2019.08.01

I-Mab Biopharma and TRACON Pharmaceuticals Announce Dosing of the First Patient in a Phase 1 Trial of the CD73 Antibody TJD5 in the U.S. in Patients with Advanced Solid Tumors

Shanghai, September 10, 2019, I-Mab Biopharma (I-Mab), a China and U.S.-based clinical stage biopharmaceutical company exclusively focused on the discovery and development of potential first-in-class and best-in-class biologics in immuno-oncology and autoimmune diseases announces the signing of a collaboration agreement with Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences), an innovation-driven biopharmaceutical company to evaluate the combination therapy of I-Mab’s TJD5, a proprietary innovative CD73 antibody with Junshi Biosciences’ Toripalimab (Trade name: Tuoyi), a recombinant humanized anti-PD-1 monoclonal antibody in patients with cancers in China.

Dr. Jingwu Zang, Founder and Chairman of I-Mab, commented, “TJD5 is an innovative CD73 antibody with best-in-class potential that has entered into Phase I trial in the US. We are very pleased to collaborate with Junshi to explore the clinical synergies with Toripalimab which is an innovative drug with distinctive treatment advantages. We are looking forward to bringing more clinical benefits to patients across various cancer types.”

Dr. Ning Li, CEO of Junshi Biosciences, commented, “As an anti multi-tumor drug, toripalimab has shown good safety and efficacy in clinical trials with mono and combination therapy. We believe, through the cooperation with I-Mab, we could continue to explore the combination potential of toripalimab and innovative drugs to improve the outcomes of immune-oncology therapy, lightening hope for more patients.

About TJD5：

TJD5 is a novel and differentiated blocking antibody against CD73, a surface enzyme on stromal cells and cancer cells responsible for the production of adenosine, which is highly immunosuppressive. It is expected to stimulate the immuno-suppressive tumor micro-environment and to work in concert with other cancer therapies such as PD-1 and PD-L1 antibodies. TJD5 is in a Phase 1 clinical trial in the US, it is a proprietary innovative CD73 monoclonal antibody from I-Mab’s discovery pipeline with best-in-class potential.

About Toripalimab (JS001, Trade name: Tuoyi)

Toripalimab. a recombinant humanized anti-PD-1 monoclonal antibody for injection is the first domestic-developed anti-PD-1 mAb granted marketing approval in China, supported by National Science and Technology Major Project. In March 2018, its New Drug Application (“NDA”) was accepted by the NMPA and put into prioritized evaluation and approval process. On Dec 2018, Toripalimab was conditionally granted marketing approval for use in the treatment of unresectable or metastatic melanoma that has failed previous systemic therapy by the NMPA, which is the first commercialized product of Junshi Biosciences. In the pivotal clinical trial, patients were observed with the ORR of 17.3% and the DCR of 57.5%, and the one-year overall survival rate is 69.3%. The NDA approval of toripalimab witnessed the pivotal step from pre-revenue biotech start-up to a commercial-stage biopharmaceutical company.

Since Toripalimab started its clinical trials at the beginning of 2016, over 30 trials have been conducted in China, the US and other countries, covering 14 kinds of tumors, i.e. NPC, UC, lung cancer, EC, HCC, TNBC, etc. Cooperations with domestic and overseas innovation pharma companies on combination therapy are also under exploration.

About I-Mab:

I-Mab is a dynamic and fast-growing global biotech company exclusively focused on developing biologics of first-in-class or best-in-class potential in the therapeutic areas of immuno-oncology and autoimmune diseases. I-Mab's mission is to bring transformational medicines to patients through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to become a fully integrated end-to-end global biopharmaceutical company with cutting-edge discovery platforms, proven preclinical and clinical development expertise, and world-class GMP manufacturing capabilities. I-Mab is well-recognized by capital markets to have successfully raised over US$400 million in equity financing since its establishment in 2016. Its recent USD 200 million Series C financing represents one of the largest amounts ever raised by a biotech company in China. For more information, please visit the Company's website at www.i-mabbiopharma.com.

About Junshi Biosciences:

Junshi Biosciences (NEEQ:833330; HKEX:1877) was founded in December 2012 by a team graduated from renown universities in China and the United States with extensive experience in the industry and international transfer of technology.

Junshi Biosciences is mainly engaged in the research and development of therapeutic antibody. The company specializes in the R&D and industrialization of innovative monoclonal antibody drugs and other therapeutic proteins (TPs) drugs. With an impressive product pipeline including 17 innovative drugs and 2 biosimilars, Junshi Biosciences is the first Chinese company to have filed investigational new drug application (IND) and new drug application (NDA) for anti-PD-1 monoclonal antibody to National Medical Products Administration (NMPA). The company is also the first domestic company to have obtained approval for IND application for anti-PCSK9 monoclonal antibody and anti-BLyS monoclonal antibody from NMPA. In April, the company obtained IND approval from the US FDA for first-in-human anti-BTLA monoclonal antibody for tumor. Junshi Biosciences has more than 1000 employees around the world, in Los Angeles and Maryland in the United States, and Shanghai, Suzhou, Beijing and Guangzhou in China. Official website: www.junshipharma.com.