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- 2026-05-18 11:04:06
- Company
- Sales of choline alfoscerate rise despite controversy
- by Chon, Seung-Hyun Oct 26, 2021 05:53am
- Sales of brain function enhancer ‘choline alfoscerate’ are on the rise in the prescription drug market. The drug recorded growth for 3 consecutive quarters despite controversy over its efficacy, reduced scope of reimbursement, and the restitution of insurance benefits. Also, with many CA products withdrawing from the market after giving up clinical re-evaluations, the market dominion has fluctuated. According to the market research institution on the 25th, the outpatient prescriptions in Q3 recorded ₩127.3 billion. This was a 5.4% decrease YOY, however, also a 3-quarter consecutive rise from the ₩116.7 billion in Q4 last year. The cumulative prescription of choline alfoscerate products was ₩368.7 billion by Q3 this year, which was a 2.3% increase from the previous year. Choline alfoscerate is currently approved for the following three indications: ▲ Secondary symptom caused by cerebrovascular defects or degenerative brain-organic psychiatric syndrome by cerebrovascular deficiency; ▲ Emotional and behavioral change; and▲ Senile pseudo depression.’ Despite the recent flood of issues from clinical reevaluations, reduced scope of reimbursement, and negotiations for restitution of insurance benefits, sales of choline alfoscerate have stayed strong in the prescription market. The amount of choline alfoscerate prescriptions in Q3 nearly doubled from Q3 2017, 4 years ago. The safety and efficacy of choline alfoscerate are currently on the testbed, and the governments’ pressure to reduce the drug's insurance benefits is still ongoing. Choline alfoscerate became the first subject of the unprecedented restitution negotiations. At the end of last year, the Ministry of Health and Welfare ordered the National Health Insurance Service to sign an insurance benefits agreement ‘to return the prescription amount if the clinical trial fails.’ 8 months after the negotiation order, the companies have comprehensively agreed on the restitution rate of 20%. What is noteworthy is that the overall market size showed growth even though some of the choline alfoscerate products withdrew from the market after giving up re-evaluations. The MFDS had first ordered clinical re-evaluations to 134 companies, and 57, less than half, of the companies received approval for their clinical reevaluations. In other words, 77 companies have given up reevaluations and decided to withdraw from the market. Some of the companies have officially withdrawn from the market by voluntarily withdrawing their licenses. The interpretation is that these products were replaced by other choline alfoscerate products. The market dominion for each product had also been fluctuating. Some products showed a sudden surge in sales by absorbing prescriptions of products that withdrew from the market. Sales from market leaders, Daewoong Bio and Chong Kun Dang, recorded sales at a similar level to previous years. Sales of Daewoong Bio’s Gliatamine fell 1.6% from the previous year to record ₩28.1 billion in Q3, and Chong Kun Dang’s Gliatilin recorded ₩23.4 billion, a 3.3% decrease from Q3 of the previous year. Mid-sized pharmaceutical companies including Korea Prime Pharm, Hutecs Korea Pharmaceutical, Dongkoo&Pharma, HLB Pharma showed high growth.
- Policy
- Dongkook started developing Dukarb's IMD
- by Lee, Tak-Sun Oct 26, 2021 05:53am
- Boryung's Dukarb (Amlodipine Besylate+Fimasartan Potassium Trihydrate), which reexamination ends in May next year, is competitively developing. While multiple pharmaceutical companies such as DongKoo Bio have already begun developing generics, DongKook has also started developing IMD. On the 22nd, the MFDS approved Dongkook's phase 1 clinical trial plan for DKF-407. The test drug names of DKF-407 are Fimasartan and S-Amlodipine, similar to Dukarb. However, Amlodipine has started to differentiate itself by using S-Amlodipine, which maximizes the efficacy of the drug through isomer separation technology. Several pharmaceutical companies have joined the development competition since the constraint was approved for a phase 1 clinical trial plan for the candidate substance DKB21001. Arlico and Navipharm were also approved for phase 1 clinical trials, all of which are known to be IMD like Dongkook. Generic development as IMD is interpreted as a strategy to avoid Dukarb's composition patent, which ends in August 2031. Pharmaceutical companies that have begun development have also raised a passive trial to confirm the scope of rights to avoid Dukarb composition patents. If composition patents are avoided, generics will be able to launch on the market after February 1, 2023, when the material patent ends. In addition, since Dukarb's re-examination will end in May next year, late-stage pharmaceutical companies are expected to hurry to develop it to review permission accordingly. The consignment production restriction law, which took effect in July, is also cited as the background of multiple pharmaceutical companies joining the development war. This is because, under the law, development and manufacturers can only produce consigned production to three companies. Analysts say that more pharmaceutical companies are likely to develop generics in the future as there are currently 30 to 40 pharmaceutical companies that have joined the Dukarb patent avoidance trial. Boryung, which owns the original Dukarb, is paying attention to diversifying the product lineup in preparation for the generics market. Dukarb is an item with a performance of 35.1 billion won last year. For this reason, competition between original and generics is expected to be fierce over market strategies.
- Policy
- Up to 500 ppl will be allowed at events from next month
- by Kim, Jung-Ju Oct 26, 2021 05:53am
- The government has set a three-phase strategy starting next month for the ‘Living with COVID-19’ era. The measure comes 1 year and 10 months since the government implemented disease control and prevention measures for COVID-19. In particular, events and gatherings of less than 100 people will be allowed starting next month, and temporary performance centers that accept more than 500 audiences will be operated at a test run in the first phase, then the limit will be lifted from the second phase, and allow large-scale events. The Central Disaster Management Headquarters and Central Disease Control Headquarters of the Ministry of Health and Welfare today (25th) held a public hearing on the ‘implementation plan for recovery to daily life from COVID-19 ' and announced the plans above. The implementation plan to return to daily life became possible with the rapidly increasing COVID-19 vaccination rate in Korea. The 2nd vaccination rate is expected to reach 70% at the end of this month, which will reduce the COVID-19 mortality rate and set the basis for returning to daily life. In addition, the prolonged COVID-19 had increased the burden on the economy and medical system, increasing the need to recover to daily life and overcome the burden. The return to daily life measures presented by the government will be implemented in 3 phases. The project will be implemented in ‘4+2 week’ intervals starting next month, then settle down to recover to daily life. The first phase of the reorganization will begin on the 1st of next month by lifting the limits on commercial facilities, followed by the second phase 6 weeks after that allows large-scale events from mid-December, then to the third phase in February next year that lifts the restrictions set on private gatherings. In particular, the number of people allowed at events and gatherings that are currently restricted to less than 50 at level 3 and a blanket ban of all events at level 4 Social Distancing measures, will be changed so that events with less than 100 people will be allowed regardless of the vaccination status from the first phase of reorganizations. At the same time, events with less than 500 people may be held if all members have completed vaccinations. Also, temporary performance centers that accept more than 500 audiences will be operated on a test run. From the second phase of reorganization, large-scale events will be allowed without limiting the number of people. From the third phase of reorganizations, the limit on the number of people for events will be completely lifted, and the events may be held while just observing the basic quarantine rules. The authorities announced that they will prepare phased measures to return to daily life based on the social consensus drawn from discussions from the “Committee to Support Recovery to Daily Life from COVID-19” and feedbacks that were continuously collected from public hearings, etc.
- Policy
- Hanmi Pharmaceutical's Esomezole Plus has been approved
- by Lee, Tak-Sun Oct 26, 2021 05:53am
- Competition is fierce with the emergence of Hanmi Pharmaceutical, which topped the PPI single-drug market. Hanmi Pharmaceutical's Esomezole Plus will launch in the highly competitive PPI+ antacids complex market. As Hanmi has a high market share with Esomezole, a single PPI drug, it is expected to cause significant changes in the current market composition if the complex is released. The MFDS approved Hanmi Pharmaceutical's Esomezole Plus 40/350mg on the 22nd. This product is a combination drug that combines "Esomeprazole magnesium trihydrate," a PPI-based gastroesophageal reflux disease treatment, and "Magnesium Hydroxide," a antacid. This is the first time that the ingredient has been combined. The side effects of secreting acid at night and the late expression of medicinal effects, which are disadvantages of PPI single drugs, are supplemented through antacids of PPI+ antacids complex drugs. In particular, the market size of Chong Kun Dang's Eso Duo (Esomeprazole Magnesium Trihydrate+Sodium Bicarbonate) has increased significantly every year since its launch in 2018. With the success of Eso Duo, new PPI+ antacids complex drugs are also appearing one after another. Yuhan, GC Pharma, and Chong Kun Dang were licensed in February for a composite that combines Esomeprazole Magnesium Trihydrate+Sodium Bicarbonate. All 24 generics for Eso Duo were also listed in September. They succeeded in challenging patents and succeeded in launching them early. The emergence of Hanmi Pharmaceutical is expected to have another impact on the market. Hanmi Pharmaceutical's PPI single-drug Esomezol topped the related market with 23.2 billion won based on UBIST in the first half of last year. As Hanmi steadily increased their customers, they beat original drugs such as Nexium. During the same period, Chong Kun Dang's Eso Duo, a PPI+ antacid reading item, recorded 7.8 billion won in offshore prescription performance. Although it is smaller than a single system, it is steadily rising. Against this backdrop, competition is expected to intensify as Hanmi Pharmaceutical enters the market. Hanmi's Esomezole Plus 40/350mg is used to treat erosive reflux esophagitis and should be taken on an empty stomach 1 hour before meals. It proved its efficacy by comparing the drug with a single drug in clinical trials in healthy adults.
- Company
- Merck will actively support Korea to become one of the top 5
- by Oct 26, 2021 05:53am
- Korea M Lab Collaboration CenterM Lab has promised to actively invest and expand cooperation with domestic companies to expand its capabilities in Korean vaccine production and bio-process. In an online press conference hosted to commemorate the 5th anniversary of its establishment on the 21st, M Lab said, "We will support Korea to leap into one of the top five global vaccine production powerhouses." M Lab explores pharmaceutical bio companies' ideas for developing new drugs and provides solutions to solve important process development and production problems. It is located in eight countries around the world, including the United States, France, China, and Singapore, and was located in Songdo, Incheon in 2016. Merck Life Sciences invested a total of 10 million euros (about 12 billion won) for the 1865㎡ M Lab Center. M Lab supports professional education and skills in a wide range of fields, including drug development, manufacturing, and guarantee. Non-GMP research facilities allow customers to improve their R&D processes through the M Lab simulation system without being affected by the actual production line. M Lab has provided more than 540 customized training programs over five years and has helped practice more than 240 state-of-the-art facilities. It has formed a technology strategy partnership with more than 100 domestic pharmaceutical bio companies such as Samsung Biologics, Chong Kun Dang, and SK Bioscience. As large-scale biopharmaceutical production facilities have been established in Korea over the past decade and the need for vaccine and cell gene therapy has been increasing, M Lab also plans to expand cooperation in this field. Kim Yong-seok, general manager of process solution business, said, "Global is also paying attention to the growth potential of the Korean biotech industry. In particular, we expect biopharmaceutical production facilities to achieve the largest growth after the U.S. and China, he explained. He said, "In the past, we mainly collaborated with large pharmaceutical companies, but in the future, we will also cooperate with growing bio ventures to contribute to the construction of Korea's bio-eco system." In particular, bio ventures are rich in R&D ideas, but they are having difficulty in concrete demonstration methods. M Lab predicts that it will be able to educate them on scale-up technologies necessary in the initial process development and commercialization process and provide services for development optimization. It also expressed its intention to actively contribute to Korea's leap into the world's top five vaccine producers. Merck is also affiliated with a consultative body of vaccine companies composed of the Korean government and domestic pharmaceutical bio companies. It is determined to invest to support vaccine production and expand bio-processing capabilities. The domestic pharmaceutical bio industry has grown rapidly for 10 years, but it is difficult to recruit talent. The government, Incheon, and Yonsei University are establishing a K-NIBRT consortium to foster professionals in the vaccine and bio sectors. Merck will also participate in the consortium to support training programs and dispatch of experts. On November 4, the "Virtual M Lab Open House" will be held to guide bio-process education, job consulting, and recruitment information for college students majoring in life science. As national expectations for the biopharmaceutical industry grow after the COVID-19 incident, we will contribute to the growth of the industry by providing customized solutions and services through M Lab and sharing expertise and know-how, he said. "We will establish ourselves as a win-win partner that grows together through collaboration with Korea, which has unlimited potential," he said.
- Company
- ‘Brilinta’ generic to be released next month
- by Kim, Jin-Gu Oct 25, 2021 05:50am
- Pic. of Brilinta Generics of AstraZeneca’s oral antiplatelet therapy Brilinta will be released next month. However, only 6 of the 25 companies that received first generic exclusivity will be releasing actual products. The small number of releases is interpreted to be caused by the domestic companies' declining interest in Brilintagenerics. According to industry sources on the 22nd, the substance patent for Brilinta will expire on the 20th next month. In other words, generics that had avoided the formulation patent of Brilintawill be allowed to be released from the 21st next month. Currently, 25 companies have successfully avoided Brillinta’s formulation patent and acquired first generic exclusivity. However, only 6 of these companies will be releasing actual generics. The companies are Chong Kun Dang, Samjin Pharm, Genuone Sciences, Alvogen Korea, and Hana Pharm. The other 19 companies including Hanmi Pharmaceutical and Boryung Pharmaceutical are adjusting their schedules for its release. The companies, which already own other antiplatelet therapies with different ingredients are in no rush to release the generics. This is in stark contrast to 2015 when generic companies competitively challenged Brillinta’s patent. At that time, the ticagrelor market showed promise to expand significantly. This was why around 30 companies in Korea had challenged the substance, formulation, and crystalline form patent of Brilinta. According to the market research institution UBIST, outpatient prescriptions for Brilinta, which recorded 4.8 billion won in 2014, then rose to 7 billion won in 2015. The market continued to grow until 2019 when it peaked at 10.8 billion won. However, sales fell to 9.8 billion won last year. And 4.3 billion won’s worth was prescribed in the first half of this year. At this trend, it is likely that outpatient prescriptions of Brilintamay see a decline for 2 consecutive years. The industry pointed to the existence of strong competitors such as aspirin, clopidogrel, sarpogrelate, and the introduction of new oral anticoagulants (NOACs) that have coinciding indications that quickly gained popularity, as the reason why Brilintais performing less than expected. Also, the relatively high price of ticagrelor APIs is one reason why generics are hesitant to produce their generics. An official from a company that postponed their generics’ release said, “The bottom line is, marketability is low and the price of its API is high, so the generic is not very profitable. That is why we decided to wait and see how the companies that first enter the Brilinta market do then enter the market as latecomers.”
- Opinion
- [Desk's view] It should also prepare for "With Corona"
- by Chon, Seung-Hyun Oct 25, 2021 05:50am
- The government has announced that it will shift the COVID-19 quarantine system to a "step-by-step daily recovery" (with COVID-19) centered on the management of the number of critically ill patients or deaths. As the proportion of COVID-19 vaccination completion exceeds 70%, a relaxed quarantine system such as lifting restrictions on operating hours for multi-use facilities such as restaurants and cafes is expected to be implemented. The pharmaceutical industry is also gradually moving to prepare for "With Corona." Along with the COVID-19 pandemic, the number of people working at home seems to be reduced and the number of people working at the company is increasing. Some companies terminate the flexible working system implemented to avoid overlapping working hours of executives and employees as much as possible. In fact, the pharmaceutical industry has changed a lot in the COVID-19 situation that has been going on for more than a year and a half. The drug prescription market has changed significantly. Markets such as antibiotics and Jinhae girders have shrunk significantly as the number of flu and cold patients has plummeted due to strengthened personal hygiene management to prevent COVID-19. As the COVID-19 vaccination expanded, the pain reliever "Tylenol" jumped to the top in general drug sales. The market landscape has also changed as companies that have benefited from COVID-19 have emerged one after another. SK Bioscience's performance jumped sharply due to the consignment production of the COVID-19 vaccine. Samsung Biologics' performance has soared due to consignment production of COVID-19 antibody treatments, and it is also preparing to produce a Moder or COVID-19 vaccine. Diagnostic kit companies have exceeded 1 trillion won in sales. Pharmaceutical companies' R&D capabilities were also focused on conquering COVID-19. Many pharmaceutical bio companies have rushed to develop COVID-19 vaccines and treatments. Celltrion, which was focusing on biosimilars, developed its own COVID-19 treatment "Regkirona." On the other hand, in general, domestic companies' R&D performance has been lower in technology exports than before COVID-19. The spread of COVID-19 has reduced direct exchanges with global companies and focused on non-face-to-face promotion, so they have not been able to actively win technology exports. Even if the government gradually eases the quarantine system, it will not return to its daily life before COVID-19 in a short period of time, but pharmaceutical companies should gradually prepare for "With COVID-19." If R&D capabilities are actively appealed at large domestic and international academic conferences in the future, it is expected that technology exports, which have been stagnant, will also become active. The development of COVID-19 treatments and vaccines also requires strategies. It is necessary to reflect on whether the R&D efforts to conquer COVID-19 were simply a trick to boost stock prices. Many people in the pharmaceutical industry were also hurt by COVID-19. However, we hope that the COVID-19 crisis will serve as an opportunity for our pharmaceutical industry to become more mature.
- Policy
- HIRA “Will improve RSA and prior authorization system”
- by Lee, Hye-Kyung Oct 25, 2021 05:50am
- The increasing number of applications filed for reimbursement decisions on the use of ultra-high-priced new drugs, such as ‘Zolgensma’ and ‘Keytruda’ that cost 2.5 billion won and 500 million won per shot, respectively, has upped the National Assembly’s demand for the improvement of the Risk-sharing Agreement system (RSA) and prior authorization system. The Health Insurance Review and Assessment Service, which is in charge of the first step to reimbursement, has expressed its position that it will continue to work to determine a reasonable price for drugs and improve the patients’ accessibility to such drugs. At the written responses provided by HIRA after the NA Health and Welfare Committee’s audit that was conducted on the 15th, HIRA expressed its will to improve the RSA and prior authorization system. In-soon Nam the Democratic Party of Korea inquired on the RSA evaluation system and on the direction for mid-to-long-term policy improvement that the authorities will take to address the issue. HIRA explained that comparing the period 2008-2013 (before implementing the RSA system) to 2014-2020 (after implementing the RSA system), the reimbursement rate of anticancer drugs had risen from 58% to 76%, rare disease drugs from 79% to 86%, making a positive influence in improving the listing rate of pharmaceuticals in general. In other words, the authorities explained that the RSA system had helped improve new drug accessibility and reinforce NHI coverage. Also, in the process of operations, subjects for RSA were expanded in July 2019 to drugs subject to special exemption of calculation as rare and severe incurable disease treatments that exceed 2 years of life expectancy, and even to latecomer drugs in October last year. HIRA assured, “To overcome the uncertainties in the long-term effect of the increasing ultra-high-priced drugs, we will prepare a separate RSA scheme to meet the characteristic of each drug, such as a performance-based RSA system." NA member Yeong Suk Seo of the Democratic Party of Korea proposed improving the prior approval system to minimize the fiscal burden of ultra-high-priced new drugs. Seo pointed to the need to regulate prescriptions to ensure the quality of medicines that are ultra-high-priced, require high-level technology, or have high patient risk by systemizing the prior authorization program. Currently 4 products including Strensiq inj., Immune Tolerance Induction (ITI) therapy, Soliris inj. Ultomiris, inj., have received prior authorization. HIRA said, “We agree with the need to secure justification for the administration and prescription of new drugs. We will review the necessity of prior authorization when listing ultra-high-priced drugs." Also, HIRA added that the need to manage patients by unit, the efficiency of the management method, and the need for prompt prescription of such drugs should be considered for medicines that require high-level technology or have high patient risk. HIRA said, “We will discuss with the government and review the reimbursement standards for prescriptions of such medications and procedures.”
- Opinion
- [Reporter's view] Disclosure of the results of the Committee
- by Eo, Yun-Ho Oct 25, 2021 05:49am
- The results of the Cancer Drugs Benefit Appraisal Committee were released from the 13th. The HIRA has accepted complaints continuously filed in the pharmaceutical industry. Some point out that they are not satisfied yet, but it can be said that it is encouraging in itself because the HIRA expressed its intention to deliver the exact reason for the success at the request of the company. In the pharmaceutical industry, discussions on expanding insurance benefits for new drugs have been focused on the Cancer Drugs Benefit Appraisal Committee along with the COVID-19 incident.The Cancer Drugs Benefit Appraisal Committee, which was discussing the clinical usefulness of drugs, began examining the financial burden last year. Since then, as more and more drugs are pending in the pharmaceutical industry due to the Cancer Drugs Benefit Appraisal Committee, even companies have submitted economic evaluation data to the subcommittee. Of course, there may have been many pharmaceutical companies that were greedy last year, and there may have been many drugs that were not clinically useful. So the industry's argument was focused on transparency. This was not a necessary procedure only for the pharmaceutical industry. This is because knowing which drugs have been judged to be unsuitable for what reason, greedy pharmaceutical companies can be criticized and make efforts to find a compromise. Of course, the disclosure of the details of the discussion is 'not yet', but the transparency of the committee has risen to the first level. Beyond the pharmaceutical industry, the healthcare industry is facing a new era. Patients, or their families, now search for surgical papers and search for new drug information in the clinical trial database clinic at clinicaltrial.gov. If domestic licensed drugs do not receive insurance benefits, complaints will pour out to the relevant ministries, the HIRA and the MOHW. The anger of patients and their families looking at "the medicine that exists but cannot be taken" is indescribable. The urgency that cannot be estimated unless it is a party, the level of knowledge of the people who have risen, and the administrative power resulting from the development of the Internet are amazing. Transparency in the process of listing or expanding insurance benefits for new drugs will gradually increase in the future. Both the government and pharmaceutical companies should now fear social views that include desperation. The disclosure of the results of the Cancer Drugs Benefit Appraisal Committee is welcome for now.
- Company
- Boryung Pharmaceutical acquired Zyprexa's domestic rights
- by Kim, Jin-Gu Oct 25, 2021 05:49am
- Boryung announced on the 21st that it has signed an asset transfer contract with Eli Lilly for the schizophrenia treatment "Zyprexa (Olanzapine)." Through this contract, Boryung will take over all rights from Eli Lilly, including domestic copyrights and permits for Zyprexa. Zyprexa is the world's most prescribed treatment for schizophrenia since its launch in 1996. It is a drug used for schizophrenia and bipolar disorder and controls the imbalance of Dopamine in the brain. According to IQVIA, a pharmaceutical market research firm, Zyprexa generated 14 billion won in sales in Korea last year. It occupies about 50% of the domestic Olanzapine market. Boryung plans to further strengthen its central nervous system (CNS) treatment business through the acquisition of Zyprexa. Boryung has CNS drugs such as Buspar (mental inhibitor), Prozac (central stimulant), and Strattera (behavioral disorder). Boryung's goal is to add Zyprexa to achieve 50 billion won in annual sales in the CNS sector by 2025. The contract was made as part of the Legacy Brands Acquisition (LBA) strategy announced by Boryung in July. LBA refers to the acquisition of original medicines that maintain a certain level of sales and market share even after patent expires. It acquired the domestic rights of the anticancer drug Gemzar (Gemcitabine) from Lilly in May last year. CEO of Boryung Jang Doo-hyun said, "The acquisition of Zyprexa has provided an opportunity for a new leap forward in the CNS treatment business." "In order to continue to acquire products that can contribute to Boryung's growth in the future, we are considering a number of products that are leading the domestic and foreign treatment markets," he said.
