SinoMab BioScience Limited (HKEX 3681.HK, “SinoMab”) announced with Suzhou Sinovent Pharmaceuticals Co., Ltd. (“Sinovent”) today that they have entered into an exclusive licensing agreement with Everest Medicines (HKEX 1952.HK, “Everest”) to out-license the right to develop and commercialize SN1011 (referred as “XNW1011” by Sinovent), a covalent reversible Bruton’s tyrosine kinase (BTK) inhibitor, to Everest globally for the treatment of renal diseases.
Under the terms of the agreement, SinoMab and Sinovent will receive USD $12 million in initial upfront payments from Everest and up to $549 million as future development, regulatory, and commercial milestone payments, as well as high single-digit to low double-digit royalties on global net sales.
SN1011 is a next-generation covalent reversible BTK inhibitor that exhibits high selectivity, excellent pharmacokinetics property, robust target engagement and a safety profile that supports continued development based in part on results from a completed Phase 1 study with healthy subjects conducted by SinoMab in China.
This Phase I clinical trial is to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and recommended Phase II dose of SN1011 in the treatment of autoimmune disease. In this study, 71 healthy subjects were enrolled, and the highest dosage was ascended to 800 mg in single ascending study and 600 mg in multiple ascending study. None of the subjects reported serious adverse event (SAE). SN1011 is well tolerated with an excellent safety profile. Clinical study report is expected to be released by the end of the third quarter of this year. Following the approval of Investigational New Drug (IND) applications of SN1011 for pemphigus vulgar (PV) and systemic lupus erythematosus (SLE), SinoMab is initiating a Phase II clinical study targeting PV in China. The Company also plans to initiate a Phase II clinical study targeting SLE in near future.
Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab, said, “Since our listing, SinoMab has been actively exploring and identifying opportunities for collaboration and partnership, including but not limiting to in-license and out-license of preclinical and clinical assets, to further strengthen our pipeline and expand our global presence. The out-license of SN1011 is a key milestone in our business development efforts. Alliance with Everest is not only recognition of the potential of SN1011, but also demonstration of the strength and rapid advancement of our pipeline.”.
About BTK Inhibitor
Bruton’s tyrosine kinase (BTK) is an essential component of the B-cell receptor signaling pathways that regulate the survival, activation, proliferation, and differentiation of B lymphocytes. Targeting BTK with small molecule inhibitors has been demonstrated to be an effective treatment option for B-cell lymphomas and autoimmune diseases.
Sinovent is a global biopharmaceutical company focused on discovery, development, and commercialization of innovative medicines to address significant unmet clinical needs. Headquartered in Suzhou, China, the Company has established a highly efficient, fully integrated global R&D organization with presence in China, US and Australia. Leveraging our scientific expertise and proprietary discovery platforms, Sinovent has developed a robust and balanced pipeline, which consists of five first-in-class or best-in-class clinical programs, and many more preclinical programs. The Company’s diseases areas of focus include oncology, metabolic and infectious diseases. For more information, please visit its website at www.sinovent.com.cn
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company’s therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com
About SinoMab BioScience Limited
SinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company’s flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis, systemic lupus erythematosus, pemphigus vulgar, non-Hodgkin’s lymphoma, asthma, and other diseases with major unmet clinical needs.
Topic: Press release summary