5 Chinese firms receive COVID treatment sublicenses

The Geneva-based Medicines Patent Pool's offer of a non-exclusive sublicense to several Chinese enterprises to produce the generic version of Pfizer's oral COVID-19 treatment can help mitigate poor access to COVID-19 medicines, industry experts and business leaders said on Friday, adding the offer is also a recognition of the Chinese makers' capability to produce high-quality drugs.

The MPP, a UN-backed public health organization, announced on Thursday its sublicense agreements with 35 manufacturers in 12 countries and regions－including five in China－to produce and supply the raw ingredients for nirmatrelvir and/or the finished drug itself co-packaged with ritonavir, for 95 low- and middle-income countries (excluding China) that account for about 53 percent of the world's population.

According to the MPP, Pfizer will not receive royalties from sales of nirmatrelvir from the MPP sublicensees while COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization.

The nirmatrelvir tablets and ritonavir tablets combination is a co-packaged oral COVID-19 treatment under the brand Paxlovid.

The drug has now been approved for emergency use or conditional approval in more than 50 countries.

Earlier this week, China released its latest COVID-19 diagnosis and treatment guidelines, and included the drug in them. In February, it had granted the treatment conditional approval.

On Thursday, 21,200 boxes of Paxlovid completed Customs clearance procedures at Shanghai for entry into China, according to a report by Shanghai-based digital news service provider The Paper.

The MPP sublicensing is the result of the voluntary licensing agreement signed by the MPP and Pfizer in November 2021. The manufacturing facilities to be used to make the products under the sublicense will be subject to approval by a strict regulatory authority or pre-qualification by the WHO.

Among the five Chinese firms, Zhejiang Jiuzhou Pharmaceutical Co Ltd is sublicensed to produce the active pharmaceutical ingredient－API－nirmatrelvir, while the other four firms, including Apeloa Pharmaceutical Co Ltd, will produce both the ingredients and the finished drugs.

Shanghai Fosun Pharmaceutical Industrial Development Co Ltd, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co Ltd, Shanghai Desano Pharmaceuticals Co Ltd and Zhejiang Huahai Pharmaceutical Co Ltd complete the list of five sublicensees in China.

Shi Lichen, founder of medical consulting firm Beijing Dingchen Consultancy, said: "Chinese enterprises have provided a lot of important anti-COVID-19 materials to the outside world since the COVID-19 outbreak.

"The inclusion of the enterprises in the MPP program has again demonstrated Chinese enterprises' capability to meet regulatory requirements for the production and supply of quality medicines after a short preparation period."

Wu Yifang, chairman and CEO of Fosun Pharma, said Fosun Pharma always regards innovation as a core driving force for development. Given its global footprint, Fosun Pharma can help address unmet clinical needs and improve the accessibility and affordability of COVID-19 treatments in low- and middle-income countries worldwide.

"We will continue to contribute to the global pandemic response on COVID-19 and to help save more lives," Wu said.

Huahai Pharmaceutical also said the MPP has strict requirements on sublicensees' capabilities to ensure high-quality R&D, production, management, and overseas commercialization among many others.

The MPP can provide an effective platform for Chinese enterprises to go global, as they can use the MPP platform to enhance global ties and further tap overseas markets, thanks to their newly improved innovation capacity, which should enable them to produce more original drugs, the company said.