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- 2026-03-14 21:27:04
- Company
- Medytox in legal dispute with its Chinese partner
- by Kim, Jin-Gu Jan 25, 2023 06:08am
- Medytox has been embroiled in a 120 billion won legal dispute with its Chinese botulinum toxin partner. Medytox officially announced on the 20th that Gentix Ltd., a subsidiary of the Chinese company Bloomage Biotechnology, had filed a claim for damages against Medytox to the Singapore International Arbitration Centre (SIAC). Gentix had claimed that Medytox violated the contracted terms of their Chinese joint venture. In addition, Gentix requested SIAC to confirm the company’s right to terminate the agreement. The amount claimed for damages is HKD 750 million (approximately KRW 118.8 billion). Based on the end of the third quarter of last year, this is equivalent to 26.4% of Medytox's total capital of KRW 449.2 billion. Medytox established Medybloom China with Bloomage Biotechnology in 2015 to prepare for entry into the Chinese market. Medytox had planned to sell its botulinum toxin product to the Chinese market through the newly established company. However, the plan was put to a halt in July last year with Bloomage announcing intentions to terminate its cooperative relationship with Medytox. At the time, Bloomage is said to have pointed to how Medytox did not supply products for sale as the reason for termination. On this, Medytox said, "We believe that no violations of such that have been claimed by the other party has been made, and plan to actively respond with our legal representatives.”
- Company
- LG Chem completes acquisition of US bio-company AVEO
- by Kim, Jin-Gu Jan 20, 2023 06:07am
- Executives and employees including LG Chem Vice Chairman Hak Cheol Shin (first row, fourth from the left), AVEO CEO Michael Bailey (next to VC Shin), LG Chem Life Sciences President Jeewoong Son (first row, far left) met to take a celebratory photo LG Chem has completed the acquisition of the US bio-company AVEO Pharmaceuticals and plans to make the leap to become one of the 'global top 30 pharmaceutical companies focusing on the oncology business. On the 19th, LG Chem announced that it had invested KRW 707.2 billion (USD 571 million) in its U.S. affiliate, ‘LG Chem Life Science Innovation Center,’ to acquire AVEO Pharmaceuticals on the 18th. The company plans to complete the M&A process by the 20th. LG Chem received approval for the HSR filing on December 1, 2022. Afterward, the merger passed the shareholders’ meeting and was approved by the Committee on Foreign Investment in the United States (CFIUS) on the 17th. After the acquisition, AVEO will be integrated as a subsidiary of LG Chem. However, the company will be operated independently as before based on its oncology business capabilities. AVEO Pharmaceuticals, which was established in Boston, MA in 2002, owns full capabilities ranging from clinical development, approval, sales to marketing in oncology. The company received FDA approval for its targeted therapy Fotivda for the treatment of renal cell carcinoma in 2021. In only 2 years since the release of the new drug, the company raised KRW 130 billion last year, and sales are expected to grow over 60% and achieve KRW 210 billion this year. The US securities companies expect sales of Fotivda to reach KRW 450 billion by 2027. Through the acquisition, LG Chem aspires to grow as a global pharmaceutical company in the field of oncology. In the mid-to-long term, the company will transfer the company’s new anticancer drug pipeline to AVEO and accelerate the commercialization of new oncology drugs in the US. LG Chem is currently developing cell therapies and immune checkpoint inhibitors in the preclinical stage. With the merger, the Life Science Innovation Center, which owns strengths in early-stage research and manufacturing process development, will be in charge of ▲discovering promising anticancer candidate substances, ▲preclinical and early-stage clinical trials, and the ▲commercialization process development, and AVEO, which owns know-how in clinical development and sales in the US market, will be in charge of ▲later stage research of the company’s oncology pipeline, and ▲commercialization. In addition, the company plans to continue reinforcing its anticancer product portfolio by promoting the introduction of oncology tasks in late-stage clinical trials near commercialization. LG Chem plans to invest KRW 2 trillion in its bio-business by 2027 and release 4 or more new drugs in the fields of oncology and metabolic diseases in the global market by 2030. Also, the company plans to achieve sales of KRW 2 trillion by 2027 by expanding sales in existing businesses such as diabetes, vaccines, growth hormones, and oncology. After sales of new drugs currently under development begin in earnest in 2030, LG Chem expects sales to continue to grow by hundreds of billions of won each year. Hak Cheol Shin, Vice Chairman & Chief Executive Officer at LG Chem, said, “We will focus on fostering Aveo as a future bio hub that can drive the growth of our oncology business and combine and maximize synergies of our business to make the leap forward and become one of the 'global top 30 pharmaceutical companies focusing on the oncology business.’ Michael Bailey, CEO of AVEO, said, “The merger has brought AVEO one step closer to its vision of ‘improving the lives of cancer patients.’ By combining the capabilities of the two companies, we will grow to another level and become a company that continues to release new drugs
- Company
- Anti-depressant Brintellix generic for exclusivity succeeded
- by Jan 20, 2023 06:07am
- Myungin Pharmaceutical (CEO Lee Dong-myung) and Unimmed Pharmaceutical (CEO Kim Gun-nam) announced on the 18th that they succeeded in invalidating the patent for the antidepressant Brintellix. The Korean Intellectual Property Tribunal recently made a decision to cite the claim on Brintellix purpose patents filed by both companies against Lundbeck Korea. Lundbeck Korea has a total of two material patents that expire in May 2027 and usage patents that expire in November 2028 related patents that expire in November 2028. Myeongin Pharmaceutical and UniMed Pharmaceutical have filed invalid and passive claims for patents for use. The decision also outlined generic for exclusivity for Brintellix's generics. Myungin Pharmaceutical and Unimed met the requirements for "first trial request" and "first item permit application" by filing a series of requests for judgment in March last year. In June, the Ministry of Food and Drug Safety applied for the first simultaneous generic item license. As both companies win the patent invalidation trial, only the two pharmaceutical companies are expected to acquire generic for exclusivity use of Brintelix. Brintellix was approved domestically in August 2014 as a multi-acting antidepressant through direct regulation of serotonin receptors involved in depression and inhibition of serotonin reabsorption. According to IQVIA, a pharmaceutical market research firm, Brintelix's annual sales continued to grow by double digits every year to 8.7 billion won in 2020, 9.7 billion won in 2021, and 10.4 billion won in 2022. Myungin Pharmaceutical and Unimed Pharmaceutical will be able to sell generic products exclusively for nine months after May 10, 2027, when the substance patent expires.
- Company
- The Brain disease prescription market disappears
- by Chon, Seung-Hyun Jan 19, 2023 05:59am
- Pharmaceutical companies lost 30 billion won a year due to Oxiracetam. Prescription loss became a reality as it failed to prove its efficacy in an eight-year clinical re-evaluation. Following acetyl-L-Carnitin last year, the annual prescription market worth 100 billion won has disappeared due to the failure of clinical re-evaluation of cerebrovascular-related drugs over the past year. According to the Ministry of Food and Drug Safety on the 18th, prescription and preparation were suspended because Oxiracetam failed to prove the effectiveness of "improving symptoms of vascular cognitive impairment" as a result of clinical trial reevaluation. Oxiracetam has been licensed to improve cognitive impairment due to Alzheimer's type dementia, multiple infarction dementia, and organic brain syndrome caused by brain failure. Cognitive disorders include decreased memory, attention, and concentration, speech and behavioral disorders, emotional anxiety, and lack of motivation. The Ministry of Food and Drug Safety announced the clinical re-evaluation of Oxiracetam in March 2015. According to the clinical revaluation design, indications were adjusted in 2019 due to the improvement of vascular cognitive impairment. Oxiracetam's deadline for submitting clinical re-evaluation data was set in March 2019, but the deadline for submitting the data was extended twice and finally closed in June last year. As a result of reviewing the clinical trial data, it was concluded that it failed to prove its efficacy, and decided to discontinue the prescription. As a result, Oxiracetam is expected to lead to the deletion of indications and exit from the market eight years after the announcement of clinical re-evaluation. According to UBIST, a drug research agency, the number of outpatient prescriptions for Oxiracetam last year was 21.3 billion won. Oxiracetam formed a prescription market of 30.8 billion won and 31 billion won in 2017 and 2018, respectively. Since the adjustment of indications in 2019, the prescription volume in 2020 has decreased by 26.6% from two years ago to 22.6 billion won, and the decline has continued in 2021 and last year. According to the prescription amount by item, Korea Pharmaceutical's Neuromed showed the largest prescription performance of KRW 11.8 billion last year. This clinical re-evaluation means that Korea Pharmaceutical will lose 11.8 billion won annually. Samjin Pharmaceutical's Neuracetam recorded 5.1 billion won in prescriptions last year, while Hwanin Pharmaceutical's Neuoxitam and Kwangdong Pharmaceutical's Neuropia raised 2.8 billion won and 1.5 billion won, respectively. As a result, drugs related to brain diseases will be removed from the market for the second consecutive year following acetyl-L-Carnitin last year due to failed clinical re-evaluation. Dong-A ST's Nicetile, acetyl-L-Carnitin, has been approved for use in "primary degenerative disease" or "secondary degenerative disease caused by cerebrovascular disease." In 2013, the Ministry of Food and Drug Safety ordered a clinical re-evaluation of acetyl-L-carnitine drugs. The re-evaluation clinical trial was conducted in two groups according to indication. Dong-A ST took the lead in conducting a clinical trial of "primary degenerative disease." Hanmi Pharmaceutical was in charge of clinical trials of "secondary degenerative diseases caused by cerebrovascular disease." As a result of clinical trials, the indication was deleted in July 2019 because it failed to prove the primary degenerative disease. In August last year, it was concluded that the "secondary degenerative disease caused by cerebrovascular disease" also failed to prove its effectiveness. In other words, as a result of nine years of clinical re-evaluation, all indications were not proven, leading to the exit procedure. Acetyl-L-carnitine preparations also suffered from clinical design. It is known that it took about two to three years to set up a clinical design while designing a new clinical trial reflecting the latest scientific standards. At the request of the pharmaceutical company, the deadline for clinical re-evaluation of primary degenerative diseases was extended by two years, and the submission of clinical trial data for secondary degenerative diseases was extended by four years, which resulted in failure. Acetyl-L-Carnitin drugs formed an outpatient prescription scale of 72.6 billion won in 2017 and 74.8 billion won in 2018, but fell to 64 billion won and 51.1 billion won in 2019 and 2020, respectively. With the deletion of the first indication, the market size has been reduced. Last year, the prescription record was 31.6 billion won, but it finally disappeared from the market. As of last year, Hanmi Pharmaceutical's Carnitil left 11 billion won and Dong-A ST's Nicetile left 5 billion won in prescriptions. In 2017 and 2018, Oxiracetam and acetyl-L-Carnitin collaborated on a total of 103.4 billion won and 105.9 billion won in prescriptions. The pharmaceutical industry has become inevitable to lose about 100 billion won a year due to the failure of clinical re-evaluation of oxiracetam and acetyl-L-carnitine drugs.
- Company
- 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.
