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- 2025-12-25 12:25:16
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- Expectations rise for prescription of tumor-agnostic drugs
- by Eo, Yun-Ho Jan 03, 2022 05:56am
- Preparations to prescribe`tumor-agnostic' anticancer drugs in the field are well underway. According to industry sources, Bayer Korea’s neurotrophic tyrosine receptor kinase (NTRK) inhibitor Vitrakvi (larotrectinib) has passed the drug committee (DCs) of general hospitals in Korea including the Seoul National University Hospital. Thus, Vitrakvi's prescription is expected to start in earnest when Bayer reaches an agreement with the National Health Insurance Service in the ongoing pricing negotiations. Vitrakvi, which was approved in May last year, is going through the reimbursement listing application process through the pharmacoeconomic evaluation exemption system. In November, the agenda passed the NHIS Pharmaceutical Benefit Evaluation Committee. Roche’s ‘Rozlytrek (entrectinib), Vitrakvi’s competitor with the same mechanism of action, is also undergoing pricing negotiations with the NHIS. Vitrakvi is indicated for use in adult and pediatric patients with solid cancer who have progressed after using conventional treatment options or have no suitable treatment options available that have NTRK gene fusions without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity. In other words, it may be used in virtually most cancer types with an identified NTRK gene. Do-youn Oh, Professor of Oncology at Seoul National University Hospital, said, “After prescribing to a 6-year-old patient with thyroid cancer, Vitrakvi showed such good results that the patient’s cancer mass that had metastasized to the lungs became almost invisible from imaging findings. Also, the side effects that I had concerns about almost did not appear.” Meanwhile, Vitrakvi’s approval was based on data from a Phase I trial on adults 18 years and older, Phase II NAVIGATE study on pediatric and adult patients over the age of 12, and the Phase I/II SCOUT study on pediatric patients aged 1 month to 21 years that included those with primary CNS tumor. According to an efficacy review conducted on 55 patients with identified NTRK fusion in the 3 studies prescribe above, Vitrakvi’s overall response rate (ORR) was 75% and partial response 53% in various cancer types (including soft tissue sarcoma, infantile fibrosarcoma, salivary gland tumors, thyroid cancer, lung cancer, melanoma, colon cancer, gastrointestinal stromal tumor, cholangiocarcinoma, appendiceal carcinoma, breast cancer, and pancreatic cancer) Vitrakvi showed an effect not only in adults but also in pediatric patients. Twenty-four patients aged 1 year or less participated in the studies above, to whom the drub showed the same efficacy as in adult patients. As a result, Vitrakvi was approved for use in both pediatric and adult patients.
- Company
- Samsung Biologics denies rumors of Biogen's acquisition
- by Jan 03, 2022 05:55am
- Biogen shares fluctuated on reports that Samsung Group is trying to acquire U.S. pharmaceutical company Biogen for 50 trillion won. Samsung said, "It's not true."Some media recently observed that Samsung Group has begun negotiations after a preliminary review to acquire Biogen. The acquisition is expected to reach 50 trillion won. Shortly after the report, Biogen shares fluctuated. Biogen shares, which started at $235, soared to a maximum of $265.54, and closed at $258.31, up 9.46% from the previous day. However, Samsung Biologics announced its official position on the 30th that it is "not true at all." Biogen, a multinational pharmaceutical company, was established in the United States in 1978 and is developing treatments mainly for neurological diseases such as stroke and Alzheimer's disease. Last year, annual sales reached $1344 billion (about 15.448 trillion won). In Korea, a corporation was established in 2017 with the SMA treatment Spinraza. Biogen drew attention by offering the first Alzheimer's treatment. The U.S. Food and Drug Administration (FDA) approved the beta-amyloid target drug Aduhelm in June. The FDA External Advisory Committee recommended non-approval with unsatisfactory clinical data, but the FDA granted Aduhelm an item license. However, there were also controversies such as suspicions that Biogen continued to meet FDA members to approve Aduhelm and that it applied to post-hoc to produce good results in phase 3. On top of that, too high drug prices were also a problem. Lower-than-expected sales performance also played a negative role. Biogen shares, which soared to $414.71 with Aduhelm's permission, are on a downward trend. Until early this month, it did not recover to the previous level of $250 to $280. Biogen is putting all its energy into phase 4 clinical trials after Aduhelm's marketing. If Phase 4 fails to prove clear validation data, Eduhelm may be revoked based on FDA judgment. Biogen is also related to Samsung. It co-founded Samsung Bioepis with Samsung Biologics in 2012. Currently, biosimilar products developed by Samsung Bioepis are in charge of global sales.
- Company
- Record number of new homegrown drugs released this year
- by Chon, Seung-Hyun Dec 31, 2021 05:51am
- Domestic pharmaceutical and biopharmaceutical companies this year had received approval for four new drugs. This is the most amount of new drugs released in a single year since the first homegrown drug was introduced in 1999. Major companies with an annual sales record of 1 trillion won such as Yuhan Corp, Celltrion, Hanmi Pharamcetucial, and Daewoong Pharmaceutical have made this performance. According to the Ministry of Food and Drug Safety on the 31st, Daewoong Pharmaceutical’s gastroesophageal reflux disease (GERD) treatment ‘Fexclu,’ which contains fexuprazan, was approved as a new drug on the 30th. Daewoong Pharmaceutical made this achievement in 14 years since it first started the development of Fexclu in 2007. Fexclu is a potassium-competitive acid blocker (P-CAB) GERD treatment. It has a faster onset of action than proton pump inhibitors (PPIs) and has the advantage of being able to be taken regardless of meal ingestion and the longer-lasting effect. These types of drugs had quickly settled in the market since HK inno.N introduced its first P-CAB type of new drug ‘K-CAB’ in 2018. With the approval of Fexclu, a total of 4 new homegrown drugs by local pharmaceutical and biopharmaceutical companies this year. First was Yuhan Corp’s anticancer drug ‘Leclaza’ in January, followed by Celltrion’s COVID-19 treatment ‘Regkirona’ in February and March, and Hanmi Pharmaceutical’s neutropenia treatment ‘Rolontis.’ In January, Leclaza received conditional approval for the treatment of patients with advanced non-small-cell lung cancer who have a mutation in a specific gene (EGFR) who have previously received lung cancer treatment. Leclaza is a targeted anticancer therapy that inhibits the signal transduction that is involved in lung cancer cell proliferation and growth. It is an oral tyrosine kinase inhibitor (TKI) that has high selectivity against the EGFR T790M resistant mutation. It showed superior efficacy and tolerability against lung cancer patients with brain metastasis as it can pass through the blood-brain-barrier (BBB). Celltrion’s COVID-19 antibody treatment ‘Regkirona’ received conditional approval in February. Regkirona Inj. is a recombinant neutralizing antibody produced by selecting a neutralizing antibody gene in a COVID-19 convalescent patient's blood and inserting the selected gene into a host cell that is cultured for large-scale production. Regkirona is the first locally developed COVID-19 treatment and the third COVID-19 antibody treatment in the world to be verified by the regulatory authority. It received marketing approval based on its Phase III trial results in August and its indication was extended to the treatment of high-risk adult patients with mild and moderate symptoms who have been confirmed with COVID-19 according to the provisional pathway. In March, Hanmi Pharmaceutical’s Rolontis Pre-filled Syringe inj. was approved as a new locally developed new drug. Rolontis uses recombinant technology to connect a specific protein to a human’s granulocyte-colony stimulating factor (G-CSF) analog to increase the sustainability of its effect. It is used to treat chemotherapy-induced neutropenia. It binds to the G-CSF receptor to stimulate neutrophil production. This year, domestic pharmaceutical and biopharmaceutical companies have broken the record and received approval for the largest number of homegrown new drugs in a single year, and in three years since HK inno.N received approval for K-CAB in 2018. That these new drugs were released after a long period of time by major companies that recorded annual sales exceeding 1 trillion won - Yuhan Corp, Celltrion, Hanmi Pharmaceutical, and Daewoong Pharmaceutical – is also being considered significant. Yuhan Corp released its second novel drug this year in 16 years since ‘Revancex’ in 2005. Regkirona was Celltrion’s first new drug. Celltrion had focused on biosimilars, but with the spread of COVID-19 in earnest, the company had entered into the treatment development business and succeeded in the commercialization of the treatment within a year. Rolontis is the first new biologic and the only new drug Hanmi Pharmaceutical succeeded in commercializing and is in sale. Hanmi Pharmaceutical had received approval for its NSCLC treatment ‘Olita’ in 2016 but announced the discontinuation of its development after three years, based on the strategic judgment that stopping the development is more beneficial than bearing the cost of Phase 3 clinical trial. Daewoong Pharmaceutical succeeded in developing a new drug in 20 years since Easyef in 2011. It is evaluated that the potential of success of Fexclu is high as the same class drug K-CAB’s marketability was recognized in the industry.
- Company
- 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.
- 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.
- 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.
