Antengene Announces the Completion of Its Manufacturing Center in Shaoxing to Accelerate the Commercialization of Novel Anti-Cancer Therapies

Today, Antengene Corporation Limited successfully hosted an inauguration ceremony for its manufacturing center at the Binhai Life Science and Healthcare Industrial Zone in Shaoxing. The completion of the manufacturing center paves the way for Antengene's future production of oral medicines and marks a major milestone in Antengene's transition into an innovative biopharmaceutical company with integrated capabilities in discovery, development, manufacturing, and commercialization. At this site, Antengene plans to soon initiate the manufacturing of selinexor, the company's first selective inhibitor of nuclear compound.

Mr. Hua Zheng, member of the Standing Committee of Yuecheng District, and Deputy Director of Shaoxing Binhai New Area Administrative Council, Mr. Jun Chai, Deputy Director of Shaoxing Market Supervisory Authority, Ms. Liping Wang, Director of Shaoxing Binhai New Area First Bureau for Investment Promotion and Services, Dr. Bo Shan, the Chief Scientific Officer of Antengene, Mr. Yiteng Liu, the Chief Operating Officer of Antengene, along with officials from the Shaoxing municipal government, and reporters from nearly 30 media outlets have attended the inauguration ceremony, and have witnessed the historic moment when Antengene officially commences commercial manufacturing.

Mr. Hua Zheng, member of the Standing Committee of Yuecheng District, and Deputy Director of Shaoxing Binhai New Area Administrative Council, commented: "The completion of Antengene's manufacturing center in Shaoxing marks a major milestone that will catapult the company into its next phase of rapid growth. At this golden era for the development of innovative therapies, we hope Antengene will address more unmet medical needs through its differentiated pipeline, and by broadening and deepening its discovery, development, and commercialization of antitumor therapies of novel mechanisms. We are confident that by strengthening its internal capabilities and external partnerships, Antengene will further solidify its leadership position in the biopharmaceutical industry."

Dr. Jay Mei, Founder, Chairman and CEO of Antengene, commented: "In just three years, Antengene has built a pipeline of 12 novel candidate drugs targeting four therapeutic areas, and built its manufacturing center for oral medicines in just one year. These achievements are a testimony of the exceptional innovation and speed seen in China. The manufacturing center represents a critical element in Antengene's transition into the commercial stage, and an important pillar of Antengene's vertically integrated capabilities. At this new facility, we will begin the commercial manufacturing of selinexor in China to meet the future demands from patients."

Dr. Bo Shan, Chief Scientific Officer of Antengene, noted: "Drug manufacturing is a crucial downstream capability enabling us to translate the fruits of our discovery and development programs into commercialized products. The completion of the manufacturing center will accelerate our transition into the commercial stage, seamlessly connecting our discovery and drug development to manufacturing, and provide us with the means to efficiently supply high quality drugs to patients in APAC."

A model manufacturing center built with high standard

Antengene's manufacturing center in Shaoxing has 16,300 square meters in space. To date, the company has finished renovating the plant building for the production line of solid dose formulation, installed supporting facilities and packaging line for the GMP manufacturing of solid dose formulation, and set up a quality control laboratory for raw materials and finished products. Further completing the supporting facilities at the site, a GMP-compliant storage facility (including cool storage, ambient warehouse, and Grade D sampling room) was also set up at the manufacturing center. Antengene plans to start the installation and validation of the product line of oral medicines sometime this year.

Since commencing the stage one construction of the manufacturing center in June 2020, Antengene has carefully planned production and storage spaces at the manufacturing center, while maintaining a rigorous quality standard and its commitment to patients. During the project, Antengene collaborated with several leading construction and design companies in China to establish an advanced scientific quality assurance system for the construction. All contractors were chosen to meet the international standards to assure the quality construction of the manufacturing center.

Innovating to serve patients

As a leader in the development of innovative cancer therapies, Antengene is dedicated to the discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics. Taking a combinatory and complementary approach to its R&D, Antengene has developed a highly differentiated pipeline of 12 candidate drugs with potential for synergistic combinations.

The manufacturing center is situated in the Binhai New Area of Shaoxing, Zhejiang province, a hot spot for the commercialization of advanced technologies in the Yangtze Delta region. The Binhai New Area is building a cluster of high-tech industries by leveraging its access to emerging technologies and talent pool of the Shanghai International Center for Technological Innovations, an effort that has attracted many leading biopharmaceutical and biotechnology companies to establish their presence in the Binhai New Area. Thanks to the supporting policies and technical resources offered by the Binhai New Area, Antengene has completed the construction and renovation of the manufacturing center within a year, enabling its vertical integration of capabilities covering discovery, development, manufacturing, and commercialization. The manufacturing center in Shaoxing will be the site for the commercial manufacturing and packaging of selinexor and other oral medicines. As a novel therapy targeting a broad spectrum of tumor types, selinexor has demonstrated antitumor activity in multiple hematologic malignancies and solid tumors, and is already approved in the U.S. for the treatment of multiple myeloma and diffuse large B-cell lymphoma. Antengene has submitted new drug applications (NDAs) for selinexor in China and multiple APAC markets, and expects to receive market authorizations during Q4 2021 and Q1 2022.

Propelled by the supporting polices of the Fourteenth Five-Year Plan, Antengene has achieved substantial growth demonstrating the value of its vertically integrated capabilities. Moving forward, Antengene will continue to leverage the resources and innovation ecosystem provided by the government while pursuing rigorous research and relentless innovation in the discovery and development of its products, to make its contribution to the drug discovery and development of a modern biopharmaceutical ecosystem in China.

About Antengene

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading clinical-stage R&D driven biopharmaceutical company focused on innovative medicines for oncology and other life threatening diseases. Antengene aims to provide the most advanced anti-cancer drugs to patients in the Asia Pacific Region and around the world. Since its establishment in 2017, Antengene has built a broad and expanding pipeline of clinical and pre-clinical stage assets through partnerships as well as in-house drug discovery, and obtained 15 investigational new drug (IND) approvals and submitted 5 new drug applications (NDA) in multiple markets in Asia Pacific. Antengene's vision is to "Treat Patients Beyond Borders". Antengene is focused on and committed to addressing significant unmet medical needs by discovering, developing and commercializing first-in-class/best-in-class therapeutics.