Alpha Biopharma Submits New Drug Application for Zorifertinib, a Next-Generation EGFR-TKI to Treat EGFR-mutated NSCLC Patients with CNS Metastases

SHANGHAI,Jan. 30,2023 -- Alpha Biopharma,a developer of innovative drugs,announces that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for Zorifertinib,a next-generation EGFR-TKI specially designed to treat advanced EGFR-mutated non-small cell lung cancer (NSCLC) patients with central nervous system (CNS) metastases. Zorifertinib is the first EGFR-TKI to be tested in a prospective,controlled registration clinical study for this difficult-to-treat patient population,and if approved,it will bring a much-needed new treatment option for these patients.

Data released by the International Agency for Research on Cancer (IARC) of the World Health Organization (SHO) showed that there were 9.96 million cancer deaths worldwide in 2020,and 1.8 million deaths were from lung cancers,making it the most common cause of cancer deaths. Due to the low CNS penetration rate of most current lung cancer drugs,lung cancers metastasized to the CNS were poorly controlled and have become one of the leading causes of NSCLC patient deaths.

Zorifertinib is a next-generation EGFR-TKI targeting sensitive EGFR mutations (exon 19 deletion and exon 21 L858R) designed for complete blood-brain barrier (BBB) permeability. In addition,Zorifertinib is not a substrate for the efflux transporters P-gp and BCRP,which allows it to achieve and maintain effective drug exposure in the brain tissues and the cerebrospinal fluid.

The EVEREST study was a multinational,multicenter,randomized,open-label,controlled phase II/III clinical trial designed to evaluate the efficacy and safety of Zorifertinib as a first-line treatment for advanced EGFR-mutated NSCLC patients with CNS metastases. The study was carried out in 55 study sites located in the Chinese mainland,Taiwan,South Korea,and Singapore,with a total enrollment of 492 patients. The last patient last visit (LPLV) of the EVEREST study was completed in the third quarter of 2022. Results from the EVEREST study demonstrated that Zorifertinib effectively reduced the risk of disease progression and patient deaths in the target patient population and showed significant efficacy in treating metastatic lesions in the CNS. In addition,Zorifertinib's safety profile is comparable to other approved EGFR-TKI's. The primary resistance mutation at the time of disease progression is the EGFR T790M mutation.

Professor Yilong Wu,President of the Chinese Thoracic Oncology Group (CTONG) and the leading principal investigator (PI) of the EVEREST study,said,"Clinical results from this high-quality,controlled study demonstrated that Zorifertinib provided consistent and statistically significant benefits to EGFR-mutated NSCLC patients with different levels of CNS metastasis. It could provide a much-needed new treatment option for these difficult-to-treat patients. The development of Zorifertinib represents a great example of a patient-centric,targeted precision approach to address unmet medical needs.

Eric Zhang,CEO of Alpha Biopharma,"after many years of dedicated research and development,we are very pleased to witness that all pre-clinical and clinical data have demonstrated that Zorifertinib can achieve and maintain high CNS exposures,that it is safe,and it is advantageous in controlling CNS and overall disease progression in this difficult-to-treat population. We look forward to working closely with the regulatory agencies around the world to bring this innovative treatment option to patients in dire need.

About Zorifertinib

Zorifertinib is a potent,oral,reversible inhibitor of mutated EGFR (Exon19Del and Exon21L858R). EGFR is widely expressed in human epidermal and stromal cells and is highly expressed in various human malignancies,such as NSCLC. EGFR gene mutation will cause excessive epidermal growth factor receptors on the cell membrane surface,accelerate the abnormal growth and division of cells,and eventually lead to tumorigenesis. CNS metastases are common in EGFR-mutated NSCLC patients and are accompanied by a poor prognosis of earlier disease progression,shorter survival,and lower quality of life. The BBB significantly increases the difficulty of drug penetration into the CNS,which allows the CNS to be a refuge for lung cancer cells. Zorifertinib is a next-generation EGFR-TKI with full blood-brain barrier penetration targeting advanced NSCLC patients with CNS metastases and EGFR-sensitizing mutations. Zorifertinib is currently under NDA submission and has global patent protection.

About Alpha Biopharma

Alpha Biopharma is a late-stage biopharmaceutical company focusing on developing new therapies for cancers and other unmet medical needs. The Company has submitted its first NDA submission for its small molecule drug Zorifertinib to treat advanced NSCLC patients with CNS metastases and EGFR sensitizing mutations. In addition,in partnership with leading cell therapy company Wugen,Alpha Biopharma is developing memory NK-cells to treat multiple blood and solid tumors and CAR-T cells to treat T-cell lymphomas. It has initiated an IIT clinical study testing memory NK cells in relapse and recurring AML patients. Alpha Biopharma has assembled an experienced management team with solid capabilities in pre-clinical development,pharmacology,medical sciences,clinical operations,and business development to advance its innovative treatment solutions to the market and improve life quality for cancer patients and commercialization.

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