Pfizer's COVID-19 oral drug was approved for market launch, and its Chinese partners sparked market speculation

On December 22, local time, the US FDA announced that it approved an urgent authorization application (EUA) for Pfizer's new oral antiviral candidate Paxlovid for the treatment of COVID-19 infection in non-hospitalized adults at high risk of developing a serious illness. It is also the first COVID-19 oral antiviral drug approved by the FDA.

Paxlovid is a combination of the 3CL protease inhibitor nirmatrelvir with a low dose of Ritonavir, administered in combination with 300 mg (two 150 mg tablets) of nirmatrelvir and one tablet of 100 mg of ritonavir for oral administration in COVID-19 patients, 2 times a day for 5 days, in which ritonavir helps to slow down the metabolism or decomposition of nirmatrelvir, Keep its effective concentration in the body for a long time and fight the virus for a long time.

The data supporting this emergency use authorization came primarily from a randomized, double-blind, placebo-controlled clinical trial that enrolled adults who had confirmed COVID-19 positive and had not yet been hospitalized but developed symptoms. None of these patients had received the COVID-19 vaccine before and had never been infected with COVID-19. Clinical trial data suggest that Paxlovid significantly reduces the risk of COVID-19-related hospitalization or death in patients. Compared with the placebo-controlled group, the proportion of patients in the Paxlovid group who experienced hospitalization or death decreased by about 88%.

There are limits to the number of people who can use this drug. The FDA said that the age should be no less than 12 years old, weigh no less than 40 kilograms, and test positive for the new crown virus directly. These patients are at higher risk of developing severe COVID-19 disease (e.g., hospitalization or death). This is a prescription drug that can be diagnosed with COVID-19 and used as soon as possible within five days of symptoms.

In addition, the FDA said that Paxlovid's authorization does not include pre- and post-COVID-19 prophylaxis, nor does it include the treatment of critically ill COVID-19 patients, and Paxlovid is not a substitute for vaccines. In addition, emergency use authorization is not equivalent to full FDA approval.

Recently, Pfizer also reached an agreement with the Medicines Patent Pool to allow other manufacturers to produce nirmatrelvir.

It is worth mentioning that the approval of the above new drugs may also benefit some CDMO (contract custom research and development and production) companies that can provide OEM production.

In November this year, Chinese CDMO company Kai Laiying (002821.SZ, 06821.HKd) won two consecutive small molecule innovative drug CDMO orders, with a total contract amount of nearly 6 billion yuan. However, the company has not yet revealed who the specific customers are, but it has triggered market reverie.

Gloria Ying said in the 2021 semi-annual report that among the top 20 pharmaceutical companies in the world ranked by sales in 2020, the company has established cooperation with 15 companies and has continuously served 8 of them for more than 10 years, forming a strong cooperation stickiness with global pharmaceutical giants such as Pfizer, Merck, AbbVie, Eli Lilly, Bristol Squibb, and AstraZeneca.

Kai Laiying previously disclosed that during the epidemic period, the company undertook the development and production of two small molecule antiviral innovative drugs, one of which was a drug, through the application of continuous response, the key fragments were shortened from 4 steps to 1 step, and it took only 6 months to achieve tons-level scale-up production of molecules with only grams of process, significantly shortening the clinical research and development time; the other drug has now entered the third phase of clinical practice.