Recently (October 20), Hengrui Pharmaceutical Group 1 CDK4/6 inhibitor "Dalsilil doxylate tablets" submitted a class 2.4 marketing application was accepted by CDE, the indication of this application is: the combination of letrozole or anastrozole, the first-line treatment of HR+/ HER2-locally advanced or metastatic breast cancer.
Dalpiciclib (Dalpiciclib) Arekon is a novel highly selective cyclin dependent kinase 4 and 6 (CDK4/6) inhibitor independently developed by Hengri Pharmaceutical. In December 2021, it was formally approved by NMPA in combination with fulvestrant. For hormone receptor-positive (HR+)/human epidermal growth factor receptor-2-negative (HER2-) recurrent or metastatic breast cancer with disease progression after previous endocrine therapy, it is the first domestic CDK4/6 inhibitor approved. Dalsilide was launched in China in February 2022 at a price of 13,500 yuan per box (150mg*21 tablets).
In August, Hengrui Pharmaceutical announced a multicenter, randomized, controlled, double-blind phase III trial of Dalsilide plus aromatase inhibitors as first-line therapy for HR+/ HER2-advanced breast cancer. The primary end point, progression-free survival (PFS), was determined by an independent data monitoring committee (IDMC) to meet protocol-specified criteria for superiority. The results showed that Dalsilide tablets combined with aromatase inhibitors as initial treatment significantly prolonged PFS in HR+/HER2- locally advanced or metastatic breast cancer patients. According to the interim analysis presented at the 2022 European Society of Medical Oncology (ESMO) Congress, the median PFS of dalsilyl combined with letrozole/anastrozole as first-line treatment for HR+/ HER2-advanced breast cancer was 30.6 months and the objective response rate (ORR) was 57.4%.
The new indications for Dalsilide are based on the results of these studies. In addition, in the field of breast cancer, in addition to the first-line and second-line treatment of HR+/ HER2-advanced breast cancer, Dalsilyl has also been developed for postoperative adjuvant treatment of HR+/ HER2-breast cancer, neoadjuvant treatment of HR+/ HER2-breast cancer, early neoadjuvant treatment of triple-positive breast cancer, and advanced first-line and second-line treatment.
Five CDK4/6 models are available
4 for breast cancer
As an upstart in the field of breast cancer treatment in recent years, CDK4/6 inhibitors are rapidly changing the treatment landscape of HR+/HER2- advanced breast cancer. Currently, five CDK4/6 drugs have been approved worldwide (see table below), although G1Therapeutics' Cosela is approved as a bone marrow protective agent.
Of the four CDK4/6 inhibitors targeting breast cancer, Pfizer's Ibrance is the best performing market, with sales of $5.437 billion in 2021. But Ibrance sales growth has slowed in the last two years. Eli Lilly's Verzenio was approved later than Novartis' Kisqali, but it overtook Novartis's Kisqali in sales in its second year on the market and became a $1 billion blockbuster in 2021. Moreover, Verzenio is the first CDK4/6 inhibitor approved for the treatment of HR+/HER2- high-risk early breast cancer.
Health care negotiations intensify competition
There are many in the clinical stage
Among the five CDK4/6 inhibitors, Novartis' ribosilide is the only one yet to be approved in China, though it has already submitted two indications in the country. Lilly the abbe west of approved three indications at home, in about 2021 countries, lilly to 69.3% drop to abbe tabbath piece for advanced breast cancer treatment indications into medical insurance directory b, 2021, is China's first and only one into the health care of CDK4/6 inhibitors, and pp BaiXiLi negotiations failed again, no medical insurance directory. At present, a new round of medical insurance negotiations will be opened soon, and the competition of CDK4/6 inhibitors in China will be further intensified. From the access conditions, both Piperbocilide and Dalsilide meet the requirements, and Qilu Pharmaceutical and Hausen Pharmaceutical have successively obtained the approval for the production of generic piperbocilide, suggesting that the future domestic CDK4/6 inhibitors will launch a fierce price war. Who will emerge as the victor in this year's health care negotiations?
It is worth mentioning that Hengrui Pharmaceutical tarylate Dalsili tablets as the first domestic original research CDK4/6 inhibition, it is reported that in the case of not considering preferential drug delivery, Dalsili pricing for 13500 yuan a box (150mg*21 tablets), this year's medical insurance negotiations can be reduced, bring more welfare to patients, is also a big focus.
In addition, there are many CDK4/6 inhibitors targeting breast cancer in the world at present, and lerociclib for first-line and second-line breast cancer treatment is rapidly advancing in phase 3 clinical. According to the data presented at the European Congress of Oncology (ESMO) 2020, lerociclib showed better safety and tolerability, and is expected to be the best CDK4/6 drug candidate in its class.
