Our in-house discovery team focuses on the research and discovery of therapeutics in the areas of oncology and autoimmune diseases. We have collaborations with leading academic institutions in China, including Tsinghua University and Shanghai Institute of Materia Medica, to expand our in-house research capabilities. We believe our discovery effort will enable us to achieve our long-term goal of generating a sustainable internally discovered product pipeline that Zai Lab can develop and commercialize for patients around the world. This effort has resulted in the identification of a number of proprietary targets in our focus areas and we are moving these programs into preclinical development. We currently have discovery operations in Shanghai, and San Francisco, California. Our U.S. discovery unit focuses on generating large molecule therapeutics and creating a proprietary, best-in-class human transgenic mouse platform.
Zai Lab has built a strong development team with extensive experience in all key functional areas including regulatory affairs, pre-clinical and clinical development, statistics and data management, clinical operations, quality assurance as well as pharmacovigilance (PV). We have over 20 clinical trials ongoing or planned in China and have been conducting most of our clinical trials using internal resources. More than 90% of our CRAs in clinical operations have a medical or pharmacy degree and have worked previously at major multinational companies. Our clinical development team has physicians with many years of drug development expertise in relevant therapeutic areas. Our team has pioneered many “First-in China” strategies for innovative drug development, including the well-known “Green Channel“ IND approval pathway.
We have built two facilities in Suzhou, China: a commercial small molecule oral solid dosage manufacture facility and a biologics pilot manufacture facility. Both facilities are designed and built according to relevant cGMP standards of NMPA, EU and U.S. FDA. The small molecule facility, capable of producing 20 million hard capsules and 50 million tablets annually, is intended for manufacturing clinical materials and commercial oral solid dosage forms. The biologics facility focuses on producing CTA and clinical trial materials. It has been fully operational since the fourth quarter of 2018. The facility has a production area of 4,200 square meters and is equipped with an advanced GE Flexfactory single-use production line. It only took 12 months from designing to operation qualification, making it the fastest-constructed Flexfactory production line in the world.
Zai Lab currently has two marketed products and is quickly transitioning into a commercial stage company. We are currently building and expanding a highly specialized commercial team including marketing, sales, distribution, market access and government affairs to support the marketing of our products in greater China. Our commercial team members came from the most driven, entrepreneurial and scientific talent pool and they collectively have a proven track record of success in launching many of the top innovative oncology products in China. We have built a fully functional and synergistic commercial team based in Hong Kong (China) to support our product launches in that market. With deep market insights, strong local relationships and extensive industry experience, we remain committed to deliver our innovative products and improve the accessibility and affordability of transformative medicines for patients not only in China, but also globally.
We are committed to partner with academia, biotech and pharmaceutical companies around the world to discover and develop innovative medicines that will transform patients’ lives. Our team benefits from significant experience working with global organizations and has pioneered many of the collaboration models in China. Our unique combination of world-class teams, global innovative drug R&D experience, track record in clinical development in China and experienced commercial team differentiates us. The recognition of Zai Lab as the partner of choice is evidenced by our partnerships with global companies such as Tesaro, GSK, MacroGenics, Paratek, Bristol-Myers Squibb and Novocure. We are actively seeking partnerships in innovative therapies for China and worldwide, focusing on oncology, auto-immune and infectious disease areas.
Contact us at: BD@zailaboratory.com