Recently, Hengrui Pharmaceuticals and its subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. received the Notice of Approval for Clinical Trial of Drugs approved by the State Drug Administration, approving the company's novel and highly selective CDK4/6 inhibitor, dalsiril hydroxyethanesulfonate tablets, combined with HRS-1358 tablets to carry out a clinical trial for breast cancer.

Breast cancer is the number one malignant tumor affecting women worldwide. According to the Global Cancer Epidemiology Report 2024, the incidence and mortality rates of breast cancer rank first among female malignant tumors, with approximately 2.31 million new cases of breast cancer and 670,000 deaths globally each year, ranking first in terms of incidence and mortality rates of female malignant tumors [1]. In recent years, the incidence and mortality rates of breast cancer have shown a continuous upward trend in China, and it ranks fourth among the causes of cancer death.

HRS-1358 is a novel, highly efficient and selective PROTAC molecule independently developed by Hengrui Pharmaceuticals to target estrogen receptor (ER) degradation, which can potently and highly selectively degrade ER, inhibit ER transcriptional activity and downstream signaling, and then inhibit tumor cell proliferation and exert anti-tumor effects. Compared with traditional small molecule drugs, PROTAC can overcome the mutation resistance of target proteins and has higher selectivity for target proteins. There are no similar drugs on the market at home and abroad. HRS-1358 is currently being explored in clinical studies of single-agent or combined CDK4/6 inhibitors for breast cancer, aiming to provide more optional treatment options for breast cancer patients.

Dalsirix hydroxyethanesulfonic acid tablets (trade name: Aerikon), a Class 1 new drug independently developed by Hengrui Pharmaceuticals and the first independently developed novel and highly selective CDK4/6 inhibitor in China, was approved by the State Drug Administration for marketing in December 2021, with the approved indications of combining with fulvestrant for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative recurrent or metastatic breast cancer patients with progression after endocrine therapy. The approved indication is for the treatment of recurrent or metastatic breast cancer that has progressed after endocrine therapy; in June 2023, the approved indication is for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer patients in combination with an aromatase inhibitor as the initial treatment.

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