FDA approves first antibody drug of Chinese origin

An innovative biopharmaceutical drug from China has been approved by the US Food and Drug Administration (FDA) for the treatment of cancer, as the US turns to China to solve its cancer drug shortage, as reported by SCMP .

Toripalimab, an antibody drug developed by Shanghai Junshi Biosciences, received FDA approval on Oct. 27 for the treatment of nasopharyngeal carcinoma, an aggressive form of cancer that starts behind the nose in the upper part of the throat.

This is the first – and currently only – drug approved by the FDA to treat this type of cancer. It is also the first Chinese antibody drug – the development of which requires huge investments and cutting-edge technology – to enter the US market.

The United States has been a world leader in biotechnology. American pharmaceutical giants dominate the drug market at home and internationally.

But in recent years, with growing fears that the United States could extend its sanctions from computer chips to life-saving drugs, the Chinese government and Chinese companies have massively increased investment in research and development of new drugs. A way to maintain a technologically advanced export flow to the USA.

What many didn't foresee, however, was that it would be the United States that would look to China as it had difficulty producing its own drugs.

Toripalimab, which will be marketed as Loqtorzi in the United States, is an antibody drug for PD-1, a checkpoint inhibitor on immune T cells.

Malignant tumor cells express a protein that binds to the PD-1 receptor and blocks the body's immune response. Toripalimab is instead designed to bind to the PD-1 receptor, which allows the immune system to activate and kill tumors.
Junshi partnered with California-based Coherus BioSciences to bring the drug to the United States, and it is expected to be available by the first quarter of next year.

“Toripalimab is the first innovative biopharmaceutical independently developed and manufactured in China approved by the FDA,” Junshi Biosciences said in an Oct. 29 press release.

“We hope this promising therapy fills a treatment gap for international nasopharyngeal patients struggling to find effective therapies,” said Xu Ruihua, professor and doctor of oncology at Sun Yat-sen University Cancer Center and head of the drug's clinical trial . the press release.

Last year, a growing list of U.S. sanctions against Chinese technology companies showed signs of spilling over into biotechnology.

In February, biotech company Wuxi Biologics was added to the unverified list, which forced the company to comply with a huge amount of documentation in order to export from the United States.

Wuxi Biologics, which partnered with AstraZeneca to help produce the Covid-19 vaccine, acknowledged that the designation was due to a Covid-induced delay in testing procedures. The company was removed from the list late last year.

Then, in September last year, US President Joe Biden signed an executive order to promote domestic biotechnology and biomanufacturing, to “safeguard the US bioeconomy” from foreign competitors seeking to acquire their technology.

While the United States has maintained its dominant position in the industry, according to research consultancy McKinsey, in growing sectors such as biopharmaceuticals – which involves the creation of medicines using biotechnological methods – China is in second place.

In his executive order, Biden emphasized not only encouraging biotechnology research and development but also improving domestic manufacturing capacity – an area where the United States struggles to compete with China.

But in September of this year, the White House announced that the country was facing a shortage of 15 cancer drugs “due to manufacturing and supply chain issues.”

The closure of manufacturing sites has cut the supply of three major drugs, including the chemotherapy drug cisplatin, by nearly half, Washington said.

To replace the lost supply, the FDA has turned to manufacturers outside the United States, including the Chinese company Qilu Pharmaceutical, to import their cisplatin drug to help address the “critical shortage,” according to the company.

A survey conducted by the US National Comprehensive Cancer Network in September found that more than half of cancer centers use Chinese-made drugs for cancer treatment.

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The article FDA approves the first antibody drug of Chinese origin comes from Economic Scenarios .

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This is a machine translation of a post published on Scenari Economici at the URL https://scenarieconomici.it/fda-approva-il-primo-farmaco-anticorpale-di-origine-cinese/ on Sat, 04 Nov 2023 11:00:26 +0000.