Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, today announced the signing of a collaboration agreement with Shenogen Pharma Group Ltd. ("Shenogen") to evaluate the combination therapy of Innovent's Tyvyt®(generic name: sintilimab injection), a fully human anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody with Shenogen's SNG1005, in patients with advanced cancer.

SNG1005 is a conjugate of angiopep-2 and paclitaxel that Shenogen licensed from overseas. Multiple Phase II clinical trials have been completed in the United States (U.S.), and its Phase III clinical trial protocol has been approved by the U.S. Food and Drug Administration (FDA). Shenogen has the full development and commercialization rights for SNG1005 in Greater China. Currently, the Investigational New Drug (IND) application of Phase II/III clinical trial for the treatment of breast cancer carcinoma brain metastases (BCBS) in China has been approved by the National Medical Products Administration (NMPA), and the clinical trial is planned. Tyvyt® (sintilimab Injection) is the anti-PD-1 inhibitor co-developed by Innovent and Eli Lilly and Company (Lilly). On 24 December 2018, Tyvyt® (sintilimab Injection) was granted approval for market authorization by the NMPA for the treatment of patients with classical Hodgkin's lymphoma (cHL) that has relapsed or refractory (r/r) after two or more lines of systemic chemotherapy (r/r cHL).

Dr. Kun Meng, Chairman of Shenogen, commented, "The combined therapy of immune check point inhibitors and anti-tumor therapeutics has become the standard approach for the development of anti-tumor treatments. We are looking forward to close cooperation with Innovent in exploring the potential efficacy of anti-PD-1 inhibitor in combination with SNG1005. We are expecting the underlying synergistic effect in various cancers."

"SNG1005 is a first-in-class nab-paclitaxel therapeutic in development that can pass through blood-brain barrier (BBB), and we are very pleased to cooperate with Shenogen to explore the clinical synergistic efficacy with our PD-1 inhibitor. We hope to bring more clinical benefits to patients with advanced carcinomas," said Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent.

About SNG1005

SNG1005, a conjugate of angiopep-2 and paclitaxel, binds to the low-density lipoprotein receptor-related protein 1 (LRP1). LRP1 is abundantly expressed on the Blood Brain Barrier (BBB), which facilitates efficient transcytosis movement of paclitaxel across the BBB. Besides its systemic effects, it can specially pass through the BBB and reach brain lesions.

About Tyvyt® (sintilimab injection)

Tyvyt® (sintilimab injection) is an innovative drug jointly developed in Chinaby Innovent and Eli Lilly and Company. Innovent is also conducting clinical studies of sintilimab injection in the United States. Tyvyt® (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Tyvyt® (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company. Tyvyt®(sintilimab injection) has been granted marketing approval by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin's lymphoma (r/r cHL) and has been included in the 2019 Guidelines of Chinese Society of Clinical Oncology (CSCO) for Lymphoid Malignancies. There are currently more than twenty clinical studies using sintilimab injection, including eight registration studies that evaluate the efficacy of sintilimab injection in other solid tumors.

About Shenogen

Established in 2006, Shenogen has always been innovation-oriented. With the mission of "Better Medicine, Better Life," the company combines its research & development (R&D) expertise with its devotion to develop and produce anti-tumor and immune-inflammatory therapeutics, utilizing modern biotech platforms, novel targets, and intellectual properties. Our new drug candidates vary from novel small molecules, to monoclonal antibody drugs, to bis-specific antibody drugs, to antibody drug conjugates and to recombinant proteins.

Shenogen has a well experienced research & development and clinical operations team with deep international experience, including national thousand talents program laureates. Shenogen is determined to research and develop high quality novel drugs for the purpose of fulfilling patient's unmet needs.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of oncology, autoimmunity and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong, S.A.R., China Limited with the stock code: 01801.HK.

Since it was founded, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built up a robust pipeline of 20 innovative assets in the fields of oncology, ophthalmology, autoimmunity, and cardiovascular diseases. Sixteen assets have entered into clinical development, four have entered Phase 3 clinical trials, three monoclonal antibodies have their New Drug Application (NDA) under review and two of them have been granted with priority review status, and one, Tyvyt® (sintilimab injection), is now approved for relapsed or refractory classical Hodgkin's lymphoma (r/r cHL).

Innovent has built an international team of advanced talents in high-end biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, Hanmi and other international pharmaceutical companies. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives. 

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. 

About Innovent Biologics' strategic collaboration with Eli Lilly and Company

In March 2015, Eli Lilly and Company (Lilly) and Innovent Biologics (Innovent) announced one of the largest biotech drug development collaborations in China to date between a multi-national and domestic company. Under the terms of the agreement, Lilly and Innovent shall collaborate on the development and potential commercialization of at least three cancer treatments over the next decade. In October 2015, they announced an expansion of their drug development collaboration. These collaborations represent that Innovent has struck one of the most comprehensive strategic collaborations of any Chinese company with a multinational partner in terms of the scope and breadth ranging from discovery to commercialization and involving up to six therapeutic antibodies for cancers.

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