Incyte (NASDAQ:INCY) and InnoCare (HKEX: 09969) today announced that Incyte and a subsidiary of InnoCare have entered into a collaboration and license agreement for the development and commercialization of tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in Greater China.

Under the terms of the agreement, InnoCare will pay Incyte US$35 million up front, and Incyte is eligible to receive up to an additional US$82.5 million in potential development, regulatory and commercial milestones, as well as tiered royalties.

InnoCare will receive the rights to develop and exclusively commercialize tafasitamab in hematology and oncology in mainland China, Hong Kong, Macau and Taiwan.

“The collaboration with InnoCare allows us to accelerate the expansion of our partnered portfolio in China,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “We believe InnoCare will be an excellent partner to accelerate the development of tafasitamab, and if approved, help bring this innovative therapy to patients and healthcare providers in Greater China.”　

“We are honored and excited to partner with Incyte, and are committed to making tafasitamab, an FDA-approved treatment, available to eligible patients in Greater China, upon approval. The strategic collaboration with Incyte will not only enhance our strength in the field of hematology and oncology, but also offer us good opportunity to explore the potential clinical benefit of our BTK inhibitor orelabrutinib in combination with tafasitamab,” said Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare. “In addition, we believe that tafasitamab, an innovative CD19 antibody, is critical to solidifying our long-term strategy to strengthen our large molecule capabilities and to enhance combinational therapies with our existing pipelines.”

The transaction is effective immediately upon the execution of the collaboration and license agreement.

About Tafasitamab

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb^® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi^® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi^® is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

In June 2021, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the conditional marketing authorization of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT). The CHMP opinion is currently being reviewed by the European Commission, which has the authority to grant marketing authorization for medicinal products in the European Union (EU).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi^® is a registered trademark of MorphoSys AG.

XmAb^® is a registered trademark of Xencor, Inc.

About Incyte

Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases. We strategically focus on lymphoma, solid tumors, and autoimmune diseases with high unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, New Jersey and Boston.

Incyte Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether and when tafasitamab will be approved for use in Greater China or elsewhere; whether and when InnoCare will bring tafasitamab to market in Greater China; the potential of tafasitamab to treat patients with relapsed or refractory DLBCL or for any other indication; the potential for Incyte to receive royalties and payments from InnoCare for development, regulatory and commercial milestones; and the potential for Incyte to broaden its ability to bring new medicines to cancer patients in Asia and elsewhere, contain predications, estimates and other forward-looking statements.

These forward-looking statements are based on the Company's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company’s clinical trials, supply chain, other third-party providers and development and discovery operations; determinations made by regulatory authorities; the Company’s dependence on its relationships with its collaboration partners; the efficacy or safety of the Company’s products and the products of the Company’s collaboration partners; the acceptance of the Company’s products and the products of the Company’s collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its annual report for the year ended December 31, 2020, and the quarterly report on Form 10-Q for the quarter ended June 30, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.

InnoCare Forward-looking Statements

This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.

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