we will collaborate with different IVD companies because they have the license to make and sell these kinds of products.

VoL: How can this pandemic be an opportunity for LumiSTAR to take off globally?

YFC: We see this as our big opportunity, indeed. We have started collaborating with other big companies in Taiwan because they already have their marketing channels globally, maybe not for COVID-19, but they do have different testing kits that they have launched for decades. The collaboration can assist us in accelerating our product commercialization.

VoL: Apart from these two projects you have in the pipeline, are there any other projects which you are currently working on?

YFC: Yes, we have already commercialized our cardiotoxicity testing platform; assays and service are all launched. We are also focusing on different disease models for drug discovery using iPSC technology. We collaborate with a hospital to collect patients’ samples, and then to make iPS cells. The differentiated cells can resume patients’ disease phenotypes. We are developing various bio-imaging based screening assays to support high throughput screening on these models to help pharmas do clinical trials in a dish to evaluate their drug candidates in advance. However, if the disease model for phenotypic screening is from the patient’s sample, more things need to be tackled regarding regulations before the official launch. So we are also working on constructing disease models by genetic mutations on the iPS cell lines to speed up the commercialization process. Neurodegenerative disease models such as Alzheimer’s disease (AD), and Parkinson’s disease (PD) and the corresponding screening assays are all now under development.

VoL: How do you evaluate the current situation with different countries trying to develop a COVID-19 vaccine or a new drug?

MWC: In order to bring the world back to ‘normal’, it is necessary to have COVID-19 vaccine and effective drugs at hand. However, some scientific reports indicate that it is unlikely the drugs and vaccines offer lifelong protection as the virus mutates quickly. Therefore, developing efficient and effective rapid test methodology still plays an important role in controlling the pandemic.

YFC: In general, it takes a long time to develop

an effective vaccine. But the market is there, it’s so competitive. As for drug discovery, we have also developed a platform for anti-COVID-19 drug screening. The platforms are designed to target different steps of virus life cycle: receptor binding, entry, replication and assembly. Through this platform, we are examining various herbal extracts from traditional medicine to get into this competitive field from different approaches. We’re not focusing on well-known small compounds.

VoL: Considering the present COVID-19 situation, Taiwan’s “face mask diplomacy” has put the country all over the news. Taiwan has stepped up its production of face masks and other PPE and has been donating millions of masks to the world with the “MIT” brand. What kind of implication may the MIT brand have for the biotech industry? How do you think people are now seeing Taiwan as a role model in the biotech industry?

YFC: Because of the COVID-19 outbreak, there are many Japanese companies looking for Taiwanese biotech companies for research and services. So we do have these kinds of opportunities here in Taiwan. It is a known fact that Taiwan is a safe place where schools and companies remain open for normal life, so they are willing to open doors to collaborate with Taiwanese companies to explore other opportunities.

MWC: Yes, we received lots of these requests recently.

VoL: How can LumiSTAR become a key partner or associate in this global fight against COVID-19?

YFC: We developed world-class drug screening platforms and detection methodology for rapid tests, and we believe that these innovations and products can make contributions to control the pandemic. We also have a very strong team to provide contract service in high quality.

MWC: Apart from COVID-19 related technology, LumiSTAR has other well-developed imaging-based high throughput drug screening platform, assays and service. We are happy to provide drug testing service for pharmas to help them keep their pipelines development, reducing the impacts caused by COVID-19.

and are ready to grow something visible above the ground, which is revenue. We have been building up a reliable, scalable and certified platform like a solid groundwork, which has attracted investors to join our works and be ready to grow valuable outcomes closely together “above the ground”.

RS: I always believed our advantages would be in technology and engineering, not original inventions. So our commitment is to make the highest quality products with affordable cost.

VoL: Could you share with the readers the characteristics and main uses of microarray products?

RS: Our core technology is called DNA Microarray. Since it had been invented a few decades ago, it has become the first technology that can simultaneously detect genes at whole genome (20000-30000 genes) level. Before that, people could only detect tens of genes at one time. This huge difference enabled lots of new discoveries since many gene-related diseases or biological mechanisms are so complicated that researchers would need to investigate the comprehensive gene network in order to understand it. This technology has now been commonly used for clinical applications and even for the general public. We believe that early disease detection via genetic test will be the future trend so non-invasive and ultra-sensitive assays will be in high demand.

Jack Huang: For the prenatal and postnatal applications, we use a single microarray to detect 400 rare diseases for prenatal screening, that is our key service here in Taiwan and we expect to expand to other countries.

RS: Regarding the pregnancy product, most people usually know about Down syndrome but it is actually only one of the 6,000 inherited diseases, and with our product we can detect more than 400 hundred at a time, so it is very convenient for parents to be less worried.

JH: The product is focused on intellectual delay and developmental disorder such as Prader-Willi syndrome, Developmental Delay and Intellectual Disorders (DD/ID), two areas of diseases detected by one single chip.

RS: This is very important because according to the data of the WHO, more than 5% to 8% of children have DD/ID diseases every year. Our product is so powerful such that if we do a general screening of the population, we can decrease by more than 50% that 5%, which is very significant and impactful. We are trying to make this product accessible and affordable to everyone.

JH: The incidence rate for birth defects in China is about 6-8%, so the Chinese government is working very hard to reduce the rate of birth defects. That is why I believe it is good timing to enter the market of other countries.

RS: 6% in China represents over 1 million of the population; it is a high number of risk.

VoL: Are you launching any new products in 2020?

RS: The future trend for genetic testing is non-invasive and ultra-sensitive. In 2020, we may launch an ultra-sensitive research kit which improves current detection limit by 50000 times. What this improvement means to us is, as an example, if you have to draw 500cc of blood, in the future you would only need one drop of blood with this kind of technology – that is how sensitive is.

VoL: What is your perception about the current state of the biotech industry here in Taiwan?

SY: I think it’s poised for taking off. When I joined the company, Phalanx Biotech positioned itself with an outstanding platform that can embed a lot of proven concepts into the development of biochips, from now on, as an original microarray developer, our prenatal and postnatal genetic testing services have become very supportive for doctors to fulfill their clinical needs to identify rare diseases by leveraging our biochips to read signals. With regards to moving on to the global arena, we are soldiering on to further optimize our genetic testing services to create cost effective, big-scale and commercialized services to tap into the growing market needs worldwide.

I believe the biotech industry in Taiwan can follow the same pattern and spirit from the ICT industry to

make our biotech business grow successfully. That’s why Phalanx Biotech has been crossing boundaries, seeking international partnerships and engagements in the past few years to shape our products to become more competitive and globalized.

Phalanx BioTech is one of the global four DNA microarray companies in the world along with three other respected American counterparts, Illumina, Affymetrix and Agilent. In other words, we are also the only microarray developer in Asia, a region foreseen to have the highest growth in next decade.

VoL: Given your academic and professional experience and seeing the growth of the biotech industry in Taiwan, what do you think is the potential of this industry in the coming years, not just for Phalanx Biotech, but for the industry as a whole?

SY: A long time ago, when the semiconductors industry started in Taiwan, nobody knew it would go this far and reach such a high global profile. Currently, the status of Taiwan’s biotech industry is at the stage similar to semiconductors 30 or 40 years ago. Taiwan’s biotech industry has outstanding resources in terms of our National Healthcare Insurance System, our talents pick medical services as the first choice for their career path, all these have planted seeds in the biotech industry as a promising future, although there is still a space to grow in term of developing a bigger scale of services. I would not be surprised if Taiwan’s biotech became the next generation leading industry, like ICT.

VoL: What does Taiwan need to do to become a global innovation center?

SY: The factors to become a global innovation center is very much dependent upon a strong international network connection and a friendly capital environment for risk-taking investment. Apart from that, we need to identify our strengths to compatibly partner with global counterparts, which are known as the original innovators, to enlarge the scale of the global market. For instance, Facebook and Tesla started in the U.S., and are known for the power of innovation, which is their strength. However, the innovative giants would need to leverage the other partners’ strength from the other side of the globe to enlarge their global services. That would be the moment for the other players to get involved to form the global innovation center. To apply that scenario to the genomic business, we are

one of those players to compatibly partner with to form a global innovation hub in the genetic testing industry.

Taiwan is a global powerhouse in technology, IT, and computing systems. As biotech evolves, we are creating new services that marry breakthroughs like artificial intelligence with Big Data, derived from the human genome. Taiwan boasts a world-class healthcare system and a broad medical talent base. Strengthening biotech collaborations will help upgrade the nation’s R&D capabilities, increase the global competency of Taiwan companies and raise the country’s profile as a hub of innovation.

Currently, Phalanx Biotech Group has joined a talent development project initiated by the Taiwanese government, named LIFT, to provide an incubation environment for overseas biotech talents to return to bring in new blood. Additionally, Phalanx Biotech and Taipei Medical University have joined hands to collaborate in industry-academia classes and to cultivate talents for connection with the enterprise. By having more resources to promote the brands to the international market, it will also allow the world to see the top medical team from Taiwan!

VoL: What is Phalanx Biotech Group’s message for our international audience of FORTUNE readers?

RS: We are one of the four global DNA microarray companies in the world and we are the only one located in Asia. Since the inauguration of array technology, key international developers except us had focused on technology improvement at array density. Instead, Phalanx Biotech persisted on both quality and cost effectiveness of our manufactured engineering. Nowadays, DNA microarray has commonly been used in clinics and general publics, so high quality and massive quantity products are highly demanded. It indicates that our persistence for both quality and cost for our microarray technology has successfully tapped into the demands of the market, which is now the right moment for us to soldier on! I hope FORTUNE magazine readers worldwide can recognize that Taiwan’s biotech industry has such a company, Phalanx Biotech Group, to obtain the capability to stand up proudly in the global arena.

it is quantitative and very accurate, which is a big advantage in many clinical applications.
The second area is for reproductive medicine. The panel chips are used to help increase the success rate of in-vitro fertilization (IVF) treatments. Nowadays, many people do not have children until later so they have more difficulties in terms of fertilization. We are also seeing that the sperm count of men in their 30s is decreasing greatly.
The reproductive medicine is a very important growing area for us. Each IVF cycle takes 4-6 months and the success rate is somewhere around 20%. Therefore, improving the success rate is very important. We have been developing molecular tests to help physicians improve the success rate. We help in terms of choosing the right timing for implantation. Our product, MIRA, is available to clinics and physicians, and it is used to identify the best window of implantation. The other product under development will be used to identify healthy embryo, non-invasively, which avoids the risk of endangering the embryo.
The QuarkBio team also works on microRNA. Our unique PanelChip analysis system allows us to accurately profile RNA expressions, and microRNA is into regulating 90% of human gene expressions. Our efforts in using microRNA in developing panels for clinical applications have been quite successful and it will be an important new frontier, for diagnostics in the future.

VoL: What are your strategies to sell these products in other markets?

JL: For QuarkBio, the content of the chip is very important and we are developing our own content-based on microRNA, mostly for liquid biopsy. We also work with our customers to develop their products and convert it to our chip. We are looking for partners and agents that can help market and sell our products to labs. We have a combination of new platform and new assays. One example is RecurIndex, an assay used in the area of breast cancer prognosis to determine if the patient has to go through chemotherapy after surgery. Last year at ASCO, there was a big issue about over-treating breast cancer patients. After most surgeries, patients are put through chemo therapy and it is believed that a large percentage of cases are not necessary.

VoL: As the Chairman of Taiwan Biotech Industry Association, what are your insights regarding the current state of the biotech industry in Taiwan?

JL: The biotech industry in Taiwan has been growing for the last ten to fifteen years. Ten years ago, there were only 38 publicly listed companies. At the end of 2018, we had 122 companies listed, so in terms of the listed biotech companies, we have grown more than three times in last ten years and the market cap has grown about ten times. That is an indication of the quality and the size of the biotech industry in Taiwan.

We also have been able to push a few new drugs from discovery to the market. Overall industry revenue has increased, but not as fast as the market capitalization. Many of the companies are still not making money, but the number of revenue-generating companies has increased significantly. We have six drugs that have received approval from the FDA in the United States, the Taiwan FDA, and also in Europe. For example, TROGARZO® by TaiMed is the first biologics drug for HIV second-line treatment. This is one of the new drugs that has recently been approved and is now going into the market in the U.S. and in Europe. We have not seen high revenue yet, but can expect them to grow in the near future. The other is ONIVYDE® by PharmaEngine. Those are just two examples out of the six approved drugs on a global scale.
There has been a lot of progress, and in terms of medical devices, we have 49 that have received FDA approval. At the same time, there are clinical trials - currently there are 295 trials ongoing, out of which 171 are FDA-approved clinical trials, so that means there are a lot more in the pipeline.
Taiwan is one of the earliest countries allowing cell therapy to be used clinically. Cell therapy can be used for cancer treatment and for regenerative medicine such as cartilage or skin repair. We know that, as of now, the Taiwan FDA has already received more than 50 applications and four have been approved for clinical use. This is one of the new areas in biomedical technology. There are only very few countries that allow for cell therapy, so this is another indication of Taiwan’s recent progress.

Taiwan is known for its National Health Insurance system. CEO Magazine ranks Taiwan’s healthcare system as number one in the world. The healthcare system is of a high quality and utilizes our national database. In other countries, once you change hospitals or insurance, you lose the data. Taiwan has this kind of data, and it has been collected for more than 25 years. It is a huge database and they

have just recently released a whole batch of images to the industry and academia for AI research. They are creating a lot of projects that would be able to make use of our unique big data from National Health Insurance in combination with AI, and that is a very important initiative that would come into fruition at some point.

WH: We are about the same as last year, our performance is around the same. A few things have contributed to that success. Before COVID-19 became a pandemic we closed off the deal with Vietnam, so we are actually selling our PRP kits to Vietnam. We obtained a license and found a good dealer that can help us, so we are actually exporting the kits to Vietnam. That is one of the things. The other thing is that we knew, in terms of skincare, we needed to have more outlets, not just within our clinics, but where everybody is able to buy. And that has proven to be a clever idea, especially during the pandemic. So we rebranded our whole skincare product and made it available online, so those were the biggest two moves we did during the pandemic. I would not say we were not affected by COVID-19 but we are doing about the same as last year.

VoL: Looking forward to 2021, what are some of the strategic plans you have in place?

WH: We are looking for a pharmaceutical company or a biotech company. One of the biggest things is clinical studies. Because of COVID a lot of the studies were put on hold. We have to continue our clinical studies. But like we said before, we are trying to find out more indications that PRP can be applied to. Here in Taiwan, the injection of PRP is very well known. In hospitals it is mostly for the clinics or rehab. So they do injections or pain management. We are trying to move onto gynecology and dental — those are two things we are doing right now and we hope to be able to see some footfall.

The other thing is — in Europe there are a lot of bans in animal testing, we do not do it. One of the other areas we are going to move into is artificial skin that is available for other people to do testing on. Whether or not it is penetration, whether or not it is UV absorption or all these testings, we want to get these things done. These are good because what we know from the pandemic is, you try to do social distancing, so these things not only replace animals but they can do the testing and interpret the results themselves. So it is kind of the whole package, they can do everything themselves.

VoL: How much of a business opportunity do you see in regenerative medicine globally?

WH: It is really a growing business we can see. We established this company more than ten years ago, and at the time there was no law for cellular therapies. At the time the government did not know much about this. Five years ago there was a massive fire at a waterpark, there were close to 500 people who got majorly burned. That was caused by the color party where they spray all these thick powders and then some of the lights had a spark and caused a fire. And everyone was burning in fire, and it turned into hell. That reminded me of tempura, you’re making yourself like a tempura, once there is a fire you catch it so easily.

We were in touch with a lot of great regenerative medicine in people in the United States and Japan and one of them was about burns. So we and a lot of the academic families helped that product come into Taiwan and that CEO was kind enough to give it for free to the victims, as Taiwan and Japan always had a good relationship. Although it cost a great deal of time, we were able to apply that to only five patients at the end, because a lot of them needed immediate treatment, but it was not until then that the government realized “wow, that’s such a product.” There are things that we did not know of and so many different things that are going on in this world. Now the government is really pushing that through, so there are around seventy-something cellular and gene therapy products available in the market in the whole world.

VoL: Given the global team that you have in place, with headquarters in Taiwan and a growing operation in the U.S., China, Korea, Japan and soon Germany, how do you maintain the standards of quality and excellence?

KL: People realize that we have the same goal, as we are working for the same excellence. In our company we are very transparent, so everybody can access the progress of the projects and be involved in the projects. We are making a breakthrough, and more importantly, people working with our company truly believe they can help patients.

VoL: What do you think is the potential of the pharmaceutical and biotech industries in Taiwan over the coming years?

MS: I think that the Taiwanese biotech industry is going through a renaissance, as they did in the past with technology and semiconductors when Taiwan became known as a hub of technology and high quality manufacturing. Taiwanese biotech is heading in the same direction. They have access to talent; many Taiwanese were educated in the United States and in Europe, and the Taiwanese Government has worked hard to create a positive business culture in the country.

I also believe that Taiwan is very well positioned to become a gateway to the east and its location also provides access to talent not only from the U.S., but also in China, Japan, and other Asian countries. It is an exciting time for Taiwanese biotech.

VoL: There is a growing demand in the biotech industry on the global stage. How do you see the Taiwanese biotech industry really working together and taking advantage of this global interest in biotech?

KL: Collaboration is seen as good from the government point of view. Working together starts from government, and the cluster effect from companies being close together is ongoing. In terms of global demand, we are a good example; we got an EMA approval, in fact we were probably the first Taiwanese company and also a Chinese company in general to do so. To receive first approval from EMA we started from ground zero, starting from discovery, development, manufacturing, and then marketing and

sales. All together for a fully-integrated company.

More importantly, the government put up the new National Biotechnology Research Park nearby where the new Development Center for Biotechnology (DCB) office is. This is a very good beginning; it will have a great impact in 10 to 20 years. They are also going to put a new building called Biocluster in Taipei City, so this whole area will be a bit like Cambridge in Boston, not only because of the companies here, but also because there are many big hospitals close by in this area. Not only in Taipei actually, but also in Taichung and Kaohsiung because there are many manufacturing sites Taichung Science Park. So Taiwan would play a major role. When a country has a GDP at a certain level you need a lot for medical needs, but also create some medical industries.

VoL: What are your plans to list the company in the U.S.?

KL As we are listed on the Taipei Stock Exchange, we have many requests to do so. JP Morgan and UBS have talked to us to see if we can get listed in NASDAQ. We have spoken with JP Morgan and Morgan Stanley, and try to see if we can get listed in Hong Kong. Taiwan still has great potential even if now the biotech and pharmaceutical stocks are not trading so high. I believe we will be looking to go ADR (American Depository Receipt)sometime next year. We are going to start small to try and test the waters because we are going to market the product in the U.S.

VoL: With the company’s future strategic plans, how do you see PharmaEssentia in the coming years?

KL: We are entering a phase of tremendous growth so it is a very exciting time for our company. Ropeginterferon will be the first product approved for the initial treatment of high-risk PV and that in itself is a big achievement because no other products recommended by the guidelines as initial treatments have undergone large scale clinical studies. For PV patients, this will be a great step forward in finally having an approved initial therapy for the treatment of their disease.

We will move from being a classical research and

development organization into a fully-commercial organization which will require us to develop our commercial arm and sales force. This will also mean a steady revenue stream that will enable us to invest in other research activities and will serve as a platform for future growth. The most exciting achievement, however, is building a business from scratch. Dr. Lin and his team have been working on the Ropeginterferon molecule for years, they now have the opportunity to see something that was just an idea come to fruition.