On November 23, 2021, China National Medical Products Administration (NMPA) approved TYK Medicines to conduct the TY-302 capsule phase I/II clinical study, a combination treatment for the HR+ and HER2- breast cancer.

The incidence and mortality of breast cancer remain high, among which hormone receptor positive (HR+) breast cancer accounts for 70% to 80% of all breast cancers, and is the largest subtype of breast cancer. With the increase of therapeutic drugs and treatments, the follow-up treatment selection of breast cancer patients developed drug resistance after long-term treatments is still a difficult problem to be solved urgently in clinic.

TY-302, a CDK4/6 inhibitor, received the NNMP clinical trial notification in 2019. Currently, a phase I single-drug dose escalation study is on-going, with 13 patients with solid tumors have been enrolled, No DLT events were reported, and the safety and tolerance is good. According to the mechanism of action, preclinical efficacy of TY-302 and clinical results of similar drugs, TY-302 is fully supported to combine with selective estrogen receptor modulators (SERM) in the treatment of breast cancer patients. It is expected to further meet the urgent clinical needs of patients with breast cancer, provide patients with more clinical drug choices, and prolong the overall survival time of patients.

The Center for Drug Evaluation of China National Medical Products Administration accepts the application:

About TY-302

TY-302, a CDK4/6 inhibitor individually developed by TYK Medicines, Inc, acts on CDK4 and CDK6 targets, down-regulating Rb phosphorylation levels, leading to G1 phase arrest and inhibiting tumor cell proliferation. Preclinical studies showed that TY-302 is similar to Palbociclib in terms of mechanism of action, antitumor activity, pharmacokinetic (PK) characteristics, safety pharmacological characteristics, etc. TY-302 is clinically intended to be used for the treatment of Estrogen Receptor (ER) positive and Human Epidermal Growth Factor Receptor 2 (HER2) negative advanced breast cancer, or in combination with Abiraterone acetate for the first-line treatment of metastatic castration-resistant prostate cancer (mCRPC).

About TYK Medicines, Inc.

TYK Medicines is an innovative biotechnology company based in China, facing the global, focusing on researching and developing international cutting-edge new drugs. The company has established a high-efficiency innovative drug research and development platform, with fully functioned instruments, covering multiple pharmaceutical fields including drug synthesis, biological fermentation, drug analysis, bioanalysis, and formulation research, and is committed to becoming the best domestic and world-class new drug research and development company.