Sun Pharma, China Medical System Holdings enter into two license agreements

Sun Pharmaceutical Industries Ltd on Thursday announced that one of its wholly-owned subsidiaries has entered into a licensing agreement with a subsidiary of China Medical System Holdings Ltd. (CMS) for the development and commercialization of Tildrakizumab, an innovative biologic product, for psoriasis and psoriatic arthritis in Greater China (including Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan). Sun Pharma's subsidiary has also entered into an exclusive licensing agreement with a subsidiary of China Medical System Holdings Ltd. (CMS) for the development and commercialization of Cyclosporine A 0.09% (CsA) eye drops, which is an innovative formulation, for dry eye disease in Greater China.

In separate statements, Sun Pharma said, "Under terms of the license agreement, CMS will pay Sun Pharma an initial upfront payment, regulatory and sales milestone payments, and royalties on net sales, the terms of which are confidential. CMS will be responsible for development, regulatory filings and commercialization of the product in China."

"The initial tenure of the agreement shall be 15 years from the first commercial sale of Tildrakizumab in Greater China, and may be extended for additional 3 years’ subject to certain conditions defined in the agreement," it added.

Cyclosporine A 0.09% (CsA) eye drops

Cyclosporine A 0.09% ophthalmic solution (CsA) is a patented, novel, proprietary nanomicellar formulation in a clear, preservative-free, aqueous solution. This nanomicellar technology uses micelles, which are gelatinous aggregates of amphipathic (both hydrophobic and hydrophilic) molecules formed at a well-defined concentration.

Tildrakizumab-asmn

Tildrakizumab-asmn is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leadingto inhibition of the release of pro-inflammatory cytokines and chemokines. It was approved by USFDA in March 2018 and is being currently marketed in the US under the ILUMYATM brand name.

Dilip Shanghvi, Managing Director, Sun Pharma, said in a statement: “This licensing agreement marks our entry into the Greater China market which is the second largest pharmaceutical market globally. Sun Pharma is committed to growing its dermatology franchise, with Tildrakizumab as its lead product. We continue to build our pipeline and capabilities in this important therapeutic area of significant unmet need. We are excited to be partnering with a leading pharmaceutical company like CMS to offer Tildrakizumab as an alternative treatment for psoriasis and psoriatic arthritis in Greater China."