On March 17, the Geneva medicines patent pool (MPP) announced the list of Pfizer covid-19 oral drug authorized enterprises. A total of 35 companies were authorized and Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) were successfully selected. On the 18th, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) confirmed the above selection through announcement.
MPP said that the licensed companies have demonstrated their ability to meet MPP's requirements on production capacity, regulatory compliance and international standards for quality assurance drugs.
huge incremental market demand
Pfizer's paxlovid is an oral small molecule covid-19 virus treatment drug. It is a combination therapy formed by two 150mg nimatovir tablets and one 100mg ritonavir tablet. At present, many countries and regions around the world have approved paxlovid emergency use authorization or temporary authorization. On February 11, 2022, the drug was also approved by the State Drug Administration of China (nmpa) for conditional listing.
In March 15th, the National Health Protection Commission and the State Administration of traditional Chinese Medicine released the New Coronavirus pneumonia diagnosis and treatment plan (trial version ninth). As one of the key revisions, namatvir tablets / ritonavir tablets (paxlovid) have been written into the new diagnosis and treatment plan.
At present, many countries and regions in the world have established paxlovid orders to Pfizer. However, due to the relative shortage of production capacity, Pfizer expects the supply of paxlovid to reach 120 million courses in 2022 (of which the US and UK governments have booked at least 22.75 million courses, and Pfizer also promises to supply 10 million courses to low-income countries).
According to the analysis of some securities companies, considering that this MPP authorization covers 95 low - and middle-income countries, it is expected that the demand in the end market will increase significantly. Chinese enterprises authorized by MPP are expected to share the above market increment. As a leading enterprise in the export of Chinese preparations, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) has the first mover advantage of global layout. This time, it was authorized by MPP, adding new impetus to the further improvement of its international business.
international business recovery or performance recovery
As a leading enterprise of China Meheco Group Co.Ltd(600056) internationalization, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) is the first pharmaceutical company in China to pass the FDA preparation quality certification and own the drug approval number. It is also the first Chinese pharmaceutical company to realize large-scale preparation sales in the United States.
Since the "valsartan incident" broke out in 2018, Huahai's US business, especially the sales of us preparations, has been greatly impacted. In recent years, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) has focused on risk prevention and cultivating "internal skills". During the import ban period in the United States, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) relying on the overseas market operation experience accumulated for many years, quickly established a terminal market sales team in Japan, Southeast Asia and other countries and regions. According to the company's 2020 annual report, the company's overseas distribution has covered more than 100 countries and regions, and its international business shows a trend of regional diversification. In 2021, Huahai will gradually recover the market through continuous development, while promoting lean production internally, making full preparations for the full recovery of the U.S. market.
Recently, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) southern Sichuan production base has successfully passed the official review of the European Union, which also witnessed the continuous improvement and stability of Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) quality management system. At the same time, the production area has passed the certification of China and many international mainstream official quality systems for many times.
It is understood that, originally affected by the ban, the approval of many anda document numbers (including products competing for the first imitation and challenging patents) to be approved by the FDA in the United States has also stalled. After the lifting of the ban, these anda numbers are expected to be approved successively in 2022 and later years. Together with the previous old varieties, they will greatly improve the development of Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) 2022 and future business in the United States.
In addition, in recent years Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) through the Anda reporting / double reporting strategy and the vertical integration advantage of "API + Preparation", the company takes active participation in centralized procurement as the cut-off point, and the growth momentum of preparation business in China is very strong. The number of times that the pharmaceutical enterprises in the Yangtze River Delta won the bid continued was far ahead of the results of 1 in recent years.
