Chinese firms have expressed an interest in producing an experimental Covid-19 drug developed by US pharmaceutical companies Merck and Ridgeback Biotherapeutics – under a global programme for their distribution in developing countries.
The UN-backed Medicines Patent Pool (MPP) recently reached an agreement with Merck to grant sublicences for other pharmaceutical firms to produce generic versions of the experimental molnupiravir antiviral pill, for supply to 105 middle- and low-income countries. And Chinese companies are among applicants seeking the royalty-free sublicences.
In an interview with the South China Morning Post, MPP executive director Charles Gore said many companies have shown interest, including those from China, India and Pakistan.
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The drug, which is still pending approval from the US Food and Drug Administration, has received intense interest after early trials showed that it could cut hospitalisation and deaths by half among patients with early Covid-19 symptoms. If approved, it would be the first oral pill to treat the disease.
Merck announced on October 27 that it had reached an agreement with MPP to allow drug makers in other countries to produce the pills for affordable global access. The application process for sublicences will be open for a two-week period.
Gore said MPP did not have too many contacts with Chinese companies before, but the role of Chinese pharmaceuticals was changing.
“In a very short period of time, China has gone from being a low-middle-income country wanting to get health products as cheap as possible to a huge producer of those health products, and of patents, and innovation,” he said.
In selecting producers for the Merck pills, MPP would evaluate their financial stability, the reach of the companies, their experience and quality control.
The public health organisation is hoping that increased supply through sublicensing can help lower the prices of the drug in developing countries.
Earlier reports quoted experts as saying they hoped the price could drop to as low as US$10 per five-day course, compared with the US$700 per course reportedly paid by the US government.
“We’re going to be very careful to have a very geographically dispersed manufacturing base for this … in Asia, in Africa, and Latin America to make sure that there are local firms doing it,” Gore said.
The MPP also hopes the drug makers would have a footprint in the countries they intend to sell, so they would have experience in getting local approvals.
“Ideally, we want our sublicensees to get World Health Organization pre-qualification or approval from a stringent regulatory authority, rather than just going to their local regulator.”
Since China is not among the 105 countries in the deal with MPP, even if any Chinese producers get the sublicence, they will not be able to sell the drug in China.
Countries not on the list will have to buy the drug from Merck.
MPP will also consider how many licences it should grant by gauging the needs in the 105 developing countries.
One uncertainty is the emergence of coronavirus variants.
“There are not that many countries that do genomic surveillance, which means a lot of countries are very slow to determine if they have got new variants,” Gore said.
“And new variants can make a whole [lot of] difference to your estimate on the number, [especially] if we get a new highly transmissible variant [that is] even more transmissible than the Delta variant.”
MPP, which focuses on sharing drug technologies, has experience in patent sharing for HIV and hepatitis C treatments. But Gore said the patent sharing mechanism can be useful to increase access to Covid-19 vaccines.
Both Pfizer and Moderna have rejected calls by US President Joe Biden to waive their mRNA vaccine patents, citing reasons including that it would set off a race for raw materials.
Asked if MPP would consider speaking to Chinese pharmaceuticals should China succeed in developing its own mRNA vaccines, Gore said he would welcome talks with them.
“Absolutely. I hope they come to talk to us,” he said.
MPP usually contacts pharmaceuticals for therapeutics in the early stage, but more time would be needed to make sure an experimental vaccine works.
“Not all mRNA vaccines have worked, as, you know, some had spectacular failures … We want to wait and see and at least get some results that are positive.”
MPP is now assisting the WHO in a mRNA technology transfer hub in South Africa. But Gore said that if boosters are needed every year, cheaper options such as vector vaccines should be considered for patent sharing.
Gore said there has been no talks between Chinese pharmaceuticals and MPP for patent sharing of vaccines, but noted that some countries may not have the ability to produce inactivated vaccines because of the high safety standards required.
China’s Sinovac and Sinopharm have both developed inactivated vaccines which received WHO emergency approval earlier this year.
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This article Chinese drug makers want to produce US Covid-19 pill for poorer nations first appeared on South China Morning Post