Securities code: 600196 stock abbreviation: Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) No.: lin2022-016 bond Code: 143020 bond abbreviation: 17 Fuyao 01
Bond Code: 143422 bond abbreviation: 18 Fuyao 01
Bond Code: 155067 bond abbreviation: 18 Fuyao 02
Bond Code: 155068 bond abbreviation: 18 Fuyao 03
Bond Code: 175708 bond abbreviation: 21 Fuyao 01
Shanghai Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) (Group) Co., Ltd
Announcement on media coverage
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 and special risk tips:
● contents of this License:
MPP (i.e. “drug patent pool organization”) granted Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) industry, the holding subsidiary of the company, to use relevant patents and proprietary technologies to produce molnupiravir (mk-4482 and eidd-2801) (hereinafter referred to as “cooperative drugs”) for covid-19 treatment in the region (i.e. 105 low-income countries / regions such as India, Pakistan and C ô te d’Ivoire) Non exclusive license for commercialization and related rights.
● special risk tips:
1. This license is non exclusive; The licensed areas are 105 low-income countries / regions such as India, Pakistan and C ô te d’Ivoire, excluding China.
2. 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.
3. The production and sales of cooperative drugs in the region 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 group based on this license can obtain the listing approval of local drug regulatory authorities 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 this announcement, the group has no orders in hand for cooperative drugs and has not carried out relevant production.
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 specific cost and pricing of cooperative drugs under this license cannot be determined temporarily. Given that this license is intended to help 105 low – and middle-income countries / regions obtain cooperative drugs affordable, the relevant pricing is expected to be lower than that of the original research products or in other high-income countries.
In conclusion, the impact of this license on the current and future revenue and profit of the group cannot be predicted.
5. According to public information, as of the date of this announcement, the drug has only (mainly) obtained the conditional marketing approval of the UK drug and Health Products Administration (MHRA), the emergency use authorization (EUA) of the US Food and Drug Administration (FDA), the emergency special approval of the Ministry of health, labor and welfare of Japan, etc. As of the date of this announcement, the clinical data of the cooperative drug is still limited, and the use of the drug may cause unreported serious adverse events or unexpected adverse events.
1、 Media coverage
Recently, MPP issued an announcement and relevant media reported that MPP authorized 27 pharmaceutical enterprises including Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) to produce covid-19 oral drug molnupiravir.
2、 Verification of relevant information
On January 7, 2022, the holding subsidiary Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) industry and MPP signed a sublicense agreement on the authorized production of covid-19 oral drug molnupiravir. The main contents are as follows:
1. License content
Based on msd-mpp agreement, MPP grants Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) industry a non exclusive license to use relevant patents and know-how to produce, commercialize (including registration, retail, distribution, etc.) and relevant rights of covid-19 oral drug molnupiravir (mk-4482 and eidd-2801) in the region (i.e. 105 low-income countries / regions such as India, Pakistan and C ô te d’Ivoire), The above production includes molnupiravir’s raw materials (drugs) and finished drugs (preparations).
Cooperative drugs will be produced in production facilities 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. Patent license fee
Depending on the nature of the purchaser, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) industry shall pay a patent license fee to MSD at 5% or 10% of the annual net sales (as defined in the agreement). However, based on the msd-mpp agreement, the above-mentioned patent license fee will be charged from the month after who announced that covid-19 is no longer listed as a “public health emergency of international concern”.
4. Other
Based on msd-mpp agreement, MSD reserves the right to revoke or change the license granted to MPP cooperative drugs at any time.
MPP has the right to terminate this sublicense in accordance with the sublicense agreement.
5. Take effect
The effective date of the sublicense agreement is January 7, 2022.
6. Applicable law and dispute resolution
The courts of New York have exclusive jurisdiction.
If a dispute cannot be settled through negotiation, it can be settled by litigation.
3、 Basic information of cooperative drugs
Molnupiravir (mk-4482, eidd-2801) is an oral ribonucleoside drug jointly developed by MSD and Ridgeback. It can inhibit the replication of sars-cov-2 (the pathogenic factor of covid-19 virus). At present, it is mainly used to treat mild to moderate covid-19 pneumonia.
The drug was conditionally approved by the UK drug and Health Products Administration (MHRA) in November 2021; In December 2021, it successively obtained the emergency use authorization (EUA) of the U.S. Food and Drug Administration (FDA) and the emergency special approval of the Ministry of health, labor and welfare of Japan.
According to the MPP official website（ https://medicinespatentpool.org/ ）According to the published information, including Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) industry, MPP has granted non exclusive licenses for production, commercialization and related rights to 27 pharmaceutical enterprises around the world to supply molnupiravir to 105 low-income countries / regions 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、 Risk tips
1. This license is non exclusive; The licensed areas are 105 low-income countries / regions such as India, Pakistan and C ô te d’Ivoire, excluding China.
2. 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.
3. The production and sales of cooperative drugs in the region 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 group based on this license can obtain the listing approval of local drug regulatory authorities 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 this announcement, the group has no orders in hand for cooperative drugs and has not carried out relevant production.
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 specific cost and pricing of cooperative drugs under this license cannot be determined temporarily. Given that this license is intended to help 105 low – and middle-income countries / regions obtain cooperative drugs affordable, the relevant pricing is expected to be lower than that of the original research products or in other high-income countries.
In conclusion, the impact of this license on the current and future revenue and profit of the group cannot be predicted.
5. According to public information, as of the date of this announcement, the drug has only (mainly) obtained the conditional marketing approval of the UK drug and Health Products Administration (MHRA), the emergency use authorization (EUA) of the US Food and Drug Administration (FDA), the emergency special approval of the Ministry of health, labor and welfare of Japan, etc. As of the date of this announcement, the clinical data of the cooperative drug is still limited, and the use of the drug may cause unreported serious adverse events or unexpected adverse events.
China Securities News, Shanghai Securities News and securities times are the designated information disclosure newspapers and periodicals of the company. The information published by the company is published in the above designated newspapers and periodicals and the website of Shanghai Stock Exchange（ http://www.sse.com.cn. ）The announcement published shall prevail. Please invest rationally and pay attention to risks.
6、 Interpretation
The emergency use authorization of pharmaceutical products, issued by the US Food and Drug Administration (EUA), refers to the authorization of the Drug Administration (FDA) for the use of unapproved pharmaceutical products and unapproved uses of approved products under actual or potential emergencies
MPP refers to medicines patent pool, a non-profit public health organization supported by the United Nations
MSD and MSD refer to Merck sharp & Dohme Corp
The license agreement signed between MSD and MPP in October 2021. According to this agreement, the MPP msd-mpp agreement refers to the further sublicense granted by MSD to other manufacturers to supply molnupiravir (mk-4482 and eidd-2801) with quality assurance.
Ridgeback means Ridgeback biotherapeutics LP
Stringent regulatory authority (strict regulatory authority), including international human medication SRA, refers to members of the technical requirements Coordination Council (ICH), or ICH observers and regulatory authorities related to ICH members
Who refers to the World Health Organization, one of the specialized agencies under the United Nations
The company / Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) refers to Shanghai Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) (Group) Co., Ltd
The group refers to the company and its holding subsidiaries / units
Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) industry refers to Shanghai Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) Industry Development Co., Ltd., which is a holding subsidiary of the company
Licensee
It is hereby announced.
Board of directors of Shanghai Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) (Group) Co., Ltd. January 21, 2002
