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- 2025-12-24 05:42:10
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- Generic drugs occupy 41% of antidiabetics market in 9 mths
- by Kim, Jin-Gu Jan 19, 2023 05:58am
- Generic products of off-patent drugs are quickly increasing their influence In the DPP-4 inhibitor class antidiabetic drug market. The market share held by generic versions of the original Galvus (vildagliptin) that were launched after the patent expiry of the original drug in March last year increased to 41% at the end of last year. The market share held by generic versions of Tenelia (teneligliptin), which 37 companies jumped in to manufacture, increased to 32% only two months after its release. ◆Market share of Galvus generics increase to 41%...Kyongbo and Hanmi shows greatest advances According to the market research institution UBIST on the 19th, the total outpatient prescriptions for antidiabetic drugs that contain vildagliptin amounted to KRW 46.9 billion last year. Compared to the KRW 46.6 billion made in 2021, the market size itself remained largely unchanged from the previous year. However, when dividing the drugs into original vs. generic drugs, the prescription amount of the originals - Galuvs and Galvusmet - fell 30% in one year and was replaced by generic products. The combined prescription amount of Galuvs and Galvusmet fell 30% last year to record KRW 32.4 billion from the KRW 46.6 billion it had recorded in 2021. When considering how the drug price was reduced by 29.9% with the release of the generic, the prescription volume itself is expected to have remained similar to the previous year. In the market, generic drugs recorded combined prescriptions of KRW 14.5 billion last year. Galvus generics have been continuously increasing its influence in the market ever since its launch in January last year. Since recording KRW 1.1 billion in Q1 last year, sales increased to KRW 3.4 billion in Q2 last year, then to KRW 4.8 billion in Q3 last year, and KRW 5.2 billion in Q4 last year. In the vildagliptin-containing antidiabetics market, the share held by generics increased to 41% as of December last year. The market share of generic drugs increased rapidly until September last year, then remained in the early 40% range ever since. Last year, 15 domestic companies released Galvus generics. Among the generic companies, Kyongbo Pharmaceutical and Hanmi Pharmaceutical recorded the highest prescription performance. The combined prescription amount of the two products amounts to KRW 6.3 billion. The amount was followed by Hanmi Pharmaceuticals’ Vildagle and Vildaglemet which made KRW 3.9 billion, then by Angook Pharmaceutical’s Avus and Avusmet which made KRW 2.6 billion. The other generic companies made annual outpatient prescriptions that amounted to less than KRW 1 billion each. ◆ Tenelia generics’ market share surged to 32% only 2 months after release Tenelia generics are also rapidly increasing their influence in the market 37 domestic companies released Tenelia generics after its patent expired on October 25 last year. Since then, the companies recorded KRW 2.9 billion in prescriptions in two months. As of last year, the share of teneligliptin-containing drugs in the diabetes treatment market expanded to 32% as of December last year. However, the increased prescriptions for generics did not lead to a decrease in prescriptions for the original products. Rather, the prescription amount of Handok’s Tenelia and Tenelia M, the original products, increased slightly from KRW 47.7 billion in 2021 to KRW 48 billion last year. This is because the drug price of the original product has not been lowered despite the generic’s release. The generic companies developed products using salts that are different from the original, which allowed the original drug to maintain its previous price. No single product recorded remarkable performance among Tenelia generics. All 37 companies are recording prescriptions ranging around KRW 100 million. A pharmaceutical industry official said, “Fierce sales competition is ongoing between generic companies to secure a market share in the earlier stages of the generic release. We expect this competition to continue until the patent for another DPP-4 inhibitor, Januvia, expires in September this year."
- Company
- Paclitaxel copyright transfer
- by Kim, Jin-Gu Jan 19, 2023 05:58am
- Taxol & GenexolThe domestic copyright of Paclitaxel anticancer drugs has shifted one after another. Samyang Biopharmaceuticals' Genexol, the No. 1 item in the market, will be jointly sold by HK inno.N instead of Boryung. Boryung will jointly sell BMS Taxol, the original product, for the first time in seven years instead of Genexol. The annual sales of the two products are worth 21 billion won for Genexol and 9 billion won for Taxol. According to the pharmaceutical industry on the 16th, Boryung will jointly sell BMS Taxol in Korea from January 1 this year. Taxol is a cytotoxic anticancer drug composed of Paclitaxel. It is widely used for various cancers such as ovarian cancer, breast cancer, lung cancer, and gastric cancer. It has been nearly 30 years since it was approved in Korea in 1996, but it is still widely used. According to IQVIA, a pharmaceutical market research firm, Taxol's sales in 2021 are 9 billion won. In the case of last year, it generated 5.8 billion won in sales by the third quarter. Boryung is associated with Taxol. BMS and Taxol have been jointly sold for eight years from 2008 to 2015. The joint sales contract will bring Boryeong back to its original products for the first time in seven years. Boryung co-sold its rival Genexol until just before. Boryung jointly sold Samyang Biopharmaceuticals Genexol for six years from 2016 to last year. Since 2018, the second year after Boryung took charge of sales, Genexol has risen to the top market share of the Paclitaxel ingredient. Since then, Genexol has steadily maintained its No. 1 sales in the Paclitaxel market. In 2021, Genexol's sales were 21.7 billion won. Last year, it recorded cumulative sales of 16.5 billion won in the third quarter. From Boryung's point of view, there is a situation in which they have to compete with the products they have grown to be the No. 1 in the market. HKinno.N was in charge of Genexol, which Boryung was selling. HKinno.N and Samyang Biopharmaceuticals recently signed a joint sales contract for domestic sales and marketing. At higher general hospitals in Seoul and the metropolitan area, the two companies are jointly in charge of sales and marketing, while HKinno.N is in charge of other areas. HKinno.N also has a deep connection with Genexol. Samyang Holdings co-sold the product for 13 years from 2001 to 2013, when it developed Genexol with Paclitaxel Generics. The joint sales deal reunited the two companies for the first time in 10 years. For HKinno.N, the key is how solid Genexol's market share is. As Boryeong has recently put a strong drive into the anticancer drug business, a fierce competition is expected in this market. HKinno.N has CalmTOP, Aloxy, and Akynzeo in the anticancer field. Through this Genexol partnership, HKinno.N plans to further increase its status in the anticancer drug market and actively expand its pipeline. Kwak Dal-won, CEO of HKinno.N, said, "Just as the two companies have collaborated for a long time and made good results, we expect this Genexol to lead to positive results." Lee Young-Joon, CEO of Samyang Holdings, said, "HKinno.N has been selling Genexol for more than 10 years, so it has a high understanding of the product and has a professional anti-cancer drug sales organization." "We will firmly maintain our No. 1 position in the domestic market through a partnership with HKinno.N," he stressed.
- Company
- The Canadian gov. has put the drug price system on hold
- by Kim, Jin-Gu Jan 18, 2023 06:04am
- Korea to add Canada to drug price reference country this year...The domestic drug price reduction variable disappears. The reorganization of the drug price system, which was promoted by the Canadian government, has been temporarily suspended. Analysts say that the Canadian Ministry of Health officially announced that it would come up with a new reform plan due to strong opposition from the local pharmaceutical industry and that the plan to reevaluate the prices of premium drugs has virtually been canceled. Canada's move is also expected to affect South Korea's decision on the price of salaried drugs. In Korea, Canada has been added to the drug price reference country since this year. ◆ Canada's Ministry of Health decided to temporarily suspend the implementation of the drug price reform plan According to the pharmaceutical industry on the 14th, Health Canada recently requested the PMPRB (Patented Medicine Prices Review Board) to suspend the implementation of the drug price guideline reform plan. PMPRB has pushed for a reform of the patented drug price system since 2019. The reform plan focused on lowering the price of excessively high patented drugs. The core of the reform plan is to give the authority to investigate and re-evaluate ex officio whether the price of previously listed patented drugs is not expensive. To this end, a new price regulation device was added. It adds pharmacoeconomic value, including cost-effectiveness analysis data, the size of the drug market in Canada, Canada's gross domestic product (GDP), and per capita GDP. 캐나다 보건부는 작년 6월 새로운 지침을 시행하겠다고 예고했으나(위), 최근 새로운 지침은 2023년 1월 1일에 시행되지 않는다고 밝혔다(아래). 캐나다 보건부 홈페이지 캡처 On top of that, the drug price reference countries were reorganized into 12 countries, including Korea, Japan, Australia, Belgium, the Netherlands, Norway, Spain, France, Germany, Italy, Sweden, and the United Kingdom. The existing U.S. and Switzerland were excluded. The intention is to lower the average price of foreign drug prices by excluding the U.S. and Switzerland, which have high drug registration prices. Ministry of Health estimated that $13.2 billion could be saved over the next 10 years by reforming the drug price system for the first time in more than 20 years. ▲Canada's Health Ministry announced in June last year that it would implement the new guidelines (above), but recently announced that the new guidelines will not take effect on January 1, 2023 (below). Capture Health Canada However, the implementation of such a reform plan has been delayed. It was originally scheduled to take effect in January 2020, but it was implemented on July 1 last year after four delays due to opposition from the Canadian pharmaceutical industry and the influence of COVID-19. The most strongly opposed part of the industry's re-evaluation of the price of such drugs was scheduled to take effect on January 1 this year after preparing a new plan with a grace period. The industry has consistently protested, and in the end, Canada's Ministry of Health has decided to suspend the reform of the drug price system, saying it needs more review. At the same time, he said he would come up with a completely new version of the reform plan. Temporary guidelines are expected to remain in place until a new reform plan is prepared. ◆The new drug price reference country Canada's drug price cut variable disappears There have been constant concerns in the domestic pharmaceutical industry that the implementation of the new drug price system in Canada will lead to a reduction in drug prices in Korea. Canada was added as a new drug price reference country this year. As of January 1 this year, the country subject to foreign adjusted average price calculation has been reorganized from A7 (Japan, France, Germany, Italy, Switzerland, the United Kingdom, and the United States) to A8 with Canada added. The government has expressed its willingness to refer to the drug prices of A8 countries for the reevaluation of quality medicines as well as the registration of new drugs. In this situation, concerns have been raised that if the Canadian drug price decreases, the Korean drug price referring to it will also decrease. However, as Canada's reorganization of the drug price system has been temporarily put on hold, it is interpreted that variables that will affect Korea's reduction in drug benefit prices have also disappeared. In response, a pharmaceutical industry official said, "It is welcome that the potential risk factors that will lead to a domestic drug price cut have disappeared," but added, "However, since the Canadian government is still willing to cut drug prices and has decided to come up with a new reform plan, we should carefully look at future changes."
- Company
- Biktarvy, applies to the expansion of pediatric indications
- by Eo, Yun-Ho Jan 18, 2023 06:04am
- HIV treatment Biktarvy is aiming to expand pediatric indications in Korea. According to related industries, Gilead Science Korea recently submitted an application to expand indications for pediatric patients who weigh at least 14kg to 25kg of the HIV compound Biktarvy and have no experience in antiretroviral treatment or have been suppressed by existing antiretroviral treatment. The efficacy of Biktarvy in pediatric patients was confirmed through data from cohort 3 of clinical trials in a single clinical trial with phase 2/3 open markers. In the study, Biktarvy low-dose tablets were found to be generally drug-resistant and effective for 24 weeks in HIV-1-infected children with suppressed virus levels. Child patients enrolled in cohort 3 were continuously treated for 48 weeks and were able to continue receiving medication during the extended phase. 91% (20/22) of participants maintained virus level suppression at week 24 after switching to Biktarvy, with an average CD4% change of 0.2%. Biktarvy entered the market in earnest by applying salary in July of the same year after receiving approval from the Ministry of Food and Drug Safety in January 2019. According to IQVIA, a pharmaceutical market research firm, Biktarvy showed its potential from the first year of its launch, and its sales jumped from 400 million won to 4.6 billion won in just one quarter. In 2020, quarterly sales increased to 6.6 billion won, 7.9 billion won, and 9.8 billion won, respectively.
- Company
- Curing terminal cancer without treatment options
- by Jan 17, 2023 06:02am
- Mr. A, a 60-year-old Korean male patient, was diagnosed with gastric cancer several years ago. After struggling to treat the disease for several years, the hospital told A that there was no other treatment option available for him and that he may not be able to live for more than 6 months. As a last resort, A registered to enroll in the KOSMOS study and was told there was a breast cancer treatment available for the genetic mutation he was found with during genetic testing. The breast cancer drug stayed effective for over a year, and after seeing a significant reduction in tumor size, A left his hospital bed and was able to receive the outpatient treatment he had only dreamed of. The stage has been set to create a Korean-style precision medical ecosystem that can provide personalized treatment opportunities for cancer patients with terminal cancer who no longer have treatment options like Mr. A. A large-scale project involving academic societies, hospitals, research institutes including the Korean Society of Medical Oncology, Korean Cancer Study Group, Korea Health Industry Development Institute, National Cancer Center, Roche Korea, and Lunit Inc. is set to start this year. ◆Use without indication or approval ’OK’…brings new hope to terminal cancer patients The clinical project, KOSMOS2(KOrean precision medicine networking group Study of MOlecular profiling guided therapy based genomic alterations in advance Solid tumors II), will be recruiting 1,000 patients for 3 years. Subject patients are those with terminal-stage cancers that have a life expectancy of 6 months or less. In general, these patients are advised to leave the hospital because there is no other drug available for their use in the hospital. Therefore, their caregivers travel from hospital to hospital in search of one that can take care of their beloved’s illness just a little more. When left with no other option, most of them end up receiving hospice care. Enrolling in the KOSMOS2 study could open up new opportunities for these patients. First, patients who enroll in the KOSMOS2 study receive next-generation sequencing (NGS) to check for genetic mutations. Roche Korea provides an NGS-based comprehensive genomic profiling (CGP) Foundation Medicine Service. The results are stored on ‘Navify Tumorboard,’ Roche Diagnostic Korea’s multidisciplinary tumor board (MTBs) that was developed specifically for cancer treatment. It is a multicenter MTB that has been first attempted in the KOSMOS project that allows associated companies to share data. Academic specialists in pathology, oncology, and bioinformatics formed 6 teams to meet twice a week to analyze the patients' mutation status and discuss available drugs and treatment strategies. In the KOSMOS2 study, patients can attempt to be treated with drugs that are not approved in Korea or has no indication for their cancer if the doctors deem the drug appropriate. Therefore, the patient can receive treatment with a new drug that is not normally available, and the drug cost is borne by the pharmaceutical company. Of course, not all patients can receive treatment with new drugs. A drug that targets the patient’s mutation that had been identified through genetic testing has to first exist. The academic society estimated that around 30% of the patients will be able to receive treatment with new drugs. However, in the KOSMOS1 study, which became the basis for the KOSMOS2 study, more patients than expected were provided treatment opportunities. This was an unexpected achievement of precision medicine that even surprised the specialists. ◆Organic cooperation for Korean precision medicine...established a system for a virtuous cycle In the KOSMOS2 study, academic societies, research institutes, hospitals, and pharmaceutical companies organically work together to bring out the best results for each patient. The Korean Society of Medical Oncology and the Korean Cancer Study Group will lead the study, developing the specific design for the study and generating clinical and genomic data. As the Ministry of Food and Drug Safety’s designated national cancer data center, the National Cancer Center will be providing the technology and infrastructure required to build an integrated database for precision medicine. The NCC will also select and classify the collected data to provide a high-quality DB. Roche Korea will support pharmaceuticals and the optimal precision medical platform. To promote the project, the Korea Health Industry Development Institute will connect institutions, domestic and foreign pharmaceutical companies, and genome and software companies for collaboration. The first patient was recently enrolled in the KOSMOS2 study, which has been recruiting patients since the second half of last year. The study will enroll patients for 2 years, follow up for 1 year, and conclude the study after 3 years. The KOSMOS2 research project will provide patients with new treatment opportunities, and enable academia to realize precision medicine in the true sense regardless of their affiliation or region. Research institutes and industries can use high-quality genetic DB of cancer patients to conduct new research such as new drug development. In other words, a virtuous cycle of precision medicine and innovative new drug development will be created. Yong-Woo Kim, Lead of the Biopharmaceutical Industry Team at KHIDI, said, “It is important to build an integrated clinical genomic database as the basis for precision medicine and new drug development of pharma and bio companies in Korea. The organic cooperation between the government, academia, hospitals, and companies, will not only bring destructive innovation in precision medicine, but it will also mark the starting point for the revitalization of precision medicine in Korea."
- Company
- Despite the largest export of diagnostic kits ever, we canno
- by Kim, Jin-Gu Jan 17, 2023 06:02am
- Exports of domestic diagnostic kits broke the record last year. However, export performance in the second half of the year is on the decline. Analysts say that as the global COVID-19 situation calms down, exports of diagnostic kits, which have been on a high march, are returning to the level of previous years. According to the Korea Customs Service on the 16th, exports of diagnostic kits in Korea amounted to USD 3.34908 billion last year. It increased 63.6% from $2.047.32 billion in 2021. This is the highest performance ever. Domestic diagnostic kits have grown rapidly with the spread of COVID-19. Exports of diagnostic kits, which stood at only $253.26 million until 2019, rose vertically to $2.170.87 billion in 2020. It then recorded $2.047.32 billion in 2021. In the first half of last year, export performance increased further. Early last year, the average monthly exports soared to $435 million due to the simultaneous resurgence of COVID-19 around the world. Exports of diagnostic kits also plunged as the global COVID-19 crisis has subsided since the second half of last year. The average monthly export of diagnostic kits in the second half of last year was only $123 million. As the global pandemic is nearing an end, it is predicted that the export performance of diagnostic kits will also return to the level of previous years. Major diagnostic kit companies are also coming up with various measures to prepare for a decrease in global demand. SD Biosensor focused on expanding its appearance and entering the global market through mergers and acquisitions. In July last year, it announced that it would acquire Meridian Bioscience, a U.S. in vitro diagnostic company, for 2 trillion won. The acquisition will be jointly carried out by SD Biosensor and private equity fund operator SJL Partners. SD Biosensor and SJL Partners will take over at a rate of 60% and 40% respectively and invest in Columbus Holding Company, a special purpose corporation (SPC) jointly established in the United States. Madeira Acquisition and Meridian, SPC subsidiaries 100% of Columbus Holding Company, merge and enter Columbus subsidiary. SD BioSensor has been steadily expanding its global distribution network since last year. On top of that, the acquisition of Meridian made it official to enter the world's largest diagnostic market and focused on expanding the global distribution network. On top of that, the company plans to further expand its global territory through additional acquisitions. Seegene is focusing on developing diagnostic kits other than COVID-19. Seegene is developing reagents and equipment that diagnose diseases other than COVID-19 through massive R&D expansion. They include reagents for diagnosing cervical cancer (HPV), sexual intervention (STI), and respiratory diseases other than COVID-19.
- Company
- Stelara biosimilar of Dong-A ST succeeded in clinical trials
- by Chon, Seung-Hyun Jan 17, 2023 06:02am
- Dong-A ST announced on the 16th that the Stelara biosimilar DMB-3115 has confirmed its safety and effectiveness in clinical trials. On the same day, Dong-A ST introduced the results of DMB-3115's global phase 3 clinical trial top line and announced that it would apply for item permission to the U.S. and European health authorities in the first half. Dong-A ST conducted a global phase 3 clinical trial of the Stelara biosimilar DMB-3115 on a total of 605 patients in nine countries, including the United States, Poland, and Estonia, from 2021 to the end of last year. Developed by Janssen, Stelara is a treatment for inflammatory diseases such as plate psoriasis and psoriatic arthritis, Crohn's disease, and ulcerative colitis. It is a blockbuster product that recorded sales of $9.134 billion in 2021. In clinical trials, DMB-3115 has proven its validity for European and U.S. item licensing. As a result of evaluating psoriasis area and severity index, which are the primary evaluation variables for European EMA item licensing, DMB-3115 statistically demonstrated therapeutic equivalence with Stella. In the US FDA evaluation index for item licensing, DMB-3115 confirmed the equivalent validity of Stelara. The safety assessment also confirmed that DMB-3115 is equivalent to Stelara. The proportion of subjects with even one new or worsening adverse reaction after administration of clinical trial drugs was about 54% in the group administered DMB-3115 and about 57% in the group administered Stelara. At 28 weeks, about 55% of the group change from Stella to DMB-3115 occurred, and no clinically significant difference was observed. The proportion of subjects with even one serious adverse reaction was similar, about 2% in the group administered DMB-3115 and about 3% in the group administered Stella. It did not occur in the group that changed from Stelara to DMB-3115 at 28 weeks. Dong-A ST said, "We plan to apply for DMB-3115 item permits in major overseas countries such as the United States and Europe in the first half of this year."
- Company
- Novartis charged with 'rebate' has been fined
- by jung, sae-im Jan 16, 2023 07:47pm
- Novartis and Media Fines…Suspension of imprisonment for those involved Novartis Korea, accused of providing illegal rebates of about 2.6 billion won to doctors, was finally fined by the Supreme Court. On the 12th, the Supreme Court rejected the appeal filed by Novartis Korea, related parties, and media outlets who were convicted in the original trial for violating the Pharmaceutical Affairs Act, and confirmed a fine of 40 million won issued to Novartis Korea. They were indicted in 2016 on charges of giving a total of 18.1 billion won in product advertising expenses to media outlets such as medical journals between 2011 and 2016, and paying 2.59 billion won to doctors in the name of manuscript fees or advisory fees. The lower court sentenced Novartis Korea to a fine of 40 million won and the media to a fine of 10 million won to 25 million won, respectively. Novartis Korea officials were sentenced to one year in prison, suspended, and fined. All five media representatives involved were sentenced to prison and suspended. Novartis Korea's former CEO was acquitted.
- Company
- Next-Generation ADC Enhertu launches in Korea
- by jung, sae-im Jan 16, 2023 07:39pm
- Enhertu, which Korean breast cancer patients urged for quick permission last year, was released in Korea this month. Analysts say that it will change the paradigm of secondary treatment for HER2-positive breast cancer with a superior effect compared to existing treatments. Daiichi Sankyo held a press conference at the Westin Chosun Hotel on the 12th to commemorate the launch of the ADC (antibody-drug conjugation) new drug Enhertu in Korea. Enhertu is an anticancer new drug approved by the Ministry of Food and Drug Safety in September last year. It can be used for HER2-positive breast cancer (secondary) and stomach cancer (third). Park Yeon-hee, Professor of Hematology and Oncology at Samsung Medical Center Enhertu is a next-generation ADC jointly developed by AstraZeneca and Daiichi Sankyo. ADC is a drug made by connecting "Antibody" that binds to a specific target antigen on the surface of cancer cells and a "Payload" that has the function of apoptosis with "Linker." It is a drug that selectively acts only on cancer cells to increase treatment effects and minimize side effects. Existing ADCs have caused tumor resistance for various reasons, resulting in some poor efficacy. Enhertu was developed to compensate for these shortcomings and provide optimal anti-tumor effects. Drugs with a new mechanism of action were applied, and a high and uniform drug and antibody ratio was set. ◆"The breast cancer data is amazing"…Expected to expand the indication Park Yeon-hee, a professor of hemato-oncology at Samsung Medical Center, who was the speaker at the meeting, introduced Enhertu's major data and welcomed it, saying, "I'm happy to release Enhertu in Korea, which has proven excellent effects in breast cancer clinical trials." Major breast cancer clinical studies in Enhertu include DESTINY-Breast01 and Breast03. The Breast01 study measured the effectiveness and safety of Enhertu in tertiary or higher patients with extensive treatment. The Breast03 study is a phase 3 clinical trial compared to Kadcylla (T-DM1) when Enhertu was used as a secondary treatment. As a result of the final updated Breast01 study in March 2021, N Hutu achieved the first evaluation variable with an objective response rate (ORR) of 62%. The median reaction duration (mDOR) was 18.2 months, the median progression duration (mPFS) was 19.4 months, and the median total survival period (mOS) was 29.1 months, respectively. Enhertu Professor Park said, "In the clinical trial, Enhertu recorded a high number of 19.4 months of PFS. "OS also showed 29.1 months even though there was no drug available after this," he explained. Enhertu also demonstrated excellent effectiveness in direct comparison with the first-generation ADC treatment Kadcylla. As a result of the Breast03 study, Enhertu reduced the risk of disease progression or death by 72% compared to Kadcyla by 34.1% with a progression-free survival rate of 75.8% at 12 months. Kadcyla's mPFS was 6.8 months, while Enhertu did not reach the evaluation value. Professor Park also expressed high expectations for Enhertu's additional indications. HER2 is low-expression breast cancer. These patients account for half of breast cancer patients, but they are not suitable to use existing HER2-targeted treatments, which is an area with high unmet demand. In a clinical trial announced last year, Enhertu first introduced it in the area of HER2 underexpression by reducing the risk of disease progression or death by 50% compared to the chemotherapy group. Currently, it has acquired an American indication. Professor Park said, "I personally have high expectations for HER2 low-expression breast cancer indications," and added, "I hope the expansion of domestic indications will not be delayed further." ◆"Highly toxic but manageable, Enhertu's benefit should be applied" Enhertu has a high risk of side effects as much as its excellent effect. The most common adverse event in the Breast03 study was interstitial lung disease (ILD), which was cited as the most cautious side effect when using Enhertu. The rate of epileptic lung disease in the Enhertu group was 10.5%, which was higher than that of the Kadcylla group at 1.9%. Professor Park said, "It is true that it is more toxic than conventional drugs," but added, "But it can be managed sufficiently by dose control." He then said, "Fatal side effects were mainly found in Japanese patients, and I don't think this case can be expanded to the entire Asian region." Side effects are something to be careful about, but the prognosis varies depending on how a specialist manages them. "From my experience, I think it is manageable," he added. Professor Park urged Enhertu to register his benefit quickly. Professor Park stressed, "At least the indication received now should be covered by insurance benefits as soon as possible." Daiichi Sankyo is known to have applied for a salary registration for Enhertu breast cancer and gastric cancer on December 28 last year. The HIRA is awaiting the introduction of the Cancer Disease Review Committee. Kang Bo-sung, head of the marketing division of Daiichi Sankyo's anti-cancer drug division, replied, "We will actively discuss with health authorities to register our quick benefit."
- Company
- Last year's drug trade deficit was the largest ever
- by Kim, Jin-Gu Jan 16, 2023 06:03am
- Vaccine exports hit an all-time high, but have been on the decline since the second half of the year. Last year, pharmaceutical exports fell 23% year-on-year. The export performance of medicines, which had been on a high march for two years from 2020 to 2021, is gradually returning to the previous year's level as the global spread of COVID-19 subsides. Drug imports exceeded $10 billion for the first time last year. The drug trade deficit soared to more than $4 billion as pharmaceutical exports plunged and import performance increased slightly. Vaccines, a representative COVID-19 beneficiary item, also recorded the highest version ever last year, but monthly, the decline has been evident since the second half of the year. Drug exports in the last 10 years (US$ million, data and customs office) According to the Korea Customs Service on the 16th, Korea's drug exports last year amounted to 6.27421 billion dollars compared to $8.12144 billion in 2021, which decreased by 22.7%. Domestic drug exports steadily increased until 2021. In particular, exports had increased steeply since 2020 when COVID-19 began to spread around the world. Drug exports rose vertically from $3.695.9 billion in 2019 to $6.8935 billion in 2020. In 2022, it increased further to $8.12144 billion. In other words, it has increased 2.2 times in two years when the pandemic is prolonged. However, since the second half of last year, the spread of global COVID-19 has gradually subsided, leading to a decrease in domestic drug exports. In particular, as the end of the year approaches, exports are clearly decreasing. Exports, which averaged $584 million in the first quarter of last year, fell to $446 million in the fourth quarter. It is the first time since the first quarter of 2020, just before the spread of the COVID-19 crisis that the average monthly drug exports reached the $400 million range. Drug imports topped $10 billion for the first time. Last year, pharmaceutical imports amounted to USD 10.27534 billion, an increase of 4.5% from the previous year. While pharmaceutical exports plunged, imports increased slightly, widening the drug trade deficit to the largest ever. Last year, the drug trade balance recorded a deficit of $4.0113 billion. It is the largest since $3.211 billion in 2014. Drug imports in the last 10 years (US$ million, Data and Customs Service) ◆K-Vaccine Achieves Highest Export Performance Ever…a sharp drop in the second half of the year Following 2021, vaccines contributed to exports last year. Last year, domestic vaccine exports amounted to 941.12 million dollars up 81.5% from the previous year. Vaccines also account for a significant increase in total drug exports. Until 2020, the proportion of vaccine exports was only 2.5%, but in 2021, it more than doubled to 6.4%. Last year it rose further to 15.0%. Exports of domestic vaccines have surged since December 2021. Novavax and Moderna vaccines produced by SK Bioscience and Samsung Biologics have begun to be exported in earnest. Last year, exports averaged nearly 130 million dollars in the first half of the year. However, since the second half of last year, exports of vaccines have decreased significantly. The average monthly vaccine exports in the second half of last year were only $27 million. Analysts say that it has returned to a similar level to before the consignment production of the COVID-19 vaccine. As the global COVID-19 vaccination rate decreases, exports of domestic vaccines are also expected to remain at the previous year's level.
