Overview

Simcere is a research and development driven Chinese pharmaceutical company committed to bringing high quality, effective therapies to patients by combining in-house R&D with partnerships. Simcere focuses its efforts on the therapeutic areas of oncology, neurology, inflammation/immunology, cardiovascular and infectious diseases.

The company has over 50 products on the market with three R&D centers, four GMP facilities, and three overseas branches located in the US and Europe. Simcere has achieved a 30% compound annual growth rate in four consecutive years.

Global investment and collaboration

In 2020,

– Simcere and G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, signed an exclusive licensing agreement for the development and commercialization of trilaciclib across all indications in Greater China. G1 would receive $14 million upfront payment, sales royalties, and up to $156 million in future milestone payments

– Simcere reached a collaboration with Primary Peptides, a privately held biotech company in Canada, on an exclusive license to develop and commercialize an innovative product for the treatment of stroke. Under the agreement, Simcere receives exclusive rights to develop and commercialize the product in Greater China, while Primary Peptides retains rights in all other markets.

In 2019,

– Simcere and South Korean pharmaceutical company GI Innovation entered into an exclusive regional licensing agreement for the development and commercialization of a class of innovative drug candidates including GI-101, potential first-in-class bi-specific fusion proteins for the treatment of solid tumors. Simcere will be responsible for the clinical development, regulatory approval, and commercialization of the assets in Greater China. GI Innovation received an upfront payment, milestone payments, and tiered royalties in the above territories.

– Simcere and Aeromics announced a collaboration and exclusive license agreement for AER-271, a clinical-stage anti-edema therapy, being developed for the treatment of stroke and other indications, in Greater China. According to the agreement, Simcere will be responsible for the clinical development and commercialization of AER-271 in Greater China.

– Simcere and JW Pharmaceutical (KRX:001060) signed a collaboration and exclusive licensing agreement for anti-gout drug candidate URC-102 in China. According to the agreement, Simcere will be responsible for the clinical research, registration, and commercialization of URC-102 in China. Under the terms of the agreement, JWP will receive an upfront payment, milestones, and sales royalties from commercialization in China.

– Simcere and DSM Nutritional Products Ltd Branch Pentapharm reached an exclusive collaboration agreement to jointly develop and commercialize Batroxobin Concentrated Liquid Defibrase® in China. Under the terms of the agreement, DSM Pentapharm will be responsible for the application and registration of Batroxobin Concentrated Liquid Defibrase® in China, assisting Simcere in developing Batroxobin Injection, and supplying Batroxobin Concentrated Liquid Defibrase® exclusively and solely to Simcere. Simcere will be responsible for the development, application and registration of market authorization, production and commercialization of Batroxobin Injection.

R&D

For the years of 2017, 2018, and 2019, Simcere’s research and development costs accounted for 5.5%, 9.9%, and 14.2%, respectively, of its total revenue for the total periods. The company has established three R&D centers in Nanjing, Jiangsu; Shanghai; and Boston, the US. With the approval of the Ministry of Science and Technology of PRC, Simcere established the only state key laboratory of translational medicine and innovative pharmaceuticals in the PRC pharmaceutical industry.

At present, the company has nearly 50 innovative product candidates in different stages of development, including small molecule pharmaceuticals, large molecule pharmaceuticals and CAR T-cell therapies. More than 10 product candidates are at the clinical stage, have been submitted NDA or have obtained NDA pending market launch.

Products and Market

Simcere focuses R&D efforts on innovative and high entry-barrier generic pharmaceuticals in oncology (including cell therapy), central nervous system disease, and autoimmune disease therapeutic areas. Its current product portfolio included over 40 brands, including two category I innovative drugs and six first-to-market drugs in China. The company’s existing product portfolio includes over 10 products recommended in more than 40 clinical practice guidelines and pathways issued by government authorities or prestigious professional associations, and over 20 products in the NRDL.