Antengene Corporation Limited, a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that it has entered into a strategic collaboration with WuXi Biologics, and STA Pharmaceutical Co., Ltd., a leading Contract Development and Manufacturing Organization to accelerate the discovery, development and manufacturing of the Company's antibody-drug conjugate (ADC) asset. This is the second partnership between Antengene and WuXi Biologics for GMP manufacturing services following the announcement of a bispecific antibody CDMO service collaboration in October 2020. Through a parallel approach that mobilizes both in-house R&D capabilities and external partnerships, Antengene aims to further advance the development of its preclinical ADC candidates.
Focused on addressing the unmet medical needs of patients in China and the Asia Pacific region, Antengene has been making progress on in-house discovery programs for six innovative preclinical assets, including an ADC. As a result of these rigorous efforts from Antengene's discovery team, a number of these preclinical assets are already in manufacturing stage. ADCs are complex molecules composed of a payload (or toxin) that is attached to a monoclonal antibody intermediate through linkers. Due to its high-precision targeting and potent activities, ADCs have emerged as a promising new modality in targeted cancer therapies. Through this collaboration, WuXi Biologics and WuXi STA will provide services for the process development, scale-up, and GMP manufacturing of ADC drug intermediates. Antengene will focus on the discovery of the monoclonal antibody, the core element of ADCs. WuXi STA will focus on the GMP manufacturing of linkers and payloads while WuXi Biologics will provide process development for monoclonal antibody and the biological conjugation as well as the subsequent GMP manufacture. All three parties will work closely to leverage the resources and technological capabilities, with the goal to accelerating the development of ADCs for the benefit of patients.
Dr. Jay Mei, Founder, Chairman and CEO of Antengene, commented: "We are pleased to form such synergistic and long-term partnerships with WuXi STA and WuXi Biologics. It has been Antengene's strategic imperative to enhance in-house discovery capabilities, and to rollout our in-house discovery programs through the establishment of the Antengene New Drug Discovery Center. Through strategic alliances and further integrating our clinical development, regulatory, and early discovery teams, we are rapidly advancing our in-house discovery programs. We believe that this collaboration will allow us to build stronger capabilities in ADC discovery by combining WuXi Biologics and WuXi STA's deep expertise in the field with Antengene's focus on innovation in R&D. I am confident that together we can bring our ADC asset towards clinical development with clinical applications that will ultimately bring benefit to patients in need."
Dr. Bo Shan, Corporate Vice President of Discovery, Early Development and CMC at Antengene，said: "We have been accelerating the in-house discovery programs of our preclinical assets. ADCs, with their therapeutic promises and vast addressable patient population, represent a modality with great clinical potential. We believe this collaboration will enable Antengene to utilize an advanced manufacturing process and quality management system for the discovery and manufacturing of high-quality ADCs for use in clinical development, and thereby further strengthen Antengene's core competitiveness in global drug development landscape."
Dr. Chris Chen, CEO of WuXi Biologics, said: "We are glad to expand our strategic collaboration with Antengene to advance its ADC program into clinical stage, leveraging our integrated biologics platforms, unparalleled capacity and world-class quality system. WuXi Biologics will continue to increase capabilities and capacities to enable global partners as they develop next-generation biologics such as ADCs for the benefit of patients worldwide."
Dr. Minzhang Chen, CEO of WuXi STA, commented: "We are delighted to strengthen our strategic cooperation with Antengene. I am confident that WuXi STA's leading capability and capacity for high potency API and conjugation chemistry for novel molecular modalities such as ADCs, along with our high quality standards in meeting global regulatory requirements, will provide the strongest support for ADC linker and payload development and manufacturing. We will continue to leverage our 'end-to-end' novel molecular modality platform to empower more partners to accelerate their development pathway to market for the benefit of global patients."
About Antengene
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading clinical-stage Asia-Pacific biopharmaceutical company focused on innovative oncology medicines. Antengene aims to provide the most advanced anti-cancer drugs to patients in China, the Asia Pacific Region and around the world. Since its establishment, Antengene has built a pipeline of 12 clinical and pre-clinical stage assets and obtained 12 investigational new drug approvals in Asia Pacific. The vision of Antengene is to "Treat Patients Beyond Borders". Antengene aims to address significant unmet medical needs by discovering, developing and commercializing first-in-class/best-in-class therapeutics.
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK), a Hong Kong, S.A.R., China-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. The company's history and achievements demonstrate its commitment to providing a truly one-stop service offering and strong value proposition to its global clients. As of June 30, 2020, there were a total of 286 integrated projects, including 141 projects in pre-clinical development stage, 125 projects in early-phase (phase I and II) clinical development, 19 projects in late-phase (phase III) development and one project in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, the U.S., Germany, and Singapore exceeding 300,000 liters after 2023, WuXi Biologics will provide its biomanufacturing partners with a robust and premier-quality global supply chain network.
About WuXi STA
STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec (WuXi STA), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with operations in China and the United States. As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA offers our worldwide partners efficient, flexible and high-quality solutions for integrated CMC (Chemical, Manufacturing, and Control) requirements from preclinical to commercial uses.
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