Hua Medicine (Shanghai) Ltd
The China (Shanghai) Pilot Free Trade Zone (SHFTZ) launched a "model company" selection campaign in March 2017, aiming to highlight its innovation and reform achievements over the past years. The six-month long event invited more than 80,000 SHFTZ-registered companies to sign up via self-recommendation or via recommendation from others.
After publication, application, on-site inspection, experts' voting and online voting, the campaign selected the top 10 model companies and six sample enterprises, covering foreign-funded, State-owned and private companies, which served as examples of successfully utilizing SHFTZ's innovative measures to enhance growth and development.
In addition, the SHFTZ has compiled a case book of first model companies for its policy innovation, with the hope of encouraging more companies to turn the Zone's innovative measures and preferential policies into their own advantages and growth points.
About Hua Medicine (Shanghai) Ltd
Hua Medicine (Shanghai) Ltd, established in 2011, is a biomedical company in China (Shanghai) Pilot Free Trade Zone (SHFTZ), specializing in the research and development (R&D) of First-in-Class and lifecycle quality management of drugs. Since its foundation, the company has focused on R & D of original innovative new medicine for diabetes. Once the medicine starts marketing, it will mark as a milestone for China in researching and developing innovative drugs of major chronic diseases.
Under China's current Drug Administration Law, marketing authorization and production are combined. This means, a Chinese biomedical company has to build up its own production lines to apply for drug registration and obtain a drug approval number. Building up a production line costs at least several hundred million yuan, which is extremely hard for a biomedical research institute or company to afford. To commercialize findings, most institutes have to sell the intellectual property rights, or the ownership of the findings. This barrier has dampened the enthusiasm of these companies. Thus, the SHFTZ launched the Marketing Authorization Holder (MAH) pilot program.
Under the MAH system, a biomedical research institute or company can be a marketing authorization holder. For those without production lines, they can outsource the production process to other qualified and capable pharmaceutical production companies. Besides, the applicant, holder and outsourcer for production can be changeable based on the MAH system. The system has benefited many patients, accelerating the commercializing procedure of biomedical research findings, reducing companies' investment and time in production facilities. It enables innovative companies to focus on the clinical development of their medicines.
Moreover, the SHFTZ has adopted a "First In and Application Later" system, which allows biomedical companies to import experimental materials into SHFTZ first and apply for customs declaration later to ensure the smooth experiment progresses. The customs clearance time also has been reduced from half a month to 2-3 days, to support the development of Chinese biomedical industry.
As a pilot company for the MAH system in the SHFTZ, Hua Medicine witnessed great development due to the zone's supportive policies and improved innovation environment of drug research and achievement transfer. The company has further fostered its biopharmaceutical industrial chain that features internationalization and marketization.