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- 2026-05-17 11:18:15
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- JW Pharm to discuss technical partnerships for its gout Tx
- by Lee, Seok-Jun Dec 22, 2021 05:56am
- JW Pharmaceutical will be discussing technical partnerships for its key new drug candidates such as URC102 and JW2286 with global pharmaceutical companies. On the 20th, JW Pharmaceutical announced that it will be attending the ‘2022 JP Morgan Healthcare Conference’ that will be held online from the 10th next month (local time) and introduce its research projects to overseas pharmaceutical companies and global investors and conduct one-on-one virtual partnership consultations. The company plans to discuss tech partnerships for its self-developed innovative drug candidates at the conference. For example, the company will be promoting the technology export of its gout treatment URC102 to the global market, other than China. JW Pharmaceutical had signed a technology transfer agreement for URC102 with a Chinese company, Simcere Pharmaceutical, in 2019. The safety and efficacy of URC102 were demonstrated through a Phase 2b clinical trial that was completed in March. The company had also started a clinical trial to extend the eligibility of the drug to patients with nephropathies. A Phase III trial on these subjects is expected to start next year. Also, the company will promote technology partnerships for its STAT3-targeted anticancer drug, JW2286. JW2286 inhibits STAT3 and is indicated for the treatment of solid tumors, such as triple-negative breast cancer, gastric cancer, colorectal cancer, etc. The company is conducting nonclinical studies and drug manufacturing research to initiate clinical trials. STAT3 is a protein that promotes the expression of multiple genes. The abnormal activation of STAT3 causes tumor cell growth, proliferation, metastasis, and drug tolerance, but none had succeeded in developing anticancer drugs targeting STAT3 so far. Also, JW Pharmaceuticals will share its latest research and clinical development strategies on JW0061, a new drug candidate for hair loss that differentiates and promotes hair follicle stem cells involved in hair formation by activating the Wnt signaling pathway that regulates cell proliferation and regeneration, and JW1601, a drug that is extending its indication to age-related macular degeneration and ophthalmologic diseases such as allergic conjunctivitis, etc.. Around 1,500 pharmaceutical and bio companies from 50 countries attend the JP Morgan Healthcare Conference every year. Companies attend the conference to introduce their pipelines and technology to global healthcare companies. Also, participating companies are provided with an opportunity to meet with funds like venture capitals, hedge funds, PFEs, etc.
- Policy
- The MFDS approved Spikevax on the 13th
- by Lee, Tak-Sun Dec 22, 2021 05:56am
- The MFDS announced on the 13th that Moderna Korea has decided to allow manufacturing and sales items for Spikevax, which was applied on November 8. Spikevax' is a COVID-19 vaccine produced by Samsung Biologics in Korea with vaccines such as Moderna Spikevax developed in Moderna, USA, which was approved for import on May 21. Samsung Biologics receives raw material drugs and produces finished drugs through processes such as filling and marking. Spikevax is the first domestic consignment production vaccine in the mRNA method among COVID-19 vaccines licensed in Korea. The MFDS said it expects the permit to contribute to the stable supply of COVID-19 vaccines in Korea as well as to leap into a global vaccine hub. The MFDS added that it will continue to work with related ministries to strengthen the monitoring system for abnormal cases after inoculation and to provide an environment in which people can be vaccinated with confidence thorough monitoring and prompt response.
- Policy
- MFDS is speeding up the COVID-19 vaccine screening
- by Lee, Tak-Sun Dec 21, 2021 06:06am
- In 2021, the MFDS focused on speeding up the screening of COVID-19 vaccines aimed at 70% of the nation's vaccinations. As a result, the screening period for COVID-19 vaccines and treatments has been significantly advanced, contributing to the achievement of the goal. Unexpected inspections have begun on manufacturers to cope with illegal manufacturing incidents triggered by media reports. In addition, as impurity issues from overseas erupted one after another this year, drugs such as Sartan and Varenicline were recovered by inducing corporate self-inspection. Choline alfoscerate formulations, which have controversy over efficacy, were prepared in June with a clinical re-evaluation plan. ◆COVID-19 vaccine and treatment screening=As the government formalized the vaccination of the COVID-19 vaccine from the first quarter, the MFDS focused on advancing the approval period by mobilizing all personnel for product screening. As a result, vaccines were approved 40 days after receipt, and the National lot release was also completed 20 days after approval. Starting with AstraZeneca in February, Pfizer in March, Janssen in April, and Moderna vaccines in May were approved one after another. Most of them were achieved 40 days after the start of the permit review, and the National Lot Release was immediately carried out, and the vaccination began quickly. The EUA system has been enacted as a law to provide an institutional environment so that it can be urgently introduced even before formal approval. As a result, in October, Moderna vaccines commissioned by Samsung Biologics were able to receive EUA and supply them to the market. ◆Illegal manufacturing= Overseas COVID-19 vaccine confirmed the capabilities of the domestic pharmaceutical industry by selecting a domestic manufacturer as a production source, but it was also revealed that it was manufactured arbitrarily unlike permission. The MFDS, which immediately went into crackdown after hearing media reports, found that BINEX and Vivozon had illegally manufactured them in March. Additives were arbitrarily changed without permission, and some document manipulation appeared in the process. As a result, manufacturing and sales of related items were temporarily suspended and recovered. BINEX was found to have arbitrarily manufactured 32 items, including consignment and consignment manufacturing. Since then, the MFDS has set up a counter for internal complaints with the GMP special planning and inspection team and started unannounced inspections of all manufacturers. As a result, violations such as Hanall Biopharma, Chung Kun Dang, Dongin-dang, Hansol, Samsung, Jeil, and Medicakorea were found. As the MFDS proceeded with administrative measures against the caught companies, some pharmaceutical companies were treated as criminal charges. Illegal random manufacturing cases are currently under investigation by the prosecution, which is expected to have repercussions depending on the situation. ◆Choline alfoscerate, outline of clinical reevaluation= The clinical trial plan for this was finally approved in June when the MFDS issued a clinical re-evaluation order last year due to controversy over the effectiveness of the "Choline alfoscerate" drug raised by the National Assembly and civic groups. Each company decided to participate in consideration of cost and probability of success. As a result, a total of 57 companies expressed their intention to participate in the group led by Daewoong Bio and Chong Kun Dang, which have the highest sales in the market. Daewoong Bio and Chong Kun Dang conduct clinical re-evaluation of the efficacy of Choline alfoscerate's treatment of Alzheimer's dementia for 4 years and 6 months and mild cognitive impairment for 3 years and 9 months. All other indications were deleted as the revaluation effect was limited to Alzheimer's dementia and mild cognitive impairment. With the confirmation of the revaluation plan, each company has since started negotiations with the NHIS to recover benefits in the event of a clinical revaluation failure.
- Company
- "MET-targeted therapy as a new personalized NSCLC solution"
- by Eo, Yun-Ho Dec 21, 2021 06:05am
- Professor Ji-Youn Han HER2, ALK, EGFR, ROS1, NTRK. These keywords have been frequent visitors in articles on anticancer drugs recently. With the discovery that effective anticancer treatments differ depending on the patient’s genetic mutation status, personalized treatments that target specific genes of each individual are being introduced. And the development of precision medicine has heralded the paradigm shift of cancer treatments to ‘gene-specific treatment’ from ‘diseases-specific treatment.’ Amid rising expectations, the first anticancer treatment that targets the MET gene was newly introduced to Korea. The treatment, Novartis’ ‘Tabrecta (capmatinib),’ was authorized for the treatment of metastatic non-small cell lung cancer (NSCLC) with MET exon 14 deletions. The new introduction of an option in this rare type that occurs in approximately 3-4% of patients with NSCLC is gaining much attention in the medical community. Dailypharm met with Ji-Youn Han, Professor of Hemato-oncology at the National Cancer Center to hear about the use and potential of MET-targeted anticancer therapies and personalized treatment that has been implemented but is yet unfamiliar to the general public. - A treatment that targets the MET mutation has landed in Korea. What significance does the introduction of this new drug bring to the lung cancer treatment paradigm? The MET exon 14 skipping mutation is very rare in lung cancer. Various clinical trials have confirmed that exon 14 skipping mutation is an oncogenic driver mutation of lung cancer. Also, patients who have MET amplification or overexpression have very poor prognoses. In this sense, the approval of Tabrecta, a treatment that demonstrated clear efficacy in MET exon 14 skipping mutation, holds great significance as the prompt introduction of MET inhibitors has become ever important. - Not many patients may be eligible to use the drug. How many will be eligible, in Korea and what other characteristics do eligible patients have? In the West, patients with MET exon 14 skipping mutations account for approximately 3% of all NSCLC patients, In Korea, the reported rate is around 2-3%. One clinical feature of the disease is that it occurs more often in elder patients than younger patients. According to clinical studies, the median age of patients was around 70. -How is the MET diagnosis environment in Korea? Several hospitals have brought in NGS testing devices after NGS-based gene panel tests were applied selective reimbursement in 2017. The MET gene is an important oncogenic driver gene that is included in most NGS panels. However, identification of MET exon 14 skipping mutation is diagnostically difficult and requires further considerations. Also, by genetic mutations, some are more fit for RNA-based NGS tests rather than DNA-based NGS tests. In particular, identifying MET exon 14 skipping mutation through a DNA-based NGS test requires further detailed diagnosis to identify hundreds of mutations that can cause exon 14 skipping mutations. On the other hand, as an RNA-based NGS test can easily discern exon 14 skipping mutations, the RNA-based NGS test may be needed to identify exon 14 skipping mutations. But in practice, RNA-based tests are used less than DNA-based tests. - Commercialization of other MET inhibitors like tepotinib is also imminent. The MET inhibitor tepotinib had differentiated patients according to treatment experience in its clinical design. According to the Phase II GEOMETRY mono-1 trial, patients who used Tabrecta as first-line had shown higher objective response rates (ORR). On the other hand, the response rate was similar in patients using tepotinib regardless of treatment history. The efficacy and safety of the two were comparable in clinical trials. The IC50 value of the two drugs that determine how much of a drug is needed to inhibit cell growth by 50%, was slightly better for Tabrecta. However, most anticancer drugs are best effective in the subject patients when prescribed at the earliest. In particular, not all patients with MET exon 14 skipping mutations who have high PD-L1 expression respond to immunotherapy treatment. Using a combination of immunotherapy-chemotherapy as first-line can increase the financial burden borne by the patients and even be less effective than Tabrecta. This is why some advanced countries like Canada believe it is necessary to thoroughly check for MET exon 14 skipping mutations by using biopsy as well as liquid biopsies in order to reduce patient burden. -Also, studies on the combined use of MET inhibitors and EGFR TKIs are also active. In particular, there are expectations that the MET inhibitors may resolve the resistance issue of 3rd generation EGFR TKIs. Around 10% of the EGFR mutated lung cancers occur due to METs. This is why a smart MET inhibitor partner may be needed to address the acquired resistance to EGFR TKI. There had been a clinical trial that tested the combined use of Tabrecta and EGFR TKI. As it is unclear which causes EGFR mutations in lung cancer - MET amplification or overexpression – the study enrolled both patients. In the trial, a patient with EGFR exon 19 deletion mutation who have experienced primary resistance participated in the trial and reached complete remission (CR). One thing to note is that we do not need to only use 3rd generation EGFR TKIs like ‘Tagrisso (osimertinib)’ when attempting combination therapies. Not only because of the price, but I believe that 1st and 2nd generation EGFR TKIs can also be sufficient partners. Also, a study on Tabrecta+Tagrisso in patients with EGFR resistance is in progress, which medical institutions in Korea are also planning to participate in.
- Policy
- What's the HIRA's solution to the drug price?
- by Lee, Hye-Kyung Dec 21, 2021 06:05am
- Measures have been prepared to improve administrative and economic losses caused by drug returns in hospitals, clinics, and pharmacies following the revision of the monthly drug benefit list and upper limit table. The HIRA has decided to provide a revision of the drug benefit list in advance starting this month. Until now, drug price files have been provided since the revision of the notice after deliberation and resolution by the Health Insurance Policy Deliberation Committee of the MOHW. However, in the future, even before the issuance of the notice, after the Health Policy Review Committee is over, the drug price file will be provided in advance from the first day of the review. The final contents of the drug price file provided in advance can be changed depending on the results of the deliberation, so it seems that it takes time to apply the billing program. It is inconvenient to use the pre-provided drug price file to check the actual transaction price when returning and settling drugs at pharmacies and to apply the final drug price file to the billing program after issuance of the notice. The reason why the HIRA came up with such an early provision of drug price files seems to be the main reason for the monthly drug price, but the suspension of execution occurs when the upper limit of the drug is adjusted due to the reduction of the benefit range. Hospitals, clinics, and pharmacies will suffer from administrative tasks such as settlement of differences in drug prices. In particular, in the case of pharmacies, if the weighted average price is incorrectly calculated due to drug price reduction or increase, it may lead to on-site investigation and administrative disposition due to inconsistency in claims.
- Policy
- MFDS cancels all Jeil’s hypertension drugs for fabrication
- by Lee, Tak-Sun Dec 21, 2021 06:05am
- The Ministry of Food and Drug Safety issued a disposition revoking the sales licenses of all hypertension drugs manufactured by Jeil Pharmaceutical after the company was found to have submitted fabricated data for approval. A total of 44 items from 15 companies including Jeil Pharmaceutical were issued the disposition. The GMP investigation that has been initiated after Binex was found to have illegally manufactured products in March has been closing on and putting the pharmaceutical companies at risk. With HLB Pharmaceutical’s ‘Twinstel tab.’ marking the start of MFDS’ dispositions, the authorities have revoked the license of 14 companies’ hypertension drugs by the 16th. The canceled products are all same ingredient drugs manufactured by Jeil Pharmaceutical. In October, Jeil Pharmaceutical was found to have fabricated its residual solvent test data among data submitted to the MFDS for authorization, upon which all related products were discontinued and recalled. The ‘MFDS Special GMP Investigation team’ that was organized after the Binex issue had conducted an investigation from September 27th to October 8th and found the above violations. Companies that have received marketing authorizations through fraudulent means are revoked their licenses under the Pharmaceutical Affairs Act. Accordingly, the MFDS had been taking steps to revoke the license of relevant items since then. The canceled items, which are all telmisartan-amlodipine besylate combinations, include the following: Jeil Pharmaceutical’s ‘Telmiduo Tab,’ Kuhnil Biopharm’s ‘Partone Tab,’ GC Cross’s ‘Greencross Telmiamo Tab,’ Dongsung Pharm’s ‘Telmisapin Tab,’ Mcnulty Pharmaceutical’s ‘Mac duo Tab,’ Myungmoon Pharm’s ‘Telmiones Tab,’ Sungwon Adcock Pharm’s ‘Twinstan Tab,’ HLB Pharmaceutical’s ‘Twinstel Tab,’ LG Chem’s ‘Novarsc T Tab,’ Yungjin Pharm’s ‘Astel Tab,’ Yu & Life Science’s ‘Telosapin Tab,’ Joonghun Pharm’s ‘Telostar Tab,’ Theragen Etax’s ‘Twincure Tab,’ and Pharvis Korea’s ‘Troika Tab,’ As of the 16th, products from 36 companies have been revoked their licenses. Most were caused by Jeil Pharmaceutical’s license revocation due to data fabrication and other items were also caught on charges of arbitrarily manufacturing products and revoked permissions. Companies that were caught with violations this year include Medica Korea, Jeil Pharmaceutical, Samsung Pharm, Hansol Pharm, Dong In Dang Pharmaceutical, Chong Kun Dang, Hanall Biopharma, Vivozon, and Binex. Among these Binex was sent to prosecution by the MFDS’s Central Criminal Investigation Office for violating the Pharmaceutical Affairs Act.
- Company
- Is there a shortage of chickenpox vaccines?
- by Moon, sung-ho Dec 21, 2021 06:05am
- Contrary to the opinions of the medical community, SK Bio and GC Pharma said, "There is no problem in supplying chickenpox vaccines." The shortage of influenza (flu) vaccines in the second half of this year is causing confusion due to concerns that chickenpox vaccines may also be insufficient. Pharmaceutical and bio companies that produce chickenpox vaccines say there is no problem with supply, but there are already opinions that they should prepare for the shortage of vaccines at medical sites centered on related societies. According to the medical and pharmaceutical industries on the 25th, GC Pharma's "Barycela" is currently available for vaccination. There are 'Vari-L Vaccine' by Boranpharma and Sky Varicella by SK Bioscience. Among them, as the government recently declared "With Corona", there are opinions concerned about the increase in the number of people with infectious diseases such as flu and chickenpox at the medical site. Professor Eom Joong-sik (Infectious Medicine) at Gil Hospital said, "According to related data, infectious medicine doctors believe that the rate of wearing masks has definitely fallen. Considering that the flu and chickenpox are often occurring, the amount of contact is increasing." Accordingly, medical scientists and societies are concerned about the shortage of chickenpox vaccines and are preparing for the possible shortage of vaccines through changes in vaccination guidelines internally. There is a sense of crisis due to the fact that they already experienced a shortage of flu vaccines in the second half of the year. Currently, the government is vaccinating chickenpox vaccines free of charge for infants 12 to 15 months old. A KAPID executive said, "GC Pharma has stopped supplying chickenpox boxes and the launch of a next-generation vaccine, an alternative item, is also being delayed. It was originally scheduled to be released last year, but it was postponed to early this year, but we haven't heard of the release plan yet. As a result, we believe there is a possibility that the launch will be delayed further, he hinted. Another KAPID executive said, "In the case of chickenpox, if there is a shortage of vaccines, we are internally sharing the opinion that new, that is, initial vaccinations should be delayed and patients subject to secondary vaccinations should be vaccinated first." He then said, "It hasn't happened yet, so we're preparing for now." He said, "It would be fortunate if SK Bioscience, which accounts for the largest volume, supplies it normally." Pharmaceutical and bio companies that are supplying chickenpox vaccines to Korea say there is no problem at the moment. They say they are overly concerned at the clinical site. GC Pharma explains that it can supply its new product Barycela in earnest from the second half of this year, replacing Suduvax, which has decided to suspend supply. It is true that the plan to start supply in January this year after obtaining product approval in March last year has been delayed due to problems such as prolonged Corona and delayed NIP registration, but it has entered the normalization stage from the second half of the year. An official from GC Pharma said, "After deciding to stop supplying Suduvax, we will be able to supply Barycela, which was developed as a next-generation vaccine, without any problems. As a result of internal confirmation, we believe that the supply is going well enough." SK Bioscience, which accounts for the largest portion of the domestic chickenpox vaccine supply, is in a position that there will be no problem in supplying vaccines like GC Pharma. An official from SK Bioscience said, "As of the third quarter, Sky Varicella's share among chickenpox vaccines in Korea was 43%," and emphasized, "In the case of flu vaccines, there were some difficulties in producing and supplying chickenpox vaccines."
- Company
- Losartan products are about to be withdrawn from the market
- by Kim, Jin-Gu Dec 20, 2021 06:12am
- With the recovery of Losartan with excessively detected impurities, pharmaceutical companies are considering strategies after recovery measures are completed. Many pharmaceutical companies that did not have a very high market share in the Losartan market are reportedly considering gradually withdrawing from the market after the recovery is completed. It is predicted that the pace of market reorganization will accelerate after the recovery measures are completed. According to the pharmaceutical industry on the 20th, a large Korean pharmaceutical company A is discussing ways to stop selling the product line after the recovery of Losartan is completed. Company A has five Losartan items, and some or all of these products are subject to collection. According to UBIST, a pharmaceutical market research firm, the amount of outpatient prescriptions for company A's five Losartan items last year was more than 7 billion won. It is confirmed that more than 5 billion won was prescribed cumulatively by the third quarter of this year. The pharmaceutical industry interprets the reason why Company A is considering withdrawing the market as to resolve uncertainties. Since NDMA impurities were first discovered in Valsartan in 2018, the pharmaceutical industry has struggled with the impurity crisis every year. In particular, since all impurity incidents occurred in unexpected situations, it was difficult for companies as sales suspension and recovery were repeated after detecting impurities. Moreover, in the case of Company A, it is considered the background of considering withdrawal from the market since it has various ARB drugs such as Telmisartan, Candesartan, Valsartan and and Irbesartan. An official from Company A said, "Nothing has been accurately decided yet. Losartan's prescription performance is not bad, but other ARB-based drugs are larger in terms of the total amount of prescription," he said. The pharmaceutical industry predicts that pharmaceutical companies, including Company A, will withdraw from the market after the recovery of the Losartan hypertension treatment is completed. As of last year, the amount of outpatient prescriptions in the hypertension treatment market, including Losartan, was 320.8 billion won, with two companies, Hanmi and Organon accounting for more than half (53.9%). Hanmi's five types of Losartan recorded 122.4 billion won in prescriptions last year, accounting for 38.1% of the market share. Organon accounts for 15.8%. It was followed by 3.9% per Chong Kun Dang, 3.0% of SK Chemicals, 2.9% of Samik, 2.4% of Kyung Dong, 2.2% of HK inno.N, and 2.0% of Daewoong Bio. In addition, 91 companies are competing for the remaining 27.5%. Most pharmaceutical companies' annual prescriptions are less than 500 million won. The MFDS announced on the 7th that all or some manufacturing number products of 295 items from 98 companies that were detected or feared to exceed the daily intake allowance will be voluntarily recovered. The pharmaceutical industry is in the process of recovering the product.
- Opinion
- [Reporter’s View] Have we secured enough COVID-19 pills?
- by Dec 20, 2021 06:12am
- The world is in preparations to use oral COVID-19 treatments to end the pandemic. Following the UK, Demark became the second country to authorize the use of MSD’s (US Merck’s) ‘molnupiravir,’ with the EU and the US also reviewing approval of the said drug. Pfizer’s oral treatment ‘Paxlovid’ is also under regulatory review. Korea has also joined in the preparations and started the review process for ‘molnupiravir,’ and signed an advance purchase agreement with MSD and Pfizer for 312,000 courses of their treatments (242,000 courses from MSD and 70,000 courses from Pfizer). The authorities also significantly increased the budget for such purchases. Although 36.2 billion won was first allocated for COVID-19 treatments, the National Assembly had passed 192 billion won as reserve funds for additional purchases of such treatments on the 14th. As a result, a total of 228.2 billion won is being invested for oral COVID-19 treatments in Korea. Considering the total purchase volume alone, it may seem that Korea has secured a sufficient amount of oral treatments. However, with the pros and cons of the two treatments taking shape, it is questionable whether the amount and ratio of the two were a wise purchase. The government believes that there is a sufficient supply of oral treatments to prescribe to non-hospitalized COVID-19 patients who will be at high risk of progressing to severe disease. The weekday daily confirmed COVID-19 cases as of December 19th was 6,834 per day, with an average of 755 hospitalizations per day. The drug will be used on COVID-19 patients with comorbidities such as old age, obesity, diabetes, heart condition, etc among the daily 6,079 non-hospitalized cases. Although the molnupiravir that Korea purchased the most is, in theory, effective against all COVID-19 variants, the most recent clinical trial left lingering questions regarding its efficacy against the more recent variants. Although interim analysis of patients that were confirmed with COVID-19 between May and August showed that molnupiravir reduced the risk of hospitalization and death by half compared to placebo, the same drug had much less effect, a 30% efficacy in reducing risk on those who were confirmed with COVID-19 between August and October. The reduced efficacy in the second half of the period when the delta mutation was dominant has been raising concern that molnupiravir may not be so effective against the delta variant. Also, a long-term safety concern has been raised on molnupiravir as a ribonucleoside analogue that enters the COVID-19 virus’s RNA. The concerns raised had deepened the authorities’ concerns over how to set the target patient group for the oral treatment. In other words, the number of patients that may be authorized to recieve molnupiravir may be partially restricted or limited. Pfizer had announced clinical trial results of Paxlovid demonstrating an 89% efficacy in high-risk patients. ALso, ongoing clinical trials indicate that there is a higher likelihood that a broader range of patients will be allowed to use Paxlovid. Pfizer is conducting trials on non-hospitalized patients at low risk of hospitalization or death (EPIC-SR) and as post-exposure prophylaxis on patients exposed to COVID-19 (EPIC-PEP). According to Pfizer’s announcement on the 14th, Paxlovid may reduce the risk of progression to moderate-to-severe disease by 70% in standard-risk patients such as healthy non-elderly adults or those who have risk factors but have received vaccinations. Based on such observations, the 242,000 courses of molnupiravir may not be used as much as expected and the 70,000 courses of Paxlovid may not be enough. Also, the price of Paxlovid may increase if molnupiravir has a lower-than-expected effect. Pfizer had raised the price of its COVID-19 vaccines in August for similar reasons. This is why we cannot rest assured with the 310,000 courses that we secured in advance.
- Company
- EMA designated Hanmi's HM15211 as ODD
- by Kim, Jin-Gu Dec 20, 2021 06:12am
- Hanmi Pharmaceutical's LAPSTriple Agonist, HM15211 announced on the 17th that it has been designated as ODD by the European Medicines Agency (EMA). According to Hanmi Pharmaceutical, EMA recently designated it as ODD for the treatment of primary sclerosing cholangitis, PSC. The LAPSTriple Agonist has previously been designated as ODD by the FDA. It was designated as a rare drug in March last year, and was once again designated as ODD in May this year. With this designation, LAPSTriple Agonist has become a new drug that has received a total of four rare drug designations, including three from the FDA and one from the EMA. Including this, Hanmi Pharmaceutical will hold a total of 18 ODD designated records (9 FDA cases, 6 EMA cases, and 3 MFDS cases) with 10 indications from 6 pipelines. At this point, it is the highest record among domestic pharmaceutical companies. LAPSTriple Agonist is a triple agonist that acts as a simultaneous activation of GLP-1 receptors, glucagon receptors, and GIP receptors. Based on multiple pharmacological effects, it is expected that excessive accumulation of bile acids in the liver will be reduced and liver inflammation and fibrosis will be suppressed to dramatically improve the quality of life of patients. Hanmi Pharmaceutical confirmed the effects of LAPSTriple Agonist on reducing bile acid accumulation and anti-inflammatory and anti-fibrotic effects. Primary sclerosing cholangitis is a chronic progressive bile identity liver disease caused by unknown intrahepatic biliary tract inflammation and fibrosis. The FDA and the EMA's designation of ODD is a system that supports the smooth development and permission of treatments for rare and intractable diseases or life-threatening diseases. In Europe, the cost of applying for permission will be reduced, and various benefits such as exclusive rights for 10 years will be granted when approving the first marketing permit among products of the same affiliate.
