Innovent Announces First Patient Dosed in a Phase 1b Clinical Trial of Sintilimab plus Surufatinib in Advanced Malignancies in China

SUZHOU, China, July 8, 2020 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, today announced that the first patient has been successfully dosed in a Phase 1b clinical trial (CIBI391A101) of TYVYT® (sintilimab injection) plus surufatinib in China.

CIBI391A101 is a Phase 1b clinical study conducted in China to evaluate sintilimab plus surufatinib in the treatment of patients with advanced malignancies. The primary objectives of the study are to evaluate the safety, tolerability, and initial anti-tumor efficacy of surufatinib in combination with TYVYT® (sintilimab injection).

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated: "Sintilimab is an anti-PD-1 monoclonal antibody drug jointly developed by Innovent and Lilly. It has been proven effective and safe in a variety of tumors including classic Hodgkin lymphoma, lung cancer, esophageal cancer, etc. Surufatinib selectively inhibits the tyrosine kinase activity associated with VEGFR and FGFR, which both inhibit angiogenesis and CSF-1R, which regulates tumor-associated macrophages. Therefore, the combination of sintilimab and surufatinib may result in synergistic anti-tumor activity, and we are looking forward to the positive results of the clinical trials of sintilimab plus surufatinib, and hope the therapy could benefit more patients."

About CIBI391A101

CIBI391A101 is a Phase 1b clinical study to evaluate the safety, tolerability, and initial anti-tumor efficacy of sintilimab plus surufatinib in patients with advanced malignancies.

About TYVYT® (Sintilimab Injection)

TYVYT® (sintilimab injection), an innovative drug developed with global quality standards jointly developed by Innovent and Lilly in China, has been granted marketing approval by the NMPA for relapsed or refractory classic Hodgkin's lymphoma after second-line or later systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT® is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL), in November 2019. In April 2020, the NMPA accepted the supplemental new drug application for TYVYT® in combination with ALIMTA® (pemetrexed) and platinum as first-line therapy in non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT® combined with Gemzar® (gemcitabine for injection) and platinum chemotherapy met the predefined primary endpoint in the Phase 3 ORIENT-12 study as first-line therapy in patients with locally advanced or metastatic squamous NSCLC, TYVYT® monotherapy met the primary endpoint in the ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma as well.

TYVYT® 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-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT® to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registration or pivotal clinical trials.

About Surufatinib

Discovered and developed solely by Chi-Med (Hutchison China MediTech Limited), Surufatinib (HMPL-012) is a novel, oral drug candidate that selectively inhibits the tyrosine kinase activity associated with VEGFR and FGFR, which both inhibit angiogenesis and CSF-1R, which regulates tumor-associated macrophages, promoting the body's immune response against tumor cells. Surufatinib's unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

In China, an NDA for surufatinib for the treatment of non-pancreatic neuroendocrine tumors (NET) was accepted for review (and subsequently granted Priority Review status) by the NMPA in November 2019 after the SANET-ep Phase 3 study successfully met its primary endpoint of improved progression-free survival. A second NDA is being submitted after the SANET-p Phase 3 study in pancreatic NET also successfully met its primary endpoint of PFS in January 2020. Surufatinib is in several other proof-of-concept clinical trials in China.

In the United States, starting in late 2020 Chi-Med plans to submit an NDA for surufatinib in NET, following an agreement with the U.S. FDA that it will be based on the successful SANET-ep and SANET-p studies, and existing surufatinib U.S. clinical data. Surufatinib was recently granted Fast Track Designations for both pancreatic and non-pancreatic NET, and Orphan Drug Designation for pancreatic NET.

Chi-Med currently retains all rights to surufatinib worldwide.

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 cancer, metabolic, autoimmune and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully-integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 23 valuable assets in the fields of cancer, metabolic, autoimmune diseases and other major therapeutic areas, with 18 in clinical development, 5 in Phase 3 or pivotal clinical trials, 2 under NDA reviews with priority review status by the NMPA, while 2 products, TYVYT® (sintilimab injection) and BYVASDA® (bevacizumab biosimilar), officially approved for marketing in China. TYVYT® has been the only PD-1 inhibitor included in the NRDL since 2019.

Innovent has built an international team of advanced talents in cutting-edge biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly, Adimab, Incyte, Alector, MD Anderson Cancer Center, Hanmi and other international partners. For more information, please visit: www.innoventbio.com.

About Chi-Med

Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com.

SOURCE Innovent Biologics, Inc.

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