Background

Since time immemorial, life on earth has been engaged in an arms race between millions of organisms that have tried to outwit each other via offensive and defensive weaponry. Whether contained in the air, water, or on land, pathogens including viruses, bacteria, and many kinds of fungi have evolved greater and more sophisticated infectious capabilities. Ever increasing in virulence, these organisms have subsequently threatened to injure and destroy both plant and animal life – including human life.

Hai Kang Life Corporation (HK-Life) – a pioneering biotechnology company established in 1999 in Hong Kong, the People’s Republic of China (PRC) – has been at the forefront of companies in Asia that have resisted such ancient but lethal plagues. The biotechnology company has developed a number of award winning inventions that have helped to detect and tackle illnesses such as Avian Influenza (AI), a flu infection in birds that can affect humans, foot-and-mouth disease (FMD), a viral infection in hoofed animals, and Severe Acute Respiratory Syndrome (SARS), a form of pneumonia. In so doing, HK-Life has played an ever increasing role in developing a global healthcare market which has been saving millions of humans and other flora and fauna from disease and death.

Inventions

HK-Life – formerly called Hong Kong DNA Chips – was established by Albert Cheung-Hoi Yu, a neuroscientist and bio-entrepreneur who has been a professor of infectious diseases and neurology at Peking University, Beijing, PRC.

The company’s first innovative biotechnology product, developed in 2000, was the H5 Avian Influenza Virus Detection Kit (H5 Kit). Using molecular biological techniques, the H5 Kit has been used to detect viruses such as AI that cause widespread flu infections and death around the world. HK-Life’s groundbreaking technology, moreover, was the patented invention known as the Electric Field Assisted Diagnostic chip (EFADchip).

User-friendly, mobile and inexpensive, the EFADchip is a molecular diagnostic unit (comprised of a chip and chip-reader or “bio-reader”) that has been used to detect the presence of pathogens based on a sample taken from a patient displaying symptoms associated with illnesses such as the flu. These samples are thereafter placed on a chip that is analyzed by a bio-reader in order for a diagnosis to be made. The entire process is fully automated and can take place at the point-of-care (where the patient is located) or at a central location such as a hospital. Hence, the device has become known as a lab-on-a-chip (LOAC). By combining DNA hybridization (a technique to measure genetic difference between two pools of DNA from different species) with other biological detection technologies, the EFADchip was a vast improvement on existing technology.

Because of this advancement and simplification, the device has become a practical, low cost, and speedy solution for diagnosticians. Instead of taking days, as it did previously, pathogen diagnoses have been reduced to a matter of hours via the EFADchip. As a result of this invention, patients are able to receive quicker and more accurate treatment. The patented LOAC system, furthermore, is highly mobile and can be installed anywhere from urban areas such as cities to remote locations including villages. EFADchip technology has the added benefit of multiple applications. The device can be used for a variety of purposes such as detecting genetic diseases; for pathogen surveillance and management; and, for environmental safety monitoring. Because of the prevalence of genetic diseases, virulent pathogens, and the need for fast diagnosis, HK-Life’s technologies have become highly desired products.

Research and Development and Partnerships

HK-Life has established a strong research and development (R&D) culture based on expert staff (including scientists, engineers and technologists) working in state of the art facilities. The biotech company has also developed robust collaborations with partners in government, academia, and industry. The company, for instance, was able to develop its first high-tech device – the H5 Kit – based on R&D funding secured from the highly competitive Innovation and Technology Fund (ITF) – a resource established by the Innovation and Technology Commission, a department of the Commerce and Industry Bureau of the Hong Kong government. Based on the ITF provision, HK-Life was also able to develop the H6, H7 and H9 Kit models in collaboration with the Biology Department of the Hong Kong University of Science and Technology, a renowned institution based in Clear Water, Hong Kong.

Moreover, through a growing network of fully owned subsidiaries and partners (such as Food Safety Laboratories Limited, a subsidiary of HK-Life), the company has continued to create new DNA-based technologies. Such devices have been used for several purposes including DNA testing (for genetically modified food); DNA finger printing (for probing the human genome and screening for diseases such as cancer); and, pharmacogenomics – the study of how a person’s genetic inheritance affects the body’s response to medicines.

Due to its development, HK-Life has expanded its R&D operation in the PRC. Established in 2007, Beijing Hai Kang DNA Chips Limited (BHK Ltd), for example, has integrated the company’s technological developments with its business aspirations and managed its entry into the Asian and international healthcare market. The R&D facility – which is situated in the internationally renowned Beijing Economic Technological Development Area – has implemented the latest technological instrumentation supported by high quality researchers with expertise in food, environment, veterinary and clinical fields.

Indeed, BHK Ltd. and other HK-Life subsidiaries have produced a wide portfolio of diagnostic test kits for the company including products that test for infectious diseases (such as Hepatitis B and FMD); diseases within aquaculture (including white spot, a disease affecting farmed fish); and, pathogens within the environment (such as the legionella bacteria – a pathogen that can be found inside air conditioning and water distribution systems and is the cause of a fever called Legionnaire’s disease).

Moreover, with internationally recognized quality standards and processes having been implemented in all of its R&D facilities, HK-Life has been able to enter international research partnerships with several organizations. The company has worked, for example, with China’s oldest veterinary medicine institution – the Harbin Veterinary Research Institute, in Harbin City, the PRC.

HK-Life’s other R&D collaborations have been with industry partners such as bioMerieux – a manufacturer of products for the biopharmaceutical industry. The company has consequently been at the forefront of companies in Asia – and, increasingly, the rest of the world – that have tackled the ever growing menace of diseases and viruses that threaten human, animal and plant life.

Branding and Commercialization

In order to maintain its competitiveness, HK-Life has implemented a strong product development and branding strategy that has differentiated it from others while creating tremendous consumer demand. The company’s highly convenient LOAC system, for instance, has allowed it to enter the cutting edge of the in vitro diagnostic (IVD) market. This highly lucrative sector is worth over US$18 billion globally for point-of-care products alone (according to Frost & Sullivan).

As of 2012, the company had three main lines of EFADchip-based products: veterinary diagnostic kits (including VetDetect, VetScreen, and Vet Extraction models); clinical diagnostic kits (in over eight categories including SARS detection and Dengue Fever detection); and, food molecular testing kits (in more than ten categories including food allergen detection and food safety testing products).

To introduce its growing range of products to new customers and clients, the company has engaged in a variety of marketing drives and produced technical, product awareness literature including publications in well-known science periodicals such as Lancet and the New England Journal of Medicine. In addition, HK-Life has engaged in product training seminars for new and potential clients; engaged in showcases at international biotech fairs and events; and, attended industry conferences and meetings with distributors and suppliers. The company’s mobile field units, for example, were presented to clients during product demonstration seminars held in 2010 at the Institute of Epidemiology, Disease Control & Research in Dhaka, the People’s Republic of Bangladesh (Bangladesh). Indeed, Dr. Yu and the company’s founding director, Dr. Terence Lok-Ting Lau, were the key speakers at the event where governmental ministries of Bangladesh (including the Ministry of Health) were represented.

The EFADchip, moreover, has been exhibited and demonstrated at well-known industry fairs such as the China Hi-Tech Fair (2010) held at the Shenzhen Convention and Exhibition Center in Hong Kong. Furthermore, the company has participated in a number of local, regional and international industry conferences such as the 3rd Annual Diagnostics Asia (2008) conference held in Singapore; BIO International Convention (2011), held in Washington, District of Columbia, United States of America (USA); and, the 1st World Biotechnology Congress in Dubai (2012), the United Arab Emirates.

With a view to enhance its corporate identity, HK-Life implemented a rebranding strategy and capacity building process which included changing its trade name and implementing internationally recognized standards of quality for its production facilities. In 2007, the company unveiled a new name – Hai Kang Life Corporation Ltd. – in an effort to facilitate expansion into new areas of research, partnership and commercialization. With a new corporate identity, HK-Life consolidated its leading position in Hong Kong when, in 2010, it was the only company in the PRC with International Organization for Standardization (ISO) accreditation for its parentage testing and genetically modified foods testing services.

HK Life’s flagship R&D facility, furthermore, satisfied the industry’s Bio Safety Level 2, which is suitable for work involving pathogenic agents that pose moderate hazards to personnel and the environment. Other internationally recognized quality standards have been satisfied by the company and its subsidiaries including those set by ISO 17025 and ISO 9001:2000 (for testing competence and for quality management systems, respectively), as well as ISO 13485 (for medical device production).

Having rebranded its corporate image and improved production processes, the company has been able to produce a growing array of brands that have been attracting new partners, clients and customers. As of 2012, HK-Life commercialized its many high quality brands to large hospitals and small clinics in Asia, the European Union (EU), the Middle East, and North America.

Patents and Trademarks

HK-Life has developed a comprehensive intellectual property (IP) strategy in order to protect its inventions and brands and to keep future avenues for expansion open. For instance, the company filed patent applications (in 2001 and 2003) for “a kit for detecting non-pathogenic or pathogenic influenza A subtype H5 Virus” via the Patent Cooperation Treaty (PCT) System managed by the World Intellectual Property Organization (WIPO).

In 2003, moreover, HK-Life filed a patent application for an “apparatus and method for detecting DNA in biological samples” also via the PCT System. The company has filed several other international patent applications including those for “nucleic acid detection” (2004), an “apparatus and methods for detecting nucleic acid in biological samples” (2004 and 2006), an “apparatus and methods for detecting DNA in biological samples” (2009), and, a “method for detection of analyte in microarray of samples and apparatus for performing such methods” (2009), all via the PCT System.

HK-Life, furthermore, filed several patent applications in one of its most important markets, the USA, via the United States Patent and Trademark Office (USPTO). In addition, the biotech company ensured that the IP of its flagship invention and brand – the EFADchip – was secured via trademark registrations in 2009 at the Hong Kong Intellectual Property Department (#301442871), the IP office of Hong Kong, PRC; and, via the State Administration for Industry and Commerce of the People’s Republic of China (SAIC), the IP office (for trademarks) of the PRC (#7395115 and #7395116).

With several inational and regional patents for its inventions and trademark registrations for its leading brand, HK-Life has established an impressive IP assets portfolio that has allowed the company to expand into new partnerships and commercialization opportunities around the world.

Environment and Public Health

HK-Life’s technologies have played an increasing role in protecting human, plant and animal life against global and local pathogens. The company’s products have been implemented in a number of areas such as food safety, environmental monitoring, and diseases detection. In a rapid response to new strains of H1N1 influenza virus outbreaks in 2007 and 2009 in Hong Kong, for instance, the company was able to produce new products – a self-contained mobile unit – that was able to serve a wide range of patients including those living in remote places.

Indeed, during a 1997 outbreak, six people died following infections from the virus when it jumped across species from birds to humans. The H5 Kit that was developed in response to this incident was successfully utilized by various agencies of the government – including the Agricultural Fisheries and Conservation Department – as part of their monitoring of imported and locally produced poultry in Hong Kong. Because the new virus strain was identified quickly with the H5 Kit, preventative measures were taken (including the mass slaughter of 1.4million affected poultry) in order to mitigate the risk of a pandemic.

Moreover, HK-Life’s products have been used for detecting potential allergens such as peanuts, soy, additives and coloring agents contained in food products. This service is particularly useful in fulfilling strict food labeling legislations in the EU, USA and other regions and countries, and in protecting the growing numbers of people affected with allergic reactions due to allergy inducing ingredients in food. Indeed, around eight percent of children and three percent of adults are affected in this way with a variety of illnesses including atopic dermatitis (a skin disorder), urticaria (also known as Hives, a skin rash), and adverse reactions such as asthma and anaphylactic shock (a full bodied reaction which may involve stomach cramping and restricted breathing and may even cause death).

HK-Life’s food monitoring and detection devices have also been used in the catering industry for cases involving food poisoning due to food-borne pathogens, cross-contaminated ready-to-eat food, or food that has undergone prolonged storage. The company’s inventions, furthermore, have been at the cutting edge of products that can detect a plethora of other diseases such as the West Nile Virus – a mosquito-borne pathogen that has spread across the world and can affect birds, humans, and a variety of other mammals.

In the global fight against infectious and potentially lethal diseases, HK-Life has emerged as a leading player in defense of humans, animals, and the environment.

Business Results

As HK-Life managed a remarkable rise in the biotechnology sector, the company also expanded its products, services and commercialization opportunities while winning multiple awards. By 2008, for instance, the biotech company had added four fully owned subsidiaries to its business portfolio. Angenomics Limited, for example, manages the marketing and global distribution of the company’s molecular diagnostic products – including the EFADchip. Other HK-Life subsidiaries include DNA-Tech Limited (which caters for national and international customers of DNA testing kits for paternity identification and pre-natal screenings); and, The Food Safety Laboratories Limited (which offers food and consumer goods testing services).

As the company has expanded its well established physical and IP assets into new commercialization opportunities, it has also attracted new clients via collaborative agreements. In 2011, for example, HK-Life entered a production partnership – to co-develop the EFADchip – with Precision Systems Science Company Limited (PSS), a developer, manufacturer and retailer of biotechnology products based in Japan. Under the agreement, PSS will develop a compact genetic analyzer called Bio Reader/EFADchip system that will consolidate both company’s positions in the global IVD market.

On the road to success, HK Life has won both national and international praise including the Hong Kong Award for Industry: Technological Achievement (2004). HK-Life was the first biotechnology company to receive such an award. In 2007, the Award of Chinese Medical Science and Technology (ACMST) was presented to Dr. Yu and his colleagues. Presented by the Ministry of Health and the Ministry of Science and Technology of the PRC, the ACMST award recognizes achievements in the medical sciences.

In addition, the company won the Best Practices Award for Product Differentiation Excellence Award for In-Vitro Diagnostics (2009) from Frost & Sullivan – a renowned international corporate development consultancy firm. This illustrious prize recognizes companies that have demonstrated effective development, leadership, and innovation strategies in the healthcare industry.

A New Lease of Life

In the global fight against widespread and deadly plant and animal viruses and diseases, HK-Life has emerged as a powerful ally with an impressive portfolio of weapons. Having patented a number of inventions, trademarked a leading brand, and established a state of the art R&D facility, the company has successfully leveraged its human and IP assets in order to develop user-friendly and effective products. Consequently, HK-Life has expanded into the region while setting its sights on the global healthcare market.

Source: WIPO