New Drug Application for Penpulimab Monoclonal Antibody (PD-1) for First-Line Treatment of Squamous Non-Small-Cell Lung Cancer Accepted by NMPA

(HONG KONG, July 2, 2021) Akeso, Inc. is pleased to announce that Penpulimab (research and development code: AK105), an PD-1 monoclonal antibody drug, for combined chemotherapy for first-line treatment of locally advanced or metastatic squamous non-small-cell lung cancer, which was co-developed by the Company with Sino Biopharmaceutical Limited (stock code: 1177.HK), has submitted the new drug application (NDA) to and accepted by the National Medical Products Administration (NMPA) of China. This is the Company's second indication of Penpulimab successfully submitted NDA in China since the acceptance of NDA of Penpulimab treatment for patients with relapsed or refractory classical Hodgkin's lymphoma who have received at least two prior therapies by the NMPA in May 2020.


Penpulimab is a new PD-1 monoclonal antibody that applies the immunoglobulin G1 (IgG1) subtype, modified by fragment crystallisable (Fc) segment, which has a slower rate of antigen binding and dissociation. Analysis shows that its crystallisable structure has unique binding epitope which continuously blocked the binding of PD-1/PD-L1, thus separates it from other PD-1 products on the market, which allows Penpulimab to enhance its immunotherapy efficacy and reduce immune-related adverse effects.


An interim analysis of Penpulimab combined chemotherapy for first-line treatment of squamous non-small-cell lung cancer shows that, as compared to the chemotherapy group, the combined chemotherapy treatment with Penpulimab has significantly prolonged the median progression-free survival (PFS), and significantly reduced the risk of disease progression or death, resulting in superior clinical benefit for the patients.


Safety data analysis of all patients treated with Penpulimab shows that Penpulimab treatment renders less cases of Grade 3 and higher immune-related adverse events, as well as less cases of immune-related pneumonia and hepatitis (currently no cases of myocarditis or pancreatitis observed). With such unique characteristics of Penpulimab, we are looking forward to the follow-up analysis of specific data on efficacy and safety, and look forward to receive approval as the standard first-line treatment for squamous cell lung cancer, so as to provide patients with better treatment options.


Recently, Penpulimab for third-line treatment of metastatic nasopharyngeal carcinoma has been submitted to the Food and Drug Administration of the United States (FDA) for a Biologics License Application (BLA) through the Real-Time Oncology Review (RTOR) programme. Previously, Penpulimab for third-line treatment of metastatic nasopharyngeal carcinoma has received breakthrough therapy designation, orphan drug designation, as well as fast track designation from the FDA.



Information about Penpulimab (PD-1 Monoclonal Antibody, AK105)

Penpulimab (PD-1 monoclonal antibody, AK105) is jointly developed and commercialized by a joint venture established by the Company and Chia Tai-Tianqing Pharmaceutical Group Co., Ltd. (Chia Tai-Tianqing), a subsidiary of Sino Biopharm. Penpulimab's Fc receptor and complement mediated effector are completely removed by mutations of Fc region, it also has a slower antigen binding offrate compared with the PD-1 antibodies that are already launched in foreign market. These features have made Penpulimab more effective in blocking the activity of the PD-1 pathway and evaded the T-cell anti-tumor activity, thus it has the potential to become an anti-PD-1 drug that can achieve better clinical efficacy.


Information about the Company

The Company is a biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of new innovative antibody drugs that are affordable to patients worldwide. Since the Company's establishment, the Company has established an end-to-end comprehensive drug development platform (ACE Platform) and system, encompassing fully integrated drug discovery and development functions, including target validation, antibody drug discovery and development, CMC production process development, and GMP compliant scale production. The Company has also successfully developed a bi-specific antibody drug development technology (Tetrabody technology). The Company currently has a pipeline of over 20 innovative drugs for the treatment of major diseases like tumors, autoimmune diseases, inflammation and metabolism diseases, 13 of which have entered clinical stage, including two first-in-class bi-specific antibody drugs (PD-1/CTLA-4 and PD-1/VEGF). The Company's vision is to become a global leading biopharmaceutical company through research and development (''R&D') of high efficacy and breakthrough new drugs that are first-in-class and best-in-class therapies.


Information about Sino Biopharm

Sino Biopharm is a leading R&D-based pharmaceutical group in China, with business covering the entire industry chain including various pharmaceutical R&D platforms, intelligent production and strong sales system. Its products include various kinds of biopharmaceutical and chemical medicines, and have gained a competitive foothold in various therapeutic categories with promising potentials, including tumors, liver diseases, cardiocerebral diseases, analgesic medicines, respiratory system medicines and orthopedic diseases.


Information about Chia Tai-Tianqing

Chia Tai-Tianqing is an innovative pharmaceutical company with integrated R&D, manufacturing and sales capabilities. It is a renowned R&D and manufacturing base in China targeting drugs on liver diseases and oncology treatment. It is a key high technology enterprise, as well as the highlighted Lianyungang new medical industry base under the State Torch Program. It ranked 16th on the list of the ''Top 100 Pharmaceutical Enterprises in China'' in 2018, and was the Chinese pharmaceutical enterprise with the best drug pipeline in 2019 (by the China National Pharmaceutical Industry Information Center). With more than 12,000 employees, Chia Tai-Tianqing's products focus on six core therapeutic areas, including oncology, liver diseases, respiratory diseases, infection, endocrine and cardiocerebral. Apart from liver diseases, Chia Tai-Tianqing has formed its unique product line in the oncology field. ''Anlotinib Hydrochloride Capsules'', a category 1 new drug, has been proven to treat three major indications including non-small cell lung cancer, small cell lung cancer and soft tissue sarcoma. It was a designated Orphan Drug for treatment of ovarian cancer and soft tissue sarcoma by the FDA. Multiple clinical trials are ongoing for other indications.

Chia Tai-Tianqing has over 1,500 R&D staff. It invests 10%12% of its annual sales revenue in R&D every year. There are more than 250 projects in its product pipeline.