We are a pioneer in the development of biopharmaceuticals in China. We have made significant investments identifying, developing and commercializing biotechnology and other pharmaceutical product candidates with significant market potential. We primarily focus on product candidates in two core therapeutic areas, nephrology and oncology. At the same time, we are expanding into other selected areas especially auto-immune diseases, where we can leverage our strengths in recombinant protein technology to develop innovative products.
We have a proven track record of successfully researching, developing and commercializing biopharmaceuticals. We have independently developed and launched EPIAO and TPIAO, two market-leading biopharmaceuticals in China. We plan to continue to diversify and expand our product pipeline through both in-house research and development and through collaboration with biotechnology and pharmaceutical companies, as well as academic institutions.
As of December 31, 2014, our research and development personnel consisted of 127 employees. Our research and development personnel includes six Ph.D.s and 34 holders of master’s degrees, most of whom have experience working in the healthcare and biotechnology research fields, including experience working in research institutions and hospitals and in the CFDA drug approval process.
Research and Development Platforms
We have three research and development platforms, including a mammalian cell-based platform, a bacterial cell-based platform and a chemical platform.
• Mammalian cell-based platform. With this platform, we develop biopharmaceuticals expressed in mammalian cells. Both our core products, EPIAO and TPIAO, were developed with our mammalian cell-based platform. In addition, we use this platform to develop mAb therapeutics. Product candidates currently being developed with this platform include NuPIAO, PEG-EPO, leukotuximab, anti-TNF a mAb, tanibirumab and DIG-KT.
• Bacterial cell-based platform. With this platform, we develop biopharmaceuticals expressed in bacterial cells. Our early products, Intefen and Inleusin, were developed with our bacterial cell-based platform. Product candidates currently being developed with this platform include pegsiticase.
• Chemical Platform. With this platform, we develop chemical pharmaceutical products primarily in collaboration with third-party companies and research institutions. Product candidates currently being developed with this platform include HIF-PH inhibitor, cinacalcet hydrochloride, sevelamer carbonate, colestilan, voclosporin, PEG-Irinotecan, DJ5, Bcl-2/xL inhibitor, IAP inhibitor, eltrombopag, nadroparin calcium and fondaparinux sodium.
Research and Development Process
Research, development and commercialization of new drugs in China include the following key milestones: discovery and pre-clinical studies; IND application to the CFDA; Phases I, II and III clinical trials; submission of new drug application to the CFDA for examination and approval; manufacturing approval by the CFDA; and GMP authorization by the CFDA.
Our discovery and preclinical studies involve the following general steps, which are similar for product candidates developed with each of our three platforms:
• Discovery. We identify and select molecules that have pharmaceutical efficacy and market potential.
• Chemistry, manufacturing and controls (CMC) development. We conduct studies including process development and controls, characterization, specification and stability studies. All these studies are carried out according to regulatory guidelines, aiming to demonstrate that the quality of the product and the manufacturing process meet a sufficiently high standard.
• Pharmacodynamics, pharmacokinetics and toxicology studies. We analyze the efficacy and safety of a product candidate on animal subjects to guide the clinical trials that follow
We continue studies of process development and controls throughout the pre-clinical and clinical stages, up until a product is commercialized. Currently, we generally rely on our in-house research and development personnel to conduct pre-clinical studies on biopharmaceutical candidates, and outsource the pre-clinical studies on chemical pharmaceutical candidates to contract research organizations.
Our research and development projects are carried out by four units within our company:
• Research institute. Our research institute specializes in developing mammalian and bacterial cell-based biopharmaceutical products and is the main unit responsible for our in-house pre-clinical research and development.
• External collaboration department. Our external collaboration department focuses primarily on identifying companies with promising chemical pharmaceutical products and mAb therapeutics and is the main unit responsible for our collaborative pre-clinical research and development.
• Clinical department. Our clinical department is in charge of designing and managing our clinical trials.
• Regulatory affairs department. Our regulatory affairs department is in charge of registering our products with the CFDA as well as monitoring our research and development projects to ensure that they are compliant with relevant PRC regulations on the development, registration and commercialization of pharmaceuticals.
Our research and development units and our business development and manufacturing departments maintain close interactions with each other to advance our research and development projects in an efficient and coordinated manner. Our clinical department and manufacturing department participate early in our research and development process, which helps us optimize our pre-clinical design decisions.
We focus our in-house research and development efforts on both novel and validated therapeutics for the treatment of diseases in the areas of nephrology, oncology, auto-immune diseases and other selected therapeutic areas. In addition to our in-house product development, we also have collaborative relationships with several biotechnology and pharmaceutical companies, as well as academic institutions to broaden our access to proprietary products. We enter into collaborative projects at different research and development stages.