AstraZeneca Announces NMPA Priority Review for Savolitinib (Volitinib) New Drug Application in MET Exon 14 Skipping Mutation-Positive Non-Small Cell Lung Cancer in China

July 29, 2020 – AstraZeneca announced that the National Medical Products Administration (NMPA) of China has officially included the new drug application for savolitinib for the treatment of non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition factor (MET) exon 14 skipping mutations in the priority review program.

Savolitinib, a MET receptor tyrosine kinase inhibitor co-developed by HUTCHMED and AstraZeneca, is indicated for the treatment of non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition factor (MET) exon 14 skipping mutations. This represents the first new drug application in China for Savolitinib as a selective MET inhibitor.

Breaking Through the Current Treatment Landscape to Bring New Hope to Patients with Rare MET Mutations

China sees over 774,000 new lung cancer cases annually, accounting for 37% of the global total.¹Approximately 80-85% of lung cancers are non-small cell lung cancer.²It is estimated that approximately 2–3% of patients with non-small cell lung cancer (NSCLC) harbor MET exon 14 skipping mutations.³For years, the treatment of lung cancer patients with rare MET mutations has remained challenging, characterized by poor prognosis and insensitivity to existing standard therapies, with a persistent lack of effective targeted drugs in clinical practice.

Savolitinib is an oral, highly selective small-molecule MET inhibitor. Its New Drug Application (NDA) is based on an ongoing Phase II clinical study in China evaluating savolitinib monotherapy in patients with MET exon 14 skipping non-small cell lung cancer (NSCLC) who have failed prior systemic therapy or are ineligible for chemotherapy (ClinicalTrials.gov Identifier: NCT02897479).

# Homegrown Innovation in China, Benefiting Domestic Patients First

Notably, savolitinib is a Class 1.1 innovative drug in China. As an original, independently developed targeted therapy incubated by a domestic pharmaceutical company, it represents a breakthrough from zero to one. This signifies that China has independently achieved first-in-class status for drugs targeting rare MET mutations, aligning local R&D with international standards.

In 2011, HUTCHMED and AstraZeneca entered into a global patent license, co-development, and commercialization agreement for savolitinib. The global development program for savolitinib includes non-small cell lung cancer and renal cell carcinoma, with ongoing exploration of other MET-driven tumors. The independent R&D, domestic launch, and future international expansion of savolitinib demonstrate the promising prospects for advancing Chinese innovations onto the global stage and accelerating the globalization of domestically developed innovative drugs.

# Priority Review

Priority Review is a program established by the National Medical Products Administration (NMPA) to encourage the research and development of potential new drugs with clear clinical value, drugs or vaccines urgently needed for clinical use, drugs for the prevention and treatment of major infectious diseases and rare diseases, as well as new pediatric drug varieties or dosage forms. Potential new drugs may demonstrate clear clinical value in the prevention and treatment of serious life-threatening conditions or diseases that significantly impact quality of life. Marketing applications for new drugs eligible for Priority Review will receive prioritized resource allocation from the NMPA during the review and approval process.⁵

About HUTCHMED

HUTCHMED (China) Limited (“HUTCHMED” or “Chi-Med”) (NASDAQ/LSE: HCM) is an innovative biopharmaceutical company that, over the past two decades, has been dedicated to the discovery and global development of targeted therapies and immunotherapies for cancer and autoimmune diseases. Currently, HUTCHMED has nine oncology drug candidates in global development and maintains an extensive commercial network in the Chinese domestic market. For more information, please visit:www.chi-med.com。

About AstraZeneca

AstraZeneca is a science-led global biopharmaceutical company focused on the research, development, manufacturing, and marketing of prescription medicines, with a particular emphasis on three major therapeutic areas: oncology, cardiovascular, renal and metabolism, and respiratory. With operations in more than 100 countries, AstraZeneca’s innovative medicines benefit millions of patients worldwide. For more information, please visitwww.astrazeneca.com

References:

1.    Global Cancer Observatory. China Fact Sheet. gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.

2. American Cancer Society. www.cancer.org/cancer/lung-cancer/about/what-is.html.

3.   Awad M et al. “MET Exon 14 Mutations in Non–Small-Cell Lung Cancer Are Associated With Advanced Age and Stage-Dependent MET Genomic Amplification and c-Met Overexpression.” Journal of Clinical Oncology 2016;34(7):721-730. doi:10.1200/JCO.2015.63.4600.

4.    S Lu, J Fang, X Li, L Cao, J Zhou, Q Guo, Z Liang, Y Cheng, L Jiang, N Yang, Z Han, J Shi, Y Chen, H Xu, H Zhang, D Zhang, J Li, L Wang, Y Ren, W Su. “Phase II study of savolitinib in patients (pts) with pulmonary sarcomatoid carcinoma (PSC) and other types of non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations (METex14+).”2020 ASCO(9519).

5. National Medical Products Administration, “Procedures for Priority Review and Approval of Drug Marketing Authorization Applications (Trial)” http://www.nmpa.gov.cn/WS04/CL2138/378606.html.