Roche Submits New Indication Application in China for Global First-in-Class CD79b ADC Polatuzumab Vedotin

On May 28, the CDE official website showed,Roche's Injectable Polivy (Polatuzumab Vedotin)(Product name: Polivy,Roche）New Indication Marketing Application Accepted.Previously, in January 2023, the product had been approved for two indications in China.

Source: CDE Official Website

Polivy is an ADC targeting CD79B developed by Roche. It was approved for accelerated marketing in the United States in June 2019.Combination of Bendamustine and Rituximab for R/R DLBCL Patients Who Have Received at Least 2 Prior Treatment Regimens, which has now been converted to full approval. In April 2023, the DLBCL indication for this product was expanded to the first-line setting.

In January 2023, Polivy (Pola) entered the Chinese market, with indications for: 1) In combination with rituximab, cyclophosphamide, doxorubicin, and prednisone for the treatment of previously untreated adult patients with DLBCL; 2) In combination with bendamustine and rituximab for adult patients with R/R DLBCL who are not eligible for hematopoietic stem cell transplantation.

In April this year, RocheDisclosed in the quarterly report, 2025Will submit Polivy in combinationMotoregulin(CD20/CD3 Bispecific Antibody)Marketing application for second-line and above DLBCL indications.

As the world's only approved CD79B ADC, Polivy has seen its sales skyrocket since its market launch.Successfully joined the blockbuster ranks in 24 yearsIn the first quarter of 25, the product's sales reached 358 million Swiss francs, a year-on-year increase of 42%.

Source: Insight Database

Insight database shows that currently, there are only four CD79B ADCs under research and development globally, apart from Polatuzumab Vedotin.Hengrui SHR-A1912 (Phase III) and Xingang Biotech NBT508 (Phase I) have entered the clinical stage.

Source: Insight Database

In May this year, Hengrui announced at the ASCO conferenceSHR-A1912 in Combination with Rituximab, Gemcitabine, and Oxaliplatin (R-GemOx) for the Treatment of R/R DLBCL: Ib/II Phase Clinical Data.The results showed,1.8 mg/kg SHR-A1912 in combination with R-GemOx was well tolerated.And its safety is consistent with each of its components. This combination therapy exhibits potent antitumor activity, with rapid and durable efficacy.

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Disclaimer:This article is for information sharing only and does not represent the position or viewpoint of Insight. It also does not recommend or introduce any treatment plans. If you have any needs, please consult and contact正规医疗机构.

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