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Hengrui Medicine's Class 1 new drug Dalsili has been approved for marketing!

 Last Update: 2022-03-09
 Source: Internet
 Author: User

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A few days ago, the State Drug Administration approved the launch of the company's self-developed Class 1 new drug isethionate dalcili tablets (trade name: Erlikang)
.

Hengrui Medicine's new class 1 hypoglycemic drug, Proline Henggliflozin Tablets, was also approved at the same time as Dalcil.

Dalsilir is the first CDK4/6 inhibitor originally developed in China.
The approved indication is for hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative endocrine therapy in combination with fulvestrant.
Treatment of post-progressed recurrent or metastatic breast cancer
.

The marketing application was included in the priority review and approval process by the State Food and Drug Administration in April 2021 as a breakthrough therapy

Dalsili: A new option closer to Chinese patients

Globally, breast cancer is the most common malignant tumor
.

HR+/HER2- is the main subtype of breast cancer, accounting for nearly 70% of all cases

Since 2018, with the launch of imported CDK4/6 inhibitors, some Chinese patients have benefited from them
.

However, the onset characteristics (age, underlying diseases, etc.

The approval of dalcilide this time is mainly based on the DAWNA-1 study: a multicenter, randomized, controlled, double-blind phase III clinical study, aiming to compare dalcilide with placebo plus fulvestrant in the treatment of previous endocrine therapy recurrence or advanced HR+/HER2- advanced breast cancer
.

The research results have been presented as an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) annual meeting in June 2021, and published in the international academic journal Nature Medicine in November 2021 (impact factor 53.

It is worth noting that 100% of the 361 patients enrolled in the DAWNA-1 study were Chinese patients
.

Hengrui Medicine continues to output innovative achievements and strive to benefit more patients

Hengrui Medicine's new class 1 hypoglycemic drug, Proline Henggliflozin Tablets, was also approved at the same time as Dalsili
.

At present, in addition to the 10 innovative drugs already on the market, the company has more than 50 innovative drugs under clinical development, and more than 240 clinical trials are being carried out at home and abroad

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