Another domestic Chinese PD-1 inhibitor enters the race for US approval
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Another domestic Chinese PD-1 inhibitor enters the race for US approval following Coherus BioSciences’ deal with Shanghai Junshi Biosciences

By GlobalData Healthcare 08 Feb 2021 (Last Updated February 8th, 2021 15:23)

Another domestic Chinese PD-1 inhibitor enters the race for US approval following Coherus BioSciences’ deal with Shanghai Junshi Biosciences
Coherus and Junshi are planning to file a BLA for the use of Tuoyi in nasopharyngeal cancer later this year. Credit: Gorodenkoff / Shutterstock.

On 1 February, Coherus Biosciences announced that it will pay $150m to Shanghai Junshi Biosciences for the rights to Junshi’s PD-1 inhibitor Tuoyi (toripalimab) in the US and Canada. Junshi is also set to receive an additional $380m in milestone payments that depend on Tuoyi’s progress. Coherus also obtained the option to acquire two of Junshi’s pipeline agents for $35m each, which could be developed in combination with Tuoyi. On 2 February, Junshi announced that it intends to invest $50m in Coherus under a stock purchase agreement. This is a step for Coherus Biosciences into new drug development. The company has previously been focused on the development of biosimilars. Tuoyi could be a lucrative product as it is already approved in China for the second-line treatment of advanced melanoma, and recently gained Food and Drug Administration (FDA) fast-track designation for the treatment of mucosal melanoma patients. It also has a breakthrough therapy designation for nasopharyngeal cancer and orphan designation for nasopharyngeal cancer and soft tissue sarcoma. However, with six checkpoint inhibitors already marketed in the US, Tuoyi faces significant competition in that space.

The deal marks a change of direction for Coherus. Its leading product, Udenyca, is a pegfilgrastim biosimilar used for the treatment of neutropenic cancer patients. Coherus also has a Biologics License Application (BLA) filed for an adalimumab biosimilar, a copycat of Abbvie’s Humira, which could prove to be lucrative. Coherus has indicated that it intends to use the funds reaped from the sale of biosimilars to invest in its fledgling immuno-oncology pipeline. Partnering with Junshi for the rights to Tuoyi could be a smart move. This is a product in late-stage development. Junshi currently has 12 ongoing Phase III trials, involving Tuoyi across a range of cancers.

Coherus and Junshi are planning to file a BLA for the use of Tuoyi in nasopharyngeal cancer later this year, which could mark the first entry of a Chinese-developed PD-1 inhibitor to the US market. There may be competition from other Chinese PD-1 inhibitors though. Encouraging results from Innovent Biologic’s/Eli Lilly’s Tyvyt (sintilimab) Phase III trial in non-small cell lung cancer (NSCLC) patients could pave the way for eventual approval in the US. However, it remains to be seen how the FDA will handle these applications since the vast majority of the clinical data comes from trials conducted entirely in Asia. Tislelizumab, originally developed by BeiGene and now partnered with Novartis, may be the best bet for a US approval. This PD-1 inhibitor has demonstrated promising results in Phase III trials of previously treated esophageal cancer and NSCLC patients, and an FDA filing could be sought as early as this year, although the planned indication remains unknown.

The potential influx of Chinese-developed PD-1 inhibitors could result in some big changes to the market if these are launched at a lower price point than their rivals. Both Tyvyt and Tuoyi entered the Chinese market with significantly lower price tags than rival PD-1 inhibitors, Merck’s Keytruda and Bristol Myers Squibb’s Opdivo. Should approvals be forthcoming in the US, a similar pricing strategy could see these China-made PD-1 inhibitors challenge the big names for a share of the immuno-oncology market.

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