"Covid-19" oral drug concept stocks are highly sought after.
At the closing on March 21, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) ( Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) . SH) and Apeloa Pharmaceutical Co.Ltd(000739) ( Apeloa Pharmaceutical Co.Ltd(000739) . SZ) both rose the limit. In addition, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) ( Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) . SH) rose 6.36% and Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) ( Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) . SH) rose 7.07%.
Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) H shares also rose 21.66%.
On March 20, Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) announced that the company was granted a non exclusive license by the Geneva medicines patent pool (MPP) for the generic API of nimatovir in Pfizer covid-19 oral drug paxlovid, which can provide paxlovid combination therapy to 95 low-income countries or public procurement institutions in the region (India, Indonesia, Egypt and other low-income countries).
Previously, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) , Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) , Apeloa Pharmaceutical Co.Ltd(000739) also successively issued the announcement of production authorized by MPP.
It is a listed company of sainuo and . Among them, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) and other four enterprises are authorized to produce "API + Preparation" at the same time, and Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) only produces API.
The 21st Century Business Herald reporter learned that Pfizer covid-19 drug MPP authorization is to provide the API technical package of the whole product SM1 and SM2 fragments of palovide, commonly known as "ctd3 document" to pharmaceutical enterprises free of charge. Pharmaceutical companies produce preparations, and then package and sell them to 95 countries / regions.
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.
mpp's authorization covers 95 countries with huge market increment
According to public information, Pfizer's paxlovid is an oral small molecule covid-19 virus treatment drug, which is a combination therapy formed by two 150mg nimatovir tablets and one 100mg ritonavir tablet.
At present, many countries and regions around the world (including the US Food and Drug Administration (FDA), the European Drug Administration (EMA) and the Ministry of health, labor and welfare of Japan) have approved the emergency use authorization or temporary authorization of paxlovid.
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.
According to the agreement signed between Pfizer and MPP in November 2021, qualified generic pharmaceutical enterprises with authorization and license in the world will be able to provide paxlovid combination therapy to 95 countries / regions (95 low-income countries such as Indonesia, Vietnam, India, Pakistan and Ethiopia), covering about 53% of the world's population, including all low-income and low-income countries in sub Saharan Africa and some middle and high-income countries, And countries that have changed from low-income to high-income in the past five years.
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).
Some industry analysts pointed out 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, which also depends on the international sales network construction and supply chain management ability of each company. At the same time, according to the data, considering that paxlovid's production process requires a large number of 38 different raw materials and reagents from global suppliers, paxlovid's upstream intermediate industry chain is expected to meet the demand To increase demand. "
Founder Securities Co.Ltd(601901) research report also mentioned that 35 enterprises authorized this time are distributed in 12 countries such as India (19), China (5) and South Korea (2), of which 26 are authorized to produce API and 29 are authorized to produce preparation. The price of generic drugs will be lower than the expected price of generic drugs and the actual supply of other countries. Considering that another covid-19 specific drug molnupiravir's generic drug of MSD is priced at 1400 rupees (about US $18.5) in India, if measured at this price level, the corresponding generic drug market space is nearly US $2 billion.
Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) won the imitation right of oral drugs of MSD and Pfizer covid-19 at the same time, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) has been authorized by MPP for many times
Referring to the impact of the above authorization on the company, Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) said in the announcement, "as of the date of this announcement, the royalties, specific costs and pricing of cooperative drugs under this license cannot be determined temporarily, and there is no way to predict the profits and income of the company in this year and future years."
In addition, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) said that the licensed product company has no orders in hand and has not started formal production. The impact of this license on the current and future performance of the group cannot be predicted.
Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) previously mentioned in the announcement, "The signing of this contract is the normal operation of the company and will not have a significant impact on the independence of the company's business. The main business of the company does not have the risk of dependence on the partners due to the performance of this contract. As of the date of this announcement, the Cooperative Drug company has no orders in hand or related production. The performance of this contract has no significant impact on the current performance of the company, and the impact on the future performance can not be predicted.".
This is not the first time that Chinese pharmaceutical companies have been authorized to imitate covid-19 oral drugs.
Prior to this, on January 20 this year, MPP announced that it had signed agreements with 27 pharmaceutical companies to allow them to produce and supply molnupiravir, an oral drug of melsadon covid-19, for 105 low-income countries or regions around the world Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) , Brightgene Bio-Medical Technology Co.Ltd(688166) ( Brightgene Bio-Medical Technology Co.Ltd(688166) . SH), Shijiazhuang Longze pharmaceutical, Shanghai deseno, Langhua pharmaceutical and other five Chinese pharmaceutical enterprises were listed among them. Among them, the top four were licensed to produce APIs and finished drugs at the same time, and Langhua pharmaceutical was licensed to produce APIs.
In other words, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) , Shanghai Desano, two Chinese pharmaceutical companies, won the imitation production rights of MSD and Pfizer covid-19 oral drugs at the same time.
In addition, according to the official website of MPP, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) has been authorized by MPP for many times in 2015 and 2017.
On March 21, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) relevant people told the 21st Century Business Herald, "since the 'valsartan incident' in 2018, the company's US business, especially the sales of us preparations, has been greatly impacted. In recent years, the company has focused on risk prevention and cultivating 'internal skills'. Relying on years of overseas market operation experience, the company has established end market sales teams in Japan, Southeast Asia and other countries and regions."
The above-mentioned person stressed that " Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) is the first pharmaceutical company in China to pass the FDA preparation quality certification and independently own the drug approval number, and it is also the first Chinese pharmaceutical company to realize large-scale preparation sales in the United States".
According to the annual report of Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) 2020, the company's overseas distribution has covered more than 100 countries and regions, and its international business shows the trend of regional diversification.
In late November 2021, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) announced that the US Food and Drug Administration (FDA) lifted the import ban on the company's South Sichuan API production base, which previously involved 29 API products and related preparation products. This means that the APIs produced by Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) South Sichuan base and the preparation products made from the APIs produced by the base, which are registered and approved in the United States, can normally enter the U.S. market.
Recently, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) southern Sichuan production base has also passed the EU review.
