I-Mab and AbbVie Announce Global Strategic Collaboration for the Development and Commercialization of Lemzoparlimab (TJC4), an Innovative CD47 Monoclonal Antibody for Cancer Immunotherapy

SHANGHAI, China and NORTH CHICAGO, U.S., Sept. 4, 2020 /PRNewswire/ -- I-Mab (Nasdaq: IMAB) and AbbVie (NYSE: ABBV) today jointly announced an extensive global strategic collaboration for the development and commercialization of lemzoparlimab (TJC4). Lemzoparlimab is an innovative CD47 monoclonal antibody independently developed by I-Mab for the treatment of various cancers. Additionally, the two parties may expand their collaboration in the future to jointly develop other combination therapies.

Lemzoparlimab is one of the most promising investigational drugs in I-Mab’s extensive portfolio of patented, innovative R&D pipelines. By targeting a unique antigen-binding epitope, it maximizes binding to tumor cells while minimizing interaction with normal red blood cells, thereby avoiding hemagglutination. This advantage distinguishes it within the global pipeline of CD47 antibody development. Preliminary clinical results from Phase 1 studies in cancer patients have demonstrated lemzoparlimab’s differentiated safety profile and superior pharmacokinetic characteristics. The trial results indicated that lemzoparlimab was well-tolerated as a single intravenous infusion across doses ranging from 1 mg/kg to 30 mg/kg, without any priming dose, and no dose-limiting toxicities or severe hematological adverse events were observed in evaluable patients. Detailed trial results will be presented at relevant international academic conferences in the second half of the year.

Dr. Zang Jingwu, Founder, Honorary Chairman, and Director of Tianjing Biotechnology, stated, “This global strategic collaboration with AbbVie to jointly develop and commercialize lemzoparlimab, a groundbreaking innovative drug, not only underscores Tianjing Biotechnology’s leading position in the field of oncology immunotherapy but also fully demonstrates the immense potential of our innovative pipeline. We are immensely proud and will strive to pioneer new frontiers, leveraging the combined strengths of both parties to accelerate the delivery of advanced, transformative therapies to patients worldwide.”

Dr. Thomas J. Hudson, Senior Vice President of Global Research and Development and Chief Scientific Officer at AbbVie, stated, “Cancer is the second leading cause of death worldwide, and there is an urgent need for innovative oncology therapeutics. The addition of I-Mab’s innovative CD47 antibody will strengthen our global clinical strategy in hematology and tumor immunology. I-Mab’s strengths and remarkable achievements in scientific research and clinical development are impressive, and we look forward to our collaboration benefiting millions of cancer patients worldwide.”

Cooperation Content

Under the collaboration agreement, AbbVie will obtain the license rights for the development and commercialization of lemzoparlimab in countries and regions outside Greater China, while Tianjing Biotechnology retains all rights to develop and commercialize lemzoparlimab in mainland China, Hong Kong, and Macau. Both parties will further design and collaborate on clinical trials globally to explore the therapeutic potential of lemzoparlimab for various types of tumors. This collaboration also grants both parties the right to expand their cooperation in CD47-related treatment solutions in the future; upon obtaining licenses, the two parties may jointly develop relevant research projects.

Going forward, the two parties will jointly oversee product manufacturing, with AbbVie leading global production and supply. This collaboration will also accelerate I-Mab’s product manufacturing and operational activities in China.

Cooperation Funds

Under the terms of the agreement, AbbVie will pay I-Mab an upfront payment of $180 million to acquire the license rights for lemzoparlimab, along with an additional $20 million as a milestone payment upon the availability of Phase 1 clinical study results, totaling $200 million. Furthermore, I-Mab will be eligible to receive up to $1.74 billion in milestone payments for the lemzoparlimab program, including $840 million for clinical development and regulatory approval milestones, with the remaining payments based on sales milestones. Upon successful commercialization of lemzoparlimab, I-Mab will also receive tiered royalties in the double digits from global net sales.

Conference Call

Tianjing Biotechnology will hold an English-language conference call today, September 4, 2020, at 8:00 a.m. Eastern Time / 7:00 p.m. Central Standard Time. The dial-in numbers are as follows:

United States:

+1-888-346-8982

International:

+1-412-902-4272

Mainland China:

400-120-1203

Hong Kong, China:

800-905-945

Meeting ID:

10147681

Live and recorded webcast conference calls and related materials will be uploaded to the following website:

http://www.i-mabbiopharma.com

The conference call replay will be available approximately two hours after the call ends. To listen to the replay, please dial +1-877-344-7529 (US) or 1-412-317-0088 (International). The replay conference ID is 10147681. The telephone replay will be available until September 11, 2020.

AboutCD47andLemzoparlimab

CD47 is a glycoprotein widely expressed on the surface of various cancer cells. It binds to SIRPα on the surface of tumor-associated macrophages, releasing a “don’t eat me” signal that inhibits macrophage-mediated phagocytosis. CD47 antibodies can block this signal, thereby enabling macrophages to attack tumor cells, making CD47 one of the most promising targets for cancer immunotherapy development. However, while targeting tumor cells, CD47 antibodies also bind to normal red blood cells, causing hematological side effects such as severe anemia, which has hindered the research, development, and clinical application of CD47 antibodies as a cancer treatment. Scientists at Tianjing Biotechnology have made a breakthrough discovery of a unique CD47 antibody, lemzoparlimab, which effectively targets tumor cells while minimizing adverse effects on red blood cells, thereby avoiding severe anemia.

A series of preclinical studies have fully demonstrated the hematologic safety advantages and superior antitumor activity of lemzoparlimab. Today, results from Phase 1 clinical trials in cancer patients further provide additional clinical validation for this differentiation. In addition to the ongoing clinical trials in patients with acute myeloid leukemia (AML) currently being conducted in China, Tianjing Biotechnology will continue to advance research in the United States on the combination of lemzoparlimab with Keytruda® (pembrolizumab) for the treatment of solid tumors, as well as with Rituxan® (rituximab) for the treatment of lymphoma.

About Tianjing Biotechnology

I-Mab (NASDAQ: IMAB) is a dynamic international biotechnology company focused on the target discovery, clinical development, and commercialization of differentiated innovative biologics in the fields of tumor immunology and autoimmune diseases. Guided by its mission to “continuously develop innovative biologics that truly transform patients’ lives,” I-Mab has rapidly built a pipeline of more than ten globally competitive innovative drug candidates through diverse approaches, including independent R&D and global collaborations, driven by its dual strategy of “rapid product launch” and “rapid proof-of-concept.” Leveraging its strong capabilities in novel drug development, along with rapidly advancing GMP manufacturing capacity and commercialization infrastructure, I-Mab is swiftly evolving from a clinical-stage biotech company into a comprehensive global biopharmaceutical enterprise. I-Mab maintains offices in Beijing, Shanghai, Hong Kong, and Maryland, USA. For more information, please visithttp://ir.i-mabbiopharma.com

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve complex and serious diseases and address future medical challenges. We strive relentlessly to make a profound impact on people’s lives through scientific innovation across multiple key therapeutic areas, including immunology, oncology, neuroscience, ophthalmology, virology, women’s health, gastroenterology, as well as the products and services in the Allergan Aesthetics portfolio. For more information about AbbVie, please visitwww.abbvie.com

Tianjing Biotechnology Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding Phase 1 trial data for lemzoparlimab (TJC4), the potential impact of clinical data on patients, the progress of Tianjing Biotechnology’s programs, and the clinical development, regulatory milestones, and commercialization of lemzoparlimab (TJC4). These factors include, but are not limited to, risks related to: Tianjing Biotechnology’s ability to demonstrate the safety and efficacy of its drug candidates; the possibility that clinical results for candidate drugs may not support further development or approval for new drug marketing applications; the content and timing of decisions by relevant regulatory authorities regarding the regulatory approval of Tianjing Biotechnology’s candidate drugs; the ability of Tianjing Biotechnology’s candidate drugs, if approved, to achieve commercial success; Tianjing Biotechnology’s ability to obtain and maintain protection for its technology and drug intellectual property rights; Tianjing Biotechnology’s reliance on third parties for drug development, manufacturing, and other services; Tianjing Biotechnology’s limited operating history and its ability to secure additional operational funding to complete the development and commercialization of its candidate drugs; the impact of the coronavirus pandemic on the company’s clinical development, commercial activities, and other business operations; and various risks more fully discussed in the “Risk Factors” section of Tianjing Biotechnology’s most recent Annual Report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in subsequent filings made by Tianjing Biotechnology with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Tianjing Biotechnology, and, except as required by law, Tianjing Biotechnology assumes no obligation to publicly update or revise any forward-looking statements due to new information, future events, or other reasons.

AbbVie Contact

Media:
Adelle Infante
(847) 938-8745
adelle.infante@abbvie.com

Investor:
Liz Shea
(847) 935-2211
liz.shea@abbvie.com

Tianjing Biotechnology Contact Person

Feng Qi, Vice President of Global Corporate Communications
Email:gigi.feng@i-mabbiopharma.com
Office Phone: +86 21 6057 8000

Zhu Jielun, Chief Financial Officer
Email:jielun.zhu@i-mabbiopharma.com
Office Phone: +86 21 6057 8000