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- 2026-05-18 17:10:27
- Policy
- Voluntary recovery of 73 drugs with excess impurities
- by Lee, Tak-Sun Sep 13, 2021 05:55am
- 73 items from about 36 companies with blood pressure exceeding impurities will be recovered. Patients can also be exchanged for normal products at pharmacies. However, the MFDS explained that concerns about human harm are very low, and that it is not a situation to stop taking them arbitrarily. It announced on the 9th that some of the drugs containing Sartans, which are treatments for hypertension, have exceeded the daily intake allowance of AZBT (1.5//day) (1.51 to 7.67//day). AZBT (5-(4'-(azidomethyl)-[1,1'-biphenyl]-2yl)-1H-tetrazole) is a substance with mutant properties (genetic mutations). The MFDS explained that the pharmaceutical company is voluntarily collecting 183 Sartan drugs from 73 items from 36 companies that exceeded the daily intake allowance among the items subject to safety investigation. It also added that only sartan drugs with AZBT less than the daily intake allowance have been shipped since September. The MFDS ordered the AZBT test results for 819 items from 125 companies with production and import records to be submitted by the end of August and received test results for 751 items from 117 companies. The MFDS said that patients taking the drug should not stop taking it, but should decide whether to continue taking it after consulting with a pharmacist, but can exchange it for a lot number below the standard if necessary. It explained that it consulted the Central Pharmaceutical Review Committee to set the daily intake capacity of AZBT, and that it was set at 1.5㎍/day by applying the ICHM7. ICHM7 sets a daily intake allowance of mutagenic impurities that do not have data such as toxicity values as 1.5//day, which is a "negligible level" when consumed daily for life (70 years). This means that the possibility of additional cancer is less than 1 in 100,000 people. The MFDS evaluated the health effects of most patients who took Sartan drugs with excessive daily intake of AZBT, and found that the possibility of additional cancer was very low. The human impact assessment of patients taking Sartan drugs with excess detection of AZBT was conducted in accordance with ICHM7, considering the results of the daily maximum dose of Sartan drugs in circulation in Korea. As a result, the possibility of additional cancer is 0.008 to 0.224 out of 100,000 "Losartan containing drugs", 0.010 to 0.298 out of 100,000 "Valsartan-containing drugs", " It is explained that 0.004 to 0.804 out of 100,000 Irbesartan-containing drugs were very low, which was "negligible" according to the ICHM7 standard. The MFDS said that it will announce additional final results after completing the ongoing AZBT test and review of the results as soon as possible, and that it will strictly manage AZBT to supply and distribute only Sartan drugs that are less than permitted to consume on the market.
- Company
- Jardiance marks new milestone in heart failure treatment
- by Whang, byung-woo Sep 13, 2021 05:55am
- With the SGLT-2 inhibitor, Jardiance (empagliflozin), proving its efficacy in heart failure with preserved ejection fraction (HFpEF), on how it will affect the domestic prescription market for heart failure is gaining attention. As another SGLT-2 inhibitor, Forxiga (dapagliflozin), was the first to receive approval for heart failure with reduced ejection fraction (HFrEF) indication, whether Jardiance’s study results could become the solid blow that could overturn the drugs' positions is gaining industry interest. The competition among SGLT-2is that are expanding their indications from their existing diabetes indications to heart failure as well as chronic diseases is also a special point of interest. The full results of the EMPEROR-Preserved clinical trial that demonstrated Jardiance’s effect on heart failure were presented recently at the ESC Congress 2021. The study showed a 21% reduction in the relative risk of cardiovascular death or hospitalization using Jardiance in HFpEF patients with or without diabetes compared to placebo, meeting its composite primary outcome. Also, in the analysis of its major secondary endpoint, Jardiance reduced the relative risk of first and recurrent heart failure hospitalization by 27%, and significantly delayed kidney function decline. On this, Jung-Woo Son, Professor of Cardiology at Wonju Severance Hospital, said, “It is encouraging that a treatment had been able to meet its primary outcome in HFpEF, in the midst of all other trials failing development for the condition. The outcomes with regards to cardiovascular deaths were a little disappointing, but the results showed enough benefit in other areas.” Dong-Ju Choi, President of the Korean Society of Heart Failure who participated as the head coordinator in the trial, stressed that the study reflected Korea’s heart failure treatment environment as 13 Korean medical institutions participated in EMPEROR-Preserved trial. With such strengths, the sentiment in the field is that there is no reason not to prescribe Jardiance after its approval as the clinical benefits are clear. However, how the prescription patterns will change will need to be observed in comparison to Forxiga, which was approved for HFrEF. A cardiology professor from a tertiary hospital in Korea who requested animosity said, “The good performance shown by Forxiga and Jardiance, has even raised discussions on their class effect. Since we have already been using Forxiga for HFrEF, doctors will be preferring Forxiga for the time being, however, there is a possibility that Jardiance will attract attention due to its versatility.” In particular, the professor predicted prescription of Jardiance would increase for patients whose diagnosis between HFrEF and HFpEF is unclear. He said, “There are heart failure patients who belong in the range between HFrEF and HFpEF, and Jardiance will have an advantage in preoccupying this market as it has presented results for both HFrEF and HFpEF. However, I know Forxiga is also conducting studies to cover the relevant areas, so on how the results will be remain to be seen.” As such, the majority of the HCPs in Korea are positive about the performance and expandability of SGLT-2is in heart failure. Therefore, the only barrier is in the drugs' progress in receiving approval and reimbursement. Forxiga is currently approved for HFrEF but is not reimbursed yet. And Jardiance is aiming to gain approval for its HFpEF indication based on its EMPEROR-Reduced trial within this year. Some industry experts have cautiously anticipated that the two drugs may be concurrently approved for reimbursement after Jardiance is approved for its HFpEF indication. Also, Boehringer Ingelheim and Lilly plan to submit the HFpEF results from their clinical trial to regulatory authorities within the year, but considering the domestic situation in which approval for drugs is processed only after FDA approval, it is unclear whether the drug will immediately be approved for prescriptions. Another variable that exists is Entresto. Novartis has applied for approval to expand the drug’s indication to the HFpEF indication.
- Policy
- Financial savings should be given for new domestic drugs
- by Lee, Jeong-Hwan Sep 10, 2021 05:58am
- The domestic pharmaceutical industry argued that new domestic development drugs, which contributed to improving the financial soundness of health insurance through steady R&D investment, should be excluded from the list of "The Price-Volume Agreement (PVA)" or introduced a system that limits the number of applications. Even after the registration of new domestic drugs, additional clinical trials to enter overseas markets, and improve drug convenience have dampened the willingness to innovate management due to drug prices under the PVA system. According to the pharmaceutical industry on the 9th, multiple pharmaceutical companies that succeeded in developing new drugs in Korea plan to point out the irrationality of the drug price follow-up management system centered on the PVA system and urge policy improvement. Pharmaceutical companies that have succeeded in developing new domestic drugs or are preparing for development are demanding that domestic new drugs that contributed to health insurance finances be excluded from PVA. The reason why domestic pharmaceutical companies are making such demands is due to the specificity and PVA of domestic new drugs. In particular, domestic companies pointed out the problem of Type Da of PVA. Type Da of PVA calculation drugs are subject to negotiation from the fourth year after the registration. Drugs with an increase of more than 60% this year or an increase of more than 5 billion won compared to last year and an increase of more than 10% are subject to negotiations. Domestic companies explain that the clause is pushing ahead with a collective reduction in drug prices between domestic and global new drugs. Specifically, in the case of global new pharmaceutical companies that enter the domestic market, it is common to release them after fully equipped with treatment indications and full contents at the time of domestic marketing approval. Even after its launch on the market, R&D expenses will continue to be spent to allow overseas marketing, add indications, develop complex drugs, increase convenience in taking them, and reduce drug prices even though sales will rise in earnest from the fourth year. The drug price negotiation guidelines say that domestic R&D investment costs are considered when negotiating, but it is not known whether R&D costs are also considered in PVA negotiations. Domestic companies said that exceptions to the PVA system for new domestic drugs, which contributed to the effect of reducing health insurance finances, are also needed. Domestic companies are taking the lead in developing complexes based on new domestic drugs in line with the characteristics of chronic diseases such as general diabetes, high blood pressure, and hyperlipidemia,, and in the case of these complexes, they are asked to be excluded from PVA negotiations or limit the PVA negotiations. An official from a domestic pharmaceutical company A said, "The PVA system is applied repeatedly only to new domestic drugs that continue to invest in R&D to expand indications or add complex drugs. Drugs that are burdensome to health insurance finances should be selected as targets for PVA negotiations." He said, "The more drugs are used in the market, the more positive they are for drug spending. These drugs need to be excluded from PVA or limited the number of applications."
- Company
- Key 3 mRNA vaccine techs are not Moderna's nor Pfizer's
- by Kim, Jin-Gu Sep 10, 2021 05:58am
- The three key technologies required for developing mRNA vaccines were revealed. These are technologies related to antigen optimization, mRNA syntehsis·modification, and manufacture of lipid nanoparticles (LNP) that correspond to steps 1, 2, and 4 of the 5-step vaccine manufacturing process. The explanation was that a biopharmaceutical company aiming to develop COVID-19 vaccines or anticancer treatments using mRNA must secure the technologies mentioned above. Even Pfizer and Modera, which produce the mRNA COVID-19 vaccines, are said to have secured patents related to the abovementioned technology through a licensing agreement. On the 8th, the Korean Intellectual Property Office (KIPO) published an ‘mRNA Vaccine Patent Analysis Report' and introduced the key technologies required for the production of mRNA vaccines. According to the report, a total of 691 mRNA vaccine-related patent applications have been filed globally. Moderna had filed for the most with 211, followed by CureVac’s 108, TranslateBio’s 67, Pfizer·BioNTech’s 60, and GSK’s 25 applications. However, the report showed that the core patent required for the production of mRNA vaccines is not owned by Pfizer nor Moderna. mRNA vaccines are produced in five steps: ▲antigen optimization ▲mRNA synthesis and modification ▲ Separation & Purification ▲LNP production ▲formulation. Among these, technologies for antigen optimization, mRNA synthesis and modification, and LNP production are the key technologies required for vaccine production. Map of COVID-19 mRNA vaccine technology relationships between companies (Source: KIPO) The technology for antigen optimization is owned by the US National Institute of Health (NIH). NIH had applied for 3 patents on ‘COVID-19 spike protein antigens,’ and one of the three has been registered in the US. Companies that develop mRNA COVID-19 vaccines like Pfizer·BioNTech, Sanofi, and GSK have signed licensing agreements with the NIH for the relevant patent. It is not confirmed whether Moderna, which had jointly developed a COVID-19 vaccine with NIH, had signed a licensing agreement for the said patent. In mRNA syntehsis·modification, patents on the ‘modified nucleic acid’ is key. Cellscript owns the patent on ‘the method reducing immunogenicity using pseudouridine.’ The patent, which had previously been owned by the University of Pennsylvania, was transferred to Cellscript. Moderna and BioNTech secured the technology through a licensing agreement with Cellscript. Two companies have the key technology related to lipid nanoparticles as patents- ‘Arbutus’ and ‘Acuitas.’ Arbutus owns multiple patents on “lipid-nucleic acid particle composition containing cationic lipids,’ and Acuitas owns multiple patents related to ‘lipid-nucleic acid particles containing cationic lipids and PEG-Lipid.’ Both play a vital role in the manufacturing of lipid nanoparticles. Pfizer·BioNTech had signed a license agreement with both companies to secure the technology. On the other hand, Moderna only signed a license agreement with Acuitas Therapeutics and is in a patent dispute with Arbutus in the US and Europe with regards to the technology. KIPO said, “Korean pharmaceutical companies and research institutions wishing to develop mRNA vaccines would need to acquire or evade the license of these patents. However, only 17% of the 691 patents related to mRNA are registered in Korea, therefore, Korean mRNA vaccine developers are less likely to get embroiled in patent dispute compared to those in the US or Europe.”
- Policy
- The evaluation criteria's determination for reimbursed drugs
- by Lee, Hye-Kyung Sep 10, 2021 05:58am
- If the administration cost is lower than that of alternative drugs, it is possible to apply for adjustment to raise the upper limit of the drug. However, it should be the case where the number of companies in the formulation with the same administration route or component is one. The HIRA recently guided the pharmaceutical industry to answer questions and comparison tables before and after the change of evaluation criteria containing "change of evaluation criteria for adjusting the upper limit amount of drugs." The evaluation criteria for this mediation application were deliberated and resolved through the Drug Reimbursement evaluation committee on the 2nd, and will be applied from September 1st. Items for adjustment application may be applied if the upper limit amount of drugs announced pursuant to Article 3 (1) 1 of the Drug Decision and Adjustment Standards is deemed remarkably unreasonable. Previously, it was possible to apply for an increase in the upper limit of drugs only if there was no replaceable drug or if there was a drug that was essential for treatment. However, due to the change in the evaluation criteria, if the number of companies in the drug with the same route or component is one, it is possible to apply for adjustment to raise the upper limit of the drug if the drug is cheaper than the alternative drug. If there is no record of production, import, or claim over the past two years, it shall be excluded when determining the number of replaceable drugs or companies. However, it falls under one of the three requirements, but excludes drugs that have been fined for violating Article 47(2) of the Pharmaceutical Affairs Act in accordance with regulations related to the National Health Insurance Act. It refers to all drugs that have been disposed of in relation to rebates. It is impossible to apply for mediation by including all rebate dispositions under the relevant regulations regardless of the period. Compared to the previous one, additional documents to be submitted have been specified, and submission documents must be submitted according to the cost calculation method of shortage-preventive drugs.
- Policy
- Will it be possible to expand the benefit of Prolia?
- by Lee, Jeong-Hwan Sep 10, 2021 05:58am
- Attention is focusing on whether the criticism that biopharmaceuticals that treat osteoporosis by preventing bone absorption or activating bone formation are not fully enjoyed due to restrictions on Korea's benefit standards can be resolved. This is directly related to Amgen's Prolia (Denosumab) and Evenity (Romosumab) access to patients, as experts argued the need every year and the National Assembly also agreed, the government said it would consider reflecting it after collecting opinions. On the 7th, the MOHW promised to improve the benefit standards reflecting the latest treatment guidelines at the "policy discussion on improving the treatment environment for osteoporosis" hosted by Rep. Lee Jong-sung of the People Power Party (YouTube). Although the MOHW has made some prospective opinions on the benefit criteria for osteoporosis drugs, it remains to be seen whether it will actually lead to an improvement in the actual standards. There are two reasons why critics say that domestic benefit standards are holding back biopharmaceuticals that treat osteoporosis. First, if the osteoporosis drug benefit period exceeds the bone density level of T-Score -2.5, it is recognized only for one year. The standard is applied to biopharmaceuticals, Prolia, including synthetic drugs such as bisphosphonate drugs, SERM drugs, and Zoledronic acid, and specialists are demanding improvement. Another critical factor is that the "ultra-risk group for osteoporosis" drug benefit standard can only be used when fractures using bone absorption inhibitors occur for more than a year. This is the standard applied to Evenity, a biopharmaceutical that promotes bone formation, and it is pointed out that evenness benefits are recognized only after bone absorption inhibitors are administered. Specifically, Prolia obtained the first treatment benefit as of April 1, 2019. If the bone density level (T-Score) is -2.5 or less, it will be applied twice a year, and if osteoporosis fractures are confirmed on radiography, it will be applied six times a year. Despite the acquisition of primary benefits, experts are calling for an improvement in the benefit standard for osteoporosis treatments such as Prolia because of the current standard for suddenly converting the benefit drug to non-reimbursement a year later if the bone density level exceeds -2.5. This is because patients' access to medicines is blocked by suspending their benefit if the drug is partially effective, even though fractures can be prevented by continuous administration of treatments. Evenity is receiving the second treatment benefit as of December 1, 2020. It is recognized only when additional conditions are satisfied based on the criteria that at least one of the existing bisphosphonate formulations is ineffective or unavailable. An additional condition for Evenness Secondary benefit is ▲ postmenopausal women aged 65 or older,▲ Bone density test results measured by Dual-Energy X-ray Absorptiometry (DEXA) in the central bone (excluding lumbar spine and femur)] showed that the bone density test was less than T-score -2.5 SD, ▲When two or more osteoporosis fractures occur (data on osteoporosis fractures must be attached for fractures that have occurred in the past). The administration period is recognized only up to 12 times every one month in a lifetime. Professor Lee Yoo-mi of Endocrinology at Severance Hospital, who attended a policy debate hosted by Rep. Lee Jong-sung, stressed that it should be improved and expanded to middle-aged people. In fact, international guidelines recommend Evenity, a bone formation promoter, as the primary drug in the ultra-high risk group. Ultra-high-risk groups, such as the elderly who have already experienced fractures, first use bone formation promoters to increase bone mass, and then prevent bone density and fracture by preventing absorption of increased bone mass with bone absorption inhibitors. This means that Korea's benefit standards are the opposite of international guidelines. At a policy debate hosted by Rep. Lee Jong-sung, both irrationalities of the domestic osteoporosis benefit standard were a hot topic. Experts pointed out all the problems of the innovation of bio-new drugs and domestic salary standards from disease risks and social costs caused by osteoporosis. The MOHW, which attended the debate, plans to collect expert criticism and review international guidelines to improve and expand the standards. Choi Kyung-ho, secretary of the insurance drug department, explained, "I agree with the pain of elderly patients due to osteoporosis and fractures and the burden of social and economic costs." He said, "We will try to improve access to new drugs so that the standards meet the latest medical guidelines, but we will also carefully review the soundness of sustainable health insurance finances."
- Company
- Medytox’s American dream falters with returned botox rights
- by Kim, Jin-Gu Sep 09, 2021 05:55am
- Medytox’s plans to overcome the license revocation in Korea by entering the US market, have come to a halt with AbbVie, which had been conducting global trials for the new botulinum toxin candidate 'MT10109L,’ returning its rights to Medytox. ◆A technology export agreement worth up to ₩400 billion was returned in 8 years On the 8th, Medytox announced that AbbVie has returned the rights concerning MT10109L, an improved botulinum toxin candidate, to its company. The right was returned in 8 years since the technology export. Medytox had signed a licensing-out agreement for its botulinum toxin candidate in 2013 to Allergan (now AbbVie) and handed over the global development and sales right of its product in all countries around the world than Korea and Japan. The agreement including the signing fee and milestone was worth $362 million (₩390 billion) The returned rights by themselves are not bad news to Medytox, as the company has no obligations to return the $100 million (₩120 billion) that it received during the term of the contract. The company had received $65 million upon signing the agreement, and an additional $35 million milestone. company However, the returned rights could be a serious blow considering Medytox’s current circumstances. Medotx’s 6 botulinum toxin products are all on the verge of license revocations. The Ministry of Food and Drug Safety had ordered the disposition to suspend sales and cancel licenses of Medytoxin 50·100·150·200, as well as Coretox, and Innotox. The court accepted Medytox’s request to suspend the execution of the administrative order, however, the MFDS’s disposition served as a major negative factor on Medytox. Medytox earned ₩140.8 billion last year, which was a 32% decrease from the previous year. To Medytox, MT10109L was the key substance that could save the company from the looming crisis. The plan was for MT10109L to enter the US market through AbbVie to overcome the crisis of license revocation in Korea. In addition, the company had planned to use the FDA approval as momentum to receive authorization for MT10109L as a new product. Until earlier this year, the plan seemed to be in smooth progress. AbbVie had started 4 global Phase III trials on a total of 1,308 subjects in December 2018. The trials were completed in March this year. The industry had expected AbbVie to submit a Biologics License Application (BLA) to the US FDA within this year. However, contrary to industry belief, AbbVie suddenly returned its rights to Medytox., putting a stop to Medytox’s plans to enter the US market. ◆Why did AbbVie return the rights after completing Phase III trials? The industry has been speculating on two reasons as to why the company had returned the rights to MT10109L after completing Phase III trials. One is the possibility of trial failure. The results of the Phase III trial may not have been satisfactory, which led to the return of rights of MT10109L to Medytox. The other is the poor relationship it has with Daewoong Pharmaceuticals. In May, Daewoong Pharmaceuticals had submitted an investigation request into MT10109L claiming that its data has been manipulated. Its argument was that MT10109L is the same product as the Innotox that was revoked in Korea, and that Innotox’s data was found to be manipulated during the MFDS investigation. On this, Medytox had refuted the claim, saying that MT10109L is a new botulinum toxin formulation and a clearly different product from Innotox. Innotox is a domestically sold pharmaceutical that complies with the MFDS regulations, however, MT10109L is a product designed for approval in the US and Europe, and is manufactured and produced in compliance with the regulations in those countries. An industry official said, “AbbVie may have determined MT10109L the same substance as Innotox. And even if the company decided the two were not the same, the FDA’s move to launch an investigation into the drug may have been a burden.” Medytox plans to soon decide whether to apply for authorization of the retrieved MT10109L in the US. A company official explained that although the rights were returned from AbbVie, the possibility of applying for approval remains as the development of the product has not been aborted. An official from Medytox said, “We have received the full clinical data from Abbvie. We will be reviewing entry into the global market while conducting data analysis. We have not decided whether to directly apply for approval or seek a new partner. It’s all being reviewed internally.”
- Policy
- A bill to revise some of the Jeju Special Law
- by Lee, Jeong-Hwan Sep 09, 2021 05:55am
- The bill banning the opening of for-profit hospitals and pharmacies in Jeju is aimed at preventing controversy over the Greenland International Medical Center by deleting special provisions on the opening of foreign medical institutions and foreign-only pharmacies. The plan aims to eliminate controversy that could cause confusion in the domestic medical system by abolishing a conditional permit system that allows the opening of foreign medical institutions and foreign-only pharmacies with permission from the Jeju Governor based on the Foreign Investment Promotion Act. Representative Wi Sung-gon of the Democratic Party of Korea submitted a bill to the National Assembly to revise some of the Jeju Special Law as of the 7th. The most important contents of the amendment are to delete Article 307 of the current Jeju Special Act, "Special Cases concerning the Opening of Medical Institutions" and Article 308 "Special Cases concerning the Opening of Foreign-only Pharmacies." Article 307 of the current law allows corporations established by foreigners to open foreign medical institutions through the approval process of the governor of Jeju Island. When permitting the establishment of a foreign medical institution, the Policy Delivery Committee for Health and Medical Service must be reviewed, and the provincial governor also included a clause approved by the MOHW. Foreign medical institutions are stipulated not to be included in medical institutions under the National Health Insurance Act and medical institutions under the Medical Benefit Act. This is the part of the provision that allows for profit-seeking medical practice. Article 308 allows foreign-only pharmacies that are not allowed by the Pharmaceutical Affairs Act to be opened after the Foreign Investment Promotion Act and the registration of the provincial governor's opening. Pharmacists engaged in foreign-only pharmacies cannot dispense and sell medicines to Koreans. However, foreign pharmacies can also be prepared and sold to Koreans in the prescription issuance group at foreign medical institutions. Foreign-only pharmacies are also not included in medical institutions under the Health Insurance Act. Article 310 allows foreign license holders to work at foreign medical institutions and foreign-only pharmacies. It also includes a clause that mandates foreign-only pharmacies to clearly indicate that they are foreign-only pharmacies inside and outside the pharmacy so that Koreans can know they are foreign-only pharmacies. A foreign license holder engaged in a foreign medical institution or foreign-only pharmacy in violation of the amendment shall be punished by imprisonment for up to five years or a fine of up to KRW 50 million. Even if foreign-only pharmacies are not properly marked, they will be sentenced to up to one year in prison or fined up to 10 million won. Rep. Wi Sung-gon abolished the special cases of foreign medical institutions (Article 307) and foreign-only pharmacies (Article 308), while carefully pointing out all provisions related to foreign medical institutions and foreign-only pharmacies. This is expected to block the possibility of opening for-profit hospitals and pharmacies regardless of the Foreign Investment Promotion Act, while eliminating the concept of foreign medical institutions and foreign-only pharmacies itself. Rep. Wi added a clause to promote the reinforcement of the publicity of health care in Jeju. Article 306 added reinforcement of publicity and development, while newly establishing matters related to major health care business plans, financing, and management. The health impact assessment of residents on climate change and other matters deemed necessary for strengthening and developing health care publicity were also added to the health care development plan. The above bill should be implemented from the date of promulgation of the enforcement date of the revised law in the supplementary provisions, and those who obtained permission to open foreign medical institutions or foreign-only pharmacies according to the previous regulations at the time of enforcement of the law can open and operate. Controversy over the legality surrounding the cancellation of the Greenland International Medical Center's permission to open remains. Jeju Island submitted an appeal to the Supreme Court against the judgment of the appeal trial on "a lawsuit to cancel the cancellation of the permission to open a foreign medical institution."
- Company
- Genome & Co acquires US firm to enter CDMO business
- by An, Kyung-Jin Sep 09, 2021 05:55am
- The KOSDAQ listed Genome & Company has acquired a manufacturing facility in the US to enter the microbiome contract development and manufacturing organization (CDMO) business. Through the acquire, the company aims to rise to a leader in both R&D and production in the microbiome market, a field with high growth potential. On the 8th, Genome & Company announced that it had acquired 966,502 shares of List Labs in the US in cash. This is equivalent to 27.17% of the company’s net worth. To internalize the production of microbiome treatment and diversify the company’s business, Genome & Company acquired 60% of List Lab’s shares and became the major shareholder of List Labs Genome & Company is a biotech company that specializes in new drug development. It was listed on KOSDAQ in December last year. The company has been using microbiomes to develop immunotherapy drugs for cancer and treatment for autism, as well as new antibody therapies. List Lab is a specialized CDMO business with 43 years of history. It owns a 2498m² sized FDA cGMP certified facility in San Jose, California that produces consigned microbiomes and biotoxins. The company had accrued an average of $9.7 million in sales annually. The company’s operation of 7 independent manufacturing spaces within the facility was positively reviewed as it allows separate production of aerobic and anaerobic microbiome-based drugs. List Labs’ manufacturing facility (Source: Genome & Company) Genome & Company’s management held an online discussion session to explain the company’s mid-to-long term vision regarding its entry into the new business area. By incorporating List Labs as the company’s subsidiary, the company aims to internalize the production of its self-developed microbiome pipeline and more stably operate clinical trials. Even after acquiring the management rights, the management said that List Lab will maintain its independent operations but expand new production facilities to increase the size of the business. The company plans to become a global microbiome CDMO leader by expanding its business area from the existing model that focused on early-phase clinical trials to late-phase clinical trials and consignment production for commercial use. The company also mentioned that it is considering listing Lists Lab on NASDAQ or other markets after the global CDMO business is in place. Microbiomes refer to a community of microorganisms. With increasing interest and attempts to affect the creation of the microbial environment for use in rare disease and cancer treatment, the microbiome industry has emerged into a blue ocean in the field of new drug development. Genome & Company expects the demand for production capacity to rise steadily in line with the continued rapid growth of the microbiome treatment market. According to the Ministry of Food and Drug Safety data, 204 microbiome treatments are currently being developed worldwide. The market size is expected to increase approximately 167 times, from $56.3 million(₩62.4 billion) in 2018 to $9.38 billion (₩10.87 trillion) in 2024. Jisoo Pae, CEO of Genome & Company who attended the session said, “Success of a microbiome-based new drug development depends on its prompt release and market preoccupation. I believe securing a CDMO will become an important factor for success in the microbiome market," He also expressed his expectations that the company’s entry into the microbiome CDMO business will add a new profit model to the company, increasing the speed of new drug development, and ultimately push the company up to a ‘first-mover’ in the global microbiome industry. Genome & Company’s microbiome CDMO project plan (Source: Genome & Company) The management had stressed that the ₩30 billion paid out in the acquisition process was 100% self-funded. The company does not plan to receive investment from external institutional investors nor intend to issue new shares. Pae emphasized, “The few media reports that Genome & Company plans to make paid-in capital increases because of the acquisition are not true. However, we may need to attract investment to expand the factory in the U.S. However, we will be attracting investments around List Labs and the U.S. subsidiary, therefore the HQ’s equity will not be affected or diluted in any way.”
- Company
- Leclaza can be prescribed at general hospitals
- by An, Kyung-Jin Sep 09, 2021 05:54am
- Leclaza Leclaza(Lazertinib Mesylate Monohydrate), a new domestic drug, is targeting the domestic lung cancer treatment market. As more than 30 major medical institutions nationwide were able to prescribe in about eight months of domestic permission, it has entered the domestic market competition, which forms 150 billion won a year. According to the industry on the 6th, Yuhan's Leclaza passed the drug committee of more than 30 medical institutions within two months of the launch of the benefit. It can be prescribed at Seoul National University Hospital, Sinchon Severance Hospital, Samsung Medical Center, and Asan Medical Center, as well as upper-level general hospitals called "Big 4," National Cancer Center, Bundang Seoul National University Hospital, Seoul St. Mary's Hospital, Hwasun Chonnam National University Hospital, Chilgok Kyungpook National University Hospital, and Pusan National University Hospital. Leclaza became the 31st new drug to be developed in Korea with conditional approval from the MFDS on January 18 this year. Patients with T790M-resistant local progressive or metastatic non-small cell lung cancer such as Iressa (Gefitinib), Tarceva(Erlotinib HCl), and Giotrif (Afatinib Dimaleate) are subject to administration. It is a mechanism that inhibits the proliferation and growth of lung cancer cells by interfering with signaling involved in lung cancer cell growth. Yuhan released it on July 1. and applied for insurance registration on December 30 last year before the item license using the "Drug Approval-Patent Linkage System," and achieved high-speed registration 165 days after the license. Despite its therapeutic effectiveness and safety comparable to AstraZeneca's Tagrisso (Osimertinib Mesylate), which acts as the same mechanism, it was recognized for its adequacy by offering low drug prices. Academic organizations consisting of clinical specialists such as the Korean Cancer Study Group, The Korean Cancer Association, Korean Society of Medical Oncology, and Korean Association for Long Cancer also showed similar efficacy and safety to Tagrisso and had a low risk of heart toxicity. It will be a new treatment alternative for patients with local progressive and metastatic non-small cell lung cancer with EGFR T790M mutations." EGFR mutation is a very common type of mutation observed in 30-40% of non-small cell lung cancers that account for 80-85% of lung cancer, occurring between exon No. 18 and 21. It is known to be more prevalent in Asians. EGFR-TKI, which can be prescribed in Korea until the release of Leclaza, is the first-generation drugs Iressa and Tarceva, Giotrif, Vizimpro, and Tagriso. According to IQVIA, a pharmaceutical research institute, five EGFR-TKI types formed a market worth 74.3 billion won in the first half of this year. Tagrisso, classified as a third-generation drug like Leclaza, accounts for 70% of the total market with 52 billion won in sales. Based on the recommended daily dose, Leclaza's insurance upper limit is about 206,900 won. It is about 10,000 won cheaper than Tagrisso (217,782 won). An official from Yuhan said, "We are happy for Leclaza to pass the DC of major university hospitals and general hospitals nationwide at the same time as insurance benefits.With the start of Leclaza prescription in July, positive treatment effects are being derived from the treatment site." He said, "If more medical institutions can prescribe within this year, we will contribute to improving the unmet medical needs of cancer patients in Korea."
