NANJING, China and UTRECHT, Netherlands,--January 08, 2018-- Simcere Pharmaceutical Group and Merus (NASDAQ: MRUS) today announced that Simcere obtained an exclusive license to develop and commercialize in China three bispecific antibodies utilizing Merus’proprietary Biclonics® technology platform in the area of immuno-oncology.
Under the terms of the agreement, Merus will be leading research and discovery activities while Simcere will be responsible for the Investigational New Drug (IND) enabling studies, clinical development, regulatory filings and commercialization of these products in China. As a key strategic component of the collaboration, Simcere will be responsible for the IND enabling studies and manufacturing of clinical trial materials in China, which will be used to assist regulatory filing and early stage clinical development for Merus in the rest of the world.
“We are very excited about the collaboration with Merus,”said Mr. Jinsheng Ren, Chairman and CEO of Simcere. “Simcere is committed to developing innovative therapeutics for the Chinese market. This collaboration provides Simcere access to Merus’leading bispecific antibody platform and has the potential to introduce multiple first-in-class immuno-oncology therapeutics in the Chinese market. The opportunity allows us to leverage our capability ,expertise and investment in China to support the development of innovative bispecific antibodies in the global markets.”
“We believe this collaboration leverages Merus’unique platform and Biclonics® suite of technologies with Simcere’s drug development experience and strong commercial presence in China,”said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. “For Merus, this represents an important step towards becoming a commercial-stage company with a strong pipeline of differentiated bispecific antibodies in immuno-oncology. There is a clear strategic fit between the two companies and we believe that by combining our collective expertise and resources, we will be able to develop innovative therapeutics in the China market and globally.”
Merus will be eligible to receive upfront, milestone payments contingent upon Simcere achieving certain specified development and commercial goals, and tiered royalty payments on sales in China from Simcere. Simcere will be eligible to receive tiered royalty payments on sales outside of China from Merus. Additional financial details were not disclosed.
About Simcere Pharmaceutical Group
Simcere is a research and development-driven Chinese pharmaceutical company committed to bringing high quality and more effective therapies to patients by combining in house R&D with partnerships. Simcere focuses its efforts on therapeutic areas of oncology, neurology, inflammation/immunology, cardiovascular and infectious diseases.
Simcere is dedicated to research & development of innovative pharmaceuticals and branded generic drugs in China, with a State Key Lab of Translational Medicine and Innovative Drug Development. By leverage of its commercial capability, all top products of the company have leading market share in China.
By leveraging partnering experience with multinational pharmaceutical companies and innovative biotech companies, Simcere continues to advance international medical scientific achievements transformation and create value for partners in China.
Merus is a clinical-stage immuno-oncology company developing innovative full-length human bispecific antibody therapeutics, referred to as Biclonics®. Biclonics®, which are based on the full-length IgG format, are manufactured using industry standard processes and have been observed in preclinical studies to have similar features as conventional monoclonal antibodies, such as long half-life and low immunogenicity.
Merus’most advanced bispecific antibody candidate, MCLA-128, is expected to soon be evaluated in a Phase 2 combination trial in two metastatic breast cancer populations. MCLA-128 is also being evaluated in a Phase 1/2 clinical trial in Europe in gastric, ovarian, endometrial and non-small cell lung cancers. Merus’second most advanced bispecific antibody candidate, MCLA-117, is being developed in a Phase 1 clinical trial in patients with acute myeloid leukemia. The Company also has a pipeline of proprietary bispecific antibody candidates in preclinical development, including MCLA-158, which is designed to bind to cancer stem cells and is being developed as a potential treatment for colorectal cancer and other solid tumors, as well as MCLA-145, which is designed to bind to PD-L1 and a non-disclosed second immunomodulatory target and is being developed in collaboration with Incyte Corporation.
For additional information, please visit Merus’website, www.merus.nl.