At 10:30 a.m. on Aug 21, 2021, in the city of Zhongshan, where summer is blooming, a cold-chain truck loaded with the first batch of over 20,000 vials of new anti-tumor drug Penpulimab injection (trade name: 安尼可®) was shipping off from Akeso’s headquarters manufacturing base (Zhongshan National Health Technology Park).
This moment concludes the nine-year endeavor of Akeso. Just half a month after obtaining the NDA approval from the NMPA, this new PD-1 monoclonal antibody that applies the IgG1 subtype modified by Fc segment, in-house developed by Akeso (9926.HK), has shipped off its first batch of products and will be put into clinical use across China, helping cancer patients with novel therapeutic treatment.
In 2018, Akeso and Sino Biopharmaceutical Limited (stock code: 1177.HK) subsidiary Chia Tai Tianqing Pharmaceutical Group signed an agreement to collaborate in the subsequent development and commercialization of Penpulimab monoclonal antibody. Chia Tai Tianqing Group has sufficient experience and strong capability in prescription drugs, especially anti-tumor drugs commercialization, which will empower Penpulimab monoclonal antibody’s excellent performance on the market after its NDA approval.
Clinical study of Penpulimab monoclonal antibody for treatment of patients with relapsed or refractory (r/r) classic Hodgkin’s lymphoma (cHL) after at least second-line systemic chemotherapy treatment shows favorable efficacy, the objective response rate (ORR) assessed by IRRC was 89.4%, complete response (CR) reached 47.1%. Penpulimab monoclonal antibody shows good safety profile, with low rate in overall drug related adverse events and immune-related adverse events, allowing a potential safety advantage.
Penpulimab monoclonal antibody has been manufactured in Akeso’s manufacturing base located at its Zhongshan headquarters, and will be shipped out across China. The manufacturing base obtained Drug Manufacturing Certificate in May 2021 and has passed the Good Manufacturing Practice compliance test (GMP compliance test).
Founder, president & CEO of Akeso, Inc., Dr. Xia Yu said, “I am glad that the NMPA has granted Penpulimab’s (安尼可®) marketing approval. Penpulimab (安尼可®) is a differentiated new anti-PD-1 monoclonal antibody. It is also Akeso’s first innovative new drug that has been approved to the market. This signifies that Akeso has successfully completed the construction of the close-loop industrial value chain of new drugs from R&D to manufacturing and to commercialization. This is also the first PD-1 monoclonal antibody drug in Guangdong-Hong Kong-Macao Greater Bay Area (the “GBA”) that is approved to the market, which marks the further improvement of biopharmaceutical innovation level of the GBA. We will continue to develop clinical studies of Penpulimab (安尼可®) for multiple tumor indications, among which the NDA for combination with chemotherapy for treatment of advanced or metastatic squamous non-small cell and monotherapy for third-line treatment of metastatic nasopharyngeal carcinoma have been accepted by the NMPA. We expect Penpulimab (安尼可®) to bring new clinical benefits to the treatment of cancer patients.
Dr. Xia Yu also points out that it is Akeso’s mission to develop affordable next-generation quality antibody protein drugs for patients worldwide with continuous research and development innovation. Currently the manufacturing of Penpulimab (安尼可®) has moved into top gear in an orderly manner. Every element, including raw materials, packing materials, and the overall manufacturing process quality control system, are in compliance with the highest quality standards.
President of Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Mr. Wang Shanchun said, “The faster Penpulimab (安尼可®) is commercialized, the earlier patients could benefit from it. For this reason, employees of Chia Tai Tianqing are well-prepared to ensure that new PD-1 monoclonal antibody Penpulimab (安尼可®) is accessible for thousands of patients from medical institutions across China. Riding on its outstanding safety and efficacy showed in clinical study, we are confident that the Penpulimab (安尼可®) will be able to gain trust from doctors and patients.”
Penpulimab (安尼可®) is currently the only new PD-1 monoclonal antibody that applies IgG1 subtype and is modified by Fc segment, which has a lower antigen binding dissociation rate and a unique binding epitope as demonstrated by analysis on crystal structure. These features allow Penpulimab (安尼可®) to effectively and continuously block PD-1/PD-L1 binding, thus differentiates it from other PD-1 products on the market, and may allow Penpulimab (安尼可®) to more effectively enhance immunotherapeutic efficacy and reduce immune-related adverse reactions, as demonstrated by improved safety profile in the clinical data.
In August 2021, NDA of Penpulimab for third-line treatment of metastatic nasopharyngeal carcinoma was submitted and was accepted by the NMPA. In July 2021, NDA of Penpulimab for combined chemotherapy for first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer was submitted and was accepted by the NMPA. In May 2021, 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 BLA through the Real-Time Oncology Review (RTOR) program.
Information about Classic Hodgkin’s Lymphoma
Hodgkin’s lymphoma is a group of malignancies that affects the lymph nodes and the tissues of the lymphatic system. The most common form is classic Hodgkin’s lymphoma (cHL), which accounts for 95% of all Hodgkin’s lymphoma incidences. It is most commonly diagnosed in young adults between the age of 15 and 30 and in older adults over age 55. Although first-line chemo-radiotherapy has demonstrated higher efficiency in cHL treatment, 10% to 30% patients relapse after responding to initial treatment, with 5% to 10% patients suffer from primary refractory disease. Although several drugs have been approved for the treatment of r/r cHL in recent years, there are still unmet expectations for safer and more effective drugs.
Information about 安尼可® (Penpulimab Antibody Injection)
安尼可® (Penpulimab antibody injection) is a new PD-1 monoclonal antibody with IgG1 subtype and Fc segment modification, which is structurally stable and less prone to aggregation. Antibody-dependent cell-mediated cytotoxicity (ADCC), acoustic doppler current profiler (ADCP) and complement dependent cytotoxicity (CDC) is avoided entirely, and antibody-drug conjugate reaction (ADCR) is lessened. Crystal structure analysis reveals a unique PD-1 binding epitope with a slower dissociation rate from PD-1 for durable blockade of PD-1/PD-L1 binding. This differentiation from other PD-1 products on the market may lead to a better efficacy and safety profile for the Penpulimab antibody.
Information about Akeso, Inc.
Akeso, Inc. 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 Pharmaceutical Group Co., Ltd. (‘‘Chia Tai Tianqing’’)
Chia Tai Tianqing is an innovative pharmaceutical company with integrated pharmaceutical R&D, manufacturing and commercialization capabilities. With more than 14,000 employees, it is a leading pharmaceutical company in China in the fields of oncology, liver diseases and respiratory diseases. It ranked 15th place in the list of the top 100 pharmaceutical companies in China in 2020, and has been awarded as the best industrial company in China in terms of pharmaceutical R&D product pipeline in 2021.
Chia Tai Tianqing takes technological innovation as its important strategy for sustainable development, making unremitting efforts to actively research and develop innovative and high- quality pharmaceutical products, Chia Tai Tianqing has formed its production in the six core therapeutic sectors, including oncology, liver diseases, respiratory diseases, infection, endocrine and cardiocerebral. Chia Tai Tianqing has invested 10% to 12% of its annual sales revenue in research and development. It has 196 ongoing research projects, including 82 new drugs. It has undertaken over 30 major national specialized projects, and has applied for over 1,500 patents in China, including over 500 patents announced in China, and over 200 patents announced overseas.