CDE intends to identify Hengrui CDK4/6 inhibitors and Junshi anti-PD-1 for breakthrough therapy

Recently, the official website of CDE showed that Hengrui SHR6390 tablets and Junshitraprizumab were planned to be included in breakthrough therapy by CDE.

Hengrui: SHR6390 tablets

SHR6390 tablet is a class 1 new drug developed by Hengrui.

On December 24 last year, Hengrui announced that the primary endpoint of the Phase III clinical study (SHR6390-III-301) for this indication met the pre-specified superiority standard.

In addition, Hengrui has also registered SHR6390 in the country for the treatment of patients with relapsed or refractory non-Hodgkin’s lymphoma in combination with anti-PD-1 antibody SHR1210, and the treatment of patients with malignant melanoma of the head and neck mucosa who have failed standard treatment with CDK4 amplification.

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At present, Pfizer and Qilu's pipercillil capsules and Eli Lilly's Abbeceil tablets have been approved for marketing.

Junshi: Teriprolizumab

Junshi Bio-PD1 Teriplimumab Injection is planned to be included in the breakthrough therapy indication as the first-line treatment of advanced mucosal melanoma.

It is worth noting that the first approved indication for Teriplizumab is the treatment of unresectable or metastatic melanoma after the failure of previous systemic treatments.

In August 2019, Junshi announced the results of an open-label phase IB clinical trial of teriprizumab combined with the anti-angiogenic drug axitinib for the treatment of advanced mucosal melanoma.

At present, the phase III clinical trial (IND) application of teriprizumab combined with axitinib for the first-line treatment of patients with mucosal melanoma has been approved by the FDA.

Mucosal melanoma is one of the subtypes of melanoma.