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                 approval  and tax breaks, to facilitate research and development of   this disease. Research on such diseases with obvious regional
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       Policy recommendations for the governments of Hong Kong and Shenzhen
                 orphan drugs. By designating rare diseases as a key research area,   association is not only advantageous to the institute, but also highly
                 the institute should be able to attract transnational biomedical   significant. On one hand, the higher number of patients in the
                 enterprises which are leaders in rare disease research to set up a   region can facilitate research, and on the other, the regional
                 presence in the Loop, thereby fostering commercialisation of the   characteristic substantially increases uniqueness of research. As
                 institute’s advanced research outcomes and expediting the   such, the institute stands a chance of developing into a reputable
                 formation of a biotech industrial cluster. Such an operating model   organisation with world leadership in these areas of research.
                 may achieve similar results in other advanced fields of study or
                 disciplines.                                               Independent operation from universities: the institute should
                                                                            operate independently from its member institutions. Doing so can
                 In addition to providing competitive remuneration and benefits   ensure the institute’s autonomy in terms of financial management,
                 packages, opportunities for pursuing advanced research and   daily operation and research directions. Being free from
                 achieving scientific breakthroughs are highly attractive to   administrative or financial restrictions placed by member institutions,
                 world-class researchers and enterprises. Moreover, the institute   the institute can expedite project progress of advanced research. In
                 can also introduce stringent regulatory mechanism in advanced   this area, much can be learnt from the mode of management of the
                 fields of technology on the cutting edge of science, such as stem   Broad Institute and the Francis Crick Institute (see Table 7 above).
                 cells and gene therapies, with a view to developing the Loop into a
                 national regulatory node, establishing a pilot area for international   The biotech mega research institute can facilitate the development of
                 biotech regulatory standards setting, and speeding up the reform   an industrial cluster and a robust biotech ecosystem. In the long run,
                 of the Mainland’s clinical trial and healthcare regimes.   it may provide advanced research support to leading transnational
                                                                            biomedical enterprises and build up a talent pool for enterprises of
                 Addressing regional concerns: the institute should consider   different sizes. Therefore, building on the basis of
                 addressing medical challenges of a regional nature. For instance,   Recommendations 1.1 and 1.2, the Loop may make greater effort
                 primary liver cancer is a common form of malignant tumour in   to attract high quality enterprises to establish a presence. Driven by
                 China, which accounts for more than half of the new cases of the   the mega research institute, the industrial cluster may develop a
                 world; 80% of the world’s nasopharynx cancer patients live in   “talent-research-enterprise” virtuous circle that lays a solid
                 China and Southeast Asia, and each year, between 35,000 to   foundation for the development of the HK-SZ biotech industry.
                 40,000 people from Southern China and Southeast Asia die from


                 52   According to the “Work Procedures for Review and Approval of Overseas New Drugs Catering to Clinical Urgent Needs”, the Center for Drug Evaluation of NMPA has established special
                   channels for a list of overseas new drugs catering to urgent clinical needs, in which technical review will be completed in three months after acceptance for orphan drugs, and six months for
                   other overseas new drugs.
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