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2026-04-10 08:38:09
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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=
Policy
Dual punishment for CSO rebate excluded from review
by
Lee, Jeong-Hwan
Apr 28, 2023 05:49am
An amendment to the Medical Service Act that applies a dual punishment system when doctors receive rebates paid by pharmaceutical contract sales organizations (CSOs) and an amendment to the Pharmaceutical Affairs Act to prohibit potential hospital/pharmacy owners and brokers from exchanging illegal hospital subsidies in exchange for prescriptions has been omitted as an agenda of the plenary meeting of the National Assembly’s Legislation and Judiciary Committee that was set to be held in the afternoon (27th) However, the amendment to the Pharmaceutical Affairs Act, which legislates the factual survey of illegally opened and operated pharmacies and publicly announces the results of illegally confirmed pharmacies, and the Narcotics Control Act, which grants pharmacies the right to refuse prescriptions of insolvent drugs that are suspected of forgery or missing some of the mandatory information, will be reviewed by the Legislation and Judiciary Committee. The bill for the illegal pharmacy factual survey and their public disclosure and refusal to dispense poor drug prescriptions are expected to be reviewed at the NA’s plenary session scheduled for tomorrow (27th) if they pass the Legislation and Judiciary Committee review. If the two bills pass the plenary session, pharmacies that have not gone through proper procedures, such as face-to-face pharmacies, will be regularly managed and regulated through factual surveys, and punitive public announcements will be possible. If passed, the difficulties front-line pharmacies have dispensing prescriptions for drugs that are suspected of being counterfeit or poor drug prescriptions issued by medical institutions without essential information such as the patient's resident registration number, will be improved. However, the bills to ban CSO rebates and illegal hospital subsidies for doctors and pharmacists will not be passed at the plenary session held this month due to the delay in their Legislation and Judiciary Committee review. In particular, the exclusion of the bill to ban CSO rebates for doctors from the Legislation and Judiciary Committee review leaves room for regret. This is because the CSO reporting system passed the plenary session of the National Assembly last month, and regulatory synergies were expected in the future when the National Assembly passed the CSO rebate ban bill this month. Legislation of the bill to ban collusion activity between pharmacies and medical institutions for prescriptions was supposed to add 'a person who intends to open an institution’ and the bill to eradicate illegal hospital subsidies and punish brokers who mediate collusions has also been delayed with the exclusion of their review by the Legislation and Judiciary Committee. In addition, a partial amendment to the National Health Insurance Act, which will enable stable financial support for health insurance by extending the effective period of state treasury support for the National Health Insurance Service to 'December 31, 2027' will also be proposed for review by the Legislation and Judiciary Committee today.
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.
Policy
JW Pharma Hemlibra will be reimbursed starting in May
by
Lee, Tak-Sun
Apr 25, 2023 05:56am
JW Pharma's Hemlibra will also be covered for patients with severe non-antibody hemophilia A from May. Previously, this drug was covered only for hemophilia A patients with antibodies. This increase in coverage is expected to greatly contribute to the quality of life of patients with severe non-antibody hemophilia A, especially pediatric patients. According to the industry on the 21st, Hemlibra has been used as a daily prophylaxis to reduce or prevent bleeding frequency in patients with severe hemophilia A (congenital factor VIII deficiency) who do not have factor VIII inhibitors since May. Even if you use it, the salary will be applied. In other words, severe hemophilia A patients without antibodies can receive health insurance benefits when using Hemlibra. In the meantime, non-antibody hemophilia patients have been using intravenous treatment two to three times a week. Hemlibra is expected to be more convenient than existing intravenous treatments because the preventive effect lasts with subcutaneous injections from once a week to once every 4 weeks. In particular, it is analyzed that it will help improve the quality of life of pediatric patients. In the parliamentary audit last year, the rapid payment of Hemlibra for pediatric patients with non-antibody hemophilia was also an issue. According to the 2019 Hemophilia Foundation White Paper, among a total of 1,746 patients with hemophilia A in Korea, 78 were antibody patients and 1589 non-antibody patients were resistant to the existing treatment (factor 8 drug). Among them, severely ill patients accounted for 1259 (72.1%). Hemlibra is a treatment for hemophilia A developed by Chugai, a subsidiary of Roche, in Japan. This time, Hemlibra's drug price will be reduced as reimbursement increases. The 30mg/1mL product is adjusted to 2.28 million won per bottle, 60mg/0.4mL to 4.56 million won, 90mg/0.6mL to 6.84 million won, 0.105g/0.7mL to 7.98 million won, and 0.15g/1mL to 11.4 million won. From May, Chinese pharmaceutical company BeiGene's anti-cancer drug 'Brukinsa 80mg' will be covered. This drug is reimbursed for the treatment of Waldenstrom's macroglobulinemia (WM). Waldenstrom's macroglobulinemia (WM) is a rare blood cancer in which the bone marrow produces large numbers of abnormal white blood cells that crowd out healthy blood cells. The US FDA approved Brukinsa as a treatment for WM in September 2021. In Korea, it is attracting attention as it is the first case in which a Chinese new drug entered the right to benefit. Brukinsa is priced at 34,100 won per capsule. Expenditure cap RSA is applied to this drug.
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.
Company
BeiGene’s ‘Brukinsa’ to be prescribed in general hospital
by
Eo, Yun-Ho
Apr 25, 2023 05:56am
Chinese pharmaceutical company BeiGene Korea's first new drug, 'Brukinsa', has been approved to be prescribed in general hospitals. According to sources from related industry, the BTK inhibitor Brukinsa (Zanubrutinib) has passed the Drug Committee of tertiary hospitals such as Samsung Medical Center, SNUH, and Asan Medical Center. As reimbursement is expected to be applied in May, it is believed that prescriptions will be available quite soon after being listed. Brukinsa has been approved in Korea in 2022, as ▲ monotherapy for adults with mantle cell lymphoma (MCL) who have received at least one prior therapy, and ▲ monotherapy for adults with Waldenström's macroglobulinaemia (WM) who have received at least one prior therapy. Among them, reimbursement is for the 'Waldenström's macroglobulinaemia' indication. After approval, only the reimbursement standard for WM was introduced and has been set at the HIRA's Review Committee for Cancer Diseases. In September of the same year, the company tried to add MCL to the list, but the results were not good. Since then, Brukinsa passed the Drug Benefit Evaluation Committee in February of this year and has recently concluded drug price negotiation and is set to be finally listed. Brukinsa is a targeted anticancer medicine that inhibits the survival and proliferation of malignant B cells by blocking the Bruton's tyrosine kinase protein, a signaling molecule that affects the survival and development of B cells. BTK inhibitors approved in Korea include Janssen's Imbruvica (Ibrutinib), AstraZeneca's Calquence (Acalabrutinib), and Ono Pharmaceutical's Velexbru (Tirabrutinib).
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