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- 2026-03-10 08:28:03
- Opinion
- [Reporter’s View] COVID-19 trials still in smooth progress?
- by Kim, Jin-Gu Jul 08, 2022 06:25am
- COVID-19 developers have been announcing that they will discontinue their clinical trials one after another. In just 10 days, Celltrion, Chong Kun Dang, and CrystalGenomics publicly announced that they will discontinue their COVID-19 clinical trials. When counting from January, the number increases to 5 with Genexine and HK Inno.N. The news of the discontinuation was received with the response that it was as expected. However, there is no reason for the companies to be criticized for discontinuing their clinical trials. Strictly speaking, only 10% of the drugs succeed in receiving final approval for their treatment or vaccine after initiating clinical trials. Rather, the companies can be regarded as being ‘honest,’ as they announced the discontinuation officially to their investors. If no official announcement is made on the discontinuation, there is no way for outsiders to know the progress made within a company. Even if a pharmaceutical company internally decides to abandon development, they can pretend that the trial is still ‘well in progress’ externally by not officially getting rid of their trials. There have been many cases where development has been silently scrapped this way. Pharmaceutical companies would sneakily announce their trial discontinuation after investors’ interest wanes. The same goes for COVID-19 trials. When pharmaceutical companies first rushed in to start clinical trials for COVID-19 treatments two years ago, there was skepticism on whether those were a ruse to ‘raise stock price.’ With this skepticism unresolved, many trials are still ‘well in progress.’ From the investor’s perspective, they can never know how many companies have been ‘serious’ in conducting their clinical trials. The Ministry of Food and Drug Safety discloses the progress of clinical trials as ▲ Completed ▲Recruiting ▲Completed Recruitment or ▲Terminated, but it is impossible to confirm how many patients were recruited after trial approval. In other words, there is no way to know how actively the company is recruiting patients for its trials. The clinical trial registry ClinicalTrials.gov operated by the US National Institutes of Health (NIH) offers a more detailed view on the progress of its clinical trials. The progress is categorized as ▲Not yet recruiting ▲Recruiting ▲Active, not recruiting)▲Suspended ▲Terminated ▲Completed ▲Withdrawn ▲Unknown. In particular, the ‘Active, not recruiting’ category deserves attention. This means the study has started, but its potential subjects have not been recruited or registered yet. It indirectly shows the company's degree of engagement in conducting its clinical trials. Starting next year, the Ministry of Food and Drug Safety plans to publicly disclose the results of the factual survey that was conducted to secure the transparency and reliability of clinical trials. However, the disclosed contents will not contain the progress made by each clinical trial. Therefore, referring to the US cases to secure transparency and trust in domestic clinical trials may also be a viable option.
- Opinion
- [Reporter's view] Revlimid passed the committee
- by Eo, Yun-Ho Jul 06, 2022 05:47am
- It is the first step forward in about four years. The maintenance therapy of the multiple myeloma treatment Revlimid has finally passed the Cancer Disease Review Committee. Maintenance therapy of Revlimid was approved in Korea in June 2018 and an application for expansion of insurance benefits was made in the same year. Since 2019, BMS has actively carried out the registration process, but there has been no progress in discussion. Revlimid was submitted to the Cancer Disease Review Committee, which attracted attention in September 2019, June 2020, and September last year due to the introduction of the CAR-T treatment Kymriah, but it failed. This is very surprising. If a patient who has already experienced cancer has this option, it will be clear. Revlimid proposed such an alternative for the first time in Multiple Myeloma (MM), a type of blood cancer with a recurrence rate of 70-80%. The NCCN in the United States recommends Maintenance therapy of Revlimid as the highest level of preferred treatment in both transplantable and impossible patients, and ESMO guidelines also recommend it as the only maintenance therapy after autologous hematopoietic stem cell transplantation. It seems to have been seen differently from the perspective of the health authorities. It is an attractive option for patients, but from the government's point of view, there was a concern about distributing insurance finances to drugs taken as a kind of prevention for patients with improved disease. It is also necessary to consider the situation in which the patient continues to remain stable without recurrence after the start of maintenance therapy. BMS is known to have proposed conditions for sharing the government's financial burden on such an unpredictable period of administration. However, it has only just begun, and the hurdles still remain. It is unclear how the drug price negotiations with the Drug Benefit Assessment Committee and the NHIS will evaluate maintenance therapy of Revlimid. Negotiations are about to begin. Rather than necessarily having to produce a result, both pharmaceutical companies and the government hope to present an alternative that involves no regret. Patients who have waited for four years and not a short time are also watching.
- Opinion
- [Reporter's view] Looking forward to another K-COVID vaccine
- by Lee, Hye-Kyung Jul 04, 2022 05:55am
- A pure domestic COVID-19 Vaccine No. 1, which was conducted by a domestic pharmaceutical company in charge of the entire process from development to production of raw materials and finished products, was released. The MFDS approved SK Bioscience's SKY Covione on the 29th. It took 549 days (1 year and 6 months) from approval of the initial clinical trial to approval of the item. SKY Covione was developed as GBP510 in May 2020 conduct non-clinical tests with the support of the Gates Foundation On December 31 of that year, phase 1 was obtained from the MFDS. Phase 3 approval, the final stage of the clinical trial, took place on August 10 last year, and it was the first time that a COVID-19 vaccine developed by a domestic company entered phase 3, and a comparative clinical method that proved its effectiveness compared to an already approved vaccine became the second in the world. Analysts say that the reason why the launch of K- COVID-19 vaccine No. 1 was moved forward has also had a significant impact on comparative clinical trials. The background of the comparative clinical design was the support of the MFDS. The MFDS operated a clinical support consultative body and supported companies to design and perform clinical trials without trial and error. It is rumored that SKY Covione chose a comparative clinical method that compares immunogenicity with AstraZeneca's Vaxzevria thanks to the design support of the MFDS. This is because it was difficult to perform clinical trials to see how much placebo and test drugs prevent the outbreak of COVID-19 at a time when most people were vaccinated during phase 3 of SKY Covione. The MFDS is operating our vaccine project to actively support the entire vaccine process from research and development of domestic vaccines to permission, and on April 25, a productization strategy support group was launched to systematically support all stages from development of public health crisis, new and new drugs, innovative medical devices, and rare drugs. Currently, EuBiologics' EuCorVac has entered phase 3 clinical trials after SKY Covione. ST Pharm, Cellid, and Quratis are in phase 1, and EyeGene and Geneone are in phase 1/2a. We hope that these companies will also be able to be approved as the second and third COVID-19 K vaccines through cooperation with the MFDS.
- Opinion
- [Reporter's view] Negotiation of Zolgensma
- by Jun 30, 2022 05:52am
- Attention is focused on negotiating the drug price of Zolgensma, a one-shot treatment and the most expensive drug in Korea. Conflicts are in full swing between the government to set the lowest price and pharmaceutical companies to be recognized as much as possible for new drugs. Zolgensma is a gene therapy approved in May last year. It is used for a severe and rare disease called SMA. This disease is causing muscles to gradually shrink. Based on the most serious type of SMN type 1, motor neurons are damaged more than 95% within six months of microtreatment, and 90% die before the age of two. Prior to Zolgensma, there were treatments for spinal muscular atrophy such as Spinraza and Evrysdi, but Zolgensma is special for patients. This is because unlike other treatments that require continuous medication, Zolgensma can fundamentally treat the disease with one dose. While existing treatments are involved in backup genes to increase SMN protein production, Zolgensma functionally replaces the deficient SMN1 gene so that protein can continue to be produced in one shot. The issue is the price of medicine. In the United States, the cost of administering Zolgensma amounts to about 2.5 billion won. Even in countries with low prices of Zolgensma, it is generally about1.9 billion won. There have been several drugs worth hundreds of millions of won so far, but Zolgensma is the first drug to exceed 2 billion won. Since Zolgensma is a single administration, the overall cost may be similar to other drugs that are multiple administrations. As ultra-high-priced drugs that need to be administered multiple times will continue to appear, it was time for the government to consider a new drug price model to be applied to ultra-high-priced drugs. As various discussions continued, Zolgensma was submitted to the HIRA about a year after applying for benefits through the patent linkage system and was recognized for its appropriateness. Earlier this month, it entered the drug price negotiation stage. The NHIS and Novartis Korea will hold two months of Zolgensma price negotiations until the 25th of next month. The government wants to set the price at the lowest level among major OECD countries. The standard that the government has in mind is known to be lower than 1.9 billion won in Japan. Pharmaceutical companies want to be recognized for the value of new drugs as much as possible. If negotiations are slow, it is the patients who are frustrated. Earlier this year, parents of SMA patients delivered their opinions to the National Assembly calling for Zolgensma. A parent who attended the meeting said, "My child has no muscles all over his body and can't eat anything with his mouth, so he lives on an oxygen respirator. Getting Zolgensma is only a hope. The longer the discussion, the more my child misses the golden time," he appealed. There are some people anxiously waiting for Zolgensma, which can be expected to be cured once administered. I hope that the two sides will not take the drug price negotiation extension for granted by only putting forward each other's positions, but will be determined to complete the negotiations within the deadline from the patient's point of view. After all, doesn't both the system and the new drug exist for patients?
- Opinion
- [Reporter's view] Only 2% of patients
- by Eo, Yun-Ho Jun 23, 2022 05:50am
- #Will the new EGFR Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer treatment, which was useless for existing TKI, be able to receive insurance benefits? It's all the same cancer, but it's different. Cancer species such as liver cancer, stomach cancer, and lung cancer, which we call, are only a simple category, and in fact, they are classified in detail. Even if tumors originate from the same organ, the difficulty of treatment varies according to this detailed classification and the number of patients also varies. For example, EGFR Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer is so rare that only 2% of EGFR mutated non-small cell lung cancer patients in Korea are identified. Until now, there has been no suitable treatment for the treatment of this disease, and the NCCN guidelines have also recommended platinum-based anticancer therapy. Even this is subject to reduction in Korea. Lung cancer is not a rare disease, but EGFR Exon 20 Insertion–Mutated Non–Small-Cell Lung Cancer can be a rare cancer. EGFR Exon 20 Insertion–Mutated Non–Small-Cell Lung Cancer has a 75% higher risk of death compared to common EGFR mutated non-small cell lung cancer, a 5-year survival rate of 8% and patient life expectancy of less than 2 years. In this situation, the anticancer drug Rybrevant, which targets EGFR Exon 20 Insertion-Mutation, will be submitted to the HIRA Cancer Disease Review Committee on the 29th to register insurance benefits. This drug, well known as Leclaza's combination therapy partner, was approved in Korea in February this year as the first targeted treatment for EGFR Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer treatment. Rybrevant confirmed the overall response rate (ORR) of 40% through a CHRYSALIS clinical study, with 4% of patients achieving CR and 36% achieving PR. In recognition of its value as a treatment for rare carcinomas, it was quickly approved by the U.S. FDA in May last year with only the results of phase 1 clinical trials, and was designated as a subject for rapid review in Korea before obtaining permission. The question is whether or not value is recognized in the benefit evaluation. As it is a drug licensed as a single-Arm clinical data without a control group, the key is whether the value of Rybrevant, which should take the PE system, can be recognized as rare cancer, not just lung cancer. The new government, which was launched last month, promised to promote a rapid registration system for anticancer drugs and treatments for severe rare diseases without alternative drugs. It remains to be seen whether the speed of registration of rare disease and rare cancer drugs in Korea can be improved in the future.
- Opinion
- [Reporter's view]Will arbitrary manufacturing be eradicated?
- by Kim, Jin-Gu Jun 08, 2022 05:56am
- A revision to the Pharmaceutical Affairs Act, which allows the imposition of "punitive fines" on pharmaceutical companies that violate GMPs, passed the National Assembly. It also included canceling the judgment of suitability for the GMP if a violation is found, and allowing a prison term of up to five years or a fine of up to 50 million won, apart from the fine. It contains the will of the MFDS that there is no longer tolerance for deceiving the authorities of permission by false or fraudulent means. What is noteworthy in the revised Pharmaceutical Affairs Act is that a 'GMP exclusive investigator' was appointed. In order to increase the administrative efficiency of GMP investigation and evaluation work, GMP manufacturing and quality control investigators were appointed and pharmaceutical manufacturers were allowed to enter and investigate. It is interpreted that the GMP Special Planning and Inspection Team, which was temporarily operated after a series of GMP violations were detected last year, will be changed to a regular operating system. There has been a role in managing and supervising pharmaceutical companies' compliance with GMP. Article 36 of the current Pharmaceutical Affairs Act designates a "Manufacturing Manager" and manages and supervises the overall drug manufacturing work. But it's actually a private law. Many manufacturing managers have long acquiesced in the evil practice of the name. There are also many expedient ways to fill out related documents in double and then take a new pharmacist to sign them. Manufacturing managers were unable to make a proper opinion from the standpoint of receiving a salary from the company. Pharmaceutical companies forced them to be loyal, and the Ministry of Food and Drug Safety remained unaware. It means that there is no role in managing and supervising drug manufacturing, so GMP violations have not continued. It's just that the law hasn't been used properly. The MFDS has steadily detected GMP violations through the pharmacist monitoring system. According to data released at last year's parliamentary audit, the MFDS conducted 1,277 pharmacist monitoring (regular monitoring + special monitoring) for 5 years and 9 months from 2016 to September 2021. In the process, 485 violations of 189 companies were detected. It means that four (38%) of the pharmacist monitoring were caught 10 times. The problem is that 118 companies have been caught twice or more. There were 45 companies caught more than four times, and two companies were caught more than 10 times. This means that there was no appropriate follow-up by the MFDS even after detecting GMP violations. The main point of the new system is to strengthen surveillance and punishment. The plan is to strengthen surveillance through GMP investigators and impose strong penalties on companies caught to prevent recurrence. Strengthening surveillance and punishment in the new system require appropriate interaction. The focus should not only be on detecting GMP violations. Without proper follow-up measures to prevent recurrence, it is meaningless even if the number of GMP violations is doubled or tripled.
- Opinion
- [Reporter’s View] Differing indication and reimb standards
- by Eo, Yun-Ho Jun 02, 2022 05:58am
- There are some cases where the insurance reimbursement standards and the indication for a drug differs. This gap emerges as not all the uses of a drug approved by the regulatory authorities may be deemed appropriate by the insurance authorities to spend their limited insurance finances on. This is why voices of complaint often arise in the field. It is impossible for the authorities to address all the complaints, but there exist cases where the non-reimbursement measure seems unreasonable, no matter how ‘financial’ the reason may be. One representative example of this is the restrictions set on switching and the period of administration. Let us look at the reimbursement standards set for the acute myeloid leukemia (AML) treatment Xospata (gilteritinib) which was recently listed for insurance benefit. The reimbursement standards for Xospata state that patients who show partial remission or higher after 2 cycles of administration and have received prior approval to receive allogeneic hematopoietic stem cell transplantation (or have presented evidence equivalent to the condition above) are allowed to receive 2 additional cycles of treatment in consideration of the preparation period for allogeneic hematopoietic stem cell transplantation. In general, the restrictions on a drug’s dosing cycle are set based on the design of the drug’s clinical trial or guidelines set by overseas authorities. However, there is no reason to limit the period of administration for Xospata. The ADMIRAL study that was conducted on Xospata shows that the drug was designed without limitation in the administration period, and the NCCN guidelines also recommend the drug as ‘Category 1’ without restricting its period of administration. JAK inhibitors that receive attention as oral rheumatoid arthritis treatments are facing a switching issue. The JAK inhibitors approved in Korea are ' Xeljanz (tofacitinib)', ' Olumiant (baricitinib)', ' Rinvoq (upadacitinib),’ etc. However, if patients switch to a different drug while receiving another, the reimbursement for their first drug is not recognized, In other words, if the patient who had switched to a different drug expecting better treatment results wishes to reuse the previous drug after seeing poor results, they may not receive reimbursement. The anti-TNF agents that had first entered the autoimmune disease treatment market had also undergone the same process. With the issue continuously raised in the field, switching of drugs such as ‘Humira (adalimumab),’‘Remicade (infliximab),’ and ‘Enbrel (etanercept)’ were finally allowed reimbursement in 2013. In Korea, the reimbursement of drugs significantly affects prescription in the field. Most HCPs in Korea give up prescribing a drug even if it is deemed necessary for a patient if the drug is non-reimbursed. Restricting fiscal spending in areas where prescriptions are needed may be toxic. In this sense, a little more trust on the health authorities’ part in the judgment made in the field would be mutually beneficial.
- Opinion
- [Reporter’s view] What was gained and lost with COVID R&D
- by Kim, Jin-Gu May 25, 2022 05:47am
- Literally, the companies have played it out to the end. By the companies, this reporter is referring to the developers of COVID-19 treatments and vaccines. Just 2 years ago, the developers had received the investors’ utmost interest. Stock prices soared when news broke out that a company is developing COVID-19 treatments or vaccines. The domestic stock market had been in a boom then, and every day, press releases on related news poured in. Some companies had even made malicious attempts to ride the investment boom. Many new treatments and vaccines were released in the past 2 years, but many of the companies that attempted to develop COVID-19 treatments and vaccines have also waved the white flag. In the case of the other companies still continuing on their R&D journey, their motive and drive have weakened significantly. Skepticism prevails over how many of these companies will continue to carry out their COVID-19 R&Ds to the end. The investors’ interest has also dropped sharply. They are no longer interested in whether the companies applied to initiate clinical trials, completed patient enrollment, or saw positive interim results. The stock prices of the companies that dangerously soared 2 years ago are making their way back. The COVID-19 R&D companies have both gained and lost much during the past 2 years. One gain is that the companies were able to imprint their names into the investors’ minds amid fierce competition. Also, the companies accumulated practical experience deriving candidate substances and conducting clinical trials in an emergency situation like the pandemic. Some companies also secured considerable cashable assets by selling their shares when their stock prices rose. On the other hand, many of these companies are losing their investors' interest and trust in return. In particular, the declining investor trust seems to be adding weight to the bubble theory in the pharmaceutical and bio industry. KRXHLTH, which represents the stock price of the pharmaceutical and bio-industry in Korea, has returned exactly to the level it had been before the pandemic. KRXHLTH rose 89.3% from 2915.31 at the start of 2020 to 5517.31 at the end of 2020 but then has been steadily declining to return to the pre-COVID-19 level of 2916.62 (as of May 20th). Among the 17 industry sectors that make up the KRX sector, the decline compared to the end of 2020 has been the largest in Healthcare. Now, there is rising concern that KRXHLTH may become lower than even before the COVID-19 outbreak. It is not about applauding the companies that have succeeded and criticizing those that failed to develop COVID-19 treatments and vaccines. It is more about asking the conscience of the companies that have carried out massive promotions about their development of COVID-19 treatments and vaccines. What did you truly gain, and what have you lost?
- Opinion
- The Minister should be appointed to lead policy continuity
- by Lee, Hye-Kyung May 20, 2022 06:11am
- On the 13th, the Yoon Seok-yeol government announced the appointment of vice ministers, ministries, and commissioners. However, as the head of the Ministry of Food and Drug Safety was excluded from the list of appointments, many talks were exchanged about the background. The most credible argument was that the appointment of the head of the affiliated agency would not have been easy at a time when the appointment of the MOHW was not made. Candidate for Minister of Health and Welfare Chung Ho-young has yet to be appointed since the personnel hearing. Some say they are trying to trade for the confirmation of Prime Minister nominee Han Duck-soo and the resignation of Minister of Health and Welfare candidate Chung Ho-young. In this situation, attention is also being paid to who will become the head of the regulatory agency, the MFDS. Oh Yoo-kyung, dean of Seoul National University College of Pharmacy, Kim In-kyu, former head of Gyeongin Office, Yoon Hyung-joo, and Seo Kyung-won, head of safety evaluation, were mentioned as candidates for his successor. All candidates seem to have the advantage of being able to maintain policy continuity and consistency as internal personnel of the MFDS. It is unclear whether the head of the MFDS, who is first appointed by the Yoon Seok-yeol government, will also be able to exceed the average tenure. The MFDS is a regulatory agency for pharmaceutical and food safety management, and frequent replacement of the head of the MFDS does not seem desirable to maintain continuity and consistency. Yoon Seok-yeol, the first head of the government's MFDS, who will be appointed soon, should be empowered to lead policies such as rapid approval of medical products such as medicines and support the development of COVID-19 treatments.
- Opinion
- [Reporter’s View] New govnt signals expanded PE exemptions
- by Eo, Yun-Ho May 18, 2022 05:52am
- The inauguration of a new government brings hope and anticipation to each and every industry. The same goes for multinational pharmaceutical companies. In the pharmaceutical industry, hopes are rising for the expanded eligibility of the pharmacoeconomic evaluation exemption scheme. Although many agendas remain in need of resolution, such as improvement of drug prices for each indication and the pre-listing post-evaluation scheme, etc., the industry believes the improvement of the PE exemption system is most realistic. This seems plausible from the third person's perspective as well. In fact, Yoon Suk-Yeol’s administration plans to promote the accelerated listing of anticancer drugs and treatments for severe and rare diseases that have no alternatives to improve patient access to such treatments. However, due to the conservative stance held by the relevant ministries such as the Ministry of Health and Welfare, Health Insurance Review and Assessment Service, and the National Health Insurance Service in improving drug prices for each indication and the application of the pre-listing post-evaluation system, no drastic change may be possible even with the administration change. But there still lies hope for improvement in the PE exemption system, as this special system that was introduced as an exception by the Korean government is still being well utilized, and the request for its improvement has been continuously raised for some time. Strangely enough, new drugs with low profitability due to a small number of eligible patients and drugs that have difficulty demonstrating cost-effectiveness even after overcoming developmental difficulties are becoming a trend and being actively introduced to the market. It may be due on one part because drugs for almost all other diseases have already been released, but still, the addition of these new treatment options cannot be bad for mankind. The industry has been requesting expanding eligibility of the pharmacoeconomic evaluation exemption scheme. The industry requested a more flexible application of the system, under which the PE exemption system is applied to drugs with no alternatives that have been approved with placebo-controlled data or be applied the same eligibility standards for the patients, etc. However, from the government’s perspective, it is difficult to open up its pockets upon every request as it has to pay the expenses from a limited budget. This is why the rumor that the PE exempted drug’s price will be set at ‘80% of the lowest A7-adjusted price’ had turned the industry upside down last year. PE exemptions are the only option for necessary drugs deemed difficult to receive pharmacoeconomic evaluations. It contains various fiscal management devices and has incorporated the ‘expenditure cap’ design ever since its implementation to protect fiscal sustainability. It’s just that with more drugs introduced to the market, more flexible management of the system may now be required for the right treatment to be prescribed to patients at the right time. In this context, on what picture the new administration has prepared to address this issue remains a focus of attention.
