On March 17, the medicines Patent Pool Foundation (hereinafter referred to as “MPP”) announced on its official website that it had signed agreements with 35 companies, which were allowed to imitate the API or corresponding preparation of nimatrilvir, one of the components of Pfizer covid-19 oral drug paxlovid, in order to promote the affordability and accessibility of the drug in the world.
Including five Chinese enterprises, namely Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) ( Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) . SH), Apeloa Pharmaceutical Co.Ltd(000739) ( Apeloa Pharmaceutical Co.Ltd(000739) . SZ), Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) ( Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) . SH), Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) ( Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) . SH) and Shanghai Desano. Among them, Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) only produces APIs, and other companies can produce APIs and preparations at the same time.
It is worth noting that the above agreement is the result of the voluntary license agreement signed by MPP and Pfizer in November 2021, which will help expand the accessibility of Pfizer covid-19 oral medicine in 95 low – and middle-income countries, accounting for about 53% of the world’s population.
According to the MPP official website, the drug patent pool organization is a public health organization supported by the United Nations. It is committed to increasing access to life-saving drugs for low – and middle-income countries and promoting drug development. So far, MPP has signed agreements with a number of patent holders, involving 13 kinds of HIV antiretroviral drugs, one HIV technology platform, three direct acting antiviral agents for hepatitis C, one tuberculosis treatment, two long-term technologies, two COVID-19 experimental oral antiviral therapy and one COVID-19 antibody diagnostic test.
On March 18, among the five Chinese enterprises involved in the above news, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) and Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) have successively issued announcements to confirm the authenticity of the license agreement. The announcements of the two companies are roughly the same in content. Both of them mentioned that based on the Pfizer MPP agreement, MPP granted the company the right to use relevant patents and proprietary technologies to produce “nirmatrelvir” and the licensed product “nirmatrelvir / ritonavir combination”, And non exclusive license (hereinafter referred to as “this license”) for commercialization (including registration, retail, distribution, etc.) and related rights of licensed products in the region (i.e. 95 countries such as India, Pakistan and C ô te d’Ivoire, excluding China).
The licensed product is a combination packaged oral small molecule covid-19 therapeutic drug, which includes two antiviral drugs, nirmatrelvir and ritonavir. The above production includes (1) the production of raw materials (drugs) and finished products (preparations) of namatvir, and (2) the production of namatvir / ritonavir combination.
Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) and Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) also indicated in the announcement that the relevant products under this license need to complete the relevant technical handover before production, and the production facilities need to be approved by SRA (strict regulatory authority) or prequalified by the World Health Organization. The production and sales of licensed products in the region can only be implemented after the approval of relevant competent authorities (including but not limited to marketing approval). Whether the licensed products can obtain the marketing approval of local drug regulatory authorities in the region and the marketing time in the region are uncertain. As of the date of this announcement, the company has no orders in hand for licensed products and has not carried out relevant production.
It is worth noting that since this cooperation aims to help 95 low – and middle-income countries affordable access to licensed products, the relevant pricing is expected to be lower than that of the original research products or in other high-income countries. According to the agreement, the company will supply the products according to the actual cost of the products (which can be verified through third-party audit) plus a reasonable price increase (to be determined).
Several institutions pointed out that China’s intermediate and API industry chain will benefit from the imitation license of Pfizer covid-19 oral medicine.
Citic Securities Company Limited(600030) said that considering that the MPP license covers 95 countries, the demand in the end market is expected to increase significantly, and it is expected that Chinese enterprises authorized by MPP are expected to share the above market increment. 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, it is expected that paxlovid’s upstream intermediate industry chain is expected to usher in a large demand.
Tianfeng Securities Co.Ltd(601162) also pointed out that China, as the world’s largest production and export region of pharmaceutical intermediates / APIs, occupies an important position in the global pharmaceutical industry chain. Chinese api enterprises have the whole industry chain supply capacity of nirmatrelvir’s raw materials – intermediates – APIs. With paxlovid’s multinational approval and global sales of MPP agreements, the order demand for intermediates / APIs involved in nirmatrelvir synthetic route is expected to further expand.
On March 18, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) closed at 50.47 yuan / share, up 2.54%, and Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) closed at 23.60 yuan / share, down 4.65%.
