China boasts second domestically developed PD-1 approval

By Ben Hargreaves

- Last updated on GMT

(Image: Getty/c8501089)
(Image: Getty/c8501089)

Related tags China Eli lilly Innovent Biologics Immunotherapy

Eli Lilly and Innovent announced that their jointly developed anti-PD-1 drug gained approval in China, becoming the second domestically produced treatment of this type.

Innovent Biologics, a Chinese biotech, teamed up with Eli Lilly to bring through Tyvyt (sintilimab) back in 2015, which has seen the biotech and pharma giant collaborate on development and commercialisation of the asset.

The biotech will be responsible for the manufacturing of the drug at its biologics production facility in Jiangsu, the largest of its kind in China.

The treatment was approved by the National Medical Products Administration of China (NMPA) for patients with classical Hodgkin’s lymphoma that has relapsed or has become refractory after two or more lines of systemic chemotherapy.

Tyvyt is the second anti-PD-1 monoclonal antibody (mAb) approved by the NMPA in recent weeks, which Innovent stated: “highlights the emergence of China in the field of immuno-oncology.”

Just days after the approval announcement, Innovent stated that the first patient had been dosed in a Phase III trial for patients with advanced, recurrent or metastatic esophageal squamous cell carcinoma.

Speaking at an event at the end of last year, Christoph Heinemann, transformation leader at Sanofi, told attendees that the speed and scale of China’s transformation​ in the pharmaceutical space was something that should be closely followed.

In particular, he pointed towards the Chinese government’s involvement in speeding up the regulatory process and investment capital flowing into the country as reasons that more domestically produced medicines will be developed and approved in the coming years.

Michael Yu, CEO of Innovent, said, “Tyvyt is an example of our success with the National Mega Innovation Program, and its approval highlights our achievements in immunotherapy and contributions to China’s efforts to deliver innovative medicines.”

In the PD-1 area, treatments already approved in the US and Europe have proven to be lucrative, with Merck’s (known as MSD in Europe) Keytruda bringing in sales of $5bn (€4.4bn) globally in the first nine months of 2018.

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