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- 2026-05-18 13:59:08
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- Sales of Arcoxia (Etoricoxib) are sluggish
- by Kim, Jin-Gu Nov 16, 2021 05:52am
- Generics for Arcoxia, an anti-inflammatory pain reliever based on COX-2 inhibitors (Etoricoxib) have been released, but sales in the market are sluggish. This is because there is still a high preference for original drugs at the medical site, and even the original drugs are pushed back by Celebrex, a leading item in the same family market. According to UBIST, a pharmaceutical market research firm on the 11th, the total prescription amount for generics for Arcoxia from June to September is around 31 million won. During this period, the original prescription amount is around 730 million won. Generic prescriptions account for only 4% of the original. Generics challenged Arcoxia's patent in September 2019. In April last year, it won the passive trial to confirm the scope of rights. It succeeded in avoiding patents that were scheduled to expire in 2023. Theragen Etex, Guju, Hana, Hutechs, Union Korea, Aju, Daewoo, Boryung, Arlico, and Reyon received generic for exclusivity from April this year to January next year. Generics have been released in earnest since June this year. Aju, Arlico, Hutechs, Hana, Theragen, and Etex are confirmed to have released generics one after another. However, for four months, their total prescription amount is only 31 million won. Hana's sales are the highest at 19 million won, and sales of the other generics are less than 10 million won. This is because the original preference is still high at the prescription site. As of last year, outpatient's prescription for Celebrex amounted to 44.7 billion won. It is more than 12 times Arcoxia's sales of 3.5 billion won.42 billion won and 2.7 billion won worth of prescriptions were prescribed by the third quarter, respectively, widening the gap by 15 times. Since 2010, more than 200 generics for Celebrex have been competing. Generics for Arcoxia have little time to compete. The generic for exclusivity period will end in January next year, but no company has started developing generics for Arcoxia yet.
- Company
- The price reduction of PE waiver drugs
- by Eo, Yun-Ho Nov 15, 2021 06:29pm
- KRPIA expressed serious concern in a comment on the 10th that the HIRA was confirmed to evaluate the cost effectiveness at 80% of the lowest A7 adjustment price when asked about the cost-effectiveness criteria of Kim Mi-ae, a member of the National Assembly. KRPIA said, "In the course of discussions with the HIRA, we have repeatedly expressed opinions that uncertainties arising from the application of the risk-sharing system in A7 countries should be flexibly evaluated according to the characteristics of each drug." In addition, it pointed out, "If the figure of 80% for which the basis for calculation is not clear is applied collectively, access to drugs subject to PE exemption, which are limited to patients with rare and severe diseases, may be severely reduced." The PE waiver drug system is mandatory to limit the total amount of annual use in response to uncertainties in A7 national indicators, and if overseas prices are further lowered during the follow-up period, tight financial management is already taking place. KRPIA said, "If we have to further cut the drug price by 20% to 80% of the lowest price in A7 countries, PE waiver drugs will actually be privately cultured. In addition, considering the purpose of the system to guarantee drug prices for drugs that need to be registered, if the HIRA sets the lowest price as an internal operating standard and applies it collectively to all drugs, there is a possibility of abuse of discretion in violation of the principle of trust protection." In addition, it pointed out that it could violate the national treatment regulations of the Korea-US FTA and the Korea-EU FTA, stressing that if the administration is operated based on an undisclosed internal operation standard and the evaluation criteria of PE waiver drugs are changed, it can be seen as a de facto discrimination measure. KRPIA said that the HIRA-industry meeting on June 17 and the MOHW's public-private consultative body on July 28 consistently argued that the application of specific figures is inappropriate and should be evaluated according to the characteristics of each drug.
- Company
- Will sales of flu treatments be recovered?
- by Chon, Seung-Hyun Nov 15, 2021 05:56pm
- According to UBIST, a drug research institute, on the 14th, the amount of outpatient prescriptions for flu treatments in the third quarter was only 7.97 million won. It fell 31.1% year-on-year. It decreased by 75.2% from the same period two years ago. The flu treatment market has been prescribing less than 100 million won for six consecutive quarters since the second quarter of last year. The market size has been insignificant since it plunged 99.8% to around 10 million won in the second quarter after hitting 8.4 billion won in the first quarter of last year. The prescription amount in the fourth quarter of last year and the first quarter of this year, which are flu epidemic seasons, was only 20 million won and 10 million won, respectively. Quarterly outpatient Rx amount for flu tx (unit: 1 million won, data: UBIST) Sales in the Oseltamivir market, the most prescribed flu treatment, have decreased significantly. Oseltamivir is the active ingredient of Tamiflu. In the third quarter, the prescription for Oseltamivir was only 7.97 million won. It fell 31.1% year-on-year and 74.3% year-on-year. Oseltamivir prescription performance soon becomes sales in the entire flu treatment market. Since the third quarter of last year, the overall prescription performance of Oseltamivir has occurred only in one item of Tamiflu. Since the third quarter of last year, there seems to be no flu treatment except for Tamiflu. This is a change in the prescription market due to the prolonged COVID-19. This is because after the spread of COVID-19, the incidence of infectious diseases has decreased significantly due to strengthening personal hygiene management such as washing hands and wearing masks, and only Tamiflu has been prescribed when patients occasionally occur. According to The KDCA, the number of suspected flu patients per 1,000 outpatients has never exceeded the epidemic standard of 5.8 this year. Status of influenza suspected cases per 1,000 outpatients (unit: name, data: the KDCA) In the ninth week of last year, the number of suspected flu patients per 1,000 outpatients recorded 6.3 and remained at the level of two to three. There have been few flu patients for about a year and eight months since early March last year. Even this month, when the winter season began in earnest, the number of suspected flu patients per 1,000 outpatients was only 3.3. In this situation, the possibility of the spread of infectious diseases such as the flu is being raised as face-to-face contact expands due to the lifting of the time limit for multi-use facilities due to the daily recovery of COVID-19. However, it is unlikely to lead to a sudden spread of infectious diseases as hygiene management such as wearing a mask is still strictly observed. An industry official said, "Since there have been few flu patients this year, production and supply of flu treatments have been virtually suspended," adding, "We will consider expanding the production and supply of treatments while looking at the increase in the number of patients."
- Opinion
- [Reporter’s View] On HIRA's price cuts for PE waiver drugs
- by Eo, Yun-Ho Nov 15, 2021 05:56am
- HIRA’s unilateral notice of its decision leaves a lingering question on whether this really was the best way to conclude the discussions. Couldn't the government have included its favorite words - "in discussion" or "in coordination" - that it uses best? The Health Insurance Review and Assessment Service responded that the criteria for evaluating the cost-effectiveness of drugs that are waived submission of pharmacoeconomic evaluation data was set at ‘80% of the lowest A7 adjusted price’ rather than the lowest A7 adjusted price to a written QA submitted by NA member Miae Kim of the People Power Party during the NA audit. This is a sort of forced conclusion and a line drawn to the persistent resistance and controversy raised by the industry. On the news, the Korean Research-based Pharma Industry Association immediately issued its criticism, expressing strong regrets. KRPIA said, “During discussions with HIRA, we have continuously expressed that the uncertainties caused by the application of the risk-sharing system in A8 countries should be flexibly evaluated according to characteristics of each drug. A blanket application of the 80% standard without clear grounds on its calculation will seriously undermine access to drugs that are subject to pharmacoeconomic evaluation exemptions that are being allowed limited use in rare and severe disease patients.” The association added that such a standard would invalidate the system in itself. Some may consider the industry’s sullen response as a natural course of making transitions. However, the response provided for the NA audit was a blow in the back from the industry’s view as the issue had not been discussed after the Ministry of Health and Welfare’s Division of Pharmaceutical Benefits had said it will continue to collect stakeholder opinions following the serious concerns that were raised in the two meetings the HIRA held with the industry (industry roundtable in June and the private consultative body in July). The pharmacoeconomic evaluation exemption system is the only way for drugs that cannot undergo economic evaluations but is necessary to receive reimbursement. Various fiscal management systems are included in the scheme, and the ‘Expenditure Cap’ design has been embraced ever since the system was implemented. With the increasing number of drugs being eligible for the system, the government could have deemed some improvement is necessary. However, the way how they implemented the system is regrettable. “We will continue discussions with stakeholders. We will review the issue.” Why HIRA was unable to implement the caution and ambiguity that it had so often implemented in the written response to the NA remains in question.
- Company
- K-COVID-19 vaccine developers will ‘power through till end'
- by Kim, Jin-Gu Nov 15, 2021 05:56am
- Domestic vaccine developers have been accelerating the last phases of their clinical trials. SK Bioscience and Genexine have started Phase III trials in Korea and abroad, and Cellid has submitted its Phase IIb/III clinical trial plan. Domestic developers have come up with new strategies to continue the development of their vaccines with the value of latecomer vaccines lowering due to the domestic vaccination rate reaching nearly 80% in Korea and the introduction of oral COVID-19 treatments imminent. ◆Cellid applied for Phase 2b/3 trial… starts development of a vaccine against variants If the clinical trial protocol is approved, the Phase IIb clinical trial will be conducted on 125 participants, and Phase III on 4,100 participants. The Phase III trial will compare AdCLD-CoV19-1 with AstraZeneca’s COVID-19 vaccine. Cellid has started a new clinical trial for its existing candidate ‘AdCLD-CoV19' after revising its virus vector. The production yield rate change has improved with the revision of the virus vector. Upon completing the phase 2a trial, Cellid said in June that it would newly develop AdCLD-CoV19-1, a revised version of the virus vector vaccine, for mass production. In addition, the company obtained the regulatory nod for a phase 1 study of AdCLD-CoV19. Apart from this, Cellid is also concurrently developing a new vaccine candidate that responds to COVID-19 variants including the Delta variant. Animal testing is currently underway for the new vaccine candidate. Cellid expects it would be able to enter Phase I clinical trials for its variant vaccines next year at the earliest. The company’s experience with its Phase IIb/III trial for AdCLD-CoV19-1 is expected help accelerate its development. Cellid’s two-track development strategy is not unrelated to the COVID-19 vaccine and treatment development situation in Korea and abroad. With the market value of latecomer vaccines decreasing, the companies have explained that the changes in their development strategies were inevitable. As of midnight on the 12th, the domestic COVID-19 vaccination rate in Korea reached 77.6 % (full vaccination rate). Therefore, the possibility of not many candidates being left for vaccination even if the company completes its vaccine development by the first half of next year as planned. Remains. In addition, the value of the latecomer vaccine has been rated even lower with the imminent introduction of oral coronavirus treatments. ◆SK Bioscience signs agreement to supply its vaccine to developing countries… Genexine to develop a vaccine as booster shot SK Bioscience and Genexine, which have started their Phase III trials ahead of Cellid, have also been facing the same dilemma. SK Bioscience plans to finish development and expand its supply to developing countries around the world by early next year. SK Bioscience signed a supply agreement with CEPI (The Coalition for Epidemic Preparedness Innovations) for the provision of its vaccines. After GBP510 is developed and is selected for the “Wave 2” (next-generation COVID-19 vaccine) project, the vaccine will be supplied globally, in Africa, South America, and Southeast Asia through the COVAX Facility. The global vaccination rate has reached around 51.3%. In developing countries, the rate is around 10% or less. Therefore, unlike in the domestic market, a sufficient supply market remains for the vaccines globally. SK Bioscience initiated its Phase III trial in August. The company expects the trial to be finalized and be approved by 1H next year. In the case of Genexine, the company changed its vaccine development strategy to developing booster shots. In August, the company applied to change its clinical trial plan for the global Phase II/III trial it has been conducting for ‘GX-19N’ in Indonesia in August. The new strategy is to develop a booster vaccine with its vaccine candidate. The clinical trial will confirm the protective efficacy of GX-19N in 1,000 participants who had been vaccinated with Sinovac or Sinopham’s inactivated vaccines 3 months earlier. Genexine plans to expand the clinical trials in Indonesia to Argentina and other countries in 14,000 patients. However, the analysts are that the decision may have been influenced by the fact that the drug, if developed, will not have much marketability, like other vaccine developers.
- Policy
- Rx drugs,allowed according to CTD starting from next year
- by Lee, Tak-Sun Nov 15, 2021 05:56am
- The MFDS announced on the 11th that it will partially revise the Regulation on Drug Product Authorization, Declaration, & Review to secure the quality reliability of generics in accordance with international standards. The revision includes improving the management of manufacturing methods such as Rx drugs manufacturing processes, deleting some submission data exemption regulations upon approval based on foreign drugs, process documents, and specifications, establishing standards for packaging disposable eye drops, and listing active ingredients in the product name. Accordingly, from November 12 next year, when licensing Rx drugs, it will be improved to describe in detail according to CTD when describing manufacturing methods such as manufacturing processes. Currently, it is summarized mainly in major manufacturing processes. In addition, the manufacturing method of the product submitted by CTD will be changed. Some submission data exemption regulations will be deleted upon permission based on the acceptance of foreign pharmacies, process documents, and specifications (Pharmacopoeia). Some data, such as toxic and pharmacological data, could have been exempted if they were listed in a foreign drugstore, but in the future, they will be required to submit data to examine safety and effectiveness based on scientific evidence. Along with this, a new standard for limiting the packaging unit of disposable eye drops will be established. In order to relieve public anxiety caused by the reuse of disposable eye drops and to provide a safe use environment for medicines, the packaging unit considering the amount of eye drops used once is defined as 0.5ml or less. Only single-component drugs are currently marked with active ingredients in the product name, but in the future, information provision will be expanded by marking active ingredients in the product name of combinations with three or less main ingredients. The revision to the drug equivalence test standards includes the preparation of biological equivalence test evaluation standards reflecting the formulation characteristics of enteric agents, and harmonization of international standards and regulations for biological equivalence test exemption standards according to the BCS. From November 12 next year, criteria for evaluating biological equivalence tests reflecting the characteristics of preparations of Enteric-coated preparations will be prepared. Starting today, the BCS exemption criteria for biological equivalence tests will be met with international standards. In accordance with the enactment of the ICHM9 guidelines, the standards for exemption from biological equivalence tests for drugs will be newly established to align international and domestic regulations equally. The MFDS said it expects the revision to raise the quality of medicines to the next level, and it will strengthen its drug licensing and management system based on Regulatory Science so that doctors, pharmacists, and patients can use quality drugs with confidence. Details can be found on the MFDS' website (mfds.go.kr > statutes/data > statute information > amendment notice, etc.).
- Company
- Hanmi Pharmaceutical's first technology export in a year
- by Chon, Seung-Hyun Nov 12, 2021 05:56am
- Hanmi Pharmaceutical is speeding up its efforts to secure profits from technology fees, which had slowed down for a while. It has secured a down payment of 10 billion won by exporting new drug technology in the past year, and expectations are high for subsequent new drug development. According to an industry on the 11th, Hanmi Pharmaceutical exported FLT3 inhibitor "HM43239," which is being developed as an innovative drug for AML treatment, to Aptose Biosciences on the 4th. Under the contract, Hanmi Pharmaceutical will receive a $12.5 million down payment (about 15 billion won) from Aptose Biosciences in cash and $7.5 million in Aptose Biosciences shares. After that, it will receive up to $47.5 million (about 485 billion won) in clinical, development, permission, and commercialization milestones for various indications. You will also receive a step-by-step royalty for sales. Hanmi Pharmaceutical completed the export of new drug technology in a year and three months. Hanmi Pharmaceutical exported a non-alcoholic steatohepatitis treatment to MSD in August last year. The GLP-1-based double agent whose rights were returned from Janssen was transferred back to MSD after a year. It is a double-acting treatment that simultaneously activates GLP-1, which helps secrete insulin and suppress appetite, and glucagon, which increases energy metabolism, and Hanmi Pharmaceutical's original technology for lapscovery, which increases drug efficacy duration, is applied. Hanmi Pharmaceutical's new technology export contract is also expected to expand technology fee profits. Hanmi Pharm is expected to temporarily recognize the down payment of $5 million (about 6 billion won) received in cash from Aptose Biosciences as technology fee revenue. Hanmi Pharmaceutical has established its technology fee revenue in earnest since 2015 when it began to produce technology export results in earnest. However, in recent years, when technology exports have become less successful, technology fee profits have decreased significantly. Until the third quarter of this year, Hanmi Pharmaceutical's technology fee revenue was only 200 million won. No technology fee revenue was generated in the first and second quarters, and 200 million won flowed in in the third quarter. Hanmi Pharmaceutical earned a total of 512.5 billion won in technology fees from down payments received from Lily, Beringer, Sanofi, and Janssen in 2015 and secured more than 10 billion won in technology fees every year. Hanmi Pharmaceutical posted 27.7 billion won in technology fees in 2016, which is the result of returning some of them due to the revision of the contract with Sanofi. Initially, Hanmi Pharmaceutical received a down payment of 400 million euros in 2015 when it signed three technology transfer contracts with Sanofi. At this time, Hanmi Pharmaceutical reflected only KRW 255.6 billion in its accounting books and chose a method of recognizing the rest in installments for 36 months. At the end of 2016, Hanmi Pharmaceutical returned 로를196 million through contract modification, including the return of the rights of some tasks (continuous insulin). Hanmi Pharmaceutical remitted about 160 million euros by revising the contract without recognizing about 160 billion won in down payment received from Sanofi as revenue (255.6 billion won in 2015 and 63.9 billion won in the first to third quarters of 2016). Hanmi Pharmaceutical earned 57.7 billion won in 2017, 44.6 billion won in 2018, and 20.4 billion won in 2019. During this period, the down payment received from Genentech was recognized in installments. Hanmi Pharmaceutical signed a technology transfer contract with Genentech in September 2016 for the RAF target anticancer drug "HM95573. If the down payment is $80 million and clinical development, permission, and commercialization are successful, the condition is to receive $830 million sequentially as a step-by-step milestone. Hanmi Pharm received a down payment of $80 million from Genentech on December 2, 2016. At that time, 93.8 billion won was deposited if 1,173 won was applied based on the won-dollar exchange rate. Hanmi Pharmaceutical recognized the down payment in installments for 30 months on its accounting books, and the period of recognition of the down payment in April 2019 ended. Last year, the company temporarily recognized $10 million in down payment secured through a technology export contract with MSD, generating 10 billion won in technology fee revenue. Hanmi Pharm has also secured additional milestones following the development of the anticancer drug "Auraxol" exported to Athensx. Hanmi Pharmaceutical can secure additional technology fees according to the development of technology export tasks. Belvarafenib, which transferred technology to Genentech, is currently conducting global clinical trials for commercialization by Genentech and Roche. "belvarafenib" is a pan-RAF inhibitor-based targeted anticancer drug. It acts as a mechanism to inhibit RAF, a type of mitogen-activated protein (MAP) kinase that mediates intracellular signaling. Genentech has proven excellent drug resistance and safety in combination with existing approved treatments and plans to expand global clinical trials for patients with NRAS melanoma. Roche added two cohorts of belvarafenib-related monologues and combination therapy to its ongoing large-scale clinical project, "TAPISTRY." "TAPISTRY" is a clinical trial aimed at providing customized treatments to metastatic solid cancer patients who cannot operate with certain mutations. According to a quarterly report submitted to the U.S. Securities and Exchange Commission by Hanmi Pharmaceutical's partner Spectrum Pharmaceuticals, Spectrum agreed to pay up to $358 million in milestones to Hanmi Pharmaceutical according to the commercialization performance of the anticancer drug Poziotinib. Spectrum plans to submit an application for FDA approval as early as this year. If "Rolontis," a treatment for neutropenia that has been applied for permission from the U.S. Food and Drug Administration (FDA), is approved, it will pay $10 million to Hanmi Pharmaceutical. Poziotinib is a pan-HER2 anticancer drug that Hanmi Pharmaceutical transferred to Spectrum in 2015. Rolontis, which was transferred to Spectrum in 2012, is a new biopharmaceutical applied with Hanmi Pharmaceutical's Labscovery platform technology that increases the duration of the drug's efficacy in the body.
- Policy
- More convenient new dementia treatments introduced to market
- by Lee, Tak-Sun Nov 12, 2021 05:54am
- Donepezil patch (Source : Icure PR material) With a series of new dementia treatments being approved in Korea, whether the market dominated by Aricept will falter is gaining attention. Aricept (donepezil hydrochloride, Eisai Korea) has been dominated the market with an 80% share in the Korean prescription market. The Ministry of Food and Safety approved Lundbeck Korea’s ‘Ebixa tablet 20mg’ on the 1st. Although Ebixa’s share in the market is much behind Aricept by performance, it is still the single Alzheimer’s treatment that ranks second after Aricept in the Korean market as a single product. The Ebixa tablet currently in the market is a 10mg formulation and is used to treat moderate-to-severe Alzheimer’s. The maximum daily dose of Ebixa is 20mg, and elderly patients over the age of 65 should take the 10mg dose twice a day. On the other hand, the recently-approved Ebixa 20mg can be taken once a day. This improved convenience in administration is expected to be received with a more positive response in the market. Previously on the 5th, the first donepezil patch was approved in Korea. The patch, which was co-developed by Icure and Celltrion, is expected to outperform oral treatments in terms of patient compliance. Icure’s Doneciv patch and Celltrion’s Donerion patch are used to treat dementia of the Alzheimer’s type and are alternately attached to the shoulder twice a week at 3-day and 4-day intervals. The patch only needs to be attached twice a week, therefore is more convenient than the existing oral formulations. With such products with improved convenience being introduced to the market, whether the products will be able to shake Aricept’s stronghold, which occupies 80% of the market, is also an area of interest. Based on UBIST, Aricept sold ₩83.9 billion in outpatient prescriptions and accounts for 80% of the original dementia treatment market. The runner-up is Ebixa, which recorded ₩13.7 billion. In particular, Ebixa’s sales have continued to increase after Daewoong Pharmaceuticals joined in co-promoting the products since July 2019. The industry expects Daewoong Pharmaceuticals to also conduct joint sales and marketing activities for Ebixa 20mg as well. Daewoong Pharmaceuticals had also pursued the development of a 20mg formulation of memantine, which is the same ingredient used in Ebixa, and received approval for its Phase I study, but did not initiate development. The analysis was that this may be due to the company’s plan to co-promote Ebixa 20mg with its original developer, Eisai. Also, the fact that Celltrion, which has a well-established domestic distribution network in biosimilars, has entered the dementia treatment market with the patch formulation may act as a variable in the market. Like all other drugs, the preference for originals is high for dementia treatments as well. However, as Celltrion has established as much trust as biosimilars in Korea for its biosimilars, this is expected to have a positive effect on its sales of the donepezil patch. The new products that were approved recently will be sole in earnest from next year after going through the reimbursement process. Therefore, the industry is paying keen attention to whether the introduction of these new drugs will shake Aricept’s sole lead in the dementia treatment market.
- GI innovation·Merck signed MOU to develop new drugs
- by Nho, Byung Chul Nov 12, 2021 05:54am
- CEO Hong Joon-ho of GI innovation (third to the left) Kim Yong-seok, head of Merck Life Science (fourth to the left) GI innovation announced on the 10th that it has signed an MOU with Merck for the manufacture and development of new biopharmaceuticals. This is the first time Merck, which has maintained cooperative relationships with CDMO (Consignment Production and Development) companies such as Samsung Biologics and Binex, has cooperated with Biotech in Korea to support the manufacture and development of new biopharmaceuticals. Merck is known to have highly appreciated GI innovation's know-how in developing CHO-produced cell lines and various pipelines. Hong Joon-ho, CEO of GI innovation, Cho Young-kyu, Oh Young-min, and Kim Yong-seok, general manager of Merck Life Science process solution business, attended the signing ceremony held at Ginnovation headquarters on the 9th. Through this cooperation, the two companies plan to create synergy in the development of new bio drugs through the use of the Merck CHOZN Platform and educational consulting for researchers. Merck's CHOZN expression system is a platform that can develop high productivity and stable production cell lines. In fact, creating biopharmaceuticals with Chinese Hamster Oval requires a long period of time (3 to 8 months), development know-how, and expensive large-scale facilities to reduce the risk of external contamination, and Merck's CHOZN expression system enables fast access to cell lines and biopharmaceutical production processes. As a result, GI innovation expects the development of high-protein cell lines that produce large-sized multi-targeted drug proteins that were difficult to manufacture through the close combination of its GI-SMARTTM platform technology and CHOZN expression system. In addition, it is expected to save time and money through the smooth supply of various subsidiary materials and increase the productivity of biopharmaceutical development. "GI innovation's own technology and global company Merck's bioprocessing technology are expected to meet to reduce time and cost in manufacturing and developing biopharmaceuticals," said Hong Joon-ho, CEO of GI innovation. He said, "As it is the first collaborative model with Biotech in Korea, not a large company, we hope that synergy between the two companies will produce excellent results." Merck aims to support GI Innovation's new fusion protein drug development process and further accelerate access to cancer and allergy drugs worldwide, said Kim Yong-seok, general manager of Merck Life Science process solution business. Through Merck's expertise in bioprocessing development, we expect to provide customers with the solutions necessary to solve the challenges throughout the new drug development process, he said.
- Company
- GX-17, aimed at treating COVID-19, resumes clinical trials
- by Kim, Jin-Gu Nov 12, 2021 05:54am
- Genexine's new anticancer drug candidate GX-I7, which had shown potential as a treatment for COVID-19, will launch a new clinical trial for anticancer drugs. On the 10th, the MFDS approved phase 2 clinical trials of Bevacizumab and Genexine GX-I7 in recurrent glioblastoma. Bevacizumab is the active ingredient of Roche's target anticancer drug Avastin. GX-I7 is a substance that Genexine is developing as a new anticancer drug. In 2017, the company launched phase 1b clinical trials for metastatic and recurrent solid cancer and began developing new anticancer drugs in earnest. Since then, he has initiated phase 1b combination therapy with cyclophosphamide in solid cancer in 2018, phase 1b/2 with Pembrolizumab (Keytruda) in recurrent and non-adaptive triple negative breast cancer, and phase 1/2 with Temozolomide (Temoram) in 2019. After the COVID-19 crisis began in earnest, the possibility as a treatment for COVID-19 was expected. In August 2020, it was approved for phase 1b clinical trials in Korea for mild COVID patients. In the United States, Genexine's U.S. affiliate NeoImuneTech launched phase 1 clinical trials for COVID-19 patients in November last year. However, in the case of COVID-19 clinical trials, it is prolonged than originally expected. The domestic clinical trial was to be conducted on 40 patients, but the recruitment of patients was still not completed after recruiting the first patient in March, seven months after clinical approval. US clinical trials of 30 people are also still recruiting patients. In this situation, Genexine is focusing again on clinical trials of GX-I7 anticancer drugs. In fact, it is confirmed that Genexine has recently been approved for clinical trials of anticancer drugs not only in Korea but also in the United States. Last month, NeoImuneTech launched phase 2 clinical trials for combination therapy with Atezolizumab (Tecentriq) of NT-I7 (US Development Name of GX-I7) in non-small cell lung cancer. Prior to this, in January this year, it was approved for phase 2 clinical trials with Opdivo for gastric and esophageal cancer patients. In August, phase 1b clinical trials were launched for patients with recurrent and refractory giant B-cell lymphoma. In addition to GX-I7, Genexine is developing GX-19N as a COVID-19 vaccine. Phase 1/2a clinical trials have been completed in Korea, and phase 3 global clinical trials are currently underway in Indonesia, Argentina, and Turkey. Genexine plans to release GX-19N in the first half of next year.
