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- 2026-04-13 14:48:09
- Policy
- Development of generics for DPP4+SGLT2 has begun
- by Lee, Tak-Sun Oct 27, 2021 05:49am
- The development of generics that combines "DPP-4 Inhibitors" and "SGLT-2 Inhibitors," which are not covered so far, is underway. This is because there are less than two years left until the end of the PMS, which can be approved for generics. Until now, the domestic market for DPP4+SGLT2 complex has not been formed due to benefit issues, but generic companies are also paying attention as benefit issues are recently being discussed. GC Pharma received approval from the MFDS on the 25th for the biological equivalence test plan of GC2123A. The active ingredients are known as Empagliflozin+Linagliptin. Empagliflozin+Linaglipin are the active ingredients of Esglito, which was approved by Beringer Ingelheim Korea in March 2017. Four years have passed since Esglito was granted permission, but it has not yet reimbursed. There are only two years left before the PMS period, when generic license applications are blocked. The PMS period ends in March 2023. Generic development began after March 2023. Currently, the DPP4+SGLT2 complex licensed in Korea is three items, including Esglito, AstraZeneca's Qtern (Dapagliflozin+Saxagliptin) and MSD's Stegluzan (Ertugliflozin+Sitagliptin), all of which are unreimbursed. Qtern also ends PMS in March 2023, and Stegluzan ends in August 2024. They need to solve the benefit issue before the launch of generics to expect market preoccupation. Until now, insurance authorities were conservative about the prescription benefits for diabetes, so only some item combinations were recognized. However, as discussions are underway recently, it is expected that the benefit issue will be solved soon. The MFDS is also improving and applying it so that it can be used in combination between affiliates. DongKoo Bio applied for permission for the Sitagliptin+Dapagliflozin in March. LG Chem is conducting commercial clinical trials for DPP-4 inhibitors Gemigliptin and SGLT-2 inhibitors Dapagliflozin, while Aju is conducting commercialization clinical trials for Linagliptin and Dapagliflozin. Patents for originals are also expected to expire by 2023, so generic development in Korea is expected to become more active.
- Company
- The supply of 8 GSK vaccines will be suspended until Feb
- by Oct 27, 2021 05:49am
- The supply of eight GSK vaccines, including Rotarix, is temporarily suspended, which is expected to disrupt the inoculation schedule. According to the pharmaceutical industry on the 26th, GSK announced a temporary suspension of supply of its vaccines to clinics and hospitals. Discontinued vaccines are ▲Rotarix (Human Rotavirus Live Attenuated), ▲Synflorix (Pneumococcal Vaccine), ▲Menveo, ▲Havrix, ▲Priorix (MMR Vaccine), ▲Boostrix (Tdap Vaccine), and▲Infanrix-IPV, IPV/Hib(DTaP vaccine). GSK said, "Some errors were found in the process of checking the registration details of its vaccines supplied to Korea, so we stopped importing and shipping additional products altogether." And GSK added, "This is a documentary error that does not affect product safety, quality, characteristics, purity, and efficacy, but this measure is expected to disrupt supply." Vaccines suspended from shipment are expected to be released by February next year. All products except Rotarix are included in the NIP. Most alternative generics exist, but some are multiple doses vaccinations and cross-vaccination with other products is not recommended, which is expected to disrupt the inoculation schedule.
- Policy
- Samsung Bio’s Moderna vaccine receives GMP certification
- by Lee, Tak-Sun Oct 27, 2021 05:49am
- The Ministry of Food and Drug Safety issued a Certificate of GMP Compliance for Samsung Biologics manufacturing facility that will be producing Moderna’s COVID-19 vaccine after signing a contract manufacturing agreement with Moderna. With the GMP certification, discussions on the domestic supply of the vaccine are also expected to gain momentum. According to industry officials on the 26th, the Gyeongin Regional Office of Food and Drug Safety issued a Certificate of GMP Compliance of a Manufacturer to Samsung Biologics’ Moderna vaccine manufacturing facility on the previous day. This was in line with what Gang-lip Kim, Minister of Food and Drug Safety, said at the National Assembly audit on the 8th, that “the GMP review will be completed within the month.” However, the GMP certification does not mean that the vaccine will immediately be supplied to the domestic market. A separate marketing authorization needs to be obtained to supply to the domestic market, but Samsung Biologics has not yet applied for the authorization. Still, the vaccine can be released in Korea through the Emergency Use Authorization scheme. Therefore, authorities including the Korea Disease Control and Prevention Agency are expected to discuss granting emergency use authorization to the said vaccine. The MFDS’ GMP certificate provides an advantage in exporting drugs and medical supplies to other countries that joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which will speed up overseas registration of the Moderna vaccines manufactured by Samsung Biologics.
- Company
- Celltrion's self-test kit has been approved for EUA
- by Chon, Seung-Hyun Oct 27, 2021 05:49am
- Celltrion announced on the 25th that the COVID-19 antigen rapid self-test kit DiaTrust COVID-19 Ag Home Test, jointly developed with Humasis recently acquired Emergency Use Authorization from the U.S. Food and Drug Administration (FDA). Celltrion received the EUA of Celltrion DiaTrust™ COVID-19 Ag Rapid Test for Professionals from the FDA in April, and the rapid self-test kit was also approved this time. The DiaTrust Home Test conducted clinical trials on 490 patients with COVID-19 symptoms in the United States from March to July, and showed 86.7% and 99.8% accuracy in sensitivity and specificity, respectively. Third-party products that have already been approved by the FDA and are in circulation in the U.S. require consecutive tests that require at least two tests regardless of symptoms. The company explains that this product requires the same continuous itest for asymptomatic patients, but for symptomatic patients, it is possible to check for infection with just one test. This product is available for those aged 14 or older and can be purchased online or offline without a separate prescription. Celltrion is planning to supply DiaTrust Home Test in the U.S. through its subsidiary Celltrion USA. For rapid supply, last-minute consultations are underway with local governments, online distributors, and offline distributors. The home test kits are handled by Humasis, a co-developer. Celltrion won a contract from DLA in the U.S. last month to supply DiaTrust for experts worth up to 738.2 billion won. An official from Celltrion said, "This EUA is based on the high reliability of Celltrion diagnostic kit products, and we will make efforts to prevent the spread of COVID-19 through early supply of products."
- 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.”
