- LOGIN
- MemberShip
- 2025-12-23 19:30:10
- Company
- Poteligel can be prescribed at hospitals
- by Eo, Yun-Ho Nov 15, 2023 05:39am
- 'Mycobacterial Breed' and 'Poteligel', a treatment for 'siary syndrome', have entered the prescription of a general hospital. According to the relevant industry, Korea Kyowa Kirin's Poteligio (Mogamulijumab) has passed the Drug Committee (DC) of medical institutions such as Seoul Asan Hospital. Potelio passed the Cancer Disease Review Committee of the Health Insurance Review and Evaluation Agency last month and is waiting for the chairman of the Drug Payment Assessment Committee. If the registration is successful, it is judged that the prescription will be made immediately. This drug is a treatment for mycoid sarcoma and sia syndrome, which targets CCR4 (C-C chemokine receptor 4). It was designated as Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) in August 2017. It has been rated as the first-in-class in the UK SMC and approved in the country in September last year. PORTRIDGEO HAS PROVEN VALIDITY THROUGH MAVORIC STUDIES. The study recruited 372 patients with recurrent, unresponsive fungal sarcoma or syndrome on the largest scale related to skin T-cell lymphoma (CTCL) systemic therapy to assess their effectiveness and safety. The study included patients with mycoccal sarcoma or syndrome who had previously received one or more (median 3 median) systemic therapy. 55% of patients had heterogeneous sarcoma, 45% had syndrome, and 77% had stage 3B or higher. 66% were accompanied by blood disease. As a result of the study, Poteligel showed a superior effect over the control group, Borinostat. Portelliggio has statistically significant improvements in non-progressive survival (PFS) compared to Vorinostat. The PFS median for Potelliggio was 7.7 months, while the control group was only 3.1 months.
- Company
- Korean bio companies intent on developing new AD drugs
- by Son, Hyung-Min Nov 15, 2023 05:39am
- Despite downturns, including the return of the rights for JW Pharmaceutical’s atopic dermatitis drug candidate, clinical trials for new drugs to treat atopic dermatitis are still ongoing in Korea. Last month, JW Pharmaceutical announced that its technology transfer agreement for its atopic dermatitis treatment JW1601 which it signed with the Denmark pharmaceutical company Leo Pharma has been terminated. JW1601 owns a dual-action mechanism that selectively acts on the histamine H4 receptors to suppress inflammation and itching. Histamine is a major mediator of allergic inflammation. However, the candidate was unable to satisfy its primary efficacy endpoint in a global Phase II trial. With no other atopic dermatitis treatment owning the same mechanism of action, the drug had the potential to become a First-in-class drug but was unable to reach the commercialization stage. However, JW Pharmaceutical plans to continue to review its direction of development and potential to acquire new indications. Clinical trials are being actively conducted on various mechanisms that suppress inflammation… stem cell treatment starts later phase trial In addition to the failed candidate that targets histamine H4 receptors, various new drug candidates that target atopic dermatitis are being developed in Korea right now. A Stem cell therapy, as well as new drug candidates targeting Bruton's tyrosine kinase (BTK), interleukin-2-inducible T-cell kinase (ITK), and Janus kinase (JAK) are also being studied for commercialization potential. One of the candidates that is evaluated to be close to commercialization is a stem cell treatment. Kangstem Biotech is a leader in the field of stem cell treatments for atopic dermatitis. The company recently completed patient administration of ‘FURESTEM-AD Injection,’ a new drug candidate being developed in a Phase III trial. FURESTEM-AD Inj is being developed as a treatment for patients with moderate-to-severe atopic dermatitis who have not responded to existing treatments. Kangstem Biotech plans to complete the Phase III trial by the first half of next year and apply for its marketing approval. Interim results of the Phase III long-term follow-up study disclosed by the company showed that in patients who were administered FURESTEM-AD Inj, 58% achieved Eczema Area and Severity Index-50 (EASI-50) in the first year, 66% in the second year, then 75% in the third year. EASI-50 refers to the percentage of patients whose dermatitis symptoms improved by more than 50% compared to the baseline. ‘SCM-AGH,’ a stem cell treatment for atopic dermatitis that is being developed by SCM Lifescience, has also secured positive results in a Phase II trial. In a clinical trial comparing the efficacy and safety of SCM-AGH compared with placebo, SCM-AGH met the primary endpoint. Also, the SCM-AGH arm saw significant results in the secondary endpoint achieving ESAI-90 at 24 weeks. Also, none of the 55 subjects who were administered SCM-AGH showed side effects. Due to safety issues that arose in some inflammation treatments the fact that no side effect occurred is considered positive. SCM Lifescience plans to conduct its Phase III clinical trial in Korea with Handok. In addition, Daewoong Pharmaceutical is conducting 2 clinical trials in the US. Its ‘DWP212525’, which targets JAK3 and TEC family kinase (TFK), is in a preclinical trial, and ‘DWP213388’, a BTK/ITK inhibitor, is in a Phase I clinical trial. Novacell, an affiliate of DongKoo Bio&Pharma, is developing NCP112, which targets G protein-coupled receptors (GPCRs) and formyl peptide receptor 2(FPR2), which are involved in the resolution of inflammation, as a treatment for mild-to-moderate atopic dermatitis. NuGel, a GPCR19-targeted inflammation modulator being developed by Chaperone in the US, has successfully entered Phase II trials.
- Company
- Will the new ADC breast cancer drug Trodelvy be reimb?
- by Eo, Yun-Ho Nov 15, 2023 05:39am
- ‘Trodelvy,’ another new ADC drug for breast cancer, is seeking reimbursement listing in Korea. According to industry sources, Gilead Science Korea has submitted an application for the reimbursement of its triple-negative breast cancer treatment Trodelvy (sacituzumab govitecan-hziy) on July 31, and the agenda is awaiting to be presented for deliberation by the National Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee on the 22nd. However, the key is in setting its drug price. Various treatment options that target different mechanisms of actions or genes have been introduced to the field of TNBC treatment, however, none has been reimbursed until now in Korea. In fact, another ADC, ‘Enhertu (trastuzumab deruxtecan)’ passed the CDDC review in May, but its reimbursement agenda has not been presented for deliberation to the Drug Reimbursement Evaluation Committee until now. Whether Trodelvy will be able to overcome the difficulties and succeed in being reimbursed in Korea remains to be seen. Trodelvy is an antibody-drug conjugate (ADC) that consists of a monoclonal antibody that binds to the cell surface antigen Trop-2 and ‘SN-38,’ a TOP1 inhibitor payload. The drug received approval from the Ministry of Food and Drug Safety in May to treat adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies, including at least one prior therapy for metastatic disease. Trodelvy is the only non-cytotoxic chemotherapy approved as a second line or higher line of treatment for the entire TNBC patient population in Korea. It can be used regardless of genetic mutations or biomarkers. The National Comprehensive Cancer Network (NCCN) guidelines recommend Trodelvy as a Category 1 preferred treatment option for adult patients with metastatic TNBC who have received prior treatment. Trodelvy’s clinical efficacy was confirmed through the Phase III ASCENT study. In the study, Trodelvy significantly reduced the risk of death by 49% compared with a treatment of physician’s choice (TPC) in patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Also, the Trodelvy arm showed a 57%
- Company
- Market for montelukast revive…overcomes impurity issue
- by Kim, Jin-Gu Nov 14, 2023 05:49am
- The market for asthma treatments containing the ingredient montelukast has succeeded in complete revival. This market shrank significantly in 2020-2021 due to the side effects issue and the COVID-19 outbreak, but made a rebound last year, and is expected to expand to the largest size ever this year. The market which remained stagnant for 2 years...is expected to revive completely after making a market rebound the previous year According to the market industry research institution UBIST on the 13th, the cumulative outpatient prescriptions of asthma treatments containing montelukast in Korea reached KRW 106.5 billion in Q3 this year. This is a 27% increase in 1 year from the KRW 83.6 billion made in the same period in the previous year. Montelukast is one of the most common ingredients used to treat allergic rhinitis and asthma. The original drug is Organon Korea’s ‘Singulair’. In Korea, MSD Korea received approval for the original drug in 2000, and around a hundred domestic pharmaceutical companies are selling generic versions with the same ingredient. The market was analyzed to have made a complete recovery this year. It had continuously grown until 2019 but then had greatly contracted in 2020-2021. In 2020, the prolonged COVID-19 crisis reduced hospital visits by children and adolescents, reducing prescriptions. During a similar period, the US Food and Drug Administration required a ‘Black box warning’ be attached to montelukast products regarding its neuropsychiatric side effects. Black box warnings are the highest level of warnings issued regarding side effects. Due to the overlapping unfavorable events, the market, which was worth KRW 119.9 billion in 2019, contracted to KRW 97.7 billion in 2020 and KRW 97.6 billion in 2021. Quarterly market size of montelukast asthma treatments But the market made a rebound last year. The market size expanded again to KRW 118.9 billion last year, which is a similar level to what it made in 2019. The market then continued to grow further this year. By quarter, it sold KRW 31.2 billion in Q1, KRW 34.7 billion in Q2, KRW 29.4 billion in Q3. The analysis is that the rise in influenza and cold patients by Q3 year has increased prescriptions to alleviate related symptoms. This is similar to how prescriptions for pseudoephedrine or cephalosporin-based antibiotics had increased during the same period. In the case of Singulair, the flagship product, the supply of some doses had even become temporarily suspended due to rising demand. In general, prescriptions for this ingredient used to be concentrated in the Q4 each year. For this reason, the industry predicts that the market for treatments with this ingredient will expand to KRW 140 to 150 billion by the end of this year. Unless there are any special issues, it is expected to expand to the largest scale ever. Sales of Singulair generics soar… Lukio 18%, Montezal 44%↑ Prescriptions for major montelukast products also increased at the same time. In the case of the original Singulair, its cumulative sales increased by 8% from KRW 20.2 billion in Q3 last year to KRW 21.9 billion in Q3 this year. Sales of its generic products had risen more rapidly. Sales of HK Inno.N’s Lukio increased by 18% from KRW 6.9 billion to KRW 8.1 billion during the same period. The price of Hanmi Pharmaceuticals Montezal increased by 18% from KRW 4.5 billion to KRW 6.4 billion. Changes in major montelukast asthma treatment prescriptions Sales of Boryung’s Asluka rose by 44% YoY to KRW 6.4 billion, Hutecs’ Singuldown by 58% to KRW 4.5 billion, Dong Kook’s Singulmon by 23% to KRW 3.7 billion, and Daewoong Bio’s Daewoong Montelukast by 78% to KRW 3.1 billion, respectively. The same goes for montelukast+levocetirizine combination drugs. Hanmi’s Monterizine is the only available combination drug. Monterizine’s cumulative prescriptions in Q3 reached KRW 11.2 billion, up 27% YoY compared with the KRW 8.8 billion raised in Q3 last year. Monterizine is also facing challenges due to the imminent entry of montelukast. 10 companies - Genupharma, Huons, Daehwa Pharmaceutical, DongKoo Bio&Pharma, Binex, Boryung Pharmaceutical, Daewon Pharmaceutical, Daewoong Pharmaceutical, Medica Korea, and Jeil Pharmaceutical – won the patent challenges against Hanmi Pharmaceuticals and owns generic exclusivity for Monterizine generics and waiting to release their generics.
- Company
- Conquest of low survival gallbladder cancer
- by Nov 14, 2023 05:49am
- In the area of bile duct cancer, where survival rates are low and treatment options are scarce, new drug candidates from domestic pharmaceutical companies have been confirmed in clinical practice and are one step closer to commercialization. HDB001A, a new drug candidate for gallbladder cancer that Handok is developing, has recently been approved by a multi-national Phase 2/3 clinical trial plan (IND) in Korea. The company plans to compare and evaluate the effectiveness of Paclitaxel alone through the combination of HDB001A and platinum-based anticancer drug Paclitaxel. Handok emerged as a dark horse in the area as HDB001A entered a late clinical trial, along with the acquisition of domestic permission for the new gallbladder cancer drug , which was introduced from U.S. company Insight. Major bioventures plan to confirm their effectiveness through the combination of new drug candidates and immunocancer drugs under development. Genome & Company GEN-101, G Innovation GI-101, and SMT Bio SMT-NK are each undergoing clinical trials in combination with Keytruda. Handok confirms the validity of Phase 2 clinical trial Handok is collaborating with Compass Therapeutics in the United States to develop a treatment for bile duct cancer. HDB001A, which is being developed, is a new drug candidate for gall cancer developed by ABL Bio, a domestic company, and the domestic copyright is held by Handok and the global copyright is held by Compass. HDB001A is known to simultaneously target DLL4 and VEGFA and play a role in the formation of new blood vessels in tumor-fine environments. The company aims to obtain conditional approval from the Ministry of Food and Drug Safety through clinical results that will end next year. Last month, SMT-NK was recognized by the Ministry of Food and Drug Safety and obtained approval for the use of drugs for clinical trials in patients with bile duct cancer. G-I Innovation is undergoing clinical phase 1 in the United States to confirm the effectiveness of GI-101 and kitluda combination therapy. It aims to secure indications for solid cancer that include bile duct cancer. The company is confirming the possibility of commercialization through combination therapy with various immune anticancer drugs. 5-year survival rate of bile duct cancer 29%, Evaluation of lack of professional treatment options for bile duct cancer Bleduct cancer is one of the cancers that is difficult to diagnose early because there are no self-aware symptoms. The 5-year survival rate for bile duct cancer is 29%, which is lower than lung cancer (34%) and liver cancer (37%). As early diagnosis is difficult, treatment options are limited. In advanced bile duct cancer, platinum-based chemotherapy has been used as a standard treatment for the past 10 years. This is a first-generation anticancer drug, a cytotoxic anticancer drug that is used not only for bile duct cancer but also for lung cancer and colorectal cancer. Side effects are also known to be high. Secondary standard therapy includes FOLFOX, but it is also not a specialized treatment for bile duct cancer. Recently, immunoanticancer agents have secured encouraging data and are attracting expectations. The impinji developed by AZ was approved as the first treatment in the country in November last year. However, targeted treatments for bile duct cancer are still insufficient. It is noteworthy whether new drug candidates from domestic pharmaceutical companies can solve the unfulfilled demand of bile duct cancer patients.
- 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.
- 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.
- 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.
