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- 2026-04-09 03:05:55
- Policy
- Drug pricing adjustment guidelines to be established soon
- by Lee, Tak-Sun Nov 14, 2023 05:49am
- With the rise of drugs that show unstable supply and the consequent rise in drugs requesting pricing adjustments, the National Health Insurance Service plans to establish a guideline for smooth pricing adjustment negotiations and disclose it soon. The NHIS recently completed expert consultations and is currently revising the final draft. According to industry sources on the 13th, the NHIS had started establishing a guideline for the pricing adjustment negotiations to simplify materials requiring submissions and ensure accurate cost analysis. Also, the authorities had collected opinions from the industry after establishing a consultative body with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. Since October, the body has started to consult with experts to establish a guideline. Currently, the NHIS completed expert consultations, and final preparations to release the final draft are said to be in progress. An NHIS official explained, “We plan to release the pricing adjustment negotiation guidelines before the end of the year. Final work is currently in progress.” Due to the rise in the number of drugs with unstable supply and demand requesting pricing adjustments, the need for a clear pricing adjustment negotiation guideline has been increasing. Moreover, the drug subject to negotiations has also increased with the NHIS’s expansion of drugs subject to adjustment applications in 2021. Previously, only drugs that did not have alternative drugs or were necessary for medical treatment were able to apply for pricing adjustments, but from 2021, drugs with an administration cost lower than their alternatives and are necessary for medical treatment and drugs that only one other company owns a drug with the same administration route and ingredient can also apply for pricing adjustments. Recently, resolving the supply and demand instability has emerged as a government task, and drugs subject to pricing adjustment are being interpreted broadly. Starting with acetaminophen at the end of last year, prices of magnesium hydroxide and pseudoephedrine were also increased through pricing adjustment negotiations, and the application for the pricing adjustment of budesonide passed the Drug Reimbursement Review Committee, and will soon begin full-scale negotiations. The adjustment negotiations aim to facilitate a stable supply of drugs by conserving drug costs. However, there was much criticism around the large amount of data submissions required, as most of the data required aligns with those required for the Drug Shortage Prevention Program. In addition, there was an opinion that an accurate cost analysis is needed by setting a fixed ratio for the general management cost and profit. NHIS plans to comprehensively collect these opinions and reflect them in the guidelines. Once the guidelines are created, it is expected to simplify the required data submissions, clarify cost analysis, and facilitate smoother drug pricing negotiations. However, drugs with an unstable supply and demand that are currently undergoing drug negotiations undergo rapid negotiations within a month through prior consultation between the public and private sectors under the condition of increasing their supply, so attention is being paid to whether these will also be able to reach an agreement within the set guidelines.
- Policy
- Regeneron enters Phase 3 in Korea
- by Lee, Hye-Kyung Nov 13, 2023 05:23am
- FDA and EMA review begins in the second half of this year for CD20 and CD3 targeted treatments. Phase 3 clinical trials for Regeneron's new lymphoma treatment drug Odronextamab are being conducted in Korea. The Ministry of Food and Drug Safety recently submitted an application from ICON Clinical Research Korea for the efficacy and safety of Odronextamab (REGN1979), an anti-CD20/anti-CD3 bispecific antibody used in combination with Lenalidomide in subjects with relapsed/refractory follicular lymphoma and marginal zone lymphoma. A phase 3, open-label, randomized clinical trial (OLYMPIA-5) was approved to compare rituximab in combination with lenalidomide. It can be viewed as a clinical trial for approval of a wide range of indications as an initial treatment for lymphoma and additional treatment for B-cell non-Hodgkin lymphoma. Odronextamab is a type of CD20 Follicular lymphoma and diffuse large B-cell lymphoma are the most frequently occurring subtypes of B-cell non-Hodgkin lymphoma. The European Medicines Agency (EMA) received PanMAA in August for the treatment of adult patients with relapsed or refractory follicular lymphoma or relapsed or refractory diffuse large B-cell lymphoma that has progressed after at least two prior systemic treatments. Subsequently, the US FDA accepted the application for priority review approval as a third-line therapy for the same indication in September. The target date for final approval is reportedly March 31 next year. It is expected to be the fourth dual antibody treatment targeting CD20·CD3 to receive FDA approval, following Roche's 'Lunsumio', AbbVie's Epkinly, and Roche's Columvi. Lunsumio', the first CD20·CD3 targeting dual antibody treatment approved by the FDA, received product approval in Korea on the 3rd. Following Epkinly and Columvi, if Odronextamab receives FDA approval, it is expected to take steps for domestic approval.
- Company
- Novartis loses 2nd trial for its Entresto patent
- by Kim, Jin-Gu Nov 13, 2023 05:23am
- The second trial over Novartis’s heart failure treatment ‘Entresto (valsartan+ sacubitril) again ended with the victory of the Korean generic companies. If the companies succeed in winning the remaining 2 suits, the companies will be one step closer to the early release of their generics. Generic companies win first and second trials on Entresto’s composition and use patent According to industry sources on the 10th, the Patent Court of Korea ruled against the plaintiff (Novartis) in the second patent invalidation trial that Novartis filed against 10 generic companies, including Hanmi Pharmaceutical, on the 9th. The patent was a composition/use patent that was set to expire in July 2027. In April 2021, 10 companies including Hanmi Pharmaceutical filed an invalidation trial on the patent. In July of the following year, the Property Trial and Appeal Board (1st trial) ruled the claims valid. After losing the 1st trial, Novartis filed an appeal to the Patent Court of Korea to cancel the trial decision. However, the 2nd trial court also ruled in favor of the generic companies. As a result, the generic companies are now one step closer to the early release of their Entresto generics. If companies win the remaining 2 disputes awaiting 2nd trial rulings, they will be eligible for early release of their generics. However, if Novartis again appeals to the second trial decision and decides to take the matters to the Supreme Court, the dispute can be prolonged with the lingering burden of early release of generics. Generic companies can become one step closer to the early release of Entresto generics if they win the other 2 remaining trials A total of 3, including the ruling made on the 9th, are being tried in the 2nd trial. One is over a crystalline patent that expires in September 2027 and the other is over a salt/hydrate patent that expires in November 2026. In the case of the crystalline patent, Elyson Pharm and other companies filed trials to confirm the passive scope of rights on the patent in January 2021, starting the dispute. The generic companies triumphed in the 1st trial. The Intellectual Property Trial and Appeal Board ruled in favor of generic companies in December 2021, and Novartis, which appealed, filed a lawsuit with the Patent Court of Korea to cancel the decision. Currently, the generic companies and Novartis are awaiting the 2nd trial ruling. The Patent Court of Korea has designated the 21st of next month as the hearing date. The generic companies also won the 1st trial for Entresto’s salt/hydrate patent, and the companies are awaiting its 2nd trial ruling. Daewoong Pharmaceuticals had first filed a suit to invalidate the patent in April 2021. In March this year, the Intellectual Property Trial and Appeal Board ruled in favor of the generic companies, issuing a decision of partial valid and partial dismissal ruling. Novartis appealed the ruling and dragged the case to the second trial. The companies had also challenged Entresto’s 2 composition patents and 1 use patent. The generic companies also won those disputes, however, Novartis did not file an appeal after losing the 1st trials, finalizing the trial decisions. Quarterly prescriptions of Entresto Faced with the imminent entry of its generics, Entresto has been rapidly increasing its prescription performance. According to the market research institution UBIST, Entresto generated KRW 14.8 billion in outpatient prescriptions in Q3. This is a 36% YoY increase compared to KRW 10.9 billion in Q3 last year. Although 6 years have passed since its release in Q4 2017, the drug is still showing high growth. Its performance rose by over 30% every quarter YoY. Its sales exceeded KRW 5 billion in Q1 2020 and expanded to more than KRW 10 billion in Q2 2022. If the current trend continues, its quarterly sales are expected to exceed KRW 15 billion in Q4 this year.
- Company
- Amvuttra receives orphan drug designation
- by Eo, Yun-Ho Nov 13, 2023 05:23am
- ‘Amvuttra,’ the first new drug for amyloidosis with polyneuropathy to be introduced since ‘Vyndaqel,’ has been designated an orphan drug in Korea. The Ministry of Food and Drug Safety announced so through a recent notice of orphan drug designation. siRNA therapy Amvuttra (Vutrisiran) is administered subcutaneously at once every three-month intervals. It inhibits the production of wild-type and mutant-type transthyretin (TTR) by targeting and silencing specific messenger RNA. Its efficacy was demonstrated through the Phase III HELIOS-A study that evaluated the efficacy and safety of Amvuttra in 164 patients with hATTR amyloidosis in 22 countries. The patients were randomized 3:1 to receive either 25 mg of vutrisiran via subcutaneous injection once every three months (vutrisiran arm, 122 patients) or 0.3 mg/kg of patisiran via intravenous infusion once every three weeks (patisiran arm, 42 patients). The efficacy of the vutrisiran arm was assessed by comparing the data with the landmark APOLLO Phase III study of patisiran that evaluated patisiran’s efficacy and safety in a comparable patient population. During the 9-month treatment period, the vutrisiran arm experienced fewer severe neurological damage than the placebo group and improved quality of life. Also, results of the timed 10-meter walk test that evaluates the patient’s walking speed and exercise ability, the vutrisiran arm showed little change compared to the placebo. Also, the arm showed an improvement in NT-proBNP, a biomarker that evaluates heart function. hATTR-PN, which occurs in 1 in 100,000, is caused by a genetic mutation in the transthyretin gene and causes systemic polyautonomic neuropathy, including symptoms related to the heart and digestive system, and eye disease. Generally, symptoms such as pain, abnormal sensations, and paralysis begin in the nerves of the lower extremities, where abnormal proteins tend to accumulate, and then affect the upper body, gradually spreading to the heart, kidneys, and eyes and causing complications. Its life expectancy is on average 7 to 12 years from symptom onset.
- Policy
- Looking at the review date for GIFT No. 1 Lunsumio
- by Lee, Hye-Kyung Nov 13, 2023 05:23am
- "The goal of the GIFT program is to shorten the general review period by 25%. The statutory review period is 120 days for chemical drugs and 115 days for biopharmaceuticals, but GIFT items In the case of, the goal is to complete the review within 90 days.” Park Jae-Hyeon, head of the rapid review division of the Ministry of Food and Drug Safety, announced on the 3rd that the actual review period for Roche Korea's Lunsumio Injection, the first GIFT product to receive domestic product approval, took 86 working days. GIFT's goal was to shorten the general review period by at least 25%. However, if you look at the period from the expedited review designation on November 29th of last year to the actual approval, it took 11 months. At first glance, you may question whether the expedited review is appropriate. Manager Park said in a recent interview with Dailypharm, "Lunsumio was reviewed for about 86 working days. As it is GIFT's first product, the licensing manager worked together to process it quickly," adding, "It took 11 months from designation to approval. “When I looked at the reason why it took, it took about 7 months to supplement the new application’s data,” he explained. According to the 'Drug Rapid Review Report' published by the Ministry of Food and Drug Safety this year, the time taken for rapid review during the drug review period, which generally takes 120 days, was 26.9 days for COVID-19 vaccines and treatments, and 81.5 days for other products. However, this statutory review period does not include the data supplementation period. The Ministry of Food and Drug Safety does not include the supplementation period in the approval review period under the current legal system. Therefore, the Ministry of Food and Drug Safety's shortened expedited review period refers to the pure review period excluding the data supplementation period. Manager Park said, “Shortening the review period is not an easy task,” and added, “The key is how well the applicant understands the supplementary matters and prepares the materials.” In particular, this year's expedited review designation has more than tripled compared to last year, and Manager Park said, "The pharmaceutical industry is interested and is applying for expedited review designation." He added, "It officially takes 30 days to review the expedited review designation, but the current employees' “Through our efforts, we are completing the designation without completing 30 days,” he said. These days, it is said that an increasing number of pharmaceutical companies do not immediately submit applications for approval even after receiving expedited review designation. This is because each company has its own circumstances, such as taking the licensing step after understanding the global market. Manager Park said, “After being designated for expedited review, the applicant must submit all documents related to the permit to the permit general manager before they are forwarded to the expedited review department.” “It’s going on,” he said. As of November 6, there were 19 items designated as GIFT brands, but the rapid review department was newly established in 2020 and the number of items designated for rapid review is 44. Once designated as expedited review, the Ministry of Food and Drug Safety shares the overall review schedule and holds product information sessions and supplementary information information sessions. In addition, the review period will be shortened through 'rolling review', which reviews materials prepared through prior review. Manager Park said, "It is meaningful that Runsumio was the first to receive approval under the GIFT name. However, shortening the review period also requires efforts from the industry. When the Ministry of Food and Drug Safety delivered the first review opinion, the parts that were not understood were discussed with the person in charge. “I think it will be helpful if we communicate with each other to understand clearly and prepare materials,” he said. Currently, items subject to GIFT are ▲medicines intended to treat serious or rare diseases such as life-threatening cancer, ▲intended for the prevention or treatment of infectious diseases that are likely to cause serious harm to public health, such as bioterrorism infectious diseases or infectious disease pandemics. It is limited to ▲ new drugs developed by innovative pharmaceutical companies designated and announced by the Ministry of Health and Welfare ▲ combinations of drugs and medical devices subject to rapid review ▲ cases where there is no existing treatment or showing clinically meaningful improvement in effectiveness, etc. compared to existing treatments. Manager Park added, “We are receiving a request to expand the GIFT target as an industry suggestion,” and added, “It is not easy as we are conducting screening work with limited manpower, but we are making efforts.” .
- Company
- NMOSD drug Enspryng likely to be reimbursed in December
- by Eo, Yun-Ho Nov 13, 2023 05:23am
- ‘Enspryng’ a new drug for neuromyelitis optica spectrum disorder (NMOSD), is expected to be listed for reimbursement in Korea within the year. According to industry sources, Roche Korea completed drug pricing negotiations with the National Health Insurance Service for the reimbursement of its NMOSD treatment Ensprying (satralizumab). Therefore, reimbursement may be applied from December at the earliest. The company had applied for the reimbursement of its Ensprying in H2 2022 after receiving approval in H1 2021. However, due to its high price, the company and authorities have found it quite difficult to set a reimbursement standard and financial sharing plan. The company had first adopted the strategy of accepting the weighted average price (WAP) of its alternative, Soliris, but due to a delay in Soliris’s reimbursement listing process for NMOSD, the company turned to the pharmacoeconomic evaluation exemption system for its reimbursement. In particular, even after passing a review by the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service in August, the company encountered difficulties in accepting the deliberation results and entering drug pricing negotiations due to the tightly set reimbursement standards. In other words, the negotiation was only possible because Roche accepted the ‘fourth or later lines of therapy’ reimbursement standard set by DREC. This therefore also conversely suggests significant restrictions on actual prescriptions after its reimbursement listing. Currently, the immunosuppressant azathioprine is used as first-line maintenance therapy for NMOSD. If a patient fails treatment with azathioprine, mycophenolate or rituximab is prescribed with reimbursement as second-line therapy. Both mycophenolate and rituximab are off-label drugs that do not have NMOSD indications. In other words, Enspryng can only be used as a third or later-line therapy in patients who fail treatment with rituximab. Therefore, it remains to be seen whether the company will seek to extend reimbursement for Enspryng after listing. Meanwhile, Enspryng’s efficacy was demonstrated through SAkuraStar and SAkuraSky clinical trials that were conducted on adult patients with anti-aquaporin(AQP4) antibody-positive NMOSD. In the SAkuraStar monotherapy study’s AQP4 antibody-positive subgroup, 76.5% of ENSPRYNG-treated patients were relapse-free at 96 weeks, compared to 41.1% with placebo. In the SAkuraSky study, which evaluated Enspryng when used concurrently with standard immunotherapy, 91.1% of Enspryng-treated AQP4 antibody-positive subgroup patients were relapse-free at 96 weeks, compared to 56.8% with placebo.
- Opinion
- [Reporter’s view] Successive large-scale technology exports
- by Kim, Jin-Gu Nov 10, 2023 05:19am
- There is some good news coming from the pharmaceutical and bio industry. Chong Kun Dang and Orum Therapeutics have signed large-scale technology export contracts with global pharmaceutical companies. On the 6th, Chong Kun Dang signed a technology export contract with Novartis worth a total of $1.305 billion (about 1.7 trillion won). This is a transfer of global development and commercialization rights, excluding Korea, for ‘CKD-510’, a new drug candidate in the HDAC inhibitor class. On the same day, Orum Therapeutic, an unlisted bio venture, signed a contract with BMS to transfer the technology of ‘DRM-6151’, a new drug candidate for leukemia. The total contract size is $180 million (approximately 230 billion won). What attracts more attention than the total contract size is the down payment. Chong Kun Dang received $80 million (approximately 100 billion won) as a down payment, and Orum Therapeutic received $100 million (approximately 130 billion won) as a down payment. The down payment is money that does not need to be returned even if the rights to develop new drugs are later returned. The down payment is evaluated as an appropriate tool to objectively reflect the value of the candidate material. The total contract size is filled with an optimistic outlook. If a candidate material does not meet detailed contract conditions such as development or approval, it will not be received. In general, it is considered a good condition if the down payment ratio is more than 5% of the total contract size. Chong Kun Dang received 6.1% of the total contract size, and Orum Therapeutic received 55.6% as a down payment. In terms of down payment, it is the largest in four years since 2019. In February 2019, SK Biopharmaceuticals received $100 million (total contract size of $530 million) and signed a technology export contract for an epilepsy new drug with AVELOS Therapeutics. Since then, several technology export contracts have been signed with a total contract size in the trillions, but it is true that looking at the contract amount alone, it was disappointing. In some quarters, controversy arose over the discrepancy between the total contract size and the down payment. However, a series of contracts were concluded with a down payment of over 100 billion won. In the pharmaceutical industry, expectations are growing whether large-scale technology export contracts concluded one after another will be able to reverse the recent slump. Recently, the pharmaceutical and bio-industry has been facing an investment cliff due to the high-interest rate situation that has continued since the coronavirus pandemic. In particular, bio ventures that focused on R&D without consistent sales were pushed into crisis as external investment plummeted. In this situation, it is ultimately R&D, the core asset of the biopharmaceutical industry, that leads to a change in the atmosphere. It is time for another R&D performance. We succeeded in revitalizing the atmosphere through a series of technology export contracts. In order to completely change the atmosphere, new R&D results must be released in the near future. I look forward to hitting consecutive hits following Chong Kun Dang and Oreum.
- Product
- ‘Cutting budget for essential drugs neglects public health'
- by Kang, Hye-Kyung Nov 10, 2023 05:19am
- The Korean Pharmacists for Democratic Society (CEO Hyeong-geun Shin) criticized the full budget for the stable supply of essential national medicines and urged for additional budget allocation. On the 9th, before the National Assembly’s Health and Welfare Committee presented and deliberated on the next year's budget and proceeded with deliberation, KPDS submitted an opinion after analyzing the 2024 budget plan. Regarding the budget plan, KPDA said, “Regarding the development and support of the pharmaceutical and bio industry, the R&D budget has been expanded significantly, including the existing Research-Focused Hospital Development Project (approximately KRW 60.5 billion), the National New Drug Development Project (approximately KRW 57.9 billion), the Pharmaceutical Industry Development And Support Project (approximately KRW 35.9 billion), Pan-Ministerial Regenerative Medicine Technology Development Project (approximately KRW 35.3 billion), Global Research Cooperation Support Project (approximately KRW 28.7 billion), Electropharmaceutical Technology Development Project (approximately KRW 6.6 billion), Drug Delivery Treatment Technology Development Project (approximately KRW 7.6 billion), Biohealth Investment Infrastructure Linked R&D Project (KRW 2.7 billion), and the new Korean ARPA-H Project (KRW 49.5 billion) and the Joint Learning-Based New Drug Development Acceleration Project (approximately KRW 2.3 billion), etc. The investment is more noteworthy as the R&D budgets of only the Ministry of Health and Welfare, the Korea Disease Control and Prevention Agency, and the Ministry of Food and Drug Safety were increased among the 31 ministries in Korea.” However, KPDA pointed out, “Although it is a small amount compared to the budget plan set for developing new drugs and fostering the pharmaceutical and bio-industry, which costs hundreds of billions of won, we analyzed the budget plan and found some points worth pointing out to improve issues that the public can feel.” The first issue was regarding the budget implementation ▲to resolve concerns about the unstable supply and demand of medicines in the field KPDA said, “A total of 247 drugs were reported to have supply interruptions and supply shortages in 2022 to the MFDS, and 172 in the first half of 2023 alone. However, in MFDS’s 2024 budget, the budget that ensures a stable supply of national essential drugs was completely cut. The KRW 1 billion that was allocated to improve the supply of medicines through consignment manufacturing for 6 items in 2023 was cut.” Therefore, assuming that there are at least 25 drugs to which the government must respond, an additional KRW 7.5 billion should be allocated, KRW 300 million per drug. KPDA said, “One of the difficulties pharmacies complain about out-of-stock drugs is the lack of a way to explain when the out-of-stock issue will be resolved or explain the out-of-stock situation to patients or prescribers. This ultimately depends on the drug supply and demand situation. So we need to improve the transparency of information regarding the drug supply and demand. For this, the Ministry of Health and Welfare announced that it will disclose distribution information through the Korea Pharmaceutical Information Service Center (KPIS), but most medical practitioners are not aware of this, and even if they go to the website, it is difficult to find the information they want. Therefore, the KPIS webpage should be completely rebuilt so that pharmacies, medical institutions, and patients can easily check the status of out-of-stock items and be aware of the expected release date of necessary drugs.” The second was ▲expanding the budget for drug safety management and side-effect damage relief Under the Yoon Suk-Yeol administration, the Ministry of Food and Drug Safety announced a fast-track program for innovative products and announced that it would improve the system to allow faster approval of medical products, but the budget for licensing reviewers in charge of reviewing the medical products had not increased for several years. KPDA said, "In the 2024 budget, the number of personnel for registering clinical trial information and reviewing reports has been reduced from 7 to 3. There is a need to increase the related budget to expand the number of medical product-related review personnel to 500 people by 2024, as in Japan.” Regarding the Side Effect Damage Relief Fund, "Even though the related fund was established 10 years ago, many people are completely unaware of it, and there have been only about 100 cases of damage relief per year for several years. The government should have actively provided guidance and promotion so that people who have suffered damage from the side effects of medicines can seek relief, but its budget is only KRW 80 million. Considering how this year’s advertising budget for drug safety is KRW 3 billion, there is an urgent need to actively execute a promotion budget for the fund.” Regarding the budget for ▲expanding the publicness of pharmacies, KPDA requested, "The government must gradually expand the number of support pharmacies to ensure people's access to medicines, and expand the system so that at least one late-night pharmacy can be operated by each local governments in the future." In addition, KPDA also insisted on ▲securing a minimum budget to guarantee reproductive health. They said, “After the 2019 decision to deem abortion unconstitutional, guaranteeing women’s reproductive health became a major social issue, but all content related to reproductive health was missing from the 2024 budget. We ask for continued research, including the opening of a website for providing related information counseling services at the government level.” In particular, KPDA added, “It is more essential than ever to secure a budget for the out-of-stock drug situation that is still unresolved."
- Company
- Korea Pharma applies for approval of its 24hr ADHD drug
- by Lee, Seok-Jun Nov 10, 2023 05:19am
- Korea Pharma announced on the 9th that it had applied for marketing authorization for its 24-hour long-acting ADHD treatment ‘Methydur SR Cap.’ Methydur is a treatment for attention deficit hyperactivity disorder (ADHD) in children and adolescents developed by Orient Pharmaceuticals in Taiwan. The main substance contained in Methydur is methylphenidate hydrochloride, and it is available in three dosages - 22mg, 33mg, and 44mg - depending on symptoms. In Taiwan, the drug underwent 5 Phase I trials and completed a Phase I trial on 113 children and adolescent patients, demonstrating its safety and effectiveness. The drug obtained marketing approval in Taiwan in 2018. Methydur reduced the side effects that commonly accompany CNS drugs and improved the risk of drug abuse by applying the 'ORADUR®' technology. Using the ORADUR technology, the drug’s drug release rate can be controlled while retaining the characteristics of a sustained-release formulation by filling the capsule with a highly viscous gel form liquid. It can reduce discomfort caused by intranasal or intravenous treatments and prevent misuse or abuse. The number of ADHD patients in Korea have been rapidly increasing every year. However, it is an over-monopoly situation, with certain products taking up more than 60% of the market share. Korea Pharma plans to provide a stable environment for drug supply to patients by introducing Methydur, which can be prescribed in various doses and has a proven safety and effectiveness. Eun Hee Park, CEO of Korea Pharma, said, “If we obtain a marketing authorization for Methydur in Korea, we will be able to provide a clinically improved treatment effect to domestic pediatric and adolescent ADHD patients that are increasing every year.”
- Company
- Development active for microbiome-based therapies in Korea
- by Nho, Byung Chul Nov 10, 2023 05:19am
- Microbiome-based therapies have been expanding their therapeutic areas from simple digestives to immunology and oncology, receiving industry attention. Based on research results that showed that imbalances in the human microbiome are highly correlated with various incurable diseases, such as cancer and obesity, and can cause immune and metabolic diseases, research is being conducted in various fields to develop treatments using microorganisms. In particular, Swiss Ferring Pharmaceuticals' Rebyota (prevention of recurrence of Clostridioides difficile (C. difficile) infection) received FDA approval last year, and Seres Therapeutics' Vowst (prevention of recurrence of Clostridioides difficile (C. difficile) infection) was also approved this year. With drugs continuing to be approved one after another, the companies are also speeding up the commercialization of their respective drugs. In line with this global trend, domestic biotech companies are also entering related fields one after another and exploring their possibilities. First, MD Healthcare is developing a new drug with a focus on extracellular vesicle (EV) secreted by microbiome. EV is a lipid bilayer membrane secreted externally by cells that serve as vital mediators of intercellular communication. The company explained that as these particles are much smaller than cells, they have high absorption capacity and thus can provide radical treatment through a mechanism that works from within the cells. MD Healthcare's representative pipeline drug, 'MDH-014', targets central nervous system diseases (CNS) such as autism spectrum disorder, Alzheimer's disease, and Parkinson's disease. The company had submitted an IND for the drug for the autism spectrum disorder indication and is planning to start Phase I trials next year.. Enterobiome is developing treatments for incurable diseases using extreme anaerobic, non-culturable, next-generation probiotic strains. The company has been developing next-generation probiotics akkermansia muciniphila and faecalibacterium prausnitzii strains that show a negative correlation with various immune and metabolic diseases in the body as pharmabiotics. According to domestic and international studies, akkermansia and faecalibacterium significantly reduced the gut microbiota composition of patients with immune diseases such as atopic dermatitis and cancer as well as metabolic diseases such as obesity and non-alcoholic steatohepatitis (NASH) compared to normal people. Also, patients who were administered the two strains saw a treatment effect. Enterobiome has currently completed non-clinical toxicity testing for its akkermansia muciniphila strain EB-AMDK19 for atopic dermatitis and is preparing to apply for an IND as a new atopic dermatitis drug early next year. Akkermansia muciniphila, observed with an electron microscope. Among companies that are developing next-generation microbiomes, the only two companies leading at the akkermansia R&D and commercialization stage are The Akkermansia Company in Belgium and Enterobiome in Korea. Enterobiome owns a source technology for a high-concentration culture that is 1,000 times more concentrated than its competitors. Liveome has been developing a microbiome therapy based on its gene recombination technology. Libiome’s microbiome-based new drug has both the characteristics of a probiotic therapy and a gene therapy and is referred to as a ‘genetically engineered microbiota therapy.’ These treatments have the advantage of being able to increase effectiveness and drug efficacy by designing and manufacturing microorganisms according to the desired mechanism. Libiome is currently conducting Phase I clinical trials in Australia for its LIV001, a candidate in its inflammatory bowel disease pipeline, that was developed using the genetic recombinant eLBP platform. The candidate was selected as a new project by the Korea Drug Development Fund in July of this year and is receiving KDDF support for related R&D costs. In addition, various companies such as KoBioLab, Genome & Company, and CJ Bioscience are developing treatments for incurable diseases using microbiome, therefore whether a next-generation microbiome drug following Vowst’s footsteps will be born in Korea is gaining industry attention.
