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- 2025-12-24 02:09:29
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- Huonslab is speeding up the development of Prolia biosimilar
- by Lee, Seok-Jun Feb 08, 2023 05:53am
- Huonslab announced on the 7th that it has confirmed that the HLB3-013 biosimilar under development is equally effective in non-clinical animal efficacy tests compared to the original Prolia. This is the result of an osteoporosis-causing model mouse at an overseas CRO institution (BioMedCore, Greece). When the original and HLB3-013 were treated equally, the effect of inhibiting osteoporosis symptoms was confirmed in various factors (average volume, density, separation, and external bone thickness of the femur). The same effect was shown at the same concentration of the test group compared to Prolia (3 mg/kg, 10 mg/kg). Prolia's mechanism of action is a drug that prevents bone destruction by binding to RANKL, an essential protein for bone-destroying osteoblasts, to suppress the formation, function, and survival of osteoblasts. Prolia is a biopharmaceutical product with improved convenience and persistence that lasts for six months with the first dose. With this effect, it is used in treatment for increasing bone density in osteoporosis patients. The patent is about to expire in 2025. Prolia's global sales in 2022 recorded about 4.55 trillion won (about $3.6 billion) and domestic sales about 100 billion won. Yoon Sung-tae, CEO of Huonslab, said, "As we have confirmed the same effect in animals, we will launch the Prolia biosimilar by conducting follow-up studies on non-clinical toxicity and clinical trials." Huonslab is a company that develops new biological drugs and biosimilars. It is developing Prolia biosimilar for the third time in Korea.
- Company
- Prescription of Celltrion’s Takeda drugs fall for 2 yrs
- by Kim, Jin-Gu Feb 08, 2023 05:53am
- Prescription performance of the 3 major chronic disease treatments that Celltrion Pharm acquired from Takeda Pharmaceutical had fallen for 2 consecutive years since their acquisition. The ‘Nesina’ series, which account for the most proportion of sales among the acquired products, recorded KRW 28.2 billion in sales last year, recording a downward trend for 3 consecutive years since 2020. Sales of the other diabetes treatment ‘Actos’ series and the hypertension treatment ‘Edarbi’ series have also shown sluggish sales in terms of prescription performance over the past 2 years. According to the market research institution UBIST on the 8th, the total prescription amount of the 3 major chronic disease treatments that Celltrion acquired from Takeda Pharmaceutical was KRW 65.4 billion last year. This is a 5% decrease from the KRW 68.9 billion recorded by the same drugs in 2021. In June 2020, Celltrion signed an agreement with Takeda Pharmaceutical to acquire the rights of 18 prescription drugs and OTCs sold by Takeda’s Primary Care Business Unit in the Asia Pacific region for a total of USD 278.3 million (KRW 307.4 billion). Under the deal, the company acquired the diabetes treatment Nesina Actos, the hypertension treatment Edarbi, and OTCs Whituben, Albothyl, etc. The acquisition process was completed in December of the same year, and work to switch the domestic marketing authorization license had been ongoing until January last year. The products are now being sold by Celltrion in Korea. The decrease in sales was most significant in the sales of the Nesina series, the DPP-4 inhibitor class diabetes treatments. Total sales of Nesina, Nesina Met, and Nesina Act recorded KRW 28.2 billion last year. Ever since their sales peaked at KRW 35.9 billion in 2019, sales steadily declined to KRW 33.4 billion in 2020, then KRW 31.4 billion in 2021. In particular, sales fell below KRW 30 billion for the first time in 6 years since 2016 last year. In the case of the Nesina series, their prescriptions have been on a decline even before the drug was acquired by Celltrion due to fierce competition in the DPP-4 inhibitor class diabetes treatment market. In addition, the release of generic versions of its competitor Galvus and Tenelia further decreased the influence of Nesina in the market. The TZD class antidiabetic Actos series and the ARB class hypertension treatment Edarbi series had also shown a slowdown in sales recently. The total prescription amount of Actos, Actos Med, and ActosRyl was KRW 25.9 billion, which was a 3% increase from KRW 25.2 billion in 2020. However, the amount had decreased by 2% from KRW 26.6. billion in 2021. Total prescriptions of Edarbi and Edarbi klo had increased by 3% in the past 2 years from KRW 10.8 billion in 2020 to KRW 11.2 billion last year. The combined prescription amount of the three product groups rose steadily from KRW 62.9 billion in 2018 to KRW 69.5 billion in 2020. However, sales then fell to KRW 68.9 billion in 2021, then to KRW 65.4 billion last year. After Celltrion acquired the products, sales performance of the Edarbi and Actos series had improved slightly, but as the performance of the Nesina series, which accounted for the largest portion of sales among the acquired products decreased significantly, this is analyzed to have led to the decrease in the total prescription amount. In the case of the OTCs Whituben and Albothyl, their sales data has not been compiled yet. However, in the case of Whituben, sales are said to have increased twofold compared to the previous year due to the increase in demand for cold medicines following the rapid increase in confirmed cases of COVID-19 last year. Sales of the Whituben series in 2021 had been KRW 2.5 billion.
- Company
- The first reverse growth of NOAC worth 230 billion won
- by Jung, Sae-Im Feb 08, 2023 05:53am
- Eliquis·Pradaxa·Xarelto·Eliquis The NOAC market, which is worth 230 billion won, fell for the first time last year. This is because the generic market for some items was opened and drug prices were cut. Generics, which competed with the original "Xarelto," secured a market worth 9 billion won last year. According to Ubist, a pharmaceutical market research firm on the 8th, the size of the outpatient prescription market in the NOAC market last year was 227.6 billion won, down 1.8% from 231.8 billion won the previous year. NOAC has attracted attention as a drug that has a lower risk of bleeding side effects than warfarin, a conventional anticoagulant, and has a great thromboembolic effect. A total of four original products are on sale. Since the early 2010s, they have replaced warfarin and gained influence in the prescription field. The NOAC market, which had been increasing every year, saw its annual prescription reverse growth for the first time in 2022. With the emergence of generics of some items, the original drug price cut was made, and it entered a downward phase. The representative one is Bayer's "Xarelto." Last year, Xarelto's outpatient prescription amount was 46.8 billion won, down 22% from 59.6 billion won the previous year. Since its launch, Xarelto prescription solutions, which have continued to grow, have turned downward since last year. The biggest blow is the original drug price due to the generic salary registration. As of August 22 last year, the Ministry of Health and Welfare cut the drug price of all doses of Xarelto (2.5·10·15·20mg) by 30%. This is because the Seoul High Court sided with the Ministry of Health and Welfare in a lawsuit filed by Bayer against the Ministry of Health and Welfare to cancel the Xarelto drug price cut. The Xarelto price was scheduled to be lowered in May 2021, when generic was first listed, but the execution was suspended until the original ruling because Bayer filed a lawsuit that the drug price cut was unfair, saying that Generic was released before the patent expired. The ruling was made after about a year and two months, and the drug price cut was finally confirmed. Xarelto's quarterly prescription, which was between 14 billion won and 15 billion won, fell sharply to 11 billion won in the third quarter. In the fourth quarter, it was 7.4 billion won, which is half the level before the drug price cut. Compared to 2020, Xarelto's prescription in the second half of last year lost 40%. The decline is expected to be steeper as additional Xarelto drug price cuts are expected this year. The government will add the original drug price to 53.55% for the first time when generic is listed, and 70% for one year after adjusting it to 53.55%. As a result, Xarelto, which was cut by only 30% last year, is expected to be cut by 23.5% to 23.6% this year. The influence of Xarelto generic is also growing. Last year, Xarelto generic products received 9 billion won in outpatient prescriptions, more than five times higher than the 1.6 billion won in the previous year. Chong Kun Dang (2.9 billion won), Hanmi Pharm (1.5 billion won), and Samjin Pharm (1 billion won) are driving the growth of the generic market. ◆Lixiana and Eliquis increase without generic penetration, 160 Billion-scale Lixiana, the No. 1 in this market, raised its prescription amount by 89 billion won last year. This is an increase of 5% compared to the previous year. Lixiana is the latest NOAC formulation to enter the market. There is a five-year difference from other drugs. Despite being generic, Lixiana succeeded in reversing in 2019 by accumulating data through direct comparative studies with other drugs. Analysts say that aggressive sales strategies with domestic companies also affected rapid growth. Lixiana, which was 4.8 billion won in 2016, expanded its size from 20.9 billion won in 2017 to 39.5 billion won in 2018, 61.9 billion won in 2019, 72.9 billion won in 2020, and 84.8 billion won in 2021. As of last year, Lixiana accounted for 41% of the original NOAC market. BMS's Eliquis ranked second in the NOAC market. Equis' prescription amount last year was 70.6 billion won, an 8% increase from the previous year. The recent increase in Eliquis' sales is largely due to the withdrawal of generics. Eliquis' growth slowed in June 2019 as it faced competition with generics. Generic companies, which won the case until the second trial, preemptively released generic, and annual prescriptions rose by nearly 10 billion won in 2020. During this period, Eliquis was 50.6 billion won in 2019 and 55 billion won in 2020. Eliquis growth, which increased by 10 billion won every year, slowed down. However, in April 2021, the Supreme Court reversed the previous ruling in the patent lawsuit and sided with BMS, taking a new turn. Immediately after the ruling, the generics withdrew from the market en masse. This is because BMS announced a claim for damages due to patent infringement. The Mayor of Eliquis generic, which was 1.2 billion won in 2019 and 9.4 billion won in 2020, shrank to 5.4 billion won in 2021, when the Supreme Court ruled. Last year, the prescription amount was 0 won as the generic benefit was deleted and all distribution inventory was exhausted. Along with this, Eliquis' prescription amount, which had slowed down, recovered to 65.2 billion won in 2021, expanding by 10 billion won again. Last year, it surpassed 70 billion won. Generics that lost the lawsuit can only sell their products after September next year. ◆Pradaxa's sales have been on the decline for 5 years Sales of another NOAC, Pradaxa of Beringer Ingelheim, have been on the decline for the fifth consecutive year. Pradaxa's prescription amount last year was 12.2 billion won, down 20% from 15.2 billion won in 2020. Unlike other formulations, Pradaxa, which expanded its size in 2017, failed to exceed 20 billion won and turned downward. Pradaxa's sales, which were 21.6 billion won in 2017, showed a clear decline to 19.6 billion won in 2018, 18.7 billion won in 2019, and 16.5 billion won in 2019. Pradaxa, which has been pushed back from the competition with NOAC Original, is also out of the interest of generics. According to the Ministry of Food and Drug Safety, 10 domestic companies were licensed for Pradaxa Generics in 2018, but none of them have been released on the market. It seems that it is meaningless to compete in the Pradaxa market, which is only 10 billion won.
- Company
- Dong-A Forxiga loses the patent dispute
- by Kim, Jin-Gu Feb 07, 2023 05:48am
- A new method of avoiding material patents virtually fails the 'prodrug' strategy, which was drawing attention. Dong-A ST lost the Forxiga patent dispute alone. Dong-A ST pushed ahead with the release of Forxiga's late drug, Dapapro, on the basis of its victory in the first trial, but the ruling put considerable pressure on sales. ◆ Dong-A ST loses patent dispute alone, Dapapro sales variable The Supreme Court's special second division ruled in the morning of the 2nd that Dong-A ST would dismiss the appeal in an appeal filed against AstraZeneca. Forxiga is protected by two substance patents. The first substance patent (10-0728085) expires on April 7, 2023, and the second substance patent (10-1021752) expires on January 8, 2024. Dong-A ST alone challenged the first substance patent, which expires first. In April 2018, Dong-A ST requested a passive judgment on the scope of rights for the first substance patent. In the first trial, Dong-A ST won. The Korean Intellectual Property Trial and Appeal Board made a trial decision on the establishment of the claim in August 2020. AstraZeneca objected, and the ruling was overturned in the second trial. The patent court ruled in favor of AstraZeneca. This time, Dong-A ST filed an appeal with the Supreme Court in protest. However, the Supreme Court finally sided with the original company. Dong-A ST has already released Posh's generic Dapapro exclusively based on the first trial victory trial in December last year. However, the Supreme Court ruling put a burden on Dapapro's sales. However, Dong-A ST won the nullification lawsuit for the second substance patent issued on the same day, so there is no problem with sales after April this year when the second substance patent expires. Patent infringement related to the forced sale of Dapapro is treated separately as a lawsuit. Currently, Dong-A ST is proceeding with a separate lawsuit against AstraZeneca and Prodrug and a patent infringement lawsuit. ◆New method of avoiding material patents The 'Prodrug' strategy, which was drawing attention, has virtually failed Dong-A ST's challenge to avoid material patents has received considerable attention from the pharmaceutical industry. This is because Dong-A ST has come up with a new material patent avoidance strategy called "Prodrug." A prodrug is a drug in the pro stage of the drug. Until just before taking the drug after it is produced, the chemical structure of the original drug is partially different in the substituent part. When you take a drug, it acts like an original drug in your body. In the pharmaceutical industry, if Dong-A ST wins, it is predicted that the challenge of material patents using the Prodrug strategy will continue. However, Dong-A ST's prodrug strategy has virtually failed to see the light as it lost consecutive second and third trials. "The strategy of avoiding material patents by Prodrug has been put on hold by the Supreme Court for now," a pharmaceutical industry official said. "However, we have to wait and see the results because Dong-A ST is filing a separate lawsuit using Prodrug."
- Company
- SGLT-2 Market ↑3x in 3 years
- by Jung, Sae-Im Feb 07, 2023 05:47am
- The domestic SGLT-2 inhibitor outpatient prescription market has grown to 170 billion won. It has more than tripled in the past three years. It has been about 10 years since SGLT-2 inhibitors entered Korea. This year, a major change is expected as a number of "Forxiga" generics leading the market are released and new domestic SGLT-2 inhibitors are also released. ◆ SGLT-2, which has grown considerably, grows evenly According to UBIST, a pharmaceutical market research institute on the 6th, the total amount of outpatient prescriptions for SGLT-2 inhibitors in Korea last year was 172.3 billion won. This is an increase of 14.8% compared to 150.1 billion won in the previous year. The market, which was about 50 billion won in 2017, quickly grew in size by expanding its influence in diabetes. It recorded 70.3 billion won in 2018 and 96.9 billion won in 2019 and surpassed 100 billion won for the first time in 2020. It is now on the verge of surpassing 200 billion won. The SGLT-2 inhibitor was evenly grown by a single agent and a combination agent The combination refers to the addition of Metformin to the SGLT-2 inhibitor component. Last year, the single agent grew by 11.1% to 98.6 billion won, and the combined system increased by 20.1% to 73.7 billion won, respectively. By product, AstraZeneca's Forxiga, Xigduo, and Beringer Ingelheim's single Jardiance recorded more than 40 billion won last year. By the manufacturer, AstraZeneca is 91.4 billion won, higher than Beringer Ingelheim's 76.1 billion won. Forxiga was the highest prescription item, up 14% from the previous year to 48.5 billion won. Jardiance then increased by 10.5% to 45.2 billion won. The combined Xigduo increased by 16% to 42.9 billion won during the same period. Beringer Ingelheim's compound "Jardiance Duo" recorded a prescription amount of 30.9 billion won, up 26.2% from the previous year, although it fell short of Xigduo. ◆ Launch of new product and generic, SGLT-2 market upheaval this year This year, a big change is expected in the SGLT-2 inhibitor market. First of all, the release of domestic SGLT-2 inhibitors is imminent. Daewoong Pharmaceutical plans to release Envlo, which was approved by the Ministry of Food and Drug Safety in November last year, within the first half of this year. The company is also speeding up the approval of the complex system. A number of generics for Forxiga and Xigduo will also be released in April. The Supreme Court ruled in favor of Forxiga's Generics on the 2nd. The ruling will allow generic companies to release generic for exclusive use from April 7, when Forxiga's first substance patent expires. A total of 14 companies, including Kyung Dong, Kukje, Daewon Pharmaceutical, Dongwha, Boryung, Samjin, Sinil, Alvogen Korea, Yunjin, Ildong, Jeil, Chong Kun Dang, Hanmi, Han Wha, etc., have 39 items of generics for Forxiga.
- Company
- Does the Xospata dosing cycle limit disappear?
- by Eo, Yun-Ho Feb 06, 2023 05:51am
- The new leukemia drug Xospata is aiming to expand insurance benefit standards again. According to related industries, Astellas Pharmaceutical Korea submitted an application to expand the salary of Acute Myeloid Leukemia treatment Xospata at the end of last year and is currently discussing the schedule for the cancer disease review committee with the HIRA. Looking at the current benefit criteria, two-cycle benefits are recognized as induction therapy for patients who are non-responsive to existing treatments or can perform homogeneous hematopoietic stem cell transplantation among FLT3 mutation-positive AML patients. However, considering the preparation period for allogeneic hematopoietic stem cell transplantation, additional two cycles are recognized only if the same hematopoietic stem cell transplant is approved in advance (or equivalent evidence is presented). In other words, the administration of Xospata is limited to up to 4 cycles. In general, when the dose cycle of a drug is limited in the benefit standard, it is based on the design of clinical research of the drug or authoritative overseas guidelines. Blood cancer treatments such as Besponsa and Blincyto have limitations on administration, which are all based on evidence. In the case of Xospata, there is no specific reason to limit the dosage cycle. According to Xospata's ADMIRAL study, it is designed without limitation on the duration of administration, and the NCCN guidelines also recommend "Category 1" without limitation on the duration. Domestic permits are also allowed to be administered until severe toxic symptoms occur or clinical benefits do not appear. Of course, the salary standard does not necessarily have to be the same as the permit, but the academic community's position is that the limited standard of Xospata is problematic. As a result, it remains to be seen whether Xospata will expand its benefit standards this year and improve the prescription environment. Xospata is a drug that targets both FLT3-ITD and FLT3-TKD mutations, which are taken once a day orally, and can be treated on their own at home without frequent hospital visits. It also improved its effectiveness compared to conventional chemotherapy.
- Company
- Mavyret occupies 85% of HCV market...sales fall 36% in 3 yrs
- by Kim, Jin-Gu Feb 06, 2023 05:51am
- Pic of Abbvie Abbvie’s Mavyret has dominated the oral hepatitis C treatment market. Last year the drug increased its market share to 85%. Despite this increase in market share, the drug’s prescription performance fell 36% over the past 3 years. The analysis is that the absolute size of the Hepatitis C treatment market, which has a limited number of patients, has been decreasing due to the near-cure effect of the treatments in the market, which eventually led to a reduction in the overall market size. ◆Mavyret occupies 85% of the HCV market...prescription performance drops 36% in 3 years According to the market research institution UBIST on the 4th, Abbvie’s oral HCV treatment Maryret’s outpatient prescriptions recorded KRW 29 billion last year. This was a 10% increase compared to 2021 and is considered to be due to Maryret’s scope of reimbursement being expanded from adults to adolescents aged 12 years or older. With the reimbursement extension, its market share increased to 85%. Mavyret had quickly expanded its influence in the market since its release in September 2018, with its benefits of being pan-genotypic and short treatment period. In 2019, its market share increased to 70% and then to 75% in 2020 and 2021. However, in the long term, the reduction in prescription performance is clear. Outpatient prescriptions fell from KRW 45.6 billion in 2019 to KRW 35.7 billion in 2020, then to KRW 26.3 billion in 2021. This amounted to a 36% decrease in prescription performance compared to 2019. The reason for the decrease in prescription performance despite the increase in market share is because of the reduced overall market size. 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, to KRW 65.1 billion in 2019, to KRW 47.4 billion in 2020, to 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 one-fourth its size in 5 years. ◆Increased cure rate had contracted market size...All HCV drugs other than Mavyret·Harvoni earn less than KRW 100 million In the pharmaceutical industry, the cause of market contraction is due to the characteristics held by HCV treatments. 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. Then, Gilead Sciences' Sovaldi and Harvoni. MSD’s Zepatier and Abbvie’s Mavyret followed, enhancing the treatment effect 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. With the rapid contraction of the market, some drugs that once dominated the market decided to withdraw from the domestic market. In March 2021, BMS voluntarily withdrew the authorization for its for Daklinza and Sunvepra. In June, Roche also voluntarily withdrew its injectable HCV treatment Pegasys from the domestic market. The situation is also similar for drugs other than Mavyret. Prescription performance of drugs that had occupied the market after Daklinza and Sunvepra, such as Zepatier, Sovaldi, and Harvoni are converging to nearly 0. In the case of Zepatier, its prescription sales had recorded KRW 19.9 billion in 2018, but then fell rapidly to record less than KRW 50 million last year. Sovaldi’s sales had also fallen to less than KRW 10 million last year from the KRW 84.3 billion in 2017, and Harvoni’s sales had fell to KRW 5 billion from the 40.9 billion in 2016. ◆Gilead releases a new drug for the first time in 5 years...makes winning bid with low price Pic of Gilead ScienceThe market contraction is expected to continue in the market. The variable is the new HCV treatment released by Gilead Science. Gilead had released Epclusa and Vosevi, its next-generation HCV treatments in November last year. These were the first new drugs for HCV released by Gilead in 5 years after Sovaldi and Harvoni. Epclusa is a pan-genotypic treatment like Mavyret. Although its treatment period is 12 weeks, 1 month longer than Mavyret, it has a more convenient means of administration of one pill once daily compared to three pill once daily administration of Mayvert. Its price had been set lower than Mavyret. Epclusa is priced at KRW 117,030 per tablet and Vosevi at 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 of Mavyret. Gilead plans to regain the glory it occupied in the past with treatments and Harvoni with its more competitive price than Mavyret.
- Company
- EXKIVITY, PO lung cancer treatment, is released
- by Jung, Sae-Im Feb 03, 2023 08:51am
- Differences between oral medication and long-lasting effects "Further study needed to find suitable patient population" The second new drug targeting EGFR mutations, which are rare in non-small cell lung cancer, has been released in Korea. Takeda Pharmaceutical's Exkivity is expected to compete with oral drugs and long reaction duration. Takeda Pharmaceutical Korea held a press conference at The Plaza Hotel in Jung-gu, Seoul on the 1st and officially announced the launch of the new non-small cell lung cancer drug 'Exkivity'. Exkivity is a targeted treatment for EGFR Exxon 20 inserted mutated non-small cell lung cancer and can be used as a secondary treatment in patients who have previously been treated with platinum-based chemotherapy. EGFR Exxon20 insertion mutation is rare enough to account for about 10% of EGFR-mutated non-small cell lung cancer and about 2% of all non-small cell lung cancer. The survival period is about twice as short as that of the Exxon19 defect and the Exxon21 (L858R) substitution mutation, which accounts for most of the EGFR mutations. It is known that the existing EGFR mutation target treatment does not work well with the Exxon 20 insertion mutation. Ahn Myung-joo, a professor of hemato-oncology at Samsung Medical Center, said, "Exon 20 mutant patients had a significantly lower prognosis and survival rate than common EGFR mutant patients," adding, "We knew the existence of Exxon 20 mutant for about 20 years, but the demand was high because there were no suitable drugs." Last year, two new drugs targeting this biomarker appeared. Janssen Rybrevant and TakedaIt's pharmaceutical Excitivity. Rybrevant is a dual antibody that targets both the EGFR Exxon20 insertion mutation and the MET mutation. On the other hand, Exkivity is the only oral drug that intensively targets the Exxon20 insertion mutation. It is expected to compete with Rybrevant with the launch of Exkivity in February. Exkivity recorded an objective response rate (ORR) of 28%, a median overall survival period (mOS) of 24.0 months, and a median progressive survival period (mPFS) of 7.3 months in clinical trials of 114 patients, respectively. The median reaction time after administration was 1.9 months, showing a rapid medicinal effect. The safety profile was also shown to be good. The most common adverse reactions were diarrhea, rash, and fatigue, which could be managed through dose reduction. In particular, Exkivity showed a long reaction duration of 17.5 months. Kim Tae-min, a professor of hematologic oncology at Seoul National University Hospital, said, "One of the important indicators when confirming the effectiveness of targeted anticancer drugs is the duration of the reaction from the first reaction to the time when the reaction lasts longer, which can ultimately lead to the patient's survival." It is expected that Exkivity will show its strength in that it has increased the convenience of taking oral drugs, unlike Rybrevant, an intravenous injection, along with a long duration of the reaction. Experts agreed that further research is needed to find a suitable patient group for each drug. Professor Kim said, "Each patient has different reactions to the drug. Some patients respond only to Exkivity or Rybrevant, and some respond to both. It is necessary to analyze it through additional data, he said. "In addition, the two drugs differ in formulation and adverse reactions, so we need to determine the appropriate drug through close communication with patients." Professor Ahn also said, "It is dangerous to compare and judge the two drugs based on this data because the number of patients currently participated in the clinical trial is only about 100," adding, "It is clear that it is more effective than conventional drugs, but more data should be accumulated."
- Company
- Enhertu quickly lands at general hospitals in Korea
- by Eo, Yun-Ho Feb 03, 2023 05:53am
- Prescription of the next-generation new antibody-drug conjugate 'Enhertu' has started in earnest. According to industry sources, Enhertu (trastuzumab deruxtecan), AstraZeneca and Daiichi Sankyo Korea’s new antibody-drug conjugate drug for HER2-positive breast cancer have passed the drug committees (DCs) of 20 medical institutions in Korea, including Samsung Medical Center, Seoul National University Hospital, Sinchon Severance Hospital, Kangbuk Samsung Medical Center, and Chonnam National University Hwasun Hospital. Most hospitals held an emergency DC meeting to generate a prescription code for Enhertu, suggesting the healthcare professional’s high interest in the drug. The drug was approved by the Ministry of Food and Drug Safety in September last year based on the DESTINY-Breast01 and DESTINY-Gastric01 trials. In Korea, Enhertu is indicated to treat ▲ unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting’ and ▲ locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. Also, in December, based on the DESTINY-Breast03 trial, the drug’s indication was expanded to treat patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. Enhertu is an ADC that combines ‘trastuzumab,’ a monoclonal antibody that binds to specific target proteins, and ‘deruxtecan,’ a strong cytotoxic agent, by a linker. ADCs act selectivity on antibody targets and apoptosis of target tumor cells allows the drug to work selectively only on the tumor cells, increasing its therapeutic effect and minimizing side effects. However, Enhertu has not been reimbursed yet in Korea. AstraZeneca and Daiichi Sankyo applied for reimbursement listing in December last year and are awaiting review by the Health Insurance Review and Assessment Service. If listed, the drug’s prescriptions are expected to increase rapidly. Sun-Young Rha, Professor of Medical Oncology at Yonsei Cancer Center, said, “Enhertu is the first and only HER2-targeted therapy that demonstrated a survival period of over one year as a treatment for advanced gastric cancer after treatment with a trastuzumab-based regimen. We hope reimbursement will be applied as soon as possible in consideration of the small number of patients.” Enhertu demonstrated a significant improvement in progression-free survival (PFS) in the head-to-head DESTINY-Breast03 trial that compared Enhertu with trastuzumab emtansine (T-DM1) in patients in patients with HER2-positive unresectable or metastatic breast cancer previously treated with one or more anti-HER2 therapy. The interim analysis results that were updated in 2022 showed that Enhertu also continued to demonstrate a clinically meaningful improvement in progression-free survival (PFS) with a 22-month improvement in median PFS over T-DM1. The median PFS for patients in the Enhertu arm was 28.8 months compared to 6.8 months for T-DM1. Also, in terms of OS, the key secondary endpoint in the trial, Enhertu demonstrated a statistically significant 36% reduction in risk of death versus T-DM1. Also, in the DESTINY-Breast01 trial, Enhertu demonstrated continued anticancer effect in patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens that include T-DM1, trastuzumab, and pertuzumab. Results showed that Enhertu met its main efficacy outcome with an objective response rate (ORR) of 60.9%. The median duration of response (DoR) was 14.8 months, and the drug showed a continued anticancer effect in severe patients with a median of 6 previous lines of treatment (range 2-27).
- Company
- Generic for Forxiga competition in the 90 Billion market
- by Kim, Jin-Gu Feb 03, 2023 05:53am
- Forxiga The patent for "Forxiga," a large diabetes treatment that produces more than 90 billion won a year, was completely lifted by the Supreme Court ruling. It is expected that patent challengers will release Forxiga generic in two months. Competition for generics is expected to intensify when the sales ban period ends in January next year due to the permission for priority sales items. ◆14 Generics are expected to be released in April this year, expanding to 90 in January next year On the 2nd, the Supreme Court ruled against 17 companies, including international drugs, in an appeal filed by AstraZeneca to side with generic companies. As a result, patent challengers will be able to release generics after Forxiga's first substance patent expires on April 7 this year. Patent challengers were qualified to release generics because they won the first and second trials. However, AstraZeneca's appeal did not rule out the possibility of a reversal decision by the Supreme Court, putting a lot of pressure on the release of Generic. The Supreme Court finally ruled in favor of patent challengers, and Generics succeeded in relieving the burden of patent infringement completely. It is expected that 14 companies that have acquired generic for exclusivity will release the product in April. Forxiga received generic for exclusivity use as 39 items of single and composite products. Generic for Exclusivity is until January 7 next year, when Forxiga's second substance patent expires. After that, more pharmaceutical companies are expected to enter the market. According to the Ministry of Food and Drug Safety, 89 pharmaceutical companies have been approved for 285 items as a single Forxiga drug and complex. This means that when the effect of generic for exclusive expires in January next year, more than 90 pharmaceutical companies will compete with the same ingredient. ◆Forxiga·Xigduo Last year's prescription amount of 91.4 billion won Drug price cuts are inevitable when General Electric is released. The reason why generics are paying keen attention to the market is that Forxiga is producing more than 90 billion won in prescriptions. According to UBIST, a pharmaceutical market research firm, Forxiga's outpatient prescription performance last year was 48.5 billion won. It increased by 14% from 42.6 billion won in 2021. Xigduo, a compound of dapaglyfluazine and metformin, recorded 42.9 billion won last year. It increased 16 percent from 36.9 billion won a year ago. Forxiga and Xigduo repeated rapid growth every year. The combined prescription amount, which was 33.3 billion won in 2017, increased 2.7 times to 91.4 billion won in five years. ▲ Forxiga and Xigduo prescription performance by year (unit: 100 million won, data UBIST) However, it is widely expected that the existing growth will be dampened if the generic is released after April this year. This is because a 30% reduction in drug prices is applied to the release of drugs with the same ingredient. Then, one year after the release of the Generic, the drug price will be further lowered to 53.55% of the existing upper limit. On top of that, AstraZeneca cannot avoid competition with Generic, which is newly entering the market. Dong-A ST released Dapflo in December last year with the same ingredients as Poshiga. Dapflo is a prodrug product with the same main ingredients but a different chemical structure from the original. When absorbed into the body, the structure changes and has the same effect as Forxiga. Dong-A ST alone challenged Forxiga's first substance patent for early release of generic. After succeeding in avoiding the first trial, Dong-A ST pushed ahead with the sale of Dapflo based on the victory of the first trial at a time when a patent dispute with AstraZeneca was underway. As a result, it released generic products about four months ahead of other companies that have acquired generic exclusivity. Dong-A ST believes that it will take risks and preoccupy the generic market, given that Forxiga generic competition is expected to be very fierce in the future. The key is how much Dong-A ST maximizes the effect of preoccupying the market for four months. Dong-A ST has its own developed Suganon as a DPP-4 inhibitor-based diabetes treatment. Dong-A ST plans to increase Dapflo's influence by linking with Suganon for the remaining two months until April when Forxiga generic is released. In this extension, Dong-A ST plans to maintain the sale of Dapflo regardless of the Supreme Court ruling. On the 2nd, the Supreme Court ruled in favor of AstraZeneca in an appeal filed by Dong-A ST against AstraZeneca on the avoidance of Forxiga's first substance patent. In response, an official from Dong-A ST said, "The first trial, which was the basis for the release of Tapflo, has nothing to do with the Supreme Court's ruling, and the second trial is currently underway due to AstraZeneca's appeal."
