Furmonertinib Received New Indication IND Approval by CDE – Comprehensive Cover, Global Synchronization

Shanghai Allist Pharmaceuticals (“Allist”) today announced the approval of an Investigational New Drug (IND) in the first line treatment of non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) exon 20 insertions using Furmonertnib by Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA). This is the first global, multi-center clinical trial of Furmonertinib approved in China; in addition, it is also the very first global, phase III, randomized, open-labeled study (FURMO-004 ) collaborated with ArriVent Biopharma, Inc. (“ArriVent”). Besides the IND approval in China, the trial is set out to enroll patients from 21 countries and currently is approved in countries, such as the United States, France, Japan, etc.


Furmonertinib, developed by Allist, is an oral, small molecule, highly brain-penetrant, pan-EGFR mutant kinase inhibitor has activity and selectivity in both NSCLC with EGFR exon 20 insertions and other uncommon EGFR mutations. According to the results presented in European Society for Medical Oncology (ESMO) in September 2021, FAVOUR study, which is a Phase Ib late stage NSCLC with EGFR exon 20 insertions, in 10 treatment-naïve patients with Furmonertinib 240mg QD, has an overall response rate (ORR) of 60% based on the Independent Review Committee (IRC) assessment and 70% based on the Investigator assessment. As for the disease control rate, it is 100% for both IRC and the investigators’ assessments. In addition to that, Furmonertinib also has a well-tolerable safety profile; it can potentially be one of the therapeutic treatments for patients with EGFR exon 20 insertions and other uncommon EGFR mutations.


Based on above data, Allist and ArriVent decided to jointly conduct the global trial, FURMO-004. The purpose is to evaluate the efficacy and safety of Furmonertinib compared to platinum-based chemotherapy in previously untreated patients with locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations.


Mr. Jie Hu, Vice President of Allist, stated, “Today, lung cancer remains the leading cause of cancer deaths. NSCLC is one of the major sub-type of lung cancer, approximately 85% of all lung cancer cases. Although there has been significant progress in the treatment of NSCLC, there is currently no approved 1st line treatment for NSCLC patients with EGFR exon 20 insertions and the prognosis is considered to be poor. In accordance with the phase Ib FAVOUR study in China started by Allist, Furmonertinib demonstrated clinical activity and well-tolerated safety. We are very pleased to further expand the progress of Furmonertinib for this type of patient with urgent medical needs globally. This IND approval not only showed the acceptance of Furmonertinib from the well-known international drug regulatory administrations, but also proved its innovation and clinical efficacy. Furthermore, the IND approvals from multiple countries imply there are huge commercial potentials for Furmonertinib in global markets.


Dr. Bing Yao, the co-founder and President of ArriVent, believed “To benefit more patients, we initiated the registered study FURMO-004. This marks a critical step in building up a global franchise for our primary drug candidate, Furmonertinib; while also laying ArriVent's position as an established company providing promising treatments for NSCLC patients.”


About Furmonertinib

Furmonertinib is a self-developed 3rd generation of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with an independent intellectual property right in China. Furmonertinib is approved and commercialized for the treatment of adult patients of locally advanced or metastatic non-small cell lung cancer (NSCLC) who experience progression during or following prior therapy with a EGFR TKI therapy with confirmed EGFR T790M positive mutations. Besides that, Furmonertinib is again approved by the National Medical Products Administration (NMPA) of China for the use in the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletion (19DEL) or exon 21 (L858R) substitution mutations on June 29th, 2022. Both 1st line and 2nd line of treatments are now included in the National Reimbursement Drug List (NRDL) for the benefits of patients in China. Currently, Allist is still in registered clinical development of the adjuvant treatment for NSCLC in EGFR mutations, that of the treatment in NSCLC with EGFR exon20 insertion and uncommon EGFR mutations.


About Allist

Shanghai Allist Pharmaceuticals Co., Ltd is co-founded by Mr. Du Jinhao, a renowned entrepreneur, and Dr. Guo Jianhui, tenured scientist of The United States National Institutes of Health (NIH) in. Headquartered in Zhangjiang Hi-Tech Park since its founding in March 2004, Allist has built itself into an innovative pharmaceutical company, discovering, developing, manufacturing and commercializing innovative medicines.

Under the development concept of “advancing long life with innovation of science and technology”, it is oriented by the unmet clinical demands in the global pharmaceutical market, with special focus on tumor treatment. Allist seeks to develop first-in-class and best-in-class medicines with uncompromised devotion to produce safe, effective, and inclusive innovative drugs with independent intellectual property rights.

After the A and A+ rounds of financing in 2019, Allist was formally listed on the Sci-Tech Innovation Board (STAR) market via the Shanghai Stock Exchange on December 2, 2020 (Stock code: 688578).


About ArriVent Biopharma

ArriVent is dedicated to accelerating the global development of innovative biopharmaceutical products. With a deep and global network, ArriVent seeks to access unique and best-in-class drug candidates at various development stages, including those coming from China and other emerging biotech hubs. Through strategic collaborations with innovative biopharma companies, ArriVent aims to globalize medicines for patients with unmet medical need in a broad range of diseases, with an initial focus in oncology.