Chinese health regulators have just given Shanghai Fosun Pharmaceutical the green light to begin clinical trials for its vaccine candidate for the novel coronavirus. The news of the approval for its clinical trial application sent the company's stocks in Hong Kong upwards on Monday. The company's shares had surged by more than 10 percent before closing 1.8 percent higher at HK$31.2 per share.
The Chinese pharmaceutical firm revealed in a filing with the Hong Kong Stock Exchange that the clinical trial application for its Covid-19 mRNA vaccine had been approved by the National Medical Products Administration (NMPA). The particular vaccine candidate had been developed in collaboration with the German pharmaceutical company BioNTech.
Under the two companies' licensing agreement, Fosun Pharmaceutical has agreed to pay BioNTech up to $85 million in licensing fees for the vaccine candidate. Fosun Pharmaceutical has also agreed to give BioNTech 35 percent of the gross profit if the vaccine does end up in the market.
Apart from its partnership with Fosun Pharmaceutical, BioNTech is also currently working with US-based Pfizer to develop two experimental coronavirus vaccines. On Monday, one of the vaccines had received a "fast track" designation from the U.S. Food and Drug Administration (FDA). BioNTech's agreement with Pfizer, unfortunately, excludes possible distribution to China.
Fosun Pharmaceutical's chief executive officer, Wu Yifang, mentioned in a statement that they will immediately begin clinical trials on its vaccine candidate. He added that the company will be working closely with the NMPA, formerly known as the China Food and Drug Administration (CFDA), and other regulatory bodies on the assessment of its vaccine candidate's efficacy and safety.
Once the clinical trials are complete and the company manages to acquire additional approval, Fosun Pharmaceutical plans to bring the product to market along with other international vaccines.
Fosun Pharmaceutical's RNA vaccine works differently from traditional vaccines as it introduces an mRNA sequence to the body. These types of vaccines are also easier and much cheaper to produce. This means that Fosun Pharmaceutical can effectively mass-produce the vaccine if it is indeed proven to be effective in preventing infection.
As of today, no mRNA vaccine has been approved for a global launch. Dozens of companies from around the world are working tirelessly to produce an effective mRNA vaccine treatment, while others are exploring other types of vaccines. Currently, around 23 coronavirus vaccine candidates are undergoing clinical trials and evaluations. Eight out of the 23 candidates are being developed by Chinese companies, directly or indirectly. Around 137 other vaccine candidates are under preclinical evaluation.
