.
BGI had previously released a statement on January 23 declaring that it has developed a real-time fluorescent RT-PCR kit for detecting the coronavirus that has been terrorizing the mainland and menacing the global economy. The firm is one of the flagship biotech companies and has been setting Chinese standards in the global arena, and known for its sequencing services.
The company is also drawing attention with its octopus-like global connections, bringing about the possibility for the company to serve global ministries and entities in case of a pandemic. Its stock price has jumped from around CNY 69 to 80 since the markets first got the hint about how serious the crisis might be – on January 20 after the Wuhan Health Commission's announcement that the virus had claimed three lives.
Yet the mainland's stock market had tumbled before it shut down for the Spring Festival. BGI and some other biotech companies are the only winners so far. The Chinese watchdog has suspended trading on the Shanghai and Shenzhen stock exchanges in an extended halt in accordance with the rest of the country's extended Spring Festival holidays. Analysts are eyeing the post-festival period to gauge the direction of the markets.
"The NMPA will continue to adopt special approval procedures for the drugs and medical devices required to fight for epidemic prevention and control, and strive to canalize them as soon as possible," the regulatory head said.