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- 2026-06-10 21:10:46
- Opinion
- [Reporter’s View] Who’s to blame the new drug reimb delays
- by Eo, Yun-Ho Nov 15, 2024 05:49am
- Expedited approval of new drugs is one of the oldest issues in the pharmaceutical industry. Shortening the insurance reimbursement review period for drugs has been discussed almost every year, and in fact, the regulatory deadline is getting shorter and shorter. This is true for both the evaluation and negotiation stages of the Health Insurance Review and Assessment Service and the National Health Insurance Service. However, it is also true that the deadline is only a deadline set for the pharmaceutical company to apply and the authorities review the application, so it is not proving to be effective in expediting the reimbursement of new drugs. The responsibility lies on both sides. First of all, many pharmaceutical companies spend a considerable amount of time between the post-approval feedback process with their respective headquarters before actually applying for reimbursement - in other words, taking their time weighing up the gains and losses. During this process, the companies may delay the timing of reimbursement to receive a higher price or give up some indications due to competition from other products. Some companies deliberately delay drug price negotiations in anticipation of being included in the government's new coverage plan, while others cancel the introduction of a drug altogether because they believe it is not marketable in Korea. The “Korea-passing” decision, where the companies forego Korea and introduce the drug to other countries first, has become commonplace. In fact, at a recent press conference, HIRA said, “Regarding the time it takes to reimburse a new drug, although the evaluation is carried out within the statutory deadline, there is a difference in the actual time taken to the listing because the companies take a considerable amount of time to supplement their data, etc. In order to quickly register a new drug, the companies must first faithfully complete documents when applying for a decision.” However, the government's “let's complete discussions in the earlier stages and send the agenda to the Drug Reimbursement Committee” decision also plays a role. If you trace back the process of listing a drug that is long overdue for listing, there are certainly cases where the companies had voluntarily withdrawn their application after the Drug Reimbursement Standard Subcommittee decided to delay the review. However, there are many cases where such withdrawal is not “voluntary.” The deferral decision is very common during drug pricing negotiations between the NHIS and pharmaceutical companies. However, we need to remember that the 60-day deadline set for negotiations is a promise, and a deadline is a deadline. Also, the NHIS has referred to the negotiation deadline as a sort of "benefit" when announcing its plan to shorten the deadline for new drugs. The problem is that there is no transparency in the progress made in those 60 days. Nothing is disclosed on what happened to the drugs that exceeded the listing review deadlines. As a result, only the patients are left to suffer in endless await. No answer nor explanation on the direction of progress is provided to those who wait in dire need. This new year, all the stakeholders involved should make collaborative efforts to reduce the period to actual reimbursement listing.
- Opinion
- [Reporter's View] The reality of drug shortage reports
- by Lee, Hye-Kyung Nov 14, 2024 05:52am
- Reports of shortages of oxytocin, an injectable drug used primarily as a labor inducer, have caused confusion in the obstetrics and gynecology field. Most obstetrics and gynecology centers that have a large number of expectant mother visits stock enough oxytocin to last 2-3 weeks, but JW Pharmaceuticals, which holds more than 70% of the prescription market, has announced a shortage of its oxytocin supply that will last until January next year. In the case of childbirth, there is no reason for a sudden surge in a drug’s demand like infectious diseases or colds, but oxytocin is designated as a national essential medicine that must ensure a stable supply as it is used to induce labor in mothers. In Korea, only two companies, JW Pharmaceutical and Yuhan Corp, manufacture oxytocin drugs. Since it is a national essential medicine with a small number of manufacturers, it seemed natural that supply and demand management would be in place, but out of the blue, the clinics and hospitals were suddenly just told that “there was no medicine.” A small hospital in a rural area with a low birth rate would have ordered the medicine on a case-by-case basis rather than keep two to three weeks' worth on hand, so the news that it would soon be out of stock must have been like a bolt from the blue. The question that first came to mind was, why is there a national essential medicine system in place if it cannot manage the supply of essential drugs? When looking closer into the situation, the cause was clear: the system was not well established enough to ensure a stable supply of the necessary drugs. The discontinuation of the manufacture, import, and supply of finished drugs must be reported to the Ministry of Food and Drug Safety 60 days before the discontinuation date. However, as the criteria for reporting shortages are set differently in each company's SOP, and there is no absolute threshold set for determining drug shortages. In the case of oxytocin, the MFDS was able to identify the shortage only after looking into Yuhan Corp’s shortage report, a company that only accounts for about 30% of the oxytocin market share. On October 28, the company reported a shortage of oxytocin on the market, stating, “There is also supply disruption for Choongwae Oxytocin Inj.. which is approved with the same ingredient. With no substitute drug available containing the same ingredient, a supply shortage is expected for a period of time, but we will be able to ensure supply from November 14, 2024.” Up until this point, JW Pharmaceutical had not notified the MFDS of its shortage. The problem was that the MFDS was not informed, but the letter sent to obstetrics and gynecology clinics and wholesalers indicated that the drug would be “out of stock until January.” Even if the drug is designated as a national essential medicine, the KFDA cannot know about the shortage without a report from the pharmaceutical company. The MFDS began to investigate the situation when it learned about JW Pharmaceutical’s oxytocin shortage via Yuhan Corp’s supply shortage report. JW Pharmaceutical, which has a higher market share, was unable to manufacture finished drugs due to issues with the API, and the MFDS reportedly supported the necessary measures and moved up the manufacturing date from January next year to December this year. This situation seems to have occurred because the threshold for shortages was not specified. Each company had a different threshold set for sending “out of stock” reports to the MFDS. Yuhan Corp reported a shortage when it crossed its threshold of shipments this year, while JW Pharmaceuticals did not report a shortage until it was likely to run out on site. It's not easy for the MFDS to keep track of the shortages of more than 500 national essential medicines every day. Unless the ministry receives a proper report, they cannot provide the necessary support, but if the product becomes out of stock even before the ministry can consider support, there is no opportunity for the authorities to take action. As a result, no medicine is available on site, with the government ending up taking countermeasures after the damage is made. Last year, the Ministry of Food and Drug Safety revised the Ordinance of the Prime Minister to pull forward the drug shortage report from 60 days to 180 days, with implementation scheduled for April next year. However, if the regulation is revised without a baseline for reporting not established, cases like oxytocin will only repeat itself. We need a system to address stockouts before there is “no medicine” on site.
- Opinion
- [Reporter's View] voluntary resignation with compensation
- by Lee, Seok-Jun Nov 13, 2024 05:54am
- As the year-end is nearing, several pharmaceutical companies are considering restructuring. Rumor has it that these companies may have plans for reducing OTC businesses and laying off staff who are age 55 or older. It remains uncertain whether it is a rumor or an actual plan, but restructuring could be possible. Over five pharmaceutical companies that were mentioned. There is a solid reason companies have chosen restructuring. It is for business efficiency. Restructuring could be an enormous benefit if laying off results in efficiency within the company. It is an approach of 'selection and focus,' losing a few if taking all is not an option. Voluntary resignation is frequently used as a method of job cuts. It is implemented to reduce the number of employees at once. It is the same as layoffs in business. However, companies utilize the voluntary resignation program instead of layoffs because layoff requirements are selective according to the Labor Standards Act and may result in conflicts and management. Korean pharmaceutical companies employ a similar method. Voluntary resignation is less frequent than that of the multinational companies, but the Korean companies have used it more often recently. At the end of last year, Korean mega-pharmaceutical companies, Ildong Pharmaceutical and GC Biopharma, conducted voluntary resignations. Likewise, Korean pharmaceutical companies are favor voluntary resignation when reducing the number of employees. Then, what is the next important step? We must consider compensation for those who are subjected to restructuring. Pharmaceutical companies' goal for restructuring is to reduce the number of employees. However, it would be better to achieve such a goal by offering a good compensation package. If restructuring is inevitable, a win-win structure must be set. Although companies may have to spend a large sum of money at once, they may have to sacrifice considering the cost-effective outcomes in a few years following restructuring. Yet, a compensation criterion has not been established for voluntary resignation. Compensation criterion vastly differs by company. Direct comparison may be difficult, but the criterion in Korean companies is different from the (consecutive years of service*2)+ N months in multinational companies. Few companies urge voluntary resignation without compensation. Companies will continue to undergo restructuring. Then, it will be necessary for Korean companies to establish a compensation criterion for voluntary resignations. Precedence will serve as a standard for those who follow. If leading restructuring companies set low compensation, latecomers will also set low standards. The situation in small and medium-sized companies will be much worse, causeing a vicious cycle. Now, an agreement between Korean companies for voluntary resignation compensation may be necessary. Better compensation will lessen the backlash from restructuring.
- Opinion
- [Reporter's View] Patience is required to foster K-Bios
- by Whang, byung-woo Nov 12, 2024 05:51am
- The performance of the domestic pharmaceutical bio industry is being evaluated with the approaching end of 2024. This year, the increased influence of domestic companies in the fields of biosimilars and CDMOs (contract development and manufacturing) and the technology transfer performance of bio ventures have been positively evaluated. However, there is also a view that the investment in venture firms has slowed down due to the overall stringent investment market and that the government's plans to foster the bio-industry are still fragmented across ministries. This is why the outlook for the domestic bio industry next year is also a mix of concerns and expectations. First of all, the biggest change is the launch of the National Bio Committee, chaired by the president. Although the Bio Health Innovation Committee under the Prime Minister was created last year, the industry has been emphasizing the need for a control tower to comprehensively manage the bio sector, so there are high expectations for the establishment of the top-level national bio policy deliberation body. While there are doubts over to what extent the National Bio Committee will be able to play its role, it is a timely creation as it will be able to address the larger discourse. In addition, the Korean version of ARPA-H, which will begin to kick off next year with the selection of companies, is also a positive bonus for the bio industry. It is also encouraging for the industry as the program is benchmarked after ARPA-H in the US and considers 'process over outcome'. In addition, the expected benefits for the bio industry from the election of Republican candidate Trump as president of the United States are also considered an opportunity for K-Bio to seize. During his candidacy, Trump considered lowering drug prices for new drugs and biosimilars to reduce the burden of medical expenses, and plans is open up the closed domestic market to overseas companies and induce competition. Korean companies will be forced to compete in the global market, but another way of looking at it is that the door will become open to all. Despite this good news, the industry is still arguing that it needs 'time' to foster the industry. While there are domestic pharma and biotech companies that are performing well overseas, it is strictly limited to a few companies. Another limitation is that the government's efforts, such as the National Bio Committee and the Korean ARPA-H project, are still in their early stages. In fact, there is no guarantee that things will go as expected, just as the government's ambitious K-Bio-Vaccine Fund investment project is struggling to raise funds due to low expectations. Government interest is like a double-edged sword. They want to see quick results for their support. For this reason, the industry is emphasizing the creation of an ecosystem rather than a near-sighted view to foster the industry. This is also a challenge for governments, who need to show results, as building ecosystems is vague and hard to visualize. However, relying on a few companies to produce tangible results may not be enough to foster the growth of the entire bio industry. Just as a deeply rooted tree on a solid foundation is not easily shaken, deep consideration of the ecosystem is necessary to establish the bio industry as Korea’s core national strategic business.
- Opinion
- [Reporter's View] Regarding the obesity drug craze
- by Son, Hyung Min Nov 08, 2024 05:46am
- There is one research and development item that is gaining explosive popularity among both global and domestic pharmaceutical companies –obesity treatment. The use of obesity drugs has also increased dramatically with the significant rise in the number of obese people around the world. Global sales of obesity drugs reached USD 6.68 billion (about KRW 9 trillion) last year, up 145.6% from USD 2.72 billion in 2022. In particular, the success of glucagon-like peptide (GLP-1) receptor agonist obesity drugs such as Saxenda, Wegovy, and Zepbound has attracted the attention of domestic and foreign pharmaceutical companies to GLP-1 drug candidates. Saxenda posted sales of KRW 1.225 trillion last year, up 9.8% YoY. Wegovy’s sales surpassed KRW 300 billion last year despite facing supply difficulties. GLP-1 was originally developed as a diabetes treatment. However, GLP-1 drugs took a major turn when Novo Nordisk's liraglutide and semaglutide showed effect in weight loss. During clinical trials of its antidiabetic drug liraglutide (trade name Victoza), Novo Nordisk noticed a weight loss effect among its enrollees. Based on the findings, the company changed the dose of liraglutide and developed Saxenda, a GLP-1 drug for obesity. The company used the same mechanism to develop Wegovy with semaglutide (Ozempic). Both Saxenda and Wegovy are now in the global market, and their non-reimbursement prices have surged with their increasing popularity. The problem is that the promise of effective weight loss through simple injections has led to increased use for cosmetic and dieting purposes. There has been a significant increase in prescriptions for weight loss in people who are not overweight and obese or chronically ill. The popularity of dietary supplements with unproven efficacy and side effects is also on the rise. However, manufacturers only highlight the weight-loss benefits of GLP-1 drugs and neglect to warn consumers about their side effects. GLP-1 receptor agonists are associated with various side effects. Side effects of GLP-1 class drugs include muscle loss, acute kidney disease, nausea, vomiting, and diarrhea. In the United States, a recent case of acute pancreatitis was reported as a side effect of an anti-obesity drug, resulting in death. Unlike diabetes, obesity is not classified as a disease and is therefore treated without reimbursement benefits. Although it is classified as a risk factor for various metabolic diseases, such as dyslipidemia and hypertension, it is not regarded as a condition that requires medication. The first treatment recommended for obese patients who visit an endocrinologist is lifestyle modification. If the weight remains uncontrolled after lifestyle modification, doctors will consider using a medication, but they are cautious about doing so because of the side effects that come with it, including rebound weight gain. While the overprescription of obesity drugs for cosmetic purposes is a serious problem, the lack of information on its side effects seems to be a major contributor to the misuse and abuse of obesity drugs. The role of the pharmaceutical industry, which has developed and is developing obesity drugs, is also important. While it is necessary to publicize how much weight loss is achieved with the use of each drug, it is also time for the public to be fully informed about their side effects. “Miracle drugs” that can dramatically reduce weight are not free from side effects.
- Opinion
- [Reporter's View] Address Actions to drug substitution
- by Lee, Jeong-Hwan Nov 01, 2024 05:51am
- "We will foremostly activate drug substation to resolve the drug shortages issue," Cho Kyoo-hong, Minister of Health and Welfare (MOHW), promised during the parliamentary audit session commenced by the National Assembly's Small Committee for Health and Welfare. This is an answer from the MOHW director to an issue of essential medicines frequently in shortage, leading to chaos in pharmacies and lower patient access to medications. The issue has been unresolved for several years. Rep. Seo Youngseok and Rep. Nam In-soon of the Democratic Party of Korea have requested the implementation of active ingredient prescriptions for cold medicines and essential medicines to resolve the issue of frequent drug shortages. Minister Cho repeatedly answered that he would improve the current situation by enabling drug substitution rather than active ingredient prescription, as the latter requires agreements between officials. According to Minister Cho, activating drug substitution beyond the current 'lower-cost drug substitution incentive' policy by the Health and Welfare Committee requires specific administrative actions, policy establishment, and implementation. In other words, their plan cannot be attained by the way MOHW said to actively participate in the legislative session to review the National Assembly submitted bill for simplifying drug substitution procedure. Passing the plenary session of the National Assembly for the bill for implementation of drug substitution that has been submitted to the National Assembly would take several months after undergoing the legislative process. It has not been considered for the Legislation and Judiciary Small Committee for Health and Welfare. During the legislative procedure, it is unknown whether the bill would face opposite opinions, overcome oppositions, and pass all legislative hurdles. During the parliamentary audit, the MOHW answered a question about the restricted implementation of active ingredient prescriptions for cold medicines by stating, "It is the terms of the medical reform agreement. Therefore, the issue requires societal discussion and a procedural agreement." Then, the MOHW must consider detailed and active administration to implement drug substitution to resolve frequent drug shortages of cold medicines and pediatric medicines. In particular, lower-cost drug substitution must be increased because the government provides incentives to strengthen the stability of the National Health Insurance finance. According to the Health Insurance Review and Assessment Service (HIRA), the incentive for drug substitution increased temporarily during the COVID-19 pandemic. After the announcement of 'With COVID-19," it returned to that of pre-COVID-19. It shows that drug substitution policy has been conservative and passive unless drug substitution is inevitable, such as during the pandemic period. Not only during this audit but also during the previous parliamentary audit, the MOHW had agreed to the necessity of supporting drug substitution and increasing the incentive rate for lower-cost drug substitution. However, the concern is that they have not suggested a concrete method to specifically address when and how drug substitution can be actively implemented. As Minister Cho promised during the parliamentary audit that he would actively implement drug substitution to resolve the drug shortages, the MOHW must provide incentives and establish an administrative policy so that pharmacies can dispense drug substitution for drug shortages without hesitation. We must not passively wait for the legislative procedure after agreeing to the bill to simplify drug substitution, which is to be reviewed by the National Assembly. Aside from passing the bill to the National Assembly, we hope to hear about MOHW's updated policy to support drug substitution in resolving the drug shortage issue by actively implementing it.
- Opinion
- [Reporter's View] Super precision medicine
- by Eo, Yun-Ho Oct 30, 2024 05:53am
- Super Precision medicine. New drugs have been developed to selectively target with more significant efficacy than before. Lately, news articles related to anticancer agents have frequently covered keywords related to genetic mutations, including MET, RET, ALK, EGFR, and ROS1. Customized treatments are becoming available, where effective treatments can be provided depending on the patient's particular genetic mutations. Pharmaceuticals targeting HER2, ALK, and EGFR have been developed, and they show superior effects in patients with particular conditions. Lately, pharmaceuticals have been developed selectively targeting difficult-to-develop gene mutations, such as ROS, NTRK, and RET. Such development of super precision medicines suggests that prescription criteria will likely change from 'disease' to 'genes'. A customizable healthcare era has arrived. However, it is still unfamiliar. Will the South Korea successfully incorporate these drugs that show efficacy regardless of cancer type once gene mutations in patients are confirmed? Previously listed targeted anticancer drugs and immune checkpoint inhibitors have faced difficulties in expanding reimbursement. One such difficulty is the high costs. However, when a drug's new use is discovered, the values and the volume of usage must be re-assessed. The process is required by the National Health Insurance system in South Korea. However, recently developed new drugs target very few patients; in other words, the number of identified gene mutations cases is few. This means that not many patients are likely to be prescribed for these new drugs. In South Korea, patients with rare diseases comprise below 1% of overall solid cancer cases. Less than 200 patients are diagnosed. Experts explain that these types of patients do not respond well to standard therapies (conventional drugs). The problem is reimbursement. Anticancer agents targeting gene mutations mentioned earlier have already been approved domestically. However, most of these drugs are still non-reimbursable. Pharmaceutical companies have continued to apply for coverage, but their attempts 'failed.' It is time to consider a reimbursement track for super precision medicine. Rather than going against the current system, we must establish different reimbursement review criteria for drugs that can be used in patients regardless of their cancer types.
- Opinion
- [Reporter’s View] Deadlines are set for a reason
- by Eo, Yun-Ho Oct 17, 2024 05:51am
- The definition of ‘deadline’ is a time limit set in advance. So what is the right thing to do if the deadline has ended without a conclusion being made? Providing a justifiable explanation is very important in administrative affairs. Explanations are necessary not only in the course of introducing or abolishing a system, but also when exceptions occur in the process of applying regulations. However, no explanation has been given when the drug price negotiation term between the NHIS and pharmaceutical companies have been extended beyond the deadline. The parties involved point to the ‘confidentiality clause’ as the reason for the lack of explanation. They do not disclose whether the negotiations will be extended or terminated. This is despite the fact that more and more drugs are entering into extended negotiations beyond the deadline. In the era of the so-called “high-priced” drugs, so many good but high-priced drugs are being released, therefore, it may be difficult for the government and pharmaceutical companies to reach an agreement within the 60-day deadline. But a deadline is a promise. Moreover, the deadline was offered as a ‘benefit’ by the government, as it has announced a plan to shorten the review deadline for homegrown new drugs. The reduced deadline was a device that limits the final negotiation period and speeds up the approval process while providing a sense of timing for the companies. However, the responsibility lies with both sides. At some point, the prolongation in negotiations becomes pervasive, and the sense that an expensive and difficult medicine can't be finished in a single term, as well as the lack of a mindset of delivering results on time, has been leading to the repetition of exceptional cases. If discussions have become difficult, the conditions for initiating the negotiations should be strengthened. The NHIS should receive strong pressure to discuss in advance the necessary documents for pharmaceutical companies to prepare at the Health Insurance Review & Assessment Service stage before the start of negotiations and to complete them within the deadline. In the end, the patient is left to wait. Patients who hear that drug price negotiations are left to just wait without promise. After 3-4 months of await, no news is heard of the drug’s reimbursement. Even when the patient calls the government and pharmaceutical companies, the only response he or she can get is that “They cannot comment on the matter.” It is understandable that the HIRA stage, which evaluates the adequacy of a drug’s reimbursement based on clinical efficacy and cost-effectiveness, and the drug price negotiation stage, which is directly related to the “financial condition” of the parties involved, can be more sensitive phases for governments and pharmaceutical companies. But one has to wonder how long the ‘confidential’ clause can be seen as a just reason. Times have changed. Patients and their families will no longer stand on the sidelines.
- Opinion
- [Reporter's view] Expanding NIP to include 9-vHPV
- by Whang, byung-woo Oct 16, 2024 05:50am
- Several treatment-related agenda items were discussed during this year's parliamentary audit of the Ministry of Health and Welfare (MOHW). Various current measures, including improvements to the drug pricing system and blood cancers, have been discussed. One is the necessity of including human immunodeficiency virus (hereafter referred to as, HPV) in the National Immunization Program (NIP). Several argued that Gardasil 9, an HPV9 included in the government's plan, should be included in the NIP. Since 2016, the nationwide HPV vaccination has been provided to girls aged at least 12. Then, since 2022, it has been expanded to include female·juveniles of 12-17 years of age, and low-income females aged at least 18-26. 2-valent‧4-valent vaccines have been included in the program, whereas 9-valent vaccine is not supported. The current issue is whether to expand the vaccination program to male juveniles. During last year's parliamentary audit, Rep. Nam In-soon of the Democratic Party of Korea requested an expanded scope of the NIP for HPV vaccines based on 'The current record of patients undergoing treatments for head and neck cancer or oropharyngeal cancer.' Rep. Suh Myung-ok, a member of the People Power Party, has presented a 'Legislative bill for partial revision of the prevention and management of infectious diseases.' The question of whether the shingles vaccine Shingrix would be included in the NIP program has drawn attention again. The remaining issue is the cost. On average, the cost of a 1-dose vaccination for Gardasil 9 and Shingrix is about KRW 200,000, thereby referred to as 'Premium vaccines.' The majority of opinions is that the problems of cost-effectiveness, regardless of the benefits brought by vaccines, hinder the government's plan to pursue this policy. However, other opinions suggest a different view towards including premium vaccines in the NIP may be necessary. This means that, beyond the cost issue, people need to consider the effects comprehensively since the preventative effects of these vaccines are proven. An effective distribution of funds may be considered because vaccinations for Shingrix have already been supported by local governments, irrespective of the current discussions within the Korea Disease Control and Prevention Agency (KDCA). Kim Yea-ji, a member of the Health and Welfare Committee (People Power Party), and Rep. Nam have emphasized that the inclusion of vaccines, such as Gardasil 9, in the program could reduce people's medical costs in the long term. However, cost-related issues remain a burden on the government, as the Korea Disease Control and Prevention Agency (KDCA)'s budget for the NIP program next year has been markedly reduced. Pharmaceutical companies may need to voice their opinions during discussions about future implementation. Considering the nature of NIP vaccines, a 'good value' approach is inevitable. Vaccines are continuously being developed, and their preventative effects are increasing. Although premium vaccines present a dilemma for NIP inclusion, changes to repeating discussions are demanding. We anticipate the government's varied approaches and discussions.
- Opinion
- [Reporter's view] Creating a virtuous cycle for K-bio growth
- by Son, Hyung Min Oct 11, 2024 05:54am
- The research and development (R&D) trend in the biopharmaceutical industry is focusing on new anticancer drugs. The field is gaining interest, especially following the clinical success of Yuhan Corp's Leclaza (ingredient: Lazertinib) and HLB's rivoceranib. In particular, most biotech companies in South Korea are confirming the clinical potential of drugs in combination with Keytruda. Keytruda is an immune checkpoint inhibitor developed by MSD and a successful blockbuster medicine with over 30 indications in South Korea alone. Keytruda's global sales this year are expected to amount to KRW 3.5 billion. Almost all biotech companies in South Korea aim to out-license their technologies to MSD through clinical trials of combination therapy with Keytruda. A combination therapy involving medicine with proven effects is highly likely to be commercialized. However, R&D in the Korean industry seems to be focusing only on anticancer drugs for the purpose of out-licensing them to a big global pharmaceutical company. To date, several biopharmaceutical companies in South Korea are reporting confirmation of the efficacy of their drugs in combination with Keytruda through preclinical trials or early-stage clinical trials. However, there have been no reports of entering late-stage clinical trials, thereby nearing commercialization, or of outstanding out-licensing. In addition to Keytruda, the next target of the biopharmaceutical industry in South Korea is Enhertu. A second-generation antibody-drug conjugate, Enhertu (ingredient: trastuzumab deruxtecan), has demonstrated efficacy and is effective for breast cancer, gastric cancer, non-small cell lung cancer, and colorectal cancer. The biopharmaceutical industry in South Korea is exploring the market for ADC anticancer drugs. Even the long-standing pharmaceutical companies and the biotech industry have shown interest in ADC development. Several companies have already begun clinical trials involving combination therapy with Enhertu. It is common for Korean companies to pursue out-licensing as it allows them to secure funds for investments in other pipelines through out-licensing and provides opportunity to discover new drugs. However, if the industry continues to chase after blockbuster new anticancer drugs, it will lead to a difficult system to develop new innovative drugs domestically. Consequently, companies must explore new fields besides anticancer drugs. Instead of pursuing a partner in a combination therapy involving a well-selling drug, they should explore a field with unmet needs to create various out-licensing opportunities. The R&D costs in the biopharmaceutical industry in South Korea are incomparably smaller than those of global pharmaceutical companies. A stable source of funds is essential to sustain a virtuous cycle. Running a company by continuously developing competitive new drug candidates and successfully out-licensing is almost impossible. As a result, it is important to have experience collaborating with other companies to secure Korean and Asian rights when discussing out-licensing agreements with a global pharmaceutical company. Pharmaceutical companies can only sustain stable earnings through selling drugs. The biopharmaceutical industry is one of the industries with a large gap between Korean and global companies. The biopharmaceutical industry cannot benefit from good deals because it cannot produce good products and sell them cheaply. Now, the biopharmaceutical industry in South Korea must consider challenging various fields and creating a system to profit from selling new drugs. Clinical trials involving combination therapy containing new drugs are already supersaturated.
