WuXi Biologics and Gloria Pharmaceuticals Announce the Licensure of the Fully Human PD-1 Antibody, GLS-010, to Arcus Biosciences

SHANGHAI and BEIJING, Aug. 17, 2017 /PRNewswire/ -- WuXi Biologics (2269.HK), a global leading open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, and its Chinese partner Harbin Gloria Pharmaceuticals Co Ltd (002437.CN), today announced that an exclusive license to the anti-PD-1 antibody GLS-010 has been granted to Arcus Biosciences, a US-based biotechnology company focused on the discovery and development of innovative cancer immunotherapies.

Gloria contracted WuXi Biologics to discover and develop GLS-010, a novel anti-PD-1 antibody, using Ligand's transgenic rat platform OmniRat®. GLS-010 is currently being evaluated in cancer patients in phase I clinical studies in China. Arcus has licensed the exclusive development and commercialization rights of GLS-010 in North America, Europe, Japan and certain other territories.

Arcus plans on developing GLS-010 as a combination product with the other product candidates in its portfolio. Based on the terms of the agreement, Arcus will pay $18.5mm in upfront payments as well as development and regulatory milestones which could total up to $422.5mm for the development and approval of 11 products that include GLS-010 as a component. WuXi Biologics and its partner Gloria, through an existing agreement will also receive commercial milestones of up to $375mm which could result in aggregate payments from Arcus of $816mm. Arcus will pay tiered royalties that range from the high single-digits to low double-digits on net sales of GLS-010.  In addition, WuXi Biologics and Arcus intend to enter into an exclusive 3-year agreement for the development of Arcus' biologics portfolio. WuXi Biologics also will be the exclusive manufacturer for GLS-010 in the licensed territories for a specified period of time.

"We are pleased that our integrated platform has enabled companies such as Gloria to enter into biologics with an exciting program. We are also excited to enter into this agreement to expedite biologics development to treat patients globally," commented Dr. Chris Chen, CEO and executive director of WuXi Biologics. "This new partnership continues to reinforce the value of our integrated service platform, the global quality WuXi Biologics commits to, and the success of our 'follow-the-molecule' strategy. 

"We are thrilled to gain access to GLS-010 in our territories," commented Dr. Tim Sullivan, Vice President of Business Development at Arcus. "This molecule will enable us to fully exploit the potential of our other immuno-oncology agents for the benefit of patients. Working with WuXi Biologics also ensures high-quality clinical supply of our biologics, an essential operational component of our strategy to develop a series of novel and best-in-class combination therapies for the treatment of cancer."

"Gloria has recently been focusing its R&D research on biologics, especially in the immuno-oncology area. We hope our efforts can bring more innovative medicines into the Chinese market in order to fill unmet medical needs," said Mr. Hongbing Yang, Chief Executive Officer of Harbin Gloria Pharmaceuticals. "It is the first time that an antibody envisioned by Gloria has the potential to reach patients worldwide. We are extremely pleased that, with our development in China and Arcus' exclusive license in many other countries in the world, each working with WuXi, that GLS-010 may become available in both China and worldwide."

About GLS-010 

GLS-010, also referred to as WBP3055, is an investigational fully human monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in the downregulation of the immune system by preventing the activation of T-cells. Other anti-PD-1 antibodies have been approved by the US FDA in multiple cancer settings. It is estimated that more than 500 clinical trials are ongoing to continue to investigate this class of biologics for more than 20 different cancer indications.

About WuXi Biologics

WuXi Biologics is the only open-access biologics technology platform in the world offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and value proposition to our global clients. For more information on WuXi Biologics, please visit: http://www.wuxibiologics.com.

About Harbin Gloria Pharmaceuticals Co., Ltd.

Gloria is a leading Chinese pharmaceutical company headquartered in Beijing. It is considered by analysts "the fastest growing pharma company in China". Gloria is also one of the most active deal makers among all the pharmaceutical companies nationwide. Gloria Pharmaceutical focuses on the following therapeutic areas: orthopaedics, cardiovascular and metabolic diseases, and oncology. For additional information, please visit www.gloria.cc.

SOURCE WuXi Biologics