Innovent and UNION Therapeutics enter into strategic collaboration and licensing agreement for Orismilast, a next-generation PDE4 inhibitor for inflammatory skin conditions

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SAN FRANCISCO and SUZHOU, China and HELLERUP, Denmark, September 27, 2021 / PRNewswire / – Innovent Biologics Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and markets high-quality drugs for the treatment of cancer, metabolic, autoimmune and disease. other major diseases and therapeutic products UNION A / S (UNION), a private, multi-active, clinical-stage pharmaceutical company focused on immunology and infectious diseases, today announced that it has entered into a collaborative agreement strategy and license for the development and commercialization of orismilast in China.

Under the terms of the agreement, UNION grants Innovent an exclusive license to research, develop and commercialize orismilast in China, including the participation and recruitment of Chinese patients for potential future global studies of orismilast. UNION will receive an upfront payment of $ 20 million and is further entitled to receive up to $ 247 million milestone payments as well as royalties on sales of orismilast in China. UNION will retain worldwide rights to orismilast outside of China.

In China there are approximately fifty million patients with atopic dermatitis and six million patients with psoriasis, and their prevalence increases with changing lifestyles. The current gold standard treatments are topical steroids, oral immunosuppressants and injectable biologics, all of which have certain limitations in terms of efficacy, safety or route of administration, presenting significant unmet clinical needs. In phase 2a clinical studies, orismilast has demonstrated first-order potential profiles under these conditions, with a combination of improved efficacy and safety, and may be well placed to meet the unmet needs of these patient populations. .

Dr. Yongjun Liu, President of Innovent, said: “We are very happy to enter into a collaboration with UNION. We have been impressed with our partner’s ability to advance the global development of orismilast and are delighted to help bring orismilast to patients in China. This collaboration further strengthens our position in the autoimmunity arena by adding potential top-notch mid-term therapy to our portfolio. Innovent is proud to be an ideal partner for global biotechnology and pharmaceutical companies in terms of accelerating the development and commercialization of new actives to benefit a wider patient population. “

Kim Kjøller, CEO of UNION Therapy, said: “We are delighted to enter this strategic collaboration with Innovent, whose in-depth knowledge and presence in China make it an ideal partner to bring orismilast to Chinese patients. We are impressed with Innovent’s track record of international partnership, advancing assets through clinical development and commercial execution. This agreement provides independent validation of our belief in the potential of best-in-class orismilast and expands our global footprint in an underserved market with significant potential. Partnering with pharmaceutical companies is at the heart of our strategy to maximize the value of our product candidates, and we are therefore delighted to enter this collaboration with an internationally renowned partner. “

About orismilast

Orismilast is a potent and selective next-generation PDE4 inhibitor with extensive anti-inflammatory properties, which was originally developed by LEO Pharma and acquired by UNION in 2020. Orismilast has generated evidence data concept positive orally in psoriasis and topically in atopic dermatitis and is being developed as a potential best-in-class or first-in-class treatment option for both diseases. The selectivity of orismilast for PDE4 subtypes B and D and the new modified release release is expected to result in an attractive therapeutic window, i.e. the combination of efficacy and tolerability improved compared to other PDE4 inhibitors. UNION has two product candidates with orismilast in phase 2 clinical development: UNI50001, an oral PDE4 inhibitor studied for the treatment of psoriasis, atopic dermatitis and hidradenitis suppurativa; and UNI50002, the topical formulation of orismilast studied for the treatment of atopic dermatitis. The safety and tolerability of PDE4 inhibitors are well understood, with two oral treatments and one topical currently approved and marketed.

About UNION Therapeutics

UNION therapys is a private, multi-active, clinical-stage pharmaceutical company focused on immunology and infectious diseases. The company is currently working with two complementary chemistry classes, covering immunology and microbiology with seven programs in clinical development. UNION is headquartered in Hellerup, Denmark, and is led by an international team combining biotechnology entrepreneurs and senior executives from the pharmaceutical industry, with a collective experience of over fifteen product approvals. Learn more at www.uniontherapeutics.com

About Innovate

Inspired by the spirit of “Start with Integrity, Succeed with Action”, Innovent’s mission is to develop, manufacture and market high quality biopharmaceuticals that are affordable to ordinary people. Founded in 2011, Innovent is committed to developing, manufacturing and marketing high quality innovative drugs for the treatment of cancer, autoimmune, metabolic and other major diseases. At October 31, 2018, Innovent has been listed on the Main Board of the Hong Kong Stock Exchange Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated, multi-functional platform that includes R&D, CMC (chemistry, manufacturing and controls), clinical development and commercialization capabilities. By leveraging the platform, the company has built a strong pipeline of 26 valuable assets in cancer, metabolic diseases, autoimmune and other major therapeutic areas, with 5 products – TYVYT® (injection of sintilimab), BYVASDA® (injection of bevacizumab biosimilar), SULINNO® (injection of adalimumab biosimilar), HALPRYZA® (injection of rituximab biosimilar) and Pemazyre® (oral pemigatinib inhibitor) – officially approved for marketing in China, 1 active NDA under NMPA review, acceptance of the biological license application (BLA) for sintilimab in the United States, 5 active ingredients in phase 3 or in pivotal clinical trials, and 15 additional molecules in clinical studies .

Innovent has built an international team with advanced talents in the development and commercialization of high-end biologic drugs, comprising many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many collaborators to advance from China the biopharmaceutical industry, improve the availability of drugs and improve the quality of life of patients. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

To note:

Sintilimab is not an approved product in United States.

BYVASDA® (biosimilar bevacizumab injection), HALPRYZA® (biosimilar rituximab injection) and SULINNO® (biosimilar adalimumab injection) are not approved products in United States.

TYVYT® (injection of sintilimab, Innovent)

BYVASDA® (injection of biosimilar bevacizumab, Innovent)

HALPRYZA® (biosimilar injection of rituximab, Innovent)

SULINNO® (biosimilar injection of adalimumab, Innovent)

Pemazyre® (oral pemigatinib inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.

Forward-looking statements

This press release may contain certain forward-looking statements which are, by their nature, subject to important risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, “intend” and similar expressions, with respect to Innovent, are intended to identify certain of these forward-looking statements. Innovent does not intend to regularly update these forward-looking statements.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not guarantees of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent’s control and are difficult to predict. Therefore, actual results may differ materially from information contained in forward-looking statements due to future changes or developments in our business, Innovent’s competitive environment, and political, economic, legal and social conditions.

Innovent, the directors and employees of Innovent assume (a) no obligation to correct or update any forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements fail to materialize or prove to be inaccurate.

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