Allist 2021 Semi-annual Report
2021/08/24

l  General Performance

Operating Income: 121 million RMB

R&D Investment: 92.63 million RMB

l  Operating Highlights

ü  Franchised Overseas, Furmonertinib Sets Sail

On June 30, Allist has reached an overseas exclusive franchise agreement with ArriVent Biopharma, Inc. Allist will receive an initial payment of $40 million and be eligible for potential registration, sales milestone payments, and commissions on overseas sales.

ü  University-Business Cooperation in Developing Original Drugs

On July 28, Allist signed a technology transfer agreement with Fudan University, obtaining all the research results, domestic and foreign patent rights and all the rights and interests of development, registration and sales of the PGAM1 inhibitor KH3 project developed by School of Pharmacy, Fudan University. Allist' product pipeline will expand strategically from lung cancer to other cancer diseases.

l  Furmonertinib Brings Fortune

ü  Accelerate Market Expansion and Increase Accessibility

In March 2021, Furmonertinib was commercially marketed in China, becoming world’s third and China’s second innovative targeted drug approved for the treatment of EGFR-T790M mutation NSCLC. At present, Furmonertinib is available in nearly 800 hospitals and about 250 DTP pharmacies covering 30 provinces and cities in China.

ü  Get incorporated in Inclusive Commercial Insurance to Benefit More Chinese Patients

Furmonertinib has been successfully incorporated into inclusive commercial complementary medical insurance programs in 10 cities, including: Shandong Linyi Insurance, Qindao e-Insurance, Zhejiang Zhouhui Insurance, Hangzhou Insurance, Ningbo Tian Yi Yong Ning Bao Insurance, Sichuan Huirong Insurance, Hebei Henghui Insurance, Guangdong Zhanjiang Insurance, Beijing Inclusive Health Insurance, Hainan Lecheng Global Special Drug Insurance.

ü  Accelerate Development of New Indications

First-line Treatment

Patient enrollment of the phase III clinical trial of first-line treatment had completed by the end of 2019. The target event number was reached in July 2021 according to researchers’ evaluation. Relevant data need to be finally confirmed based on the center imaging data.

The clinical data review of the current data is expected to be completed around September or October, then entering the subsequent NDA application preparation stage. Allist will file for the NDA as soon as possible, and the indication for first-line treatment is expected to be approved in 2022.

 

Adjunctive Therapy

In April 2021, the FORWARD program studying Furmonertinib in adjunctive therapy was officially launched. The first batch of subjects was enrolled in June.

 

20 exon insertion mutation

Phase Ib clinical studies have been carried out.

ü  Debut in the Lancetwith remarkable academic achievements

2021.01

Analysis and findings of the effect of Furmonertinib on NSCLC patients with CNS metastases presented at the 21st World Conference on Lung Cancer (WCLC 2020)

2021.03

Full article of Furmonertinib Phase IIb studies published in the Lancet Respiratory Medicine

2021.06

The process mode and treatment data of the phase IIb clinical trial of Furmonertinib presented at the 2021 annual meeting of the American Society of Clinical Oncology (ASCO 2021).

l  Corporate Highlights

ü  On March 30, Allist headquarters and R&D center located in the International Medical Park of Zhangjiang Hi-tech Park in Pudong were capped and is expected to be in operation in 2022.

ü  On April 7th, Allist was credited as Top 10 Best Listed Biomedical Companies in 2020.

ü  On June 10th, Allist and its chairman, Mr. Du Jinhao, were awarded the title of "Top 10 Drug Innovation Emerging Companies of the Year" and "Top 10 Drug Innovation Leaders of the Year".

ü  On July 23, Du Jinhao, chairman of the board, was invited to attend the symposium of innovative science and technology enterprises hosted by Li Qiang, Secretary of the Municipal Party Committee, and offered insights on the development of the industry as the only representative of biomedical enterprises.

ü  On August 1, Allist was awarded the title of "2021 Chinese Pharmaceutical Innovative Force" by the Ministry of Industry and Information Technology.