Pfizer's urgent domestic approval of Paxlovid is good for CDMO suppliers and domestic oral drugs?

TextNine Thoughts

Paxlovid's emergency approval worldwide will benefit domestic CDMO suppliers such as Asymchem and Proton

On February 11, the State Food and Drug Administration conducted emergency review and approval in accordance with the relevant provisions of the "Drug Administration Law" and in accordance with the special drug approval procedures, and approved Pfizer's new coronavirus treatment drug Nematicavir Tablets/Ritonavir Tablets with conditions.

Paxlovid is an oral small-molecule novel coronavirus therapy drug for the treatment of adults with mild to moderate novel coronavirus pneumonia (COVID-19) with high risk factors for progression to severe disease, such as advanced age, chronic kidney disease, diabetes, heart disease Patients with severe high-risk factors such as vascular disease and chronic lung disease

Figure 1: Paxlovid drug combination

01

Mechanism of action of Paxlovid

Nematevir is a SARS-CoV-2 major protease (Mpro) inhibitor known as 3C-like protease (3CLpro) or nsp5 protease

Ritonavir is an HIV-1 protease inhibitor and CYP3A inhibitor

Figure 2: Nematevir (C23H32F3N5O4)

Figure 3: Ritonavir (C37H48N6O5S2)

Since Omicron became the dominant strain, the new coronary pneumonia has further spread in the global market.

Clinical studies have shown that in patients treated with Paxlovid 3 days and 5 days after the onset of symptoms, the hospitalization or death rate of new crown patients was reduced by 89% and 88%, respectively, and the viral load was reduced by 10 times compared with the placebo group.

02

Paxlovid is approved in many countries

Which domestic pharmaceutical companies are beneficial?

Although Paxlovid has a significant effect on the treatment of the new crown, it is facing production pressure in the short term

Small molecule intermediates, APIs, preparations and other related industrial chains are calculated based on 20% of the cost of drug production.

Recently, CDMO companies Proton (USD 681 million) and Asymchem (RMB 2.

However, according to the performance report released by Asymchem, the company's annual revenue was 4.

At the same time, there are two risks that need to be paid attention to

According to the "14th Five-Year Plan for the Development of the Pharmaceutical Industry", innovative products and technological breakthroughs are the new directions for the development of the pharmaceutical industry in the future.

03

like a corona vaccine

China also needs a self-developed oral drug for the new crown

China is a big country with a population of 1.

Junshi Biology announced on December 31 that the Ministry of Health of Uzbekistan has approved the emergency use authorization of its oral nucleoside anti-new coronavirus drug VV116, which shows that VV116 is effective and safe.

VV116 was jointly developed by Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Wuhan Institute of Virology, Chinese Academy of Sciences, Xinjiang Institute of Physical and Chemical Technology, Chinese Academy of Sciences, Wangshan Wangshui, and Central Asia Drug Research and Development Center, Chinese Academy of Sciences

Preclinical pharmacodynamic studies have shown that VV116 exhibits significant antiviral effects against both the original SARS-CoV-2 strain and known mutant strains in vitro.
In a mouse model, a low dose of VV116 can increase the pulmonary titer.
Reducing the virus to below the detection line can significantly improve the pathological changes of lung tissue, showing strong antiviral efficacy
.
Preclinical pharmacokinetics and other research results show that VV116 has high oral bioavailability.
After oral absorption, it is rapidly metabolized to the parent nucleoside and widely distributed in the body tissue
.

Currently, Junshi Bio's VV116 is undergoing global multi-center clinical studies, of which 3 Phase I studies in China have been completed recently.
The preliminary results show good clinical safety.
Phase III clinical trials are underway
.
Another product, VV993 (3CL protease inhibitor), is in the preclinical stage and has the potential to be used in combination with VV116
.
VV116 is also Junshi Bio’s second new crown drug successfully “going overseas”.
Previously, Junshi Bio’s new crown neutralizing antibody JS016 has cooperated with Eli Lilly and obtained emergency use authorization in the United States
.

Figure 4: Junshi Bio's project pipeline

From the layout of Junshi's product R&D pipeline, it can be seen that Junshi's main R&D areas focus on tumors, metabolic diseases, autoimmunity, and anti-infection
.
This is in line with the goals of the key development of innovative products and technologies in the 14th Five-Year Plan for the Development of the Pharmaceutical Industry
.

Just on January 29, Junshi released the 2021 annual performance forecast.
It is expected to achieve an annual operating income of 4.
014 billion yuan in 2021, an increase of 2.
419 billion yuan compared with the same period of the previous year, a year-on-year increase of 151.
68%, of which the 2021 research and development expenses are 2.
075 billion yuan, an increase of 297 million yuan compared with the same period of the previous year, a year-on-year increase of 16.
7%, and a decrease of 933 million yuan in profit and loss compared with the same period of the previous year, a year-on-year decrease of 55.
89%
.
This shows that the listed drugs have begun to make profits, and they are blood transfusions for the research and development of the company's innovative drugs
.

During the "14th Five-Year Plan" period, Junshi will have two blockbuster drugs, toripalimab (anti-PD-1 monoclonal antibody) and new crown drugs (JS016 and VV116).
The story of the company will have a lot of room for imagination.
We look forward to Junshi turning losses into profits as soon as possible
.

In conclusion, the emergency approval of Paxlovid globally will benefit CDMO suppliers such as Asymchem and Proton
.
Being approved in China conveys China's recognition of the new crown oral drug, which will also stimulate the research and development of domestic new crown oral drug, which will also benefit CRO and CDMO companies
.

Just like Dr.
Li Ning, CEO of Junshi Bio, said: "Junshi is excited by the approval of Pfizer's oral drug, which shows that the development path chosen is the right one, and the country recognizes the value of oral drugs in the end of the anti-coronavirus and post-coronavirus stages
.
" We also look forward to the early launch of China's new crown oral drugs
.