Novartis Submits NDA for Ribociclib Succinate Tablets in China

On October 22, the CDE website indicated that Novartis's marketing authorization application for 「ribociclib succinate tablets」 has been accepted, and it is speculated that the drug may be the CDK4/6 inhibitor ribociclib.

From: CDE Official Website

CDK stands for cyclin-dependent kinase, a key kinase involved in cell cycle regulation. CDK4/6 inhibitors can effectively arrest the progression of tumor cells from the G1 phase to the S phase, halting cell division at the G1 stage, thereby inhibiting the division and proliferation of cancer cells.

Ribociclib succinate tablets (ribociclib) is the second globally approved CDK4/6 inhibitor. The drug received FDA approval in March 2017 under the brand name Kisqali, obtained EU approval in August of the same year, and achieved global sales of $687 million (+43.1%) in 2020.

Currently, four CDK4/6 inhibitors are marketed globally: Pfizer's Ibrance (palbociclib), Novartis's Kisqali (ribociclib), Eli Lilly's Verzenio (abemaciclib), and G1 Therapeutics' Trilaciclib.

CDK4/6 Inhibitors Approved for Breast Cancer

Palbociclib, the first approved CDK4/6 inhibitor, has demonstrated robust market performance, with global sales reaching $5.392 billion in 2020 and continuing to grow. Driven by immense market potential, follow-on agents continue to emerge. In terms of market share, Novartis and Eli Lilly are currently achieving substantial growth rates and are accelerating the expansion of their respective CDK4/6 inhibitor portfolios.

Data source: Insight Database (http://db.dxy.cn/v5/home/)

The competition among CDK4/6 inhibitors in China is equally intense. As for imported drugs, palbociclib and abemaciclib were approved for market launch in 2018 and 2020, respectively. With Novartis’s ribociclib now submitted for marketing approval, all three globally available agents in this class will soon become accessible in China. Generic versions of palbociclib have also emerged; Qilu Pharmaceutical secured the first generic approval in December last year, and eight other generic manufacturers have since filed applications.

Source: Insight Database (http://db.dxy.cn/v5/home/)

Regarding domestic innovative drugs, according to the Insight database, 16 domestic companies currently have related projects advancing through clinical development in China. The fastest-progressing candidate, Hengrui Medicine's "Dalpiciclib," has already been submitted for marketing approval, while Simcere Pharmaceutical's Trilaciclib (in-licensed from G1 Therapeutics), Genor Biopharma's Lerociclib, and Sihuan Pharmaceutical's Piroxiclib have all entered Phase III clinical trials.

Details of the Competitive Landscape for the CDK4/6 Target in China

Source: Insight Database (http://db.dxy.cn/v5/home/)