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- 2025-12-23 22:28:39
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- Gilead’s HCV drug occupies 19% of HCV market in 5 mths
- by Kim, Jin-Gu May 02, 2023 05:35am
- Gilead Science’s new hepatitis C treatment has made a successful soft landing in the market and derived good initial results. Epclusa and Vosevi, which were released in November last year, increased their market share to 19% in the oral hepatitis C treatment market in Q1 this year. On the other hand, the market share of Abbvie’s Mavyret, which previously dominated the market, fell from 81% in Q1 2022 to 74% in Q1 this year. ◆ The first new Gilead HCV drugs to be released in 8 years expand market share to 19% On the 2nd, according to the market research institution UBIST, the outpatient prescription sales of Gilead’s Epclusa reached KRW 1.1 billion in Q1 this year. During the same period, Vosevi’s sales recorded a prescription amount of KRW 500 million. The two drugs have occupied 19% of the total HCV market. Considering that it has been 5 months since its release, their performance is considered to be fair. Both products are HCV treatments released by Gilead in November last year. The company sought to recreate the glory it had enjoyed with Harvoni and Sovaldi with Epclusa and Vosevi. Gilead’s Harvoni and Sovaldi had once dominated the HCV treatment market. The drugs quickly replaced existing drugs with their release and recorded over KRW 100 billion in combined prescriptions in 2017. Its share soared to 77%. However, the situation changed with the introduction of the pan-genotypic treatment ‘Mavyret.’ can be used for patients with hepatitis C virus types 1 to 6, while Harvoni cannot be used for types 3 and Sovaldi cannot be used for types 5 and 6. The long treatment period of 12 weeks, compared to 8 weeks for Mavyret, also worked as a weakness for Harvoni and Sovaldi. Since then, Harvoni and Sovaldi's market share, which had reached 77% in 2017, fell sharply to 21% the following year. Last year, their share fell even further to 17%. Sovaldi’s sales fell to the extent that it faced the risk of revoking its marketing authorization during reevaluation review in 2021. ◆ Mavyret’s stronghold over the market falters after the introduction of Epclusa and Vosevi On the other hand, Mavyret quickly expanded its market share. In its first year of release, its shares soared from 12% in 2018 to 71% in 2019. Its share further increased to 85% last year, virtually dominating the HCV treatment market. In this situation, Gilead released a new hepatitis C treatment for the first time in eight years, heralding the return of the former market leader. In particular, Gilead set a lower price tag than Mavyret, expressing its will to retake the lead in the HCV market. Epclusa is priced at KRW 117,030 per tablet, and Vosevi KRW 120,836 per tablet. In terms of total treatment cost, Epclusa costs KRW 9,830,520 and Vosevi 10,150,224. This is cheaper than the KRW 10,922,352 it costs with Mavyret. The industry expects that although the treatment period of Epclusa and Vosevi is still longer than that of Mavyret by 12 weeks, their lower price and convenience in intake will further drive their occupation of Korea’s HCV treatment market. Epclusa is a pan-genotypic treatment like Mavyret. The treatment period is 12 weeks, which is about a month longer than that of Mavyret, but its administration of 1 tablet a day is simpler than that of Mavyret’s 3 tablets a day. In fact, Mavyret’s sales have been faltering since the introduction of Epklusa and Vosevi. Mavyret recorded prescription sales of KRW 6.4 billion in Q1, which is a 26% decrease from the KRW 8.6 billion it had raised in Q1 last year. Its market share has also fallen 7%p from 81% to 74%. ◆Made a successful soft landing, but the reduction in overall market size still remains a concern However, the contracting HCV treatment market remains a concern for the comapny's new treatment release. In fact, the size of the oral HCV treatment market has steadily decreased from KRW 135.3 billion in 2017 to KRW 73.7 billion in 2018, then to KRW 65.1 billion in 2019, and KRW 47.4 billion in 2020, KRW 35.1 billion in 2021, then to KRW 34.2 billion in 2022. Compared to 2017, when the market had expanded to its maximum, the market had shrunk to a quarter in 5 years. The industry pointed to the characteristics held by the HCV treatments as a cause of the market contraction. Before the introduction of direct-acting antivirals (DAAs) like Mavyret, HCV had been a very critical condition. However, the treatment effect of HCV drugs had increased dramatically with the introduction of BMS’s Daklinza and Sunvepra. With Gilead Sciences' Sovaldi and Harvoni, MSD’s Zepatier, and Abbvie’s Mavyret that followed, the treatment effect had further increased. With the treatment effect high enough to be close to a complete cure, the market size quickly contracted with the number of patients being prescribed the drug increasing within the finite number of patients in the market.
- Company
- SK Bioscience, Investing 2.4 trillion won over 5 years
- by Kim, Jin-Gu Apr 30, 2023 09:46am
- SK Bioscience has decided to invest 2.4 trillion won over the next five years. SK Bioscience announced on the 27th at 2:00 pm that it would announce its mid-to-long-term growth strategy to stock analysts and institutional investors. According to the disclosure, SK bioscience will spend 2.4 trillion won over the five years from this year to 2027 to ▲secure overseas production bases, ▲expand sales of SKYBAX, a vaccine developed in-house, ▲do CDMO business, and ▲premium vaccine business. are going to invest First of all, it secures a global production base that meets the environment and needs of each country around the world and creates various profit models to advance its assets. It plans to increase sales of SKYBAX, a self-developed vaccine project, to 220 billion won by 2024. Prior to this, the target for this year was set at 110 billion won. At the same time, the CDMO business is also in full swing. The plan is to expand the existing vaccine CDMO targeting global big pharma and promote a new bio CDMO centered on CGT. It is also accelerating its premium vaccine business. The phase 3 clinical plan for SKYBAX, a next-generation pneumococcal vaccine, will be finalized within this year, and HPV-10, a human papillomavirus (HPV) preventive vaccine, will be released in 2027. SK Bioscience expects the new HPV vaccine to generate cumulative sales of more than 2.5 trillion won over the three years after its release. It plans to launch a recombinant shingles vaccine in 2027, and to raise cumulative sales of more than 600 billion won over the next three years. SK Bioscience's sales, which were 929 billion won in 2021, decreased by 51% to 456.7 billion won last year. Operating profit fell 76% from 474.2 billion won to 115 billion won over the same period. SK Bioscience saw a surge in sales and operating profit in 2021 while consigning production of the Novavax vaccine. Sales, which stopped at 225.6 billion won in 2020, increased more than 4 times in a year, and operating profit also increased more than 12 times from 37.7 billion won. However, due to a decrease in the global corona vaccination rate, the consignment production of Novavax vaccine decreased, and as the production of existing products was stopped due to Novavax's vaccine stock change, both sales and operating profit of SK Bioscience decreased significantly.
- Company
- Hanmi, sales and operating profits highest in 8 years
- by Chon, Seung-Hyun Apr 28, 2023 05:49am
- Hanmi Pharmaceutical showed improved performance in the first quarter. Thanks to the high growth of new combination drugs such as Rosuzet and Amosartan family, both sales and operating profit recorded the highest level in eight years. Hanmi Pharmaceutical announced on the 26th that its operating profit in the first quarter was 60.5 billion won, up 47.9% from the same period last year. Sales were 361.7 billion won, up 12.6% from the previous year, and net profit was 49.6 billion won, up 98.1%. Both sales and operating profit are the highest since the fourth quarter of 2015. 2015 was a time when Hanmi Pharm recorded record-breaking performance by successively signing contracts for the export of super-large new drug technologies with Lilly, Boehringer Ingelheim, Janssen, and Sanofi. At this time, Hanmi Pharm reflected part of the down payment received from the technology transfer contract in its performance, and Hanmi Pharm posted sales of 589.9 billion won and an operating profit of 171.5 billion won in the fourth quarter of 2015 alone. The combination of new drugs developed by Hanmi Pharm with its research and development (R&D) capabilities led to an upward trend in performance. According to UBIST, a drug research institute, Hanmi Pharm raised the highest outpatient prescription amount of 219 billion won in the first quarter, taking the lead among domestic and foreign pharmaceutical companies. It rose 7.0% from the previous year, predicting the lead for six consecutive years. Hanmi Pharmaceutical ranked first in prescription performance for the first time in 2018 and then ranked first for five consecutive years until last year. Rosuzet, a combination drug for hyperlipidemia, recorded 41.5 billion won in prescriptions in the first quarter, up 13.1% from the previous year. Among all pharmaceuticals, it ranked second after Lipitor. Rosuzet, launched at the end of 2015, is a hyperlipidemia complex consisting of two ingredients, Rosuvastatin and Ezetimibe. Rosuzet is experiencing rapid growth thanks to market dominance and the popularity of its statin/ezetimibe complex. Rosuzet exceeded 100 billion won in prescriptions for three consecutive years from 2020. Rosuzet has been recording more than 10 billion won in prescriptions for 25 consecutive months from March 2021. Domestic pharmaceutical companies are entering the statin/ezetimibe market in droves and competing overheated, but Rosuzet has continued to grow rapidly based on its accumulated reliability. The Amosartan family also showed off their health. Hanmi Pharmaceutical is selling Amosartan Plus, Amosartan Q, and Amosartan X-Q, along with Amosartan, a combination drug that combines amlodipine and losartan ingredients. Amosartan Plus is a combination of three drugs: amlodipine, losartan, and chlorthalidone. Amosartan Q is a combination drug in which rosuvastatin, a hyperlipidemia treatment, is added to Amosartan. Amosartan XQ, released last year, is a product that combines amosartan with rosuvastatin and ezetimibe. Amosartan prescriptions in the first quarter were 22.1 billion won, up 3.6% from the previous year. Amosartan Plus posted 7.6 billion won, up 6.5% from the previous year, and Amosartan XQ recorded 2.3 billion won, more than doubling from the first quarter of last year. Beijing Hanmi Pharm, a local subsidiary in China, recorded sales of 111 billion won in the first quarter, up 17.% from the previous year, surpassing 100 billion won in sales in the first quarter. Operating profit and net profit were 30.8 billion won and 27.9 billion won, up more than 20% from the previous year, respectively. Compared to the same period last year, Beijing Hanmi Pharmaceutical’s main product, ‘Mommy I’, a children’s stomach medicine, grew by 31.6%, while ‘LiTong’, a laxative, and ‘Ambroxol HCl solution for inhalation’, a cough medicine, grew by 40% and 174.8%, respectively.
- Company
- Dupixent attempts to expand its reimb to infants in KOR
- by Eo, Yun-Ho Apr 28, 2023 05:49am
- Dupixent is attempting to expand insurance reimbursement to infants after succeeding to reimburse the drug to children. Dailpharm’s coverage showed that Sanofi-Aventis Korea recently submitted an application for an extension of reimbursement for infants aged 6 months to 5 years of age for its atopic dermatitis treatment Dupixent (dupilumab). Whether Dupixent, which has succeeded in expanding reimbursement to the long-awaited children and adolescent indication this month, will be able to expand its prescription area once again is gaining attention. In November last year, Dupixent expanded its indication as an atopic dermatitis treatment to the treatment of moderate-to-severe atopic dermatitis in infants aged 6 months or older whose condition is not adequately controlled despite the use of topical treatments or is not eligible for their use due to side effects. 85-90% of atopic dermatitis symptoms appear in children under the age of 5 years, and in particularly severe cases with severe symptoms, the disease may persist or recur until adulthood. However, treatments approved for patients with moderate to severe atopic dermatitis under the age of 5 are limited to topical treatments, and systemic treatments that can be used for patients who are not controlled by topical treatments are limited due to the risk of long-term skin atrophy or infection. Meanwhile, the effectiveness of Dupixent for infants was confirmed through the Phase III LIBERTY AD PRESCHOOL trial. The study evaluated the efficacy and safety of Dupixent in patients with atopic dermatitis who were not adequately controlled with topical treatments aged between 6 months and 5 years. Results showed that Dupixent significantly improved skin lesions. 28% of patients treated with Dupixent plus topical corticosteroids (TCS) had an IGA score of 0 (clear) or 1 (almost clear) skin compared to 4% with placebo (p=
- Company
- Antidiabetic Tenelia market rises 67% with entry of generics
- by Kim, Jin-Gu Apr 27, 2023 05:43am
- The teneligliptin antidiabetic market has expanded 1.7 times in a single year. This is analyzed to be influenced by the large amount of generics that entered the market in October last year. Only 5 months after its launch, prescriptions of Tenelia generics that were launched exceeded KRW 10 billion, and their market share grew to 41%. ◆ Tenelia generics Market share increased to 41%…most products sell less than KRW 300 million According to the market research institution UBIST, outpatient prescriptions of the teneligliptin antidiabetic drugs market rose to reach KRW 20.5 billion in Q1. This is a 67% market increase from KRW 12.3 billion in Q1 2022. The addition of teneligliptin generics led to the expansion of the overall market size. Thirty-seven domestic companies have released a large number of generics after the expiration of Tenelia's substance patent on October 25 last year. For the 2 months since December last year, Tenelia generics raised KRW 3.4 billion in prescriptions. Prescriptions then increased to KRW 8.4 billion in Q1 this year. In just 5 months since their release, cumulative prescriptions rose to exceed KRW 10 billion. The share of teneligliptin in the antidiabetic drug market has risen from 21% in Q4 last year to 41% in Q1 this year. However, no specific generics among the 37 companies have shown prominence. In Q1 last year, Daewon Pharmaceutical's Tenetin·Tenetin M and Mothers Pharm’s Teneglip Tab·Teneglip M each recorded KRW 900 million, Jeil Pharm's Tenepil and Tenepil Plus recorded KRW 800 million, and all others were less than KRW 300 million. ◆Due to no drug price cuts, sales of original fell only 2% in one-year The original product, Handok’s Tenelia and Tenelia M recorded KRW 12 billion in prescriptions in Q1. This is a slight decrease from the KRW 12.3 billion in Q1 last year. The release of generics has not greatly impacted the sales of the original. In general, the price of original drugs falls 30% with the release of their generics. The next year, the price falls further to 53.55% of the existing price. However, the price of Handok’s Tenelia and Tenelia M have stayed the same as before. This is because the Tenelia generics have used a different salt formation from the original. The original Tenelia uses hydrobromide, and the generics use hydrochloride or ditosylate. The National Health Insurance Service only discounts the price of drugs when a drug with the 'same formulation' as the existing product applies for reimbursement. The same formulation there means a case in which not only the ingredients but also the route of administration, dosage, method of intake, formulation, efficacy, and effect are identical. In other words, Tenelia generics are not interpreted as the same drug because the salt was different from the original product, and the drug price of the original product was not lowered as a result. ◆Januvia price falls 9%·Trajenta’s price falls 3%…negatively affected other DPP-4 antidiabetics On the other hand, other DPP-4 inhibitor-type antidiabetics, such as Januvia (sitagliptin) and Trajenta (linagliptin) were more affected by the release of Tenelia generics. In fact, the total prescription amount of MSD’s Januvia, Janumet, and Janumet XR in Q1 was KRW 37.9 billion, a 9% decrease from KRW 41.7 billion in Q1 2022. In the case of the Januvia series, sales have also partially fallen due to the impurity issue. MSD had voluntarily recalled 2 lot numbers of Januvia 50mg from March 13 because excess nitrosamine impurities, 'Nitroso-STG-19 (NTTP),' was detected in some Januvia 50mg products. However, MSD announced that the products to be recovered are only 0.35% of the total quantity. Boehringer Ingelheim’s Trajenta and Trajenta Duo had fell 3% from KRW 32.7 billion to KRW 31.7 billion in one year. Sales of Celltrion Pharm’s Nesina series fell 8% from KRW 8.7 billion to KRW 8 billion. However, LG Chem’s Zemiglo series increased by 1.1% from KRW 34.6 billion to KRW 35 billion. The sales of Novartis’s Galvus series, whose generics were released before Tenelia, had fallen 25% from KRW 9.9 billion to KRW 7.4 billion. In the same period, the total prescription amount of Galvus generics had increased by 5 times from KRW 1.2 billion to KRW 5.7 billion. The share of its generics in the market rose to 44% in Q1.
- Company
- Need strong cost control for biopharmaceuticals in 2nd half
- by Jung, Sae-Im Apr 27, 2023 05:43am
- It was predicted that the pharmaceutical and bio sectors would continue their unstable trend in the second half. It has emerged as the biggest challenge for small and medium-sized enterprises (SMEs) to withstand the harsh cold weather of the financial crisis through strong cost control. In the second half of the year, if interest rates peak and good results are achieved in promising fields such as Alzheimer's disease, ADC, and cell genes, it is predicted that the lost fighting spirit will be restored. Park Byeong-guk, researcher at NH Investment & Securities Park Byeong-guk, a researcher at NH Investment & Securities, said at the '2nd Daily Family Day' held by Daily Partners, a bio-specialized venture capital (VC), on the 26th, "In 2021 and 2022, the pharmaceutical bio sector was hit hard by rising interest rates and the economic recession. It was not included in the growth stocks in the first quarter of this year due to low market expectations,” he said. Recently, stock prices of biopharmaceuticals, excluding some large companies, have fallen significantly. According to researcher Park, the share of KOSPI pharmaceuticals and KOSDAQ pharmaceuticals is only 5.7% and 10.6%, respectively. Compared to September 2020, the peak, decreased by 3.2%p and 5.3%p. The global pharmaceutical bio also showed a similar trend. The stock price growth rate of the top 10 S&P 500 healthcare companies has fallen since 2021, and on the contrary, the decline of the bottom 10 companies has increased even more. In particular, it is analyzed that the decline was greater as the rise in interest rates had a great impact on the pharmaceutical bio sector. As a result of the knock-on effect, investment in the biopharmaceutical industry has shrunk significantly. In the first quarter of this year, US pharmaceutical and bio VC investments amounted to about US$ 3.7 billion, down 45% from the previous year. Investments were made mainly by large VCs, and the proportion of small funds with less than $50 million showed a decreasing trend. Domestically, the situation is more serious. Researcher Park said, "The amount of investment in the fund in 2021 was about 1 trillion won, and a matching fund was made with this amount, but the size decreased to 500 billion won in 2022. This year's budget is smaller." BDC) has been announced, but there is no way to open it yet, so the difficult situation continues.” As the risk increased, the issuance of mezzanines (CB, BW, EB), a major financing channel for biotechs, decreased. As of the end of October 2022, the cumulative mezzanine issuance of domestic KOSPI and KOSDAQ pharmaceutical companies was 385 billion won, down 73% from the previous year. It is expected that the unstable situation will continue in the second half. Researcher Park said, "There is a higher probability of interest rate cuts in the third quarter of this year. However, the economy is getting worse and worse, and there is still uncertainty as the worst situation can come out when prices are not set and interest rates cannot be lowered." This was reflected in growth stocks, but the bio sector was classified as a defensive stock and did not recover its fighting spirit." Anxiety in the biotech industry is rising. An official from the biotech industry who attended the event said, "Biotechs have to face the second half right away, but I don't know how to really prepare to survive." Researcher Park said, “Survival of biotech companies has become the most important issue.” “At this point, cost control is the most important. It can be done. It is different from an investor's point of view. Those aspects are seen very positively," he advised. Researcher Park said, "Last year's Nasdaq bio sector IPO results were not good, but there was one company that drew attention among them. It is a 4th-generation genetic scissors company. There needs to be a lot of clinical data that can raise the market prospects like this." "Investor sentiment will be able to recover if positive news such as approval and ADC Enhertu's expansion of solid cancer indications and interest rate peak outs are added."
- Company
- Yuhan’s Q1 operating profit rose fourfold this year
- by Chon, Seung-Hyun Apr 27, 2023 05:43am
- Yuhan Corp showed improved performance in Q1 compared to the previous year. A large amount of revenue from contract development and manufacturing (CDMO) royalties flowed in from its subsidiary Ad Pharma. Yuhan Corp announced on the 26th that operating profit based on its consolidated financial statements in Q1 was KRW 22.6 billion, which is a 3.7-fold increase from the KRW 6.1 billion in the same period of the previous year. Sales were KRW 443 billion, up 7.8% from the previous year. Yuhan Corp Its royalty revenue has increased significantly from KRW 1.5 billion in Q1 last year to KRW 7.2 billion. Yuhan Corp has signed licensing-out deals for new drug technologies from 5 global pharmacuetical companies including Janssen Biotech, Gilead Bioscience, Boehringer Ingelheim, and Processa Pharmaceuticals. Other than Processa Pharmaceuticals which had paid its upfront payment with stock, the company is recognizing the upfront payment and milestone payments from the other 4 companies in installments. In Q1, CDMO royalties have come in from its subsidiary Ad Pharma. Ad Pharma is a company specializing in the development of incrementally modified drugs. Ad Pharma has recently developed a rosuvastatin+ezetimibe combination and obtained consignment approvals from Jeil Pharmaceutical and GC Pharm. The company had also acquired Ad Pharma, a company specializing in incrementally modified drugs, for KRW 3 billion in 2017 and invested an additional KRW 7 billion last year. As of the end of last year, Yuhan Corp.'s stake in Ad Pharma was 67.7%. Yuhan Corp’s flagship businesses, including prescription drugs and over-the-counter drugs, also performed well. Sales of Yuhan Corp’s prescriptions in Q1 had increased 8.0% YoY from KRW 261 billion. Its diabetes treatment Jardiance rose 63.6% YoY to KRW 17.9 billion, and its hyperlipidemia treatment rosuvamibe made KRW 16.2 billion, recording a 63.6% rise in sales. Its over-the-counter drug sales have also increased 6.2% from the previous year to record KRW 55 billion. Sales of its non-steroidal anti-inflammatory drug antiphlamine rose 28.5 % from KRW 6.1 billion last year to KRW 7.7 billion. Its overseas sales in Q1 had also increased 24.3% from the previous year to a record KRW 69.2 billion. Yuhan Corp purchases APIs medicines produced by Yuhan Chemical and exports them to multinational pharmaceutical companies.
- Company
- GSK, cash equivalents of 250,000 won
- by Jung, Sae-Im Apr 27, 2023 05:41am
- GSK Korea's cash flow is rapidly deteriorating. It has not been able to generate cash through operating activities for three consecutive years, so money is not circulating. Cash equivalents fell to 250,000 won. Short-term borrowings borrowed to raise operating funds exceeded 90 billion won. According to the Financial Supervisory Service on the 24th, as of the end of last year, GSK Korea's cash and cash equivalents were 250,000 won, a decrease of about 100% from the previous year (15.1 billion won). Cash and cash equivalents, which were 33.2 billion won in 2018, gradually decreased to 14.9 billion won in 2019 and 6.1 billion won in 2020, and then bottomed out in 5 years. The company's cash equivalents bottomed out because cash outflows from operating activities continued for the third consecutive year. GSK Korea's cash flow from operating activities turned to an outflow of 3.6 billion won in 2020, and the amount of outflow soared to 36.5 billion won in 2021. Last year, the situation worsened with an outflow of 80.6 billion won. Looking at last year's operating cash flow excluding interest and corporate tax, the increase in trade receivables and inventories had a negative impact last year. According to GSK Korea's 'change in assets and liabilities due to operating activities' account, there was no cash flow of 24.7 billion won due to an increase in trade receivables. Accounts receivable refers to the amount of money sold by a company on credit. If sales increase on the books due to selling goods, but actual cash does not come in due to credit transactions, it is marked with a minus sign (-). The larger the negative value, the greater the number of credit transactions without payment. Compared to the previous year (6.2 billion won), account receivables increased by 30 billion won. Inventories also increased by 22.1 billion won from the previous year. GSK Korea purchases finished products from the headquarters, stocks them up, and sells them in Korea. Last year, the company suffered a cash outflow of 37.9 billion won because it could not sell goods as much as its inventory increased. As the working capital burden increased, GSK Korea's trade receivables and other receivables (accounts receivable) reached 158.7 billion won at the end of last year based on book value. This is a 19% increase over the previous year. During the same period, inventory increased by 70% from 77.7 billion won to 132.3 billion won. Companies running out of cash are raising operating funds with short-term borrowings that must be repaid within one year. GSK Korea, which borrowed 50 billion won in 2021, borrowed an additional 41.5 billion won last year. It also carried out a paid-in capital increase of 28.2 billion won. GSK headquarters and affiliate Stiefel participated in the paid-in capital increase. In particular, while new short-term borrowings have soared to 91.5 billion won in the last two years, liquidity concerns have grown as the cash equivalents currently held are only 250,000 won. Currently, short-term borrowings amount to 380,000 times cash equivalents. Trade and other debt liabilities to be paid within one year were also tallied at 39.3 billion won. To make matters worse, sales also declined last year due to the absence of new products and the suspension of vaccine supply. As the cost of sales increased, the operating profit also turned to the red. Last year, sales decreased by 9.4% from the previous year (304.4 billion won), and operating profit turned into a loss of -6.1 billion won. GSK Korea is trying to turn things around this year with Shingrix, a new shingles vaccine. Although Shingrix is more expensive than existing vaccines, it has changed the game in the global market with its overwhelmingly high preventive effect. Shingrix, which was officially released in Korea in December last year, is being sold in earnest in hospitals and clinics this year.
- Company
- GSK launches 90 cap pkg of Duodart for prostatic hyperplasia
- by Jung, Sae-Im Apr 27, 2023 05:40am
- GSK Korea (Robert Kempton, CEO of Korean corporation) announced on the 24th that it will release a 90-capsule large-capacity package of Duodart, a treatment for prostatic hyperplasia. With this release, one package can be taken for three months. The recommended dosage of Duodart is 1 capsule once daily. The Duodart 90-capsule package was sequentially supplied to wholesalers nationwide starting this month. Duodart is a 5α-reductase inhibitor (Dutasteride) + α-blocker (Tamsulosin hydrochloride) fixed-dose combination drug that was first released in Korea. The two ingredients are contained in one capsule to improve symptoms quickly and reduce the long-term risk of disease progression. It can be expected to improve medication compliance, such as minimizing the frequency of drug use, reducing the possibility of patient omissions, and simplifying treatment schedules. With the launch of this large-capacity package, GSK Korea plans to continue its efforts to improve medication compliance, which is inevitable in the treatment of benign prostatic hyperplasia. Prostatic hyperplasia is a chronic disease whose prevalence increases with age, and it is known that elderly patients are at high risk of taking multiple drugs that require attention. Multidrug use can lead to non-compliance with medications, and low medication compliance in patients with BPH has a high risk of complications such as acute urinary retention, renal failure, neurogenic bladder, BPH-related surgery, urinary tract infection, and stone formation. Lee Dong-hun, executive director of GSK Korea CEP (Core Established Products for Patients) BU Head, said, “Duodart, the first 5α-reductase inhibitor and α blocker fixed-dose combination drug in Korea, is designed to help patients with benign prostatic hyperplasia in Korea more conveniently and effectively manage their disease. I will do my best,” he said.
- Company
- Generic SPC therapies challenge 'Trajenta'
- by Kim, Jin-Gu Apr 25, 2023 05:56am
- Product photo of Trajenta Major generic companies are challenging the unlisted patent of 'Trajenta (linagliptin)', a DPP-4 inhibitor-based diabetes treatment. For 6 months since last September, 10 pharmaceutical companies have successively filed trials on 7 patents. It is believed that the companies are aiming for the release of Trajenta generics and Trajenta+Forxiga (dapagliflozin) combination products, as the product patent expires next year. According to the pharmaceutical industry, Sinil Pharmaceutical, Hutecs Korea Pharmaceutical and Hanlim Pharm recently simultaneously filed a defensive confirmation trial for the scope of rights and invalidation trial on three unlisted patents, on the 24th. The patents are for separate formulation patents that expires in April 2027. Since last September, challenges to unlisted patents of Trajenta have been continuing. In September of last year, Genuone Sciences have first filed for a defensive confirmation trial for the scope of rights against a formulation patent that expires in April 2027. Since then, Korea United Pharm, Korea Biochem Pharm, Sinil Pharmaceutical, Hutecs Korea Pharmaceutical, Hanlim Pharm, etc. have joined the challenge. In last October, Genuone Sciences, Boryung, Mother's Pharmaceutical, Kukje Pharm, and GC Biopharma have filed for invalidation trials against three different use patents of Trajenta, which expires in May 2027. In the last 7 months, 10 generic companies have challenged 7 unlisted patents of Trajenta. The patents are not listed in the Ministry of Food and Drug Safety Patent List. From the generic companies' standpoint, there is no problem in obtaining approval for a generic without challenging the patents. However, the matter becomes different when it comes to releasing an actual product. Administratively, it is possible to release a product at the time of the expiration of the patent, but there is a risk of being involved in a patent infringement lawsuit with the company of the original product. If the original company files for a patent infringement lawsuit as well as an injunction to prevent the release of the general product, the release date of the product may be delayed. This is because if the patent infringement lawsuit is lost, it could lead to a damages suit. It seems that the generic companies are challenging unlisted patents of Trajenta to resolve such uncertainties. If they succeed in avoiding or invalidating the unlisted patents of Trajenta, it could trigger the early release of generics after the product patent of Trajenta expires in June next year. In 2015, generic companies simultaneously challenged the crystalline form patent and product patent of Trajenta. However, they failed to overcome the product patent. The companies plan to release generics in June next year, as the product patent of Trajenta expires. The fact that the patent for Forxiga, an SGLT-2 inhibitor-based diabetes treatment, expired in March also seems to be a reason why generic companies are challenging an all-out attack on the unlisted patents of Trajenta. As reimbursement has recently been applied to DPP-4 inhibitors, SGLT-2 inhibitors and Metformin combination triple therapies, the combination therapy of such ingredients are expected to attract tremendous attention in the prescription drug market. It is expected that the generic companies will be releasing combination products of 'Linagliptin+Dapagliflozin' as the patent for Trajenta expires. Among major DPP-4 inhibitor-based diabetes treatments, the patents for Norvatis's Galvus (Vildagliptin) and Handok's Tenelia (Teneligliptin) have been expired. However, generic companies have been greatly interested in Januvia (Sitagliptin) and Trajenta, as the two were ranking first and second in the prescription drug market among the existing DPP-4 inhibitors. The product patent for Januvia will be expired in September this year. According to UBIST, a pharmaceutical market research institute, the prescription amount of Trajenta last year was KRW 64.2 billion. Trajenta Duo, in which metformin was added to Trajenta, recorded a prescription performance of KRW 68.3 billion.
