Nematvir production capacity

The mass production bottleneck of nematvir, Pfizer’s production is determined by sales, resulting in tight demand in the mainland market. Ritonavir is an old drug with sufficient global production capacity. The 3cl small molecule anti-new coronavirus oral drug nematvir is a new drug that Pfizer officially announced to be successfully developed on November 5, 2021, and will be put on the market in batches in the second quarter of 2022. During this period, Pfizer's Parovide was approved for import by the drug regulatory authorities in major developed regions around the world, including China, and the production of generic drugs in underdeveloped areas in 95 countries (excluding China) was allowed. At the end of 2021, the U.S. government made an initial order of 20 million treatment courses at a unit price of US$529 per treatment course. Other developed regions around the world, including the UK, Japan, South Korea and the European Union, have booked contracts for 20 million treatment courses (total media reports), and the total bookings are close to 40 million treatment courses.

Pfizer officially announced that Parovide’s sales revenue in 2022 will be US$22 billion. I calculated 220/529=041.58 million courses of treatment based on the US centralized purchasing price, which is basically in line with the above situation. That is, the global surplus supply of Palo Verde is less than 2 million courses of treatment.

The global unscheduled supply balance of Palo Verde is approximately less than 2 million courses of treatment. These 2 million courses of treatment may be exclusive to mainland China and other unbooked developed regions (such as Hong Kong and Macau). As a result, due to pre-production constraints and emerging demands (such as the opening of mainland China at the end of 2022), Parovide drug resources are scarce.

Due to objective conditions such as the shelf life of Parovide being 12 months and restrictions on long-term storage, the only solution is to make a reservation in 2023. Pfizer will produce Parovide based on new demand guidance and sales volume.

The global production capacity of nematvir drug starting material medical 99 high-content caron anhydride compound is scarce. In 2010, medical carmonic anhydride was eliminated by the WHO. Except for a small amount of laboratory reagents, commercial mass production has been discontinued for more than ten years. According to current information, only Yaben Chemical in the world announced on November 4, 2021 that it will resume mass production of 20 tons/month, and includes patented technical barriers. At the end of March 2022, Yaben Chemical officially announced that it would purchase and store caronic anhydride for its own use. At the same time, Yaben Chemical's 50,000 kilogram (50 tons) palovide (nematvir) API project was officially launched after passing the environmental impact assessment and is expected to be completed and put into production before December 31. According to the judgment of professional institutions, the full production capacity of Yaben Chemical Caron Acid Anhydride can reach 300 tons/year. It can produce 150 tons of nematvir API for 50 million treatment courses. Currently, according to Pfizer's 40 million treatment course production requirements for 120 tons of nematvir API, Yaben Chemical's normal mass production of caronic anhydride can meet the above needs. However, in the face of new demand from mainland China, the entire Palo Verde Chinese industrial chain is facing tension and shortage. According to statistics, the new caronic acid anhydride mass production project of Chinese companies has reached more than 1,200 tons, which is enough to meet the demand for over 100 million courses of Palo Verde. It has not yet been completed and put into production. Reports seem to be waiting to see further changes in the epidemic and policies.

In December 2022, mainland China unexpectedly announced a change in its anti-epidemic policy. The number of patients with new coronavirus infections in the mainland increased, and the demand for Parovide drugs increased. There is currently no data on this increase. Based on the current situation of the U.S. government releasing about 600,000 courses of Parovide every week, I compared the demand in mainland China. The balance of Pfizer's existing production can only be supplied to the mainland for January to March. Therefore, it is predicted that there will be policy guidance on the release of Parovide in mainland China, and it is appropriate to give priority to patients with urgent needs.