Securities code: Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) securities abbreviation: Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) Announcement No.: 2022023 Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456)
Announcement on the explanation of media reports
The board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the contents of this announcement, and bear individual and joint liabilities for the authenticity, accuracy and completeness of its contents.
Important content tips:
Contents of this License:
MPP (“drug patent pool organization”) granted Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) (hereinafter referred to as ” Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) ,” the company “) the use of relevant patents and know-how to produce the generic API (hereinafter referred to as” Cooperative Drug “) of nirmatrelvir (nimatovir) in covid-19 treatment oral drug paxlovid (nirmatrelvir and ritonavir), And commercialize cooperative drugs and related rights in the region (95 low-income countries such as India, Indonesia and Egypt or public procurement institutions). Special risk tips:
1. This license is non exclusive and is limited to the generic API of nirmatrelvir; The licensed areas are 95 low-income countries or public procurement institutions such as India, Indonesia and Egypt, excluding China.
2. Before the commercial production of the cooperative drugs under this license, the relevant technical handover needs to be completed, and the production facilities need to be approved by SRA (string regulatory authority, i.e. “regulating the market drug administration authority”, mainly including ICH members, ICH observers and ICH mutual recognition agreement institutions) or certified by who (World Health Organization, World Health Organization) PQ.
3. The production and sales of cooperative drugs under this license can only be implemented after the approval of relevant competent authorities (including but not limited to marketing approval). Whether the cooperative drugs produced by the company based on this license can obtain the listing approval of the local drug regulatory authority in the region and the listing time in the region are uncertain.
4. The sales of cooperative drugs under this license after listing in the region is affected by (including but not limited to) covid-19 pneumonia epidemic development, production and supply chain capacity, market competition environment, sales channels and many other factors, and there is uncertainty. As of the date of announcement, the company has no cooperation order.
The products will be supplied at the actual cost (which can be verified through third-party audit) plus a reasonable price increase (after negotiation). As of the date of this announcement, the royalties, specific costs and pricing of cooperative drugs under this license cannot be determined temporarily. Given that this license is designed to help 95 low – and middle-income countries obtain cooperative drugs affordable, the relevant pricing is expected to be lower than the company’s selling price in other high-income countries. To sum up, it is impossible to predict the profit and income of the company in this year and in the future.
5. According to public information, as of the date of this announcement, paxlovid has successively obtained (mainly including) the emergency use authorization (EUA) of the U.S. Food and Drug Administration (FDA), the conditional approval of the European Drug Administration (EMA), the emergency special approval of the Ministry of health, welfare and labor of Japan, the emergency conditional approval of the State Drug Administration of China, etc. As of the date of this announcement, the clinical data of paxlovid is still limited, and the use of paxlovid may lead to unreported serious adverse events or unexpected adverse events.
1、 Media coverage
Recently, MPP announced and relevant media reported that MPP authorized 35 pharmaceutical enterprises including Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) to produce generic drugs of covid-19 for oral drug paxlovid.
2、 Verification of relevant information
The main contents of the sublicense agreement signed by the company and MPP are as follows:
1. License content
Based on the Pfizer MPP agreement, MPP granted Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) (hereinafter referred to as ” Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) ” and “the company”) the use of relevant patents and know-how to produce the generic raw material drug of nirmatrelvir (nimatrilvir and ritonavir) of covid-19 oral drug paxlovid (nirmatrelvir and ritonavir) (hereinafter referred to as “Cooperative Drug”), And commercialize cooperative drugs and related rights in the region (95 low-income countries such as India, Indonesia and Egypt or public procurement institutions).
Before the commercial production of cooperative drugs under this license, relevant technical handover needs to be completed, and the production facilities need to be approved by SRA or certified by who PQ.
2. Product price
Actual cost (which can be verified through third-party audit) plus reasonable price increase (after negotiation).
3. Other
MPP has the right to terminate this sublicense in accordance with the sublicense agreement.
4. Applicable law and dispute resolution
If a dispute cannot be settled through negotiation, it can be settled by arbitration. The place of arbitration shall be New York, USA. The courts of New York have exclusive jurisdiction.
3、 Basic information of paxlovid
PAXLOVID is an oral small molecule COVID-19 virus therapeutic agent developed by Pfizer Inc for the treatment of mild to moderate New Coronavirus pneumonia in adults with severe risk factors.
As of the date of this announcement, paxlovid has successively obtained (mainly including) the emergency use authorization (EUA) of the US Food and Drug Administration (FDA), the conditional approval of the European Drug Administration (EMA), the emergency special approval of the Ministry of health, welfare and labor of Japan, the emergency conditional approval of the State Drug Administration of China, etc.
According to MPP official website（ https://medicinespatentpool.org/ Org /), including Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) , MPP has granted non exclusive licenses for production, commercialization and related rights to 35 pharmaceutical enterprises around the world to supply paxlovid to 95 low-income countries around the world.
4、 Basic information of the counterparty
MPP is a non-profit public health organization supported by the United Nations. Its main office is located in Geneva, Switzerland. MPP is committed to increasing access to drugs in low – and middle-income countries through innovative methods of voluntary licensing and patent pool.
5、 Impact on the company
As of the date of this announcement, the royalties, specific costs and pricing of cooperative drugs under this license cannot be determined temporarily.
It is impossible to predict the profit and income of the company in this year and in the future. This time, the company obtained the authorization of MPP, which aims to help 95 low – and middle-income countries affordable access to cooperative drugs. The company will uphold the mission of “caring for life and maintaining health” and help the global anti epidemic cause with rich experience in drug production and export.
6、 Risk tips
1. This license is non exclusive and is limited to the generic API of nirmatrelvir; The licensed areas are 95 low-income countries or public procurement institutions such as India, Indonesia and Egypt, excluding China.
2. Before the commercial production of the cooperative drugs under this license, the relevant technical handover needs to be completed, and the production facilities need to be approved by SRA (string regulatory authority, i.e. “regulating the market drug administration authority”, mainly including ICH members, ICH observers and ICH mutual recognition agreement institutions) or certified by who (World Health Organization, World Health Organization) PQ.
3. The production and sales of cooperative drugs under this license can only be implemented after the approval of relevant competent authorities (including but not limited to marketing approval). Whether the cooperative drugs produced by the company based on this license can obtain the listing approval of the local drug regulatory authority in the region and the listing time in the region are uncertain.
4. The sales of cooperative drugs under this license after listing in the region is affected by (including but not limited to) covid-19 pneumonia epidemic development, production and supply chain capacity, market competition environment, sales channels and many other factors, and there is uncertainty. As of the date of announcement, the company has no cooperation order.
The products will be supplied at the actual cost (which can be verified through third-party audit) plus a reasonable price increase (after negotiation). As of the date of this announcement, the royalties, specific costs and pricing of cooperative drugs under this license cannot be determined temporarily. Given that this license is designed to help 95 low – and middle-income countries obtain cooperative drugs affordable, the relevant pricing is expected to be lower than the company’s selling price in other high-income countries. To sum up, it is impossible to predict the profit and income of the company in this year and in the future.
5. According to public information, as of the date of this announcement, paxlovid has successively obtained (mainly including) the emergency use authorization (EUA) of the U.S. Food and Drug Administration (FDA), the conditional approval of the European Drug Administration (EMA), the emergency special approval of the Ministry of health, welfare and labor of Japan, the emergency conditional approval of the State Drug Administration of China, etc. As of the date of this announcement, the clinical data of paxlovid is still limited, and the use of paxlovid may lead to unreported serious adverse events or unexpected adverse events.
The information disclosure media designated by the company are Shanghai Securities News and the website of Shanghai Stock Exchange (www.sse. Com. CN), All information of the company is subject to the announcement published in the above designated media. Please pay attention to the risks.
It is hereby announced.
Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) board of directors
March 21, 2022
