Business description of BEIGENE-LTD from last 10-k form

Forward-Looking Statements and Market Data

        This Annual Report on Form 10-K, or Annual Report, contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Annual Report, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

        The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among other things, statements about:

    •
    the initiation, timing, progress and results of our preclinical studies and clinical trials and our research and development programs;

    •
    our ability to advance our drug candidates into, and successfully complete, clinical trials;

    •
    the ability of our drug candidates to be granted or to maintain Category 1 designation with the China Food and Drug Administration, or CFDA;

    •
    our reliance on the success of our clinical-stage drug candidates BGB-3111, BGB-A317, BGB-290 and BGB-283 and certain other drug candidates, as monotherapies and in combination with our wholly-owned drug candidates and third-party agents;

    •
    the timing or likelihood of regulatory filings and approvals;

    •
    the commercialization of our drug candidates, if approved;

    •
    our ability to develop sales and marketing capabilities;

    •
    the pricing and reimbursement of our drug candidates, if approved;

    •
    the implementation of our business model, strategic plans for our business, drug candidates and technology;

    •
    the scope of protection we are able to establish and maintain for intellectual property rights covering our drug candidates and technology;

    •
    our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties;

    •
    cost associated with defending against intellectual property infringement, product liability and other claims;

    •
    regulatory developments in the United States, China, the United Kingdom, the European Union and other jurisdictions;

    •
    the accuracy of our estimates regarding expenses, future revenues, capital requirements and our need for additional financing;

    •
    the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements;

    •
    our ability to maintain and establish collaborations or obtain additional grant funding;
    •
    the rate and degree of market acceptance of our drug candidates;

    •
    developments relating to our competitors and our industry, including competing therapies;

    •
    the size of the potential markets for our drug candidates and our ability to serve those markets;

    •
    our ability to effectively manage our anticipated growth;

    •
    our ability to attract and retain qualified employees and key personnel;

    •
    our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act;

    •
    statements regarding future revenue, hiring plans, expenses, capital expenditures, capital requirements and share performance;

    •
    the future trading price of the American Depositary Shares, or ADSs, and impact of securities analysts' reports on these prices; and

    •
    other risks and uncertainties, including those listed under "Part I—Item 1A—Risk Factors."

        These forward-looking statements are only predictions and we may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, so you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our business, financial condition and operating results. We have included important factors in the cautionary statements included in this Annual Report, particularly in "Part I—Item 1A—Risk Factors," that could cause actual future results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.

        You should read this Annual Report and the documents that we have filed as exhibits to the Annual Report with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by applicable law.

        This Annual Report includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. While we believe these industry publications and third party research, surveys and studies are reliable, you are cautioned not to give undue weight to this information.

        Please see the Glossary of Scientific Terms on page 74 for definitions of scientific terms used in this Annual Report.


PART I

        Unless the context requires otherwise, references in this report to "BeiGene," the "Company," "we," "us," and "our" refer to BeiGene, Ltd. and its subsidiaries, on a consolidated basis.

Item 1.    Business

Overview

        We are a globally focused, clinical-stage biopharmaceutical company dedicated to becoming a leader in the discovery and development of innovative, molecularly targeted and immuno-oncology drugs for the treatment of cancer. We believe the next generation of cancer treatment will utilize therapeutics both as monotherapies and in combination to attack multiple underlying mechanisms of cancer cell growth and survival. We further believe that discovery of next-generation cancer therapies requires new research tools. To that end, we have developed a proprietary cancer biology platform that addresses the importance of tumor-immune system interactions and the value of primary biopsies in developing new models to support our drug discovery effort.

        Our strategy is to develop a pipeline of drug candidates with the potential to be best-in-class monotherapies and also important components of multiple-agent combination regimens. Over the last six years, using our cancer biology platform, we have developed clinical-stage drug candidates that inhibit the important oncology targets Bruton's tyrosine kinase, or BTK, RAF dimer protein complex and PARP family of proteins, and an immuno-oncology agent that inhibits the immune checkpoint protein receptor PD-1. For each of our molecularly targeted drug candidates, we have achieved proof-of-concept by observing objective responses in defined patient populations. Our BTK inhibitor is currently in pivotal studies in North America, Europe, Australia, New Zealand, and China. Our PD-1, PARP and RAF dimer inhibitors are currently in the dose-expansion phases of their respective clinical trials. As of March 20, 2017, trials of our four clinical-stage drug candidates, as monotherapies and in combination, have enrolled a total of over 980 patients. We have Investigational New Drug, or IND, Applications in effect for our BTK, PD-1 and PARP inhibitors with the U.S. Food and Drug Administration, or FDA. All four of our drug candidates are in the clinic in China, including our BTK drug candidate being in two pivotal studies. We believe that each of our clinical-stage drug candidates is the first in their respective classes being developed in China under the Category 1.1 domestic regulatory pathway to enter into human testing and to present clinical data.

        Our research operations are in China, which we believe confers several advantages including access to a deep scientific talent pool and proximity to extensive preclinical study and clinical trial resources through collaborations with leading cancer hospitals in China. Beyond the substantial market opportunities we expect to have globally, we believe our location in China provides us the opportunity to bring best-in-class and/or first-in-class monotherapies and combination therapeutics to our home market where many global standard-of-care therapies are not currently approved or available. We have assembled a team of 348 individuals in China, the United States, and Australia with deep scientific talent and extensive global pharmaceutical experience who are deeply committed to advancing our mission to become a global leader in next-generation cancer therapies.