On March 17, the Geneva medicines patent pool (MPP) announced that it had signed an agreement with 35 pharmaceutical companies to allow them to produce the API or preparation of nimatrilvir (formerly known as 3CL protease inhibitor pf-07321332) without patent fee during the period when covid-19 epidemic is still defined as a public health emergency. The latter is one of the core components of Pfizer covid-19 oral drug paxlovid.
Among the 35 enterprises, there are 5 Chinese enterprises, namely Shanghai desaino, 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). There are only and raw materials , which can be produced at the same time.
Up to now, there are two covid-19 oral small molecule specific drugs that have been approved for marketing in the world, namely molnupiravir of MSD and paxlovid of Pfizer In January this year, MPP announced the list of “special imitation” enterprises of molnupiravir in MSD.
Accordingly, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) , desaino, two Chinese pharmaceutical companies, have both obtained the “special imitation” right of two covid-19 special drugs, MSD and Pfizer, which are currently the only two special drugs in the world.
35 pharmaceutical companies entered Pfizer paxlovid “special imitation” list
MPP is a public welfare project aimed at supplying special drugs to low – and middle-income countries at more accessible prices. Covid-19 oral medicine is one of them.
In terms of specific operation process, MPP organization will first sign cooperation agreements with original pharmaceutical enterprises, such as Pfizer and MSD; Then, as a third-party platform, invite global raw material and preparation enterprises to participate in the special imitation, and then select the appropriate list of enterprises.
During the campaign, global raw material and preparation enterprises can sign up independently. Because Pfizer paxlovid is considered to be more effective than mosadon molnupiravir, it is reported that more than 100 enterprises have signed up for paxlovid’s MPP project, and the selection work is “one in a hundred” .
Finally, a total of 35 global API and preparation enterprises were successfully selected, including the above-mentioned five Chinese enterprises. Under the MPP agreement, Pfizer and the above-mentioned 35 “special imitation” enterprises will jointly provide affordable covid-19 oral drugs to 95 low-income countries around the world, which can cover about 53% of the world’s total population.
pay more attention to “sea going ability” during review
Among many registered enterprises, how does MPP screen out suitable enterprises?
The reporter of the science and Innovation Board daily learned from a failed enterprise in China that one of the core assessment contents of MPP in screening the registered enterprises is the international production capacity and imitation speed of the enterprise.
” mpp pays special attention to whether the company’s production line has passed the international drug production management standard certification of the United States, the European Union, the United Kingdom and other countries. generally speaking, the production management standards of these countries are relatively strict.” The person from the enterprise told the reporter of science and Innovation Board daily.
After obtaining the authorization, how long will it take for the enterprise to copy paxlovid and mass produce it? This is also the focus of MPP. The above-mentioned enterprise personage said that the enterprise had calculated that it would take at least two years to realize imitation and mass production due to the needs of production line transformation. Due to the slow imitation speed, it was not “favored” by MPP in the end.
ritonavir first imitation enterprise announces production expansion again
So what is naimateway and how can it be further produced into paxlovid?
It is understood that paxlovid is composed of two core components: naimatavir and low-dose ritonavir (ratio: 300 mg naimatavir + 100 mg ritonavir).
Among them, the function of namatvir is to inhibit the combination of covid-19 virus and human body, which is the main component; The effect of ritonavir is to prolong the efficacy of namatvir. In the actual production process, the two components can be produced by different manufacturers, and finally the “assembly” can be completed through combined packaging.
In addition to the above-mentioned five Chinese enterprises, which deserve attention due to their entry into the special imitation list of naimatewe, geley pharmaceutical-b (1672. HK) has also attracted market attention. This is because Geli pharmaceutical-b (1672. HK) is the first Chinese enterprise to successfully imitate ritonavir.
Has geley pharmaceutical supplied Pfizer? Geli pharmaceutical told the reporter of the science and Innovation Board daily that due to the letter approval requirements, it is inconvenient to disclose more, but the goal of the enterprise is to become a global supplier of ritonavir oral tablets .
As of press time, golly pharmaceutical has announced to expand the annual production capacity of ritonavir to 530 million tablets, and submitted listing applications to 12 European countries. It is worth noting that in January this year, geley pharmaceutical just announced to expand the annual production capacity of ritonavir to 100 million tablets – the annual production capacity has been expanded fivefold in just two months.
It should be noted that since the MPP project is mainly for public welfare purposes, the price of “special generic drugs” will also be relatively low. In the future, whether the products can go to sea smoothly and increase the profits of the enterprise will depend on whether the drugs can be recognized by the overseas drug regulatory authorities and the overseas sales capacity of various pharmaceutical enterprises.
