Descriptions of each tissue-engineered product are to provide investors an understanding of their application and usage. Each tissue-engineered product is currently at different stages of our Business Development Process. ActivSkin, Acornea, and Gegreen have successfully completed all five steps of the Business Development Process and have begun the implementation of their sales programmes. More information is provided in our published reports and announcements.

In general, the business development process of the Group’s tissue-engineered products (“Business Development Process”) is mainly involved the following five major stages:–

  • 1. Research and development (“Stage I”) which involves potential market researches; medical application analysis; product
        development, etc.;

  • 2. Acquisition of the medical device manufacturer licence (醫療器械生產企業許可證) (the “Manufacturer Licence”) (for clinical
        trials) and conducting clinical trials (“Stage II”);

  • 3. Completion of all of the clinical trials with satisfactory results (“Stage III”) which involves the holding of a result conference
        with all clinical trials parties and the preparation of a summary report which has to be signed off by all clinical trials
        participated physicians and hospitals. The report signifies that a particular product is statistically feasible to apply on human     beings;

  • 4. Construction of production line during Stage II and Stage III above, and obtaining of medical device good manufacturing
        practice inspection result notice (醫療器械生產質量管理規範檢查結果通知書) (the “GMP Result Notice”) after completion of
        required clinical trials and after 3 successful trial productions. This GMP Result Notice is a proof of passing certain required
        standards of the production facilities of a particular product (“Stage IV”); and

  • 5. Obtaining the registration (or re-registration) certificates (“Stage V”) from China Food and Drug Administration (國家食品藥品
        監督管理總局) (“CFDA”) or provincial Food and Drug Administration. There are total of three certificates required to be
        obtained prior to commercialisation of products, they are the Manufacturer Licence, the GMP Result Notice and the
        registration certificate for medical device (醫療器械註冊證書) (the “Product Certificate”). The Manufacturer Licence is issued
        to the manufacturer for the production of the medical device for a certain group of products whereas the Product Certificate
        issued for a particular product is the final required certificate prior to selling of a product.