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- 2025-12-19 22:52:56
- Opinion
- [Reporter’sView] Revisiting gene list for NGS panel testing
- by Eo, Yun-Ho Oct 12, 2020 06:16am
- Human epidermal growth factor receptor 2 (HER2), anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) would be familiar terms for the people who have been paying a close attention to those news articles regarding anticancer treatment. Depending on the genetic mutation a patient has, effective treatment varies while treatments specifically targeting these genes are emerging one after another. In particular, such changes are apparent in the anticancer treatment scene. In the age of precise medicine, the South Korean government has stated in 2016 the customized medicine would be realized through precise medicine and that the government would also seek new emerging driving force in it. And in March 2017, the government has started applying National Health Insurance (NHI) benefit on genetic testing based on next generation sequencing (NGS) as a part of establishing the foundation of the precise medicine. It was selective reimbursement with 50 percent copayment rate on patients with 10 types of solid tumor, six types of blood cancer and three types of genetic disorders. Closely following the changes in anticancer therapy trend, the NHI benefit on NGS-based genetic testing eligible patients was widened to all solid tumors and the copayment rate was also adjusted. List of required essential gene types by diseases The NGS is a DNA sequencing technology that breaks DNA into smaller countless pieces and puts them back together. Unlike the conventional single genetic testing, the NGS allows tens or hundreds of genes to be read as a single panel, making the process cheaper and faster than before. Besides it being convenient, seeking essential genes required for NGS-based panel testing as supported by latest researches is crucial to find the most effective treatment for patients. The importance of it cannot be stressed enough as the patients has to have the essential gene eligible for the reimbursement for the NGS-based panel test. However, the health insurance authority has not revisited the list of required essential genes for last four years, when numerous treatments have been developed and obtained marketing approval in South Korea. Moreover, innovative treatments like RET or MET treatments targeting a new gene type have been found. The Ministry of Food and Drug Safety (MFDS) is also in process of preparing a bill to promptly approve precise medicine-basis new drug. One of the objectives of precise medicine is to provide customized treatment for each individual patient. And testing technology grounded on latest research findings is essential to those customized treatments. The government should take a second look at expanding the list of essential gene types for the patients’ treatment, and reconsider on improving the NGS-based panel testing.
- Opinion
- [Reporter’s view] Nikola and Korean Pharmaceutical Market
- by Kim, Jin-Gu Sep 28, 2020 06:21am
- Money flows into unsubstantiated expectations. Money begets money. The stock value jumped over the moon. Before long, It came to light. Stock prices plummeted, and investors fell into despair. It is a story about the American hydrogen truck company 'Nikola'. It was once called the second Tesla and received the attention of investors, but only controversy remains. The driving video they released turned out to be that the vehicle did not run on its own, but was ridiculously rolled on the hill. Eventually, founder Trevor Milton took responsibility for the controversy and resigned. The US Department of Justice and financial authorities have launched an investigation into the alleged fraud. The reason that raised Nikola's stock price was anticipation. Investors were hoping that it would become the second Tesla. Instead of looking at the entity of the company, they focused only on the commonalities with Tesla. Even GM, the leading automobile company in the United States, has invested $2 billion, and it said only plausible words. The Nikola crisis abroad has great implications for the Korean pharmaceutical bio stock market. Expectations that have no substance are about to collapse someday. Many pharmaceutical companies have announced that they will develop a treatment and vaccine for COVID-19. Of course, most of them are in the midst of R&D according to their plans. However, there are certainly companies where the substance is not clear. After the news that it will start developing, there is no more news. Even patient recruitment for clinical trials has not been completed. Several media began to question the company's ability and willingness to develop. Financial authorities are repeating investment warnings. Nevertheless, stock prices rise endlessly. The time is approaching when reality will be revealed. It is not yet known whether Tesla or Nikola will be the reality of the pharmaceutical companies to be confirmed soon. However, there is too much uncertainty to buy a dream only with unsubstantiated expectations. What is needed in an era of uncertainty called COVID-19 is coldness.
- Opinion
- [Reporter’s Note] Will KRPIA appoint a Korean chairman?
- by Eo, Yun-Ho Sep 21, 2020 06:12am
- While a few multinational pharmaceutical companies have confirmed their foreign executives would be leaving the position, the Korean Research-based Pharmaceutical Industry Association’s (KRPIA) board of director (BOD) is also expected to undergo some changes as well. The two foreign executives bidding farewell are MSD Korea’s CEO Avi BenShoshan and GSK Korea’s Vice President and General Manager Julien Samson. Currently, CEO Avi BenShoshan is the Chairman of KRPIA and VP and General Manager Julien Samson is a Vice-chair. The focus of the industry lies on the possibility of expanding the Korean executives among the KRPIA BODs. Considering Chairman Avi BenShoshan’s term is to last until the end of the year, KRPIA would likely to appoint an acting-chairman. Except for Vice-chair Julien Samson, Kay Bae (Sanofi-Aventis Korea) and Oh Dong-wook (Pfizer Korea) are the other two vice-chairs, who could be appointed to take the acting-chairman position. With the two foreign executives leaving, the existing BOD roster with seven Koreans and six foreigners may increase the ratio of Korean executives. The members of the organization have been raising their voices that appointing a Korean as the chairman would make more sense, because the organization’s integral role is to communicate with drug pricing-related government bodies as the multinational companies mainly supply new drugs to the Korean market. Moreover, the government affairs-related skills have been highly sought after lately to receive reimbursement on high-cost drugs the multinational companies’ recent pipelines are more focused on. In fact, Ministry of Health and Welfare’s (MOHW) drug pricing and listing divisions tend to prefer Korean executives. Chairman Avi BenShoshan was actually a first foreign executive appointed as the chairman, after seven years since 2011 the position was served by Korean executives including Lee Dong-soo (former President of Pfizer Korea), Kim Jin-ho (former GM of GSK Korea), and Kim Oak-yeon (former CEO of Janssen Korea). Having Korean executives in BODs does not always mean better. But, surely for KRPIA, this is the critical time to have more Koreans to lead the organization. Going beyond the one-dimensional goal of receiving satisfying level of drug pricing, hopefully KRPIA would appoint BODs, who can rationally and cleverly find a middle ground with the Korean health authority to ultimately ‘improve patient’s treatment access.’
- Opinion
- [Reporter’s Note] “Loonshots” in new drug development
- by An, Kyung-Jin Sep 18, 2020 06:30am
- I finally caught up to read the bestselling book, “Loonshots” that Bill Gates praised as ‘a book to carry around in your bag to read.’ The book is written by Safi Bahcall, who received a doctorate degree in physics from Stanford University and co-founded ‘Synta Pharmaceuticals.’ The author defines “Loonshots” as “a neglected project, widely dismissed and its champion written off as unhinged.” To use such ‘crazy idea’ in a formula of corporate innovation and growth, the physicist applies theories of physics like ‘phase transition,’ ‘phase separation,’ and ‘dynamic equilibrium.’ After creating a biotech company and working there for a decade as a CEO, he figured the scientific principles are not so different from corporate management. The book explains of the distinction between a ‘start-up’ and a ‘conglomerate’ with the basic concept of physics—more is different. As a scale of an organization can completely change its nature, a good design of an organization can only maintain the dynamic equilibrium, which enables the organization to keep a balance and internally communicate. But unfortunately, an organization tends to dismiss the loonshots, when they grow in scale and get stabilized. Basically, he claimed, for an organization to nurture the innovative idea that seem ridiculous in the moment, it would be more efficient to separately form groups either freely My abrupt book review is to argue that the loonshot nurturing rules and the new drug development procedure seem to share a lot in common. A life-saving new drug is also dismissed as a so-called crazy idea or loonshots in the initial development stage. The one of most well-known dyslipidemia medicine, statin had a commercialization process that shows the realistic barrier against an innovative idea. Statin has originated from teal-colored fungus found by a researcher Endo Akira working at a Japanese-based pharmaceutical conglomerate Sankyo. But because of risk of adverse reaction, the medicine was discarded by the company, and rather a U.S.-based conglomerate MSD took it over. Taking the tips from Endo, MSD finally released the first statin drug Mevacor in 1987 after conducing tens of clinical trials. With other follow-on statin drugs, the U.S. company has become one of the most successful global pharmaceutical company. In present day, many of South Korean pharmaceutical and bio companies have declared they would develop unprecedented innovative new drugs. Interestingly, the loonshot rules have been applied to an increasing number of new drug developments. One of most prevalent cases is a notion of developing a ‘spin-off’ that lets a R&D department to focus on the new drug pipeline. In 2016, Yuhan Corp co-founded a joint venture ‘ImmuneOncia’ with Sorrento Therapeutics to strategically develop new anticancer treatment. SK Chemicals spun off their new drug development division and founded ‘Tiumbio.’ Late last year, Ildong Holdings found new drug development-specializing company ‘Idience’ and transferred its new anticancer drug pipeline. Daewoong Pharmaceutical split off from its own subsidiary ‘iN Therapeutics’ in last May, and transferred ion channel new drug development platform and non-opioid analgesics, hearing loss treatment and brain disease treatment. Summing it up, the conventional pharmaceutical giants are applying the ‘phase separation’ concept to prevent halting a promising pipeline. The rules from the book may not be the correct answer. Nevertheless, we welcome the Korean companies doing all they can to achieve innovation and growth. Hopefully, their effort would result in a satisfying outcome.
- Opinion
- [Reporter’s View] A salesperson who lost a place to go
- by Kim, Jin-Gu Sep 04, 2020 06:52am
- "I went to work today, but I was just sitting in the car. I couldn't do anything other than that." Mr. A, who works as a salesperson for a pharmaceutical company in the metropolitan area, complained with frustration. He sat in the car for lunch with kimbap today. He couldn't even go to a cafe. He opened his laptop from the driver's seat, did the homework that the company gave me (I expressed it as homework instead of work), made a few phone calls, and went home. The government announced that it will temporarily level 2.5 social distancing in the metropolitan area by the 6th of this month. It was recommended to take action that is close to level 3, even if it is about 2.8. The streets became rather quiet. Many pharmaceutical companies agree on level 2.5 social distancing. It is recommended to stay at home, regardless of whether working in office or sales. They hope that the secondary spread will be soften quickly, so they will even bear some damage. However, some pharmaceutical companies did not clarify their policy of working from home at the company level. While recommending working from home, there is also a widespread expedient to not just go to the office. The middle manager thinks it's a subtle pressure. The demand for 'do not visit customers as much as possible' and the demand for 'achieve the target performance this month' are contradictory. Inevitably, the salespeople who came out have nowhere to go. Customers are reluctant to visit salespeople. It is a message that the degree is worse than when the first spread in March. Especially in the metropolitan area. There have already been a number of confirmed cases in the pharmaceutical industry, especially in sales. Mr. A expressed it as 'bad learning effect'. All pharmaceutical companies have experienced spread of COVID-19 in last March. They responded in their own ways and saved themselves. At least in the pharmaceutical industry, the spread has passed more quietly than expected. However, it is pointed out that this experience has a negative effect on the current secondary spread. It is pointed out that there is no alertness as much as at that time because it became insensitive due to the experience at the time of the first spread. Mr. A's case is the only one. He complained that it certainly tends to be taken lighter than last March. Other salespeople will not be able to overcome the pressure and will be forced to go to work. And those who have nowhere to go will wander. This is because of the wrong judgment of very few managers who pursue only the small profits in front of them. The government is planning to inevitably upgrade to level 3 social distancing if the spreading does not subside. In this situation, dangerous gambling is unnecessary. It should be borne in mind that this re-proliferation situation was also caused by a very few wrong judgments. By all means, We hope that pharmaceutical companies do not rain on their parade.
- Opinion
- [Reporter’s Note] Why so cautious with all-comers drug?
- by Eo, Yun-Ho Aug 27, 2020 06:24am
- Within the pharmaceutical industry, a drug targeting ‘all-comers’ mean it is indicated to treat all patients in non-specific stages of disease. A drug proving treatment efficacy regardless of receptor or genetic mutation sound interesting and appealing. However, the South Korean government is still conservative on the all-comers drug to this date. In some ways, it seems obvious. A wide use of a drug means increase volume of the drug used, which could develop a whole financial issue. But there seems to be more than a financial issue why the government is taking a rather cautious stance, or the careful approach on the all-comers drug. Some say the government is skeptical about the efficacy. A poly ADP-ribose polymerase (PARP) inhibitor Zejular (niraparib) is currently indicated to treat patients with ovarian cancer, and it proved its treatment efficacy in all approved treatment lines regardless of the mutation in targeted BRCA gene. However, the proven efficacy actually shows different levels of efficacy. Zejula improved median progression-free survival (mPFS) by four times in gBRCA-mutated patients, and doubled it in patients without the mutation. And the efficacy gap between the Zejula group and the control group narrowed even more for gBRCA-mutated, homologous recombination deficiency (HRd)-negative patients. Surely, the medicine demonstrated the effect and received Ministry of Food and Drug Safety’s (MFDS) approval, while its levels of efficacy differ in various patient groups. As the mechanism of the medicine has a clearly targeted gene, the government is still limiting the healthcare reimbursement on the ‘BRCA mutation’ indication, although the treatment’s other indications have also proved the efficacy. The government’s stance is understandably cautious and taking more time would not necessarily be bad. Referring to precedents, however, taking more time did not mean better decision. A first immunotherapy to be indicated for all-comers in non-small cell lung cancer (NSCLC) was a PD-1 inhibitor Opdivo (nivolumab). Initially, all specialized doctors agreed ‘PD-L1 expression rate’ was a not a marker, but the government reserved the decision on all-comers coverage and listed the treatment in 2017 on limited indication. More talks followed after then, but the coverage standards remain the same to this date. Although being careful does not hurt, the government should also take patients’ treatment access into account and consider making a compromise. Only about 15 percent of epithelial ovarian cancer patients are known to have BRCA 1/2 mutation. In other words, about 85 percent of the patients do not have BRCA gene mutation. When even doctors are concerned of financial burden and opposing against expanding coverage on a health authority-approved drug, a pharmaceutical company’s reckless demand should not be accepted. But if there is a plausible compromise plan, shouldn’t the government be more open to the discussion?
- Opinion
- [Reporter's view] Strategies for Trial & error/the evolution
- by An, Kyung-Jin Aug 25, 2020 06:14am
- In August, there was a lot of good news in the pharmaceutical and bio industry. Hanmi and Yuhan, leading domestic pharmaceutical companies, announced the news of the signing of a global technology transfer contract for the new drug pipeline, revealing the potential of R&D. The license agreements of domestic companies are developing. Earlier this month, Hanmi transferred the global copyright of a new bio-drug to treat non-alcoholic steatohepatitis (NASH) to MSD in the US. The scale of technology transfer is about ₩1 trillion. The down payment without obligation to return is ₩10 million, and royalties based on sales after commercialization are separately received. There is another reason that the industry gives a special meaning to this technology transfer contract. This is because it is a pipeline (HM12525A) that was returned from Janssen just a year ago, a GLP-1-based dual agonist named Efinopegdutide. The development process of Efinopegdutide was not easy. In November 2015, Janssen signed a technology transfer contract worth $915 million for diabetes/obesity indications. But the recruitment of patients was temporarily suspended in November of the following year. The trial was restarted in June of the following year, but the rights were finally returned in July of last year. At the time of copyright return, Janssen said, "As a result of analyzing two phase II clinical trials of type II diabetes patients with severe obesity, the weight loss goal was met, but the blood sugar control effect did not meet the internal standards." It can be said that it has proven enough to cure obesity. Two clinical data released afterwards showed potential as a treatment for obesity. Subjects who received the test drug showed significant weight loss after 12 weeks, and secured an efficacy and safety profile comparable to that of the blockbuster obesity treatment 'Saxenda'. Kwon Se-chang, CEO of Hanmi Pharm, pointed to 'HM12525A' as a key task at the JP Morgan Healthcare Conference earlier this year, and declared that he would develop the world's first once-a-weekly administered obesity treatment drug. Hanmi Pharm's management succeeded in regaining trust in the labscovery platform technology by signing a new technology transfer contract one year after operating the GLP-1-based dual agent rehabilitation project. It is not the end that the technology has been returned, and it is an evaluation that it has proved its R&D efforts by signing a trillion unit contract with Big Pharma after 4 years. The implications can also be found in the contract between Yuhan and Processa last week. Yuhan has transferred the global copyright of the functional gastrointestinal disease treatment candidate 'YH12852' to Biotech Processa in the United States. The total contract size is about ₩487.2 billion, and the down payment without a return obligation is $2 million. The down payment is received in full from Processa, and $4.5 million worth of shares is included in the total amount of technology exports. It is a small-scale biotech with little known contract partner, and there is no immediate cash inflow effect. 'YH12852' is a candidate substance for a synthetic new drug developed by Yuhan. In 2013, Yuhan initiated a phase I clinical trial in Korea for healthy adults, confirmed the excellent effect of improving bowel movements, and conducted a phase II clinical trial on patients. However, it has been pending for nearly two years without obtaining satisfactory results. Processa is planning to enter phase II clinical trial by meeting with the US FDA early next year. It made a turning point by handing over the new drug pipeline, which had not progressed in development since 2018, It showed that it is necessary to use selection, focus, and efficient strategies when using R&D strategies. Korean pharmaceutical companies have experienced a lot of trial and error with a lot of expectations and bitter taste. Numerous trials and errors have led to the evolution of new drug technology export strategies. It is nice that domestic pharmaceutical bio companies started to pay attention to practical interests when signing global license agreements.
- Opinion
- [Reporter’s Note] Clinical trial info, do we have enough?
- by Lee, Tak-Sun Aug 21, 2020 06:26am
- South Korea’s Ministry of Food and Drug Safety (MFDS) has decided to provide wider scope of information regarding clinical trial approval process from October last year. And the ministry has been uploading elaborative details about the process on its official website. MFDS explained further disclosure of the information aims to expand treatment opportunity in rare disease patients and to protect to rights of clinical trial participants. Since then the website started publishing information necessary for participating in clinical trial, such as the name of participating institute, contact information and standards of participant selection and exemption. Basically, a patient or their guardian can use the provided information to directly contact the participating institute. The scope of disclosed information expanded, however, the speed of information update has gone down. Only a handful of clinical trials’ information is uploaded on the day of approval. Even worse, some information is posted days later. Such delay in information update is now hindering patients, guardians and investors interested in the company’s clinical trial from timely acquiring the information. The website is sluggish to upload the latest clinical trial information on the homepage, and the interested users have to dig through website to find the information. And even if the information is updated, the related companies usually limit the scope of disclosed information claiming confidentiality in the material. For example, the name of clinical drug substance is not properly disclosed or labeled with a tentatively given name. These confusing naming become useless information to patients or their guardians as they cannot be identified properly. In case the Korean government only shows a tentative name, the actual drug substance used can be found in the U.S. National Institutes of Health (NIH) official website, ClinicalTrials.gov. MFDS initially announced the scope of provided information would be on par with the NIH website. However, the Korean clinical trial website has too many omitted information. Especially, the information is exceptionally more limited for products developed by a Korean company. Surely, more specific clinical trial information is provided than before. But the current system is close to incomplete for the general public, participants and their guardians to confidently say the access to information has gotten better. If the information update delay is unavoidable, the website system should compartmentalize disclosed and undisclosed information to speed up the update. Also the standard of deciding undisclosed information should be clarified for the public. The current system is more likely to leave the people looking for interested information disappointed.
- Opinion
- [Reporter’s Note] Playing the fair game of NHI coverage
- by Kim, Jin-Gu Aug 20, 2020 06:23am
- In a sports game, a referee takes over the game from time to time. When the set rules are not applied fairly, the players would naturally dispute over the biased refereeing. Such is the case for South Korea’s Ministry of Health and Welfare (MOHW) regarding the National Health Insurance (NHI). Recently, MOHW convened a general meeting for the Health Insurance Policy Deliberation Committee (HIPDC) and ultimately decided to narrow the coverage on the controversial substance, choline alfoscerate. When the revised administrative notice is preannounced within this month, the coverage would only apply to dementia patients from September and patients with other diseases would have to pay for 80 percent of the expense. Although another big issue of clinical reevaluation is yet to come, the controversy over the proven efficacy of choline alfoscerate raised since the National Assembly audit last year has been concluded for now. Regardless of the pharmaceutical industry’s strong opposition, MOHW remains unmoved with the stance of ‘no evidence, no coverage.’ The point is not the reduced coverage on choline alfoscerate. MOHW’s stance of not granting healthcare benefit on pharmaceuticals and medical practice without sufficient evidence, according to the NHI principle, is surely agreeable. But the real point is what comes next—the government announced a pilot program for the Korean herbal medicine coverage. From coming October, NHI reimbursement would be provided in Korean herbal medicine prescribed for specifically treating three diseases—menstrual pain, facial paralysis and cerebrovascular disease aftereffect. Did the government forget about the reduced coverage on choline alfoscerate, all because of lack of sufficient evidence in efficacy? Why should the billions of taxpayer’s money go to cover herbal medicine that has not even confirmed its efficacy, let alone safety? Pharmaceutical companies strictly conduct clinical trials from Phase 1 through Phase 3 to prove the efficacy and safety of a drug in development. The cost is astronomical. But why is the government voluntarily offering evaluation on efficacy and safety of the herbal medicine during the pilot program? Was the Moon Care shooting for unfairness? Their stern stance on the principle seems contradictory, or even brazen. If a referee calling two balls thrown into the same strike zone a strike and a ball, the players’ trust in the referee would plummet. Untrustworthy referee’s existence itself becomes a contradiction. MOHW should take a look back at its game of NHI coverage system and see if they are playing a fair game as a referee.
- Opinion
- [Reporter’s view] The reality of dispensing separation
- by Jung, Heung-Jun Jul 21, 2020 06:10am
- COVID-19 caused a lot of concerns in the first half of this year in outpatient pharmacies and it was also a time for indirect evaluation, revealing the negative aspect of dispensing separation. Most pharmacies are complaining of deterioration in management due to COVID-19 , and the damage to pharmacies which receive many prescriptions is even worse. In particular, the pharmacies located in front of hospitals and the pharmacies on the same floor of clinics have economic damage and the business recovery is also unclear. Although its location was competitive, it suffered significant losses in COVID-19 crisis. Even during the period of supplying public masks, the sales volume of masks in pharmacies on the same floor as clinics was generally low, and as the prescription was reduced, it was not condition to focus on OTC sales. The situation is similar for pharmacies in front of the hospital. As a result, the high dependence on location and prescription became a negative factor. The hospital is forced to wait for normal operation as soon as possible, so the pharmacists are more frustrated. Sales of some pharmacies increased due to masks, disaster relief funds, and increased visits and OTC sales. It is not that pharmacies centered on OTC are better than prescriptions. If there is a crisis in the operation of a pharmacy optimized for division of labor, it is necessary to think about new ways of operating the pharmacy. It also means that it may be necessary to re-evaluate separation of prescribing and dispensing pharmaceuticals in its 20th year and present structural improvements. Someone may come up with a consultation-type pharmacy or drugstore. Others may be talking about the initiatives of health functional foods or quarantine products. Considering that COVID-19 aftermath is prolonged and that there is no guarantee that a second COVID-19 will not occur, it is not something unreal If the pharmacy's settlement in the first half started with COVID-19 and ended with public masks, In the second half of the rest, we should take time to find answers to the questions COVID-19 asked.
