At present, EGFR-TKI targeting for lung cancer has become one of the important methods for non-small cell lung cancer. Especially for patients with advanced lung cancer, EGFR-TKI targeting** can significantly prolong survival and improve quality of life. In 2022, third-generation EGFR-TKI dominated the EGFR-TKI drug market, accounting for 73% of the market share in China0%。In the future, the market share of the third-generation EGFR-TKI will continue to increase, and it is expected to account for 93% of the Chinese EGFR-TKI market by 20336%
*: Sullivan Analysis.
The competitive landscape of China's third-generation EGFR-TKI
There are currently three generations of EGFR-TKI approved for marketing in the world, and China is currently the third-generation EGFR-TKI market with the largest number of marketed ** non-small cell lung cancer in the global market, with a total of four third-generation EGFR-TKIs, namely befacitinib, furmetinib, ametinib and osimertinib.
*: NMPA, Sullivan analysis.
According to the prospectus of Tongyuankang Pharmaceutical, as of the latest practicable date, a total of 12 third-generation EGFR-TKI drug candidates for non-small cell lung cancer in China are in clinical development. Among them, Tongyuankang Pharmaceutical's core product TY-9591 occupies a leading position among EGFR-TKI drug candidates. Notably, TY-9591 is also the only EGFR-TKI drug that has undergone head-to-head pivotal trials to date (to directly compare its efficacy with osimertinib) and is the most effective third-generation EGFR-TKI drug to date.
*: Center for Drug Evaluation, National Medical Products Administration, Sullivan Analysis.
A leading enterprise in new oncology drugs, and has established a strong drug pipeline
Founded in 2017, Zhejiang Tongyuankang Pharmaceutical Co., Ltd. (hereinafter referred to as "Tongyuankang Pharmaceutical") is a clinical-stage biopharmaceutical company, as a leading enterprise in the research and development of new oncology drugs based in China and around the world, the company is committed to discovering, developing and commercializing differentiated targets** to meet the unmet medical needs of cancer**. The Company's core business model includes the discovery, development and commercialization of small molecule drugs and other related innovative drug classes in-house to address unmet needs in the field of cancer, particularly lung cancer.
At present, the company has established a series of pipelines consisting of 11 drug candidates, including third-generation EGFR, CDK4 6 and others. Among them, TY-9591 is a potential best-in-class third-generation EGFR-TKI drug of Tongyuankang Pharmaceutical, which is in the clinical trial stage. In addition, the company includes the key product TY-302, five innovative clinical products (represented by the company's in-house developed key product TY-2136B) and four products in the preclinical stage.
*: Tongyuankang Pharmaceutical Prospectus.
A platform focusing on the research and development of small molecule anti-tumor drugs, with perfect technology and strong strength
Tongyuankang Pharmaceutical has invested heavily in R&D, with R&D costs of 2300 million yuan and 1$8.9 billion. The company's R&D team focuses on the research and development of small molecule drugs, and has a complete technology platform, covering from virtual screening, molecular libraries to optimized design in chemistry and biology. In addition, Tongyuankang Pharmaceutical also has an advanced drug analysis platform and quality control system to ensure the accuracy and reliability of data in the research and development process.
At present, Tongyuankang Pharmaceutical's main focus is on the research and development of tyrosine kinase inhibitors, and gradually expanding its business to other fields, the company's rich R&D pipeline will help promote the company's further development and bring more high-quality drugs to patients.
The core product, TY-9591, is a potential best-in-class third-generation EGFR-TKI drug
The company's core product, TY-9591, is a potential best-in-class third-generation EGFR-TKI drug with anti-tumor effects against EGFR mutations and excellent blood-brain barrier penetration。The Company is currently studying the role of TY-9591 in brain metastases of EGFR-mutant non-small cell lung cancer and locally advanced or metastatic non-small cell lung cancer with EGFR L858R mutations, mainly because there is no drug approved for brain metastases of non-small cell lung cancer in China and the global market, so there is a large clinical demand space.
According to the prospectus, TY-9591 can irreversibly bind to certain EGFR mutants, including L858R mutations, exon 19 deletions, L858R T790M mutations, and exon 19 deletion T790M mutations, thereby inhibiting downstream signaling cascades by blocking phosphorylation of tyrosine kinases and intracellular signaling pathways such as RAS RAF MEK ERK or PI3K AKT pathways, ultimately inhibiting cancer cell proliferation and metastasis. In addition, the security enhancements of TY-9591 are expected to provide a longer window.
According to the clinical trial data of TY-9591, among the 29 patients with evaluable non-small cell lung cancer brain metastases who had never received ** in the Phase 1B and Phase 2 clinical studies, 25 patients achieved intracranial partial response (PR) and 4 patients achieved complete response (CR), with an intracranial objective response rate (ORR) of 100%. In the phase 2 study, the researchers observed an overall incidence of serious adverse events of 83%, * the incidence of related serious adverse events was as low as 83%, showing a good safety profile. Based on these encouraging clinical data, Tongyuankang is conducting a pivotal Phase 2 clinical trial of TY-9591 as a first-line clinical trial for brain metastases in EGFR-mutated non-small cell lung cancer**. In addition, clinical data from the Phase 1b study showed that TY-9591 demonstrated favorable efficacy and safety in 78 evaluable patients, with a median progression-free survival (PFS) of 21 in patients with EGFR-mutated (L858R exon 19 deletion) NSCLCAt 5 months, 25 of them were patients with 19 exon deletionsAt 7 months, 19 patients with L858R mutations were present3 months. The researchers confirmed an ORR of 859%, of which 85 were in exon 19 deletion patients7% and 86 patients with L858R mutations1%。In addition, DLT was not observed, while the incidence and severity of adverse events were acceptable. The investigators are conducting a registrational Phase 3 clinical trial of TY-9591 as a first-line EGFR L858R mutation in locally advanced or metastatic NSCLC.