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- 2026-05-18 09:37:08
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- Daewoong's drug targets ₩100 bil market as 2nd P-CAB
- by Kim, Jin-Gu Dec 31, 2021 05:51am
- Daewoong Pharmaceutical succeeded in receiving approval for its potassium-competitive acid blocker (P-CAB) ‘Fexclu (fexuprazan)’ for the treatment of gastroesophageal reflux disease (GERD). It is being predicted that the new drug introduced will unfold a full-fledged competition with HK inno.N’s ‘K-CAB (tegoprazan), a GERD treatment that grew to record ₩100 billion in annual prescriptions in only 3 years since its release. ◆Received marketing authorization 14 years after starting development … 34th homegrown new drug The Ministry of Food and Drug Safety granted marketing authorization of Daewoong’s Fexclu tablet on the 30th. Fexclu will likely be designated as the 34th locally developed new drug. Daewoong started the development of Fexclu in 2007 and received approval for the drug after 14 years. This is the second new drug developed by Daewoong since the diabetic foot ulcer treatment Easyef(No.2 homegrown new drug) that was approved in 2001. Fexuprazan is a P-CAB GERD treatment. It inhibits gastric acid secretion by competitively binding to the proton pump and potassium ion located in the final stage of acid secretion from the stomach wall. It was received as it had improved the shortcomings of existing proton pump inhibitors (PPIs). It has a faster onset of action than PPIs and has the advantage of being able to be taken regardless of meal ingestion. In a clinical trial conducted by Daewoong Pharmaceutical, the new drug demonstrated superior symptom improvement and showed longer-lasting effects than the representative PPI class esomeprazole. ◆To start a full-fledged competition with the annual ₩100 billion grossing K-CAB The industry expects that a full-fledged competition with K-CAB is inevitable when Daewoong officially releases Fexclu next year. The only P-CAB drug approved as of now in Korea is HK inno.N’s K-CAB. HK inno.N received approval of K-CAB as the 30th homegrown new drug in late 2018. K-CAB quickly settled in the market and is making new history for domestic new drugs since its release in March 2019. This year, 3 years into its release, it is highly likely that the company is expected to record ₩100 billion in prescriptions this year. This is a new and first record made by a single homegrown new drug. According to the market research institution UBIST, the cumulative prescription amount of K-CAB reached ₩88 billion between January and October this year. Daewoong plans to prevent K-CAB’s sole lead in the market based on its solid position in the domestic digestive drug prescription market. Daewoong had been leading the market for the past decade selling with its ranitidine GERD treatment ‘Albis’ and AstraZeneca’s PPI-class treatment ‘Nexium.’ The two drugs had recorded the highest prescription performance in their respective markets. Daewoong decided to terminate the co-promotion agreement it had had since 2008 for AstraZeneca’s Nexium at the end of this year. It is believed that the decision was made by the company to devote itself to the sale and marketing of Fexclu. ◆HK inno.N establishes defense strategy by extending its indication and developing a new formulation HK inno.N seems to be preparing a defense strategy by extending its K-CAB indication and developing new formulations. The drug was applied for insurance benefit as a gastric ulcer treatment in November, an extension from the previous scope of reimbursement of erosive and non-erosive gastroesophageal reflux disease. Although yet to be reimbursed, K-CAB also has an indication Helicobacter pylori eradication. In addition, clinical trials to extend its indication to maintenance therapy post-GERD treatment and NSAIDs-associated PUD are ongoing. Also, HK inno.N is also developing an oral disintegration tablet formulation of its drug. The company has applied for its marketing authorization to the Ministry of Food and Drug Safety, and the company is planning to release the new formulation of K-CAB in the first half of next year.
- Company
- Competition for KRAS targeted anticancer drugs
- by Dec 31, 2021 05:51am
- Mechanism of action of KRAS inhibitor (Data: Amgen)The development of treatments targeting KRAS mutations in solid cancers, including non-small cell lung cancer, is active. This year alone, seven companies were approved for nine related clinical trials. Amgen, which is leading the competition, is undergoing a domestic permit review. According to the pharmaceutical industry on the 30th, there are a total of nine clinical trials related to KRAS that have been approved by the MFDS this year. The nine development stages were 5 cases in phase 1, 2 cases in phase 1/2, and 2 cases in phase 3. KRAS was first discovered in 1982 as a genetic mutation in solid cancers such as non-small cell lung cancer and colon cancer. In lung adenocarcinoma, patients with KRAS mutation are reported to be up to 25% in the West, and about 10-15% in Asians. Development efforts have continued for about 40 years since the discovery of KRAS, but have repeatedly failed in clinical trials. Since then, the KRAS gene signaling system has focused on subdivided targeted treatments tailored to various subtypes such as G12C, G12D, and G12F. Among them, many drugs target G12C. Amgen developed the first targeted treatment targeting KRAS G12C, which was approved by the U.S. Food and Drug Administration (FDA) in May this year under the name Lumakras. Amgen is speeding up its commercialization by applying for permission in Korea immediately. Competition to catch up with Amgen is intensifying. The pharmaceutical company closely chasing Amgen was approved for two phase 3 in June and September by Mirati Therapheutics. One case is for non-small cell lung cancer and the other for colon rectal cancer. Colorectal cancer is used in combination with the existing treatment Erbitux. KRAS development by Mirati and other pharmaceutical companies is still in its infancy. Novartis and China's InventisBio are conducting phase 1/2 each. Novartis tests the KRAS target anticancer drug JDQ443, which is being developed for advanced solid cancer patients in clinical trials approved in March. InventisBio was approved for clinical trials of "D-1553" in March. InventisBio is scheduled to end the test in October 2023 and Novartis in October 2024. Roche, Beringer Ingelheim, and Lilly have also started to develop KRAS-targeted anticancer drugs. Genentech, a Roche subsidiary that was first approved for clinical trials in March this year, plans to evaluate the safety and appropriate capacity of GDC-6036 for solid cancer patients with KRAS G12C mutations by February 2024. In April, Beringer Ingelheim was approved for two first phases of the new drug BI 1701963. One case is a clinical trial in which BI 1701963 monotherapy and another new drug, MEK inhibitor BI3011441 are tested in patients with KRAS mutated solid cancer. The other case evaluates BI 1701963 monotherapy and combination therapy with the existing MEK inhibitor Meqsel in the same patient group. BI 1701963, which is being developed by Beringer Ingelheim, is a general-purpose treatment (pan-KRAS) that targets various types of KRAS mutations, including major G12 genes. Its strategy is to maximize its effectiveness by using it in combination with MEK inhibitors. Most recently, Eli Lilly also jumped into domestic development with the approval of the first award. Lilly stopped KRAS-targeted new drug substance, which was being developed first last year, due to toxicity problems. Lilly did not stop here, but began to try again with another new drug called "LY3537982." Lilly is planning to conduct phase 1 for solid cancer patients with mutations in KRAS G12C. MSD continues to develop an immuno-cancer drug Keytruda in combination with KRAS-targeted anticancer drugs.
- Policy
- Changes in Benefit standards such as diabetes drugs
- by Kim, Jung-Ju Dec 31, 2021 05:50am
- The general principles of diabetes solvents and psychotropic drugs and some of Soliris (Eculizumab)'s detailed recognition criteria and methods for benefits change. Testosterone undecanoate, such as Andriol Testocaps Soft Cap, a male hormone drug, is classified by item, and detailed recognition criteria and methods are deleted. The MOHW announced on the 28th a partial amendment to the details (drugs) on the application standards and methods of medical care benefits. As Vildagliptin PO is newly registered next month, it will be added to the general principles of diabetes solvents, single and complex sectors. This standard will take effect and apply on the 9th of next month. Some specified doses are deleted to reflect the MFDS permits (treatment period) of Zolpidem CR 6.25 mg and Zolpidem CR 12.5 mg. Specifically, from the 1st of next month, the doses previously defined as Zolpidem 5mg and Zolpidem 10mg will be deleted. After discontinuation of Soliris administration to Atypical Hemolytic Uremic Syndrome, benefits related to recurrence are expanded. Specifically, it is the case where the improvement of symptoms is stopped according to the recommendations and decisions of the committee and the judgment of the medical staff. The part requiring medical judgment was subject to the committee's decision. Meanwhile, Testosterone undecanoate is deleted from the drug benefit list and the standard notice is also deleted, and the date of other central neuropharmaceuticals, such as Wakix Film Coated Tab 5mg, is changed from January 1 to February 1 next year.
- Company
- Introduction of oral tx for COVID-19
- by Whang, byung-woo Dec 31, 2021 05:50am
- As the U.S. Food and Drug Administration (FDA) has approved the emergency use of Pfizer's Paxlovid, the entry of oral coronavirus treatments into the market is just around the corner. On the 22nd (local time), the FDA approved the use of Paxlovid at home for high-risk adults, children over the age of 12, and patients with underlying diseases who are likely to be hospitalized in the event of COVID-19. According to the results of interim analysis of EPIC-HR, a phase 2/3 clinical trial of Paxlovid, the risk of hospitalization or death decreased by 89% in the patient group who administered the treatment within three days of symptom onset. This is higher than 50% of MSD's Molnupiravir, which previously announced interim results. In addition, Paxlovid had 0.8% (3/389) of patients hospitalized until the 28th day after random assignment, while the placebo group reached 7% (27/325). In addition, similar results were found in patients treated within 5 days of onset of symptoms. The proportion of inpatients in the Paxlovid treatment group was significantly higher at 1.0% (6/607), 6.7% (41/612) in the placebo group, and the effect of reducing hospitalization or death was 85%. In the case of Molnupiravir, 800 mg was taken twice a day and 10 times a day for 5 days, and 7.3% of patients worsened to severe and there were no deaths. 14.1% of patients taking placebo worsened to severe and 8 died, the survey showed. Kang Jin-han, head of the Vaccine Bio Research Institute at the Catholic University of Korea, said, "The reason for getting the vaccine is to prevent it from becoming severe, and even if it is a breakthrough infection, it is important to prevent medical confusion by administering oral treatments early." However, as in the early days of the introduction of the COVID-19 vaccine, supply problems remain. Paxlovid is expected to be supplied 265,000 times to the United States as early as January 2022. Paxlovid classifies 30 tablets into one batch, and the U.S. government has signed a contract for 10 million times for 530 dollars (about 630,000 won) per Paxlovid. According to Pfizer, Paxlovid, which has already been produced, is about 180,000 times, making it difficult to even digest contracts with the U.S. In response, Pfizer plans to raise its production capacity from 80 million times to 120 million times next year. In Korea, the Ministry of Food and Drug Safety also signed a contract to bring in about 70,000 installments with the emergency approval of Paxlovid, but considering that supply contracts continue around the world, it is difficult to estimate the exact timing of supply. However, there was also a view that even if the supply was insufficient, the timing would be more important than the supply as it was not conducted for the entire population like vaccines. Professor Choi Young-joon (pediatric infection) of Korea University Anam Hospital said, "In the case of vaccines, the population group was targeted, so vaccines were needed in millions to 10 million units," adding, "But in the case of treatments, setting an appropriate patient group will be more important." Mollupiravir influence? However, if Molnupiravir is approved for emergency use by the FDA following Paxlovid, the burden of supply may be shared. The problem is that there are still concerns about whether to use Mollupiravir, which is less effective than Paxlovid. Molnupiravir was evaluated as a game changer when it was released, but after discussing whether to use it during the FDA Advisory Committee review process, he managed to pass the approval recommendation with 13 votes in favor and 10 votes against. In particular, the actual effect was lowered to 30% in this process. In the case of Molnupiravir, a total of 40 tablets are taken at a time during the one-time treatment process, and the price per minute is known to be around 830,000 won, making it less competitive than Paxlovid.
- Company
- Xospata's drug price negotiation period has been extended
- by Eo, Yun-Ho Dec 30, 2021 05:51am
- Drug price negotiations for the new acute myelogenous leukemia drug Xospata, which aims to be exempted, have passed the year. Astellas Korea and the NHIS conducted drug price negotiations until the 20th to register insurance benefits for Acute Myeloid Leukemia (AML), but decided to extend the negotiation deadline without reaching a conclusion. After receiving a conditional benefit decision by the HIRA's Drug Benefit Evaluation Committee in September, the proposed evaluation amount was accepted and drug price negotiations began in November, but failed to conclude negotiations within the first deadline. As a result, it remains to be seen whether Xospata will be able to complete negotiations with the government early next year and be listed on the list. Xospata is the first FLT3 targeted anticancer drug in Korea to be approved by the MFDS as a target treatment for FLT3 mutation positive (FLT3mut+) recurrence or refractory (R/R) AML. This drug targets both FLT3-ITD and FLT3-TKD, which are divided into two mutant forms, and is an oral monotherapy that allows patients to take medication at home without having to visit the hospital frequently. It also showed higher effectiveness and safety than conventional chemotherapy. In addition, Xospata has been classified as 'Category 1', the highest recommended grade for the treatment of patients with recurrent or refractory AML with positive FLT3 mutation in the latest guidelines of NCCN. Kim Hee-je, a professor of hematology at Seoul St. Mary's Hospital, said, "With Xospata's domestic permission, patients can relieve much anxiety that they have to endure without proper treatment." Of course, it still remains a cost problem, but it is expected that it will become a standardized treatment as soon as possible after the salary is registered, he said.
- Company
- K-pharma·biopharmas make great tech export deals this year
- by Chon, Seung-Hyun Dec 30, 2021 05:51am
- Once again, Korean pharmaceutical and biopharmaceutical companies have made great technology export performance this year. Although no mega-deals that amount to top 10 licensing deals were made, technology exports were made in various areas in the industry. Also, performance biopharmaceutical companies stood out this year compared to traditional pharmaceutical companies. According to the Financial Supervisory Service and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association on the 27th, various companies including SK Biopharm, Genexine, AprilBio, Hanmi Pharmaceutical, DongA ST, Alteogen, Olix, Curacle, Daewoong Pharmaceuticals, Bio-Pharm Solutions, Voronoi, D&D Pharmatech, Peptron, KoBiolabs, HK inno.N, Handok, CMG Pharma, LegoChemBio, have inked new drug technology export deals this year. Among the companies, SK Biopharm secured the most - $40 million- in upfront payment with two technology export contracts. SK Biopharm licensed out six central nervous systems (CNS) drugs including ‘cenobamate’ to Ignis Therapeutics. For the deal, SK Biopharm received an upfront payment of $20 million and will be receiving milestone payments of $15 million and royalties on net sales in the future. Also, the Korean drug company acquired 150 million shares of Ignis (share amounts to 44.9% including common stock) through the technology export. Ignis Therapeutics was established by SK Biopharm with Shanghai-based 6 Dimensions Capital (6D). The two companies raised $180 million in investment to establish Ignis , which was the largest Series A investment in the Chinese pharmaceutical industry this year. SK Biopharm signed a licensing deal with Endo Group for the commercialization of its epilepsy drug cenobamate across Canada. Under the contract, SK Biopharm received an upfront payment of $20 million. In terms of single technology export, the largest deal this year was made by Genexine with an Indonesian company with an upfront payment of $27 million. Genexine signed a technology transfer agreement with Kalbe Farma’s subsidiary KGBio for its immuno-oncology candidate GX-I7 (Efineptakin Alpha). Also, the technology export performance of bio-ventures was prominent this year. In October, the non-listed domestic bio company AprilBio had received a one-time payment of $16 million from a Denmark pharmaceutical company Lundbeck under an agreement for the technology transfer of its autoimmune disease treatment candidate ‘APB-A1. Also, Lundbeck will pay AprilBio success-based development, regulatory, and sales milestone payments of up to $432 million related to APB-A1. In addition, Lundbeck also secured $3.6 million to produce study samples for its Phase I clinical trial. In January, GC Lab Cell’s US affiliate had signed an agreement to jointly develop three chimeric antigen receptor (CAR)-NK cell therapies with the US company MSD. Artiva Biotherapeutics, GC Lab Cell’s US affiliate, was established by GC Lab Cell in the US to develop NK cell therapies, and the agreement is expected to be worth up to $1.86 billion. In March, ImmuneOncia Therapeutics, Inc., a US joint venture of Yuhan Corp, signed a deal with the Chinese immune-oncology development company 3D Medicines for the technology transfer of its new anticancer drug candidate IMC-002. Under the contract, ImmuneOncia will grant 3D Medicines exclusive license for IMC-002 in Greater China (including Hong Kong, Macau, and Taiwan). LegoChem Biosciences announced last month that it had signed an agreement to license out its antibody-drug conjugate (ADC) technology to the European company Sotio Biotech. At the time, the company signed an agreement to receive $29.5 million as upfront payment and short-term milestones payment. LegoChem Biosciences had also received $50 million in upfront payment and short-term milestone payments by signing a joint development and technology transfer deal for its ADC anticancer candidate with the UK company Iksuda Therapeutics on the 27th. Other companies including Alteogen, Olix, Curacle, Daewoong Pharmaceuticals, Bio-Pharm Solutions, Voronoi, D&D Pharmatech, Peptron, and KoBiolabs also secured over 1 million in technology export deals this year. Among traditional pharmaceutical companies, Hanmi Pharmaceutical, DongA ST, HK inno.N, and Daewoong Pharmaceuticals also signed tech export deals this year. Hanmi Pharmaceutical signed a technology export deal with Aptose Biosciences for its innovative new drug for acute myeloid leukemia(AML), the FLT3 inhibitor ‘HM43239.’ Dong-A ST signed a global license-out agreement with Intas Pharmaceuticals for its Stelara biosimilar DMB-3115 in July under the condition of receiving $10 million upfront in payment with no obligation of return and milestone payments up to $95 million. Daewoong Pharmaceutical signed a tech export and supply deal worth $338 million with Shanghai Haini, a subsidiary of China’s Yangtze River Pharmaceutical Group in March for its gastroesophageal reflux treatment Fexuprazan. The deal includes 6.8 billion won in upfront payment and $20.4 billion in milestone payments which are paid when each phase of a clinical trial is completed. HK inno.N, Handok, and CMG Pharma also received over $1 million in upfront payment for their technology export deals.
- Policy
- Will Boryung succeed in tackling Sprycel’s patent
- by Lee, Tak-Sun Dec 30, 2021 05:51am
- Whether a generic for the second-generation chronic myeloid leukemia treatment ‘Sprycel (dasatinib, BMS)’ will be introduced following generics for the first-generation ‘Gleevec (imatinib mesylate, Novartis)' is gaining attention. If introduced, Sprycel’s generic is expected to greatly improve patient accessibility. According to the industry on the 28th, Boryung Pharmaceutical is starting to develop a generic for Sprycel. Since 2013 when the first generic Gleevec was introduced to the market, domestic pharmaceutical companies have attempted the development of a generic version of Sprycel. However, the companies were not able to progress due to patents, etc. No approvals nor bioequivalence tests were made for generic Sprycel since its PMS expiry on August 19th, 2016. Some domestic pharmaceutical companies had attempted patent challenges in 2015 but dropped their suits the same year. Sprycel’s substance patent expired last year on April 12th. Attempts at generic Sprycel started again in December last year with Boryung Pharmaceutical filing an invalidation trial and a Passive trial to confirm the scope of the patent on Sprycel’s use patent (expires on March 23rd, 2024) and crystalline form patent (expires on February 4th, 2025). Daewoong also joined in the invalidation trial on Sprycel’s use patent. Boryung Pharmaceutical then applied and received approval for a bioequivalence test protocol on 'BR2009' from the Ministry of Food and Drug Safety. The BR2009 targets chronic myeloid leukemia like Sprycel. Given this, analysts are assuming that the bioequivalence test is for the development of a generic for Sprycel. Boryung Pharmaceutical currently owns a generic version of Gleevec, ‘Glima Tab.’ The company had opened the doors for generic entry by winning the patent invalidation suit for Gleevec’s composition patent. If Boryung Pharmaceutical succeeds in releasing a generic version of the second-generation Sprycel following its success in releasing a generic for the first-generation Gleevec, the company’s status and competitivity in the relevant market is expected to further increase. However, it is difficult to predict the success as the company is in the early stages of the patent challenge. Therefore, attention is focused on whether Boryung Pharmaceutical will be able to open the tightly closed latch for generic versions in Sprycel as in Gleevec.
- Policy
- The MFDS plans to approve Daewoong's Fexuprazan
- by Lee, Tak-Sun Dec 30, 2021 05:51am
- Fexuprazan, a new drug for GERD that Daewoong Pharmaceutical has researched and developed for 14 years, is expected to obtain domestic approval soon. When Fexuprazan is released, Daewoong is expected to fill the gap in the PPI-based treatment Nexium. According to the industry on the 28th, the MFDS completed the safety and effectiveness examination of Fexuprazan and left only the final approval procedure. Fexuprazan applied for an item license to the MFDS in November 2019. Fexuprazan is P-CAB drug such as K-Cab (Tegoprazan, HK inno.N) licensed in July 2018. The advantage of P-CAB-based drugs is that they have a longer gastric acid secretion inhibition effect than conventional PPI-based drugs. Therefore, it is possible to administer regardless of meals. With the launch of K-Cab, the existing PPI-oriented GERD market structure is also changing. K-Cab is expected to achieve 100 billion won in sales this year and has risen to the No. 1 item in the market. Prior to the launch of K-Cab, the No. 1 item in the market was Nexium. Nexium is an imported drug developed by AstraZeneca and has long been sold by Daewoong Pharmaceutical in Korea. AstraZeneca recently terminated its Nexium co-promotion contract with Daewoong Pharmaceutical and chose Ildong Pharmaceutical as a new sales partner. Analysts say that Daewoo's termination of the contract for Nexium, which generates annual sales of 50 billion won, is due to the imminent approval of Fexuprazan. With K-Cab has become the next-generation leader in GERD, so it is predicted that Fexuprazan's launch will quickly resolve the gap in Nexium. If Fexuprazan is approved, it is likely to become the 34th new domestic drug. The MFDS approved two new domestic drugs this year, with No. 32 Leclaza and No. 33 Rolontis (Hanmi Pharmaceutical). If Fexuprazan is approved by the end of this year, three new domestic drugs will be released a year.
- Company
- Donepezil Patch, which is about to be released
- by Dec 30, 2021 05:51am
- Donepezil Celltrion's Donerion Patch, the world's first Donepezil patch, is scheduled to be officially released on the market in the first half of next year. The price of the patch system, which is attached twice a week, is expected to be about 5,000 won per patch. According to the pharmaceutical industry on the 28th, Celltrion Pharmaceutical is collecting hospitals to trade with ahead of the launch of Donerion Patch in the first half of next year. The Donerion Patch comes in two sizes: 87.5 mg/25㎠ and 175 mg/50㎠. If taking oral Donepezil with a dose of 5 mg per day, 87.5 mg/25㎠ can be used, and if taking a dose of 10 mg, 175 mg/50 can be used. The Donerion Patch drug price is expected to be 4,830 won for 87.5 mg/25 and 7,245 won for 175 mg/50. It is used twice a week, so it will be 9,660 won based on 87.5 mg/25 ㎠. In the case of oral Donepezil 5mg, which is taken once a day, it ranges from a minimum of 4,060 won to a maximum of 14,420 won per week. Donerion Patch is the world's first Donepezil patch system developed by Icure and obtained exclusive copyright in Korea by Celltrion. It is an IMD that has been used only for oral purposes due to difficulties in developing formulations and is commercialized as a patch agent that attaches it to the skin. It improved medication compliance and increased convenience for dementia patients who have difficulty taking drugs. Donerion Patch proved the non-equivalence of the treatment effect compared to oral Aricept in a phase 3 clinical trial conducted in patients with mild and moderate Alzheimer's dementia. As of last year, the domestic Donerion market was about 230 billion won, accounting for 80% of the total sales of Alzheimer's dementia treatments. Among them, the original Eisai's Aricept's outpatient prescription amounted to KRW 83.9 billion won. Second place was Ebixa, recording 13.7 billion won.
- Company
- Patents for representative DM drugs are expected to expire
- by Kim, Jin-Gu Dec 29, 2021 05:58am
- Next year, patents for DPP-4 inhibitor-based diabetes treatments such as Tenelia, Onglyza and Galvus will be released one after another. It is predicted that generic companies will join the domestic DPP-4 inhibitor-affiliated diabetes treatment market, which has grown to 600 billion won a year. In the case of generics for Galvus, more than 10 pharmaceutical companies are expected to release generics after January. More than 30 companies are expected to release generics for Tenelia after October. ◆Ahn-gook and Hanmi will launch generic for Galvus in January, and 12 companies will join in March According to the MFDS on the 28th, there are a total of 159 patents for medicines that expire next year. One or more patents for 79 products are scheduled to expire next year. The pharmaceutical industry's attention is focused on diabetes treatments based on DPP-4 inhibitors. This is because patents for major treatments that have emerged in earnest since the late 2000s will expire one by one from next year. The first product whose patent expires is Novartis' Galvus. On March 4 next year, material patents for Galvus and Galvusmet will expire. According to UBIST, a pharmaceutical market research firm, the total prescription amount of Galvus and Galvusmet reached 44.5 billion won as of last year. At the same time as the patent expires, 14 companies are expected to compete for generics. Among them, Ahn-gook and Ahn-gook newpharm succeeded in invalidating 55 days of the extended duration of material patents by winning the patent dispute between Novartis and the Supreme Court. Ahn-gook and Ahn-gook newpharm received the generic for exclusivity until May 29 next year. Hanmi Pharmaceutical also won the dispute with Novartis, eliminating concerns over patent infringement. Hanmi Pharmaceutical was approved for a single drug only by salt change. It can be sold regardless of Ahn-gook's generic for exclusivity. ◆Material Patent for Tenelia, Expired in October, many generics will be released In the fourth quarter of next year, patents for Tenelia, another DPP-4 inhibitor-based diabetes treatment, and Onglyza and Kombiglyze will expire. Tenelia's material patent expires on October 25. Generics overcame all other patents except material patents. This means that generics can be released immediately when only material patents expire. Generics succeeded in invalidating Tenelia's salt patent in December 2019. Since then, MTPK, the original company, has appealed, but even the patent court has sided with generic companies in September this year. The ruling was then finalized when MTPK gave up its appeal to the Supreme Court. Since the Tenelia patent has been invalidated, companies that are not involved in patent disputes after the expiration of the substance patent in October can also launch generic products. Generic competition is expected to be fiercer than other cases. In Korea, 34 companies have already been approved for related generics. ◆Onglyza patent expires in December In December next year, AstraZeneca's DPP-4 inhibitors, Onglyza and Kombiglyze, will expire. In the case of Onglyza, there are no patents other than material patents. Kombiglyze, a combination drug, had one drug license, but it already expired in March 2019. Generic can be released immediately when the material patents of the two products expire. However, generic's interest in Onglyza and Kombiglyze does not seem to be greater than other drugs. None of the pharmaceutical companies have been approved for related generics yet. It is said that no place is preparing for a related biological equivalence test. The total prescription amount for Onglyza and Komblyze last year was 27.6 billion won.
