Penpulimab Started Commercialization and Cadonilimab Filed for NDA
HONG KONG, April 1, 2022 /PRNewswire/ — Akeso, Inc. (9926.HK) ( “Akeso” ), a China-based biopharmaceutical company focusing on the development and commercialization of innovative therapeutic antibodies for Oncology & Immunology, reported 2021 annual results.
- Anniko® (Penpulimab, AK105, PD-1) obtained market entry approval from the Chinese National Medical Products Administration (NMPA). Product sales of RMB 212 million was recorded for the year ended December 31, 2021. Licensing fee recognized was RMB128.6 million from our out-licensed product AK107 (CTLA-4) to MSD (“Merck Sharp & Dohme Corp.”).
- Significant progress of clinical trials made: we submitted 4 marketing applications in 2021, including one for Cadonilimab (AK104, PD-1/CTLA-4) for the treatment of relapsed or metastatic cervical cancer, and three for Penpulimab including treatments for 1L sq-NSCLC and 3L NPC. We also obtained 37 IND approvals, and advanced 2 pre-clinical stage programs into clinical stage. As of the announcement date, we have developed over 30 innovative programs in-house, 15 of which are in clinical stage (including three out-licensed products). And our total number of pivotal or Phase III trials increased to 15. Our total R&D investment for the year was RMB1.07bn (excluding share-based compensation).
- As at December 31, 2021, total cash on hand and confirmed via other financing channels amounted to over RMB5bn, which will be sufficient to support research and development in the next two years.
Anniko® (PD-1) approved and Cadonilimab (PD-1/CTLA-4) expected to obtain approval
On August 5, 2021, our first oncology immunotherapy product, Anniko® (Penpulimab, AK105, PD-1) injection for the treatment of relapsed or refractory classic Hodgkin’s lymphoma obtained market entry approval by the NMPA in China. Product sales of RMB212 million was recorded for the year ended December 31, 2021.
In July 2021, we submitted an NDA of Anniko® in combination with chemotherapy for first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (“sq-NSCLC”) in China. In August, we submitted another NDA for third-line treatment of patients with metastatic nasopharyngeal carcinoma (“NPC”) in China. In September, 2021, we also submitted a BLA for third-line treatment of patients with metastatic NPC to the FDA through the Real-Time Oncology Review (“RTOR”) Programme.
Meanwhile, in oncology therapeutic area, we have achieved important breakthroughs on its fully in-house developed innovative products including Cadonilimab (AK104, PD-1/CTLA-4), AK112 (PD-1/VEGF) and AK117(CD47). In September 2021, we submitted another NDA in China for Cadonilimab for the treatment of relapsed or metastatic cervical cancer under priority review. As of this announcement date, Cadonilimab started three Phase III clinical trials for first-line treatment of advanced gastric adenocarcinoma or gastroesophageal junction cancer (GC/GEJ), first-line treatment of recurrent or metastatic cervical cancer, and locally advanced cervical cancer. AK112 (PD-1/VEGF) started two Phase III clinical trials for first-line treatment of PD-L1(+) NSCLC, and advanced NSCLC previously treated with EGFR-mutant Tyrosine Kinase Inhibitor (TKI) treatment. Another core product AK117 (CD47) has also started various combination therapies studies for treatment of solid tumors, and the preliminary data showed promising results.
In non-oncology therapeutic area, AK101 (IL12/23) entered into Phase III clinical study for the treatment of moderate-to-severe plaque psoriasis. AK102 (PCSK9) started Phase III clinical study for hypercholesterolemia, and a pivotal clinical study for heterozygous familial hypercholesterolemia (“HeFH”).
An experienced commercialization team is ready to launch the new product
With more innovative drugs pending to obtain approval, we have already established an experienced commercialization team with proven track record of success. As of the end of 2021, our commercialization team has more than 500 team members, and all core members have successful sales and marketing experiences. It has achieved in-depth coverage of 1500+ hospitals, 500+ DTP pharmacies, and 60+ Insurance and Charity across the country.
This professional team will be responsible for the commercialization of Cadonilimab. Based on the superior efficacy and first mover advantage of Cadonilimab in clinical studies for the treatment of cervical cancer, gastric cancer, and liver cancer, we have full confidence in a successful launch of Cadonilimab.
High-quality GMP-compliant manufacturing
As of December 31, 2021, we have developed world-class GMP facilities to support large scale commercialization and R&D plans. We currently have 23,500L GMP compliant production capacity in operation, with more capacity under construction and in planning.
Source: Akeso, Inc.