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- 2026-05-20 20:56:13
- Policy
- The MFDS releases Metformin’s NDMA test
- by Lee, Tak-Sun Jan 20, 2020 06:26am
- The MFDS has prepared a test method to properly detect NDMA (N-nitrosodimethylamine), which is a carcinogen, in the diabetes drug 'Metformin'. Unlike Ranitidine or Nizatidine, the test conditions are GC (Gas Chromatography) -MS/MS. This is the same test used by Singapore health authorities that detected NDMA in Metformin. The MFDS unveiled the test method, saying that it is also collecting drugs for sale on the market. The MFDS released its NDMA test method for Metformin using GC-MS / MS on its website on the 15th. As publicly available test methods are released, pharmaceutical companies can conduct their own tests with the test method. An official of the MFDS said, "We have prepared a test method in consideration of the test method and material properties conducted in Singapore". However, a pharmaceutical's own tests, subject to LC (Liquid Chromatography), before the test release, are expected to be re-validated. The MFDS official said that in this case, he will look at whether the LC condition test is appropriate, but it is necessary to retest as the official test method is GC. The MFDS added that it is also conducting inspections of commercial distribution items with the release of the test method. An official from the MFDS said, "We started the inspection of the distribution items on the market as we proceeded with the system investigation last month and prepared the test method, and specific test subjects and results will be disclosed later". The industry believes that NDMA has been collected and inspected for products made from the same raw materials as those for Singapore. It is observed that the source of raw materials and finished products were collected after the systematic investigation was confirmed. This is due to the fact that it takes a long time to conduct a full survey as there are 640 approved Metformin products in Korea. As the MFDS has started a full-scale investigation, the tension in the pharmaceutical industry is expected to increase. However, there are many cases where NDMA has not been detected in its own investigation, and there is no detection case outside of Singapore, so it is optimistic that there will be no problem in Korea.
- Company
- Samsung BioLogics opens new CDO lab in San Francisco
- by Lee, Seok-Jun Jan 20, 2020 06:25am
- Samsung BioLogics will establish a CDO R&D Lab in San Francisco in the first half of this year. The company is the first US corporation. Samsung BioLogics plans to further expand to other regions of the US and Europe. Samsung Biologics President Tae-han Kim and Vice President John Lim announced the plan at the JP Morgan Biohealth Conference in San Francisco. Tae-han Kim, President & CEO, Samsung BioLogics (left) & Vice President John Lim(Right) President Tae-han Kim shared the business status. President Tae-han Kim said, "We are currently conducting 35 CMO products, 47 product approvals, 42 CDO projects and 10 CRO projects, & expanding our global business with 47 product approvals". As the project accumulates, the plant utilization rate is rising. Kim said, “The first plant is nearing its maximum utilization rate and the second plant is currently in full operation, the third plant has 35% of its production capacity and will raise it to 60% this year”. Vice President John Lim announced the entry into the CDO R&D Lab in San Francisco, USA in 2020. This is to create synergy with customer satisfaction and production base in Korea through overseas expansion. "We are looking into the CDO R&D lab in San Francisco in 2020 and further expansion in other parts of the United States and Europe," said John Lim. He said, “Samsung BioLogics began expanding its value chain to CDO/CRO in 2017, and established a one-stop service from cell line development to clinical material production through sCMO, quality control/analysis, and commercial mass production. Biotech and Big Pharma have more than 9,000 locations".
- Company
- Pfizer's EGFR TKI to compete against Iressa and Giotrif
- by Eo, Yun-Ho Jan 17, 2020 06:27am
- Pfizer Pharmaceutical Korea is stepping into the lung cancer-treating EGFR TKI market. Industry sources reported, Korean health authority is expected to grant approval on Pfizer’s epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Vizimpro (dacomitinib) within the first quarter of the year. Last year, the global company has submitted a marketing approval application. Vizimpro won approvals from the U.S. Food and Drug Administration (FDA) and European Commission in October 2018 and April 2019, respectively. The drug is a first-line target therapy treating patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed EGFR exon 19 deletion or exon 21 L858R substitution mutations. It is categorized as a second generation therapy like Giotrif (afatinib) by Boehringer Ingel Heim. EGFR TKI products approved in Korea Currently, first generation AstraZeneca’s Iressa (gefitinib) and Roche’s Tarceva (Erlotinib), second generation Giotrif, and third generation AstraZeneca’s Tagrisso (osimertinib) are available for prescription. When the company releases Vizimpro, it would directly compete against Iressa, Tarceva and Giotrif. But the competitor line up would change when Tagrisso is listed as a reimbursed first-line treatment. Considering Vizimpro is a follow-on drug, Pfizer would price the drug comparatively lower and rather aim to receive reimbursement fast. Vizimpro’s efficacy was confirmed in a Phase 3 study, ARCHER 1050. The clinical study compared arms each treated with dacomitinib and AstraZeneca’s first generation medicine Iressa, and observed overall 425 patients with NSCLC. As a result, Vizimpro lowered patients’ hazard ratio 41 percent more than Iressa, whereas median progression-free survival (PFS) in the Vizimpro arm was 14.7 months compared to 9.2 months in the Iressa arm. However, Vizimpro group had more adverse reaction reported. The most common third-level and higher serious adverse reactions were acne (14 percent) and diarrhea (eight percent) in Vizimpro group, and abnormal liver enzyme level (eight percent) in Iressa group. 60 percent of Vizimpro-treated patients had to adjust treatment dose due to the side effects.
- Company
- Nexava’s patent expired, Why generics not released yet?
- by Kim, Jin-Gu Jan 17, 2020 06:24am
- Generics have not appeared even though the patent for hepatocellular carcinoma 'Nexava' (Sorafenib) has expired. Hanmi is reportedly having difficulty in generic development even though it has actively solved the patent problem. In some industries, abandonment is raised. Hanmi is poised to bring it to market as soon as the bioequivalence test and licensing process is completed. According to the pharmaceutical industry on the 14th, Hanmi Pharmaceutical has challenged to develop Nexava alone. The item went to the Supreme Court and worked hard enough to pass the patent. There are three patents on Nexava. Bayer, the original company, has registered patents for materials, crystalline patents, and formulations and uses. Among these, Hanmi has succeeded in overcoming the crystalline patent and the formulation and use patent. In 2015, Hanmi Pharm claimed a negative jurisdiction for judging crystalline patents and an invalidity trial for formulation and use patents. The patent dispute was fierce enough to go to the Supreme Court. In the end, the Supreme Court concluded the dispute over two years on the side of Hanmi Pharm in both patent disputes in 2017. As a result, Nexava-related patents were left with only one patent. The patent even expired this month. The hurdles for generic releases are gone. Nevertheless, the launch of generics for Nexava are still uncertain. As of the 14th, the generics aren’t be identified in the drug product authorization list of the agency. This is an unusual interpretation given that generics are generally released in accordance with the expiration of material patents. It did not pass the bioequivalence test. Hanmi conducted bioequivalence test in August 2015 named Hanmi Sorafenib. As a result, it failed to confirm bioequivalence test. With this, some have raised doubts about whether Hanmi has abandoned its development. Hanmi made it clear that it was not true about abandonment. Hanmi has been on the verge of reviving since March last year. It is reported that the recent recruitment of patients is over. An official from Hanmi said, "We will proceed with the application for approval as the bioequivalence test is completed". According to IQVIA, a pharmaceutical market analyst firm, Nexava's annual sales are ₩26.3 billion (as of 2018). If Hanmi succeeds in launching the generics as planned, it is expected that it will be able to secure a significant portion of Nexava's sales, as it is under exclusive development. So far, only Hanmi has succeeded in avoiding Nexava patents. Yuhan Corporation, JW pharmaceutical, and Ahn-gook Pharmaceutical challenged the patent, but withdrew the patent trial request.
- Company
- Dong-A ST finished Abbvie’s ₩48 billion down payment
- by Lee, Seok-Jun Jan 17, 2020 06:24am
- Dong-A ST completed a 36-month split recognition of the Abbvie technology export contract of $40 million (about ₩48 billion). The 36 months is a period in which the two companies are considering the selection of pipelines. In other words, the preclinical study has countdown on the assumption that the pipeline has been successfully derived. Dong-A ST transferred the technology of MertaK inhibitor DA-4501 in the process of pipelines to Abbvie in December 2016. MerTK inhibitors are a new mechanism of immunological anticancer drugs that inhibit the activity of MerTK (MerTyrosine Kinase) protein and help the immune system. According to the industry on the 15th, Dong-A ST completed the 36-month split recognition of the Abbvie technology export contract by November last year. In the meantime, the $40 million contract has been booked at $ 1.11 million (about ₩1.3 billion) monthly and $3.33 million (about ₩3.8 billion) quarterly. Dong-A ST lost fixed profits after the split recognition. However, additional milestones can be expected as clinical progress Dong-A ST's Abbvie technology export maximum milestone is $ 485 million, excluding the $ 40 million contract. As clinical progress progresses, the inflow of royalties increases. According to the company, there are no milestones for receiving pipelines. After the down payment, the following fees are based on preclinical results. Since then, the milestones will increase in size. An official of Dong-A ST explained, "The Abbvie’s split-up recognition period is the period in which the pipeline is derived, and the pipeline is expected to be derived soon. If successful, it will enter the pre-clinical". The two companies, on the other hand, are obliged to carry out joint development until pre-clinical. For this, Dong-A ST and Abbvie formed Joint Research Committee. Steps after pre-clinical will be carried out by Abbvie alone.
- Policy
- MFDS updates drug supply suspension list from Q2 2019
- by Lee, Tak-Sun Jan 17, 2020 06:22am
- Handok and Korea AbbVie are respectively suspending the supply of antiulcer treatment Gabet tablet (ecabet sodium), and hepatitis C treatment Viekira (paritaprevir-ritonavir-ombitasvir) and Exviera (dasaabuvir sodium) in Korea. According to the pharmaceutical industry on Jan. 15, Ministry of Food and Drug Safety (MFDS) recently disclosed a list of suspended drug supply suspension from the second quarter in 2019. To prevent pseudo demand (panic-buy) on the drugs, MFDS withheld immediate disclosure of the news and posted the list on the ministry’s pharmaceutical information website after six months. Accordingly, the website has been updating last year second-quarter’s drug supply suspension list from December last year. The updated list informed Handok is ceasing the sales of Gabet 500 mg tablet after its April stock goes out as its annual sales volume has been too low. The company explained, the supply of the medicine would be unaffected, because another product with the same agent (Jeil Pharm’s Ecat 500 mg tablet) is still available in the market. Moreover, the supply of hepatitis C treatment Viekira and Exviera imported by Korea AbbVie has been suspended since August last year. The decision was made as the company’s Mavyret with improved efficacy and better administration method has been released in September 2018. GlaxoSmithKline Korea also stopped supplying Haemophilus influenza type B (HIB) vaccine Vaxemhib from August last year. Apparently, the company has decided to shut down the manufacturing of the vaccine in Korea inevitably, due to the vaccine department’s plan to improve business efficiency and to integrate and check up production line. The company noted that even if Vaxemhib supply is suspended, an alternative option, LG Chem’s HIB vaccine Euhib, is still accessible. Jeil Pharm’s UFT-E 0.5 g granule supply has been cut as well since August last year due to the partner company’s decision to suspend supply in Korea. The company informed patient’s access to treatment would not be affected significantly as other capsule products with the same substance are available. Also, the company added it would hold on to its product license until the stock is completely out in the market and cancel it after confirming the stock-out. Supply of an original antibiotics, Finibax 0.25 g injection (doripenem monohydrate) marketed by Ildong Pharmaceutical, has been stopped from August last year. The importing company elaborated importing the product to Korea has been unfortunately ceased due to increasing deficit made by the high production cost. JW Pharmaceutical stopped importing enteral nutrition solution Encover from June last year as the Japanese manufacturer has stopped supplying the product. The Korean company has recently informed the product’s supply would resume from February. A pharmaceutical company is required to report MFDS of suspension of d any rug supply 60 days prior to the time. Apparently, the ministry is considering on disclosing the drug suspension information immediately to the public.
- Company
- BTX market new comers not bothered by legal dispute
- by Kim, Jin-Gu Jan 17, 2020 06:22am
- The Korean botulinum toxin market competition is reaching the peak. While the toxin strain related legal dispute has not yet been fully resolved, more and more companies are latching on to the market. Bio ventures, on top of the large and small-and-medium companies, have announced their plan to join the over-heated competition. On Jan. 13, Ministry of Food and Drug Safety (MFDS) cleared two botulinum toxin items, ‘Bienox’ and ‘Hitox,’ respectively from BNC Korea and BMI Korea. Founded in 2007, BNC Korea specializes in aesthetic plastic surgery medical devices like dermal filler and hyaluronic acid filler. Established in 2005, BMI Korea is the only pharmaceutical company to base in Jeju Island. It has been mainly manufacturing injections for anesthesia and pain. It seems their strategy is to first receive approval as an export product, and to win sales approval in Korea after conducting clinical trial in the future. With the export approval, the companies may export the products overseas without marketing approval in Korea. The strategy has worked for Huons, when its botulinum toxin product first got cleared for export under the name of ‘Hutox’, and received approval for Korean market later under the name of ‘Liztox.’ Including BNS Korea and BMI Korea, now 12 pharmaceutical companies have Korean government-approved botulinum toxin products. The number goes down to eight, excluding importers like Allergan, Merz and Ipsen. The rest of the list consists of Medytox, Hugel, Daewoong Pharmaceutical, Huons, Pharma Research Bio, Chong Kun Dang Pharmaceutical, BNC Korea and BMI Korea, in the order of approval date. Botulinum toxin products approved by MFDS The list expands to 18 companies if companies with botulinum toxin in development are added. All the latecomers are new bio companies, such as Jetema, Protox, Kanzen, Eubiologics, and Inibio. According to sources, Jetema has recently applied for MFDS’ export approval. The company has been approved as a pharmaceutical manufacturing company in January 2019. The purpose of the company seems to be clear and focused on manufacturing botulinum toxin products. On the other hand, Protox completed the construction of its botulinum toxin production facility in Hyangnam Pharmaceutical Industry Cluster in Hwaseong, Gyeonggi Province. The facility has a capacity to manufacture approximately 2.7 million vials a year. The company plans to conduct Phase 1 trial this year on its independently developed product, ‘Protoxin.’ Eubiologics and Inibio had their clinical trial protocols passed in March and December last year, respectively. Kanzen has registered botulinum toxin strain discovered on a snow mountain. Botulinum toxin products in development As a result, an unprecedentedly intense competition is expected to unfold in Korea. Currently, there are about three to seven global pharmaceutical companies supplying botulinum toxin products. Starting from Allergan, Ipsen and Merz, other global companies like Galderma, US WorldMeds, Revance Therapeutics and Lanzhou Bioengineering are in the game. In around 2022 and 2023, at least 14 companies would be competing against each other with 16 items according to the companies’ development plans. As blunt as it is, the competition would inevitably do more damage. The market, once led by Medytox and Hugel, has gotten saturated with Daewoong Pharmaceutical and Huons joining the market. Sources confirmed Medytox and Hugel have stopped growing already. Also the unresolved legal dispute over the source of botulinum toxin strain could be a burden for the new challengers. At the moment, Medytox and Daewoong Pharmaceutical are preceding astronomically expensive litigation on the source of botulinum toxin strain. The litigation would get close the final decision in around June. An insider of the industry commented, “Depending on the final decision, the two companies may proceed with next litigation.”
- Company
- Mabthera anticipating indication on pediatric polyangiitis
- by Eo, Yun-Ho Jan 16, 2020 03:07pm
- MabtheraPharmaceutical industry is expecting anticancer treatment Mabthera to get indicated for treating pediatric patients in Korea. The industry source reported Roche Korea has submitted an indication expansion application to Ministry of Food and Drug Safety (MFDS) for Mabthera (rituximab) to treat 2-year-old and older pediatric patient with granulomatosis with polyangiitis (GPA) and microscopic plyangiitis (MPA). The application was for intravenous administration of Mabthera, and it is expected to get cleared within this year considering general processing period. The two diseases are rare angiitis that flares up inflammation in small vessels and significantly decreases blood volume, resulting in damaging major organs like lung and kidney and affecting skin. In September last year, the U.S. Food and Drug Administration (FDA) has approved the pediatric indication for Mabthera under a priority review with orphan drug designation. The approval was based on Phase 3 study that consisted of 25 patients aged from six to 17 years with the diseases. The clinical trial observed 14 patients achieving remission after six months of Mabthera treatment, and every patient achieving remission after 18 months. During the study, infections, infusion-related reactions and nausea were the most common side effects reported. And also, patients participating in the study with pediatric GPA and MPA have been observed with hypogammaglobulinemia. Indicated not only for treating hematologic cancer, but also for autoimmune conditions like rheumarthritis, Mabthera has formed an approximately five-trillion-won market (according to IQVIA data from 2018) in the U.S. alone. Currently, the treatment has an emerging competition in the U.S. as Pfizer and Korean company Celltrion’s co-marketed biosimilar with expanding indications.
- InterView
- “Why it took 20 years for new flu drug Xofluza to be out”
- by Eo, Yun-Ho Jan 16, 2020 03:07pm
- Since the 2009 flu pandemic, Tamiflu became a prescription drug with household name like Viagra. Tamiflu (oseltamivir) is a good drug. It shifted the world’s paradigm on influenza management and became the symbol of neuraminidase inhibitor drug. However, the unmet medical needs still exist in the market. Antiviral agent can always develop resistance, but for influenza treatment, no other agent than neuraminidase inhibitor is recommended. In Korea, the influenza vaccination rate boasts a top world class level, but 2.26 million patients have been infected with influenza in 2018. After two decades since Tamiflu was commercialized, Roche has showcased Xofluza (baloxavir). The new drug has a novel mechanism of action that inhibits polymerase acidic endonuclease and treats influenza with only a single dose (Tamiflu requires a five-day treatment). Daily Pharm met with Roche’s Principal Global Medical Director, Aeron Hurt, and spoke with him about the meaning and possibility created by developing Xofluza. He used to serve as a senior research scientist at the World Health Organization (WHO) Collaborating Centre for Reference and Research on Influenza. -What was your role at WHO? And what motivated you to be interested in influenza out of all infectious disease to study? At WHO, I led a team of researchers to analyze and monitor antiviral agents and vaccine for patients with influenza. Analyzing antiviral agents and vaccines’ effect at a research center in Melbourne, Australia, I came to realize the necessity and urgency to mange influenza better and more effectively. And naturally, I got interested in and passionate about advocating the importance of antiviral agent and vaccine to effectively manage influenza. -When it comes down to ‘influenza management,’ it is divided into ‘prevention’ and ‘treatment’ blocking the viral transmission. What is your idealistic management plan incorporating the two factors? First, the National Immunization Program (NIP) has to generate the maximum effect with limited resource. Accordingly, the government could consider conducting or expanding NIP focusing on patient group with high risk of inducing complications or with possibility of optimal vaccination effect. As WHO recommends, patient groups of the highest priority for vaccination—the elderly, children, individuals at high risk of medical complications and pregnant women—should be provided with quadriavalent vaccine than trivalent vaccine for better coverage of influenza vaccination. As far as treatment goes, it is crucial to use an exceptional antiviral treatment as promptly and widely as possible when it is released. Same goes for Xofluza and other antiviral treatment to be released in the future. Instead of saving the new and effective antiviral treatment as a last resort for a pandemic, patients’ symptoms should be alleviated by treating the patient with effective antiviral from the beginning, while social and financial burden of influenza should be lowered. -It sounds like you have Xofluza in mind. Could you elaborate on the major clinical outcomes of the treatment for the readers to fathom its efficacy? Xofluza demonstrated its positive efficacy in CAPSTONE-1 study treating a healthy patient group aged 12 to 64 diagnosed with acute influenza symptoms and CAPSTONE-2 study treating patient group aged over 12 at high risk of serious flu complications. Top-line findings of CAPTSONE-1 study evaluating the flu treatment on healthy adult and adolescent, Xofluza reduced the median time to alleviation of symptoms by approximately 26.5 hours compared to the placebo group. And it also demonstrated comparatively faster cessation of infectious viral shedding than the placebo. Xofluza’s median time of viral shedding marking 24.0 hours (about a day) was meaningful, as the placebo group took 96.0 hours (about four days) and oseltamivir group took 72.0 hours (about three days). Meanwhile, the CAPSTONE-2 study evaluated the treatment’s effect on elderly patient and who are at a high risk for influenza-related complications. The study also found exceptional effect of Xofluza as its median time to alleviation of symptoms in high-risk patient group took 73.2 hours (about three days), cutting down around 29 hours from the placebo group (102.3 hours). Moreover, Xofluza reduced the time to cessation of viral shedding in 48.0 hours, which was about more than 50 percent improvement than the placebo (96.0 hours) and oseltamivir groups (96.0 hours). -In the CAPSTONE-1 study, pediatric patients aged 12 to 19 years did not receive Tamiflu. What was the reason? The study was conducted in the U.S. and Japan from December 2016 to March 2017. The reason why adolescent patients from 12 to 19 were not in the Tamiflu group was because Tamiflu was not recommended to adolescent patients in Japan when the study initiated. Currently, the limitation has been lifted. For your reference, CAPSTONE-1 study had to apply equivalent condition to all participants in the U.S. and Japan, so the U.S. participants from age 12 to 19 only received Xofluza and placebo. -The outcomes of CAPSTONE-1 does not seem to show significant difference between Xofluza and placebo arms’ time to alleviation of symptoms The time to alleviation of symptoms between two groups may not have shown exceptional difference as the evaluation of ‘symptom’ could be subjective. The severity of symptoms could differ from each individual. And a patient infected with influenza virus show cytokine response, which is induced regardless of decreased virus titer. Therefore, it would be quite difficult to reduce the time to alleviation of symptoms by 24 hours more than the available antiviral agents, despite the new antiviral agent considerably shortens time of viral shedding. The most important differences between Xofluza and existing antiviral treatment are reduced time of viral shedding and lessened risk of complications. -With Tamiflu, there was an issue with neuropsychiatric events. Was there any similar event reported from Xofluxa study? The company is closely monitoring patients who have taken Xofluza, and there has not been any report of adverse neuropsychiatric event so far. Influenza itself could affect patients in neuropsychiatric event. And also, the correlation between oseltamivir and neuropsychiatric event in treated patient has not been proven. So medical professionals should carefully consider treatment benefit and adverse reaction from antiviral treatment and prescribe Xofluza according to the patients’ individual conditions. The same applies to Tamiflu. Although there were reports of adverse reaction in Japan about a decade ago, but the Tamiflu prescription limitation has been lifted and the public’s perception has been changing as well. -The present indication for Xofluza is quite narrower than other available flu treatments. Are there any other ongoing clinical studies? A few studies have been completed, but the outcomes have not been officially announced, yet. They specifically were on post-exposure prophylaxis and pediatric patients. The prophylaxis study evaluated probability of a patient diagnosed with influenza transmitting the virus to their household members, who have been administered with Xofluza. The study result found the risk of influenza virus infection has gone down by 86 percent when administered with Xofluza. Another clinical study, MINISTONE evaluated virus titer and time to alleviation of symptoms in children aged one to less than 12. Also, there are three more clinical studies currently calling for participants. The first one is for infants younger than 12 months, whereas the second one named FLAGSTONE is evaluating the efficacy and safety of Xofluza in combination with the current standard of care, compared to the standard of care alone from hospitalised patients. The study would administer Xofluza not by single dose, but by total three times respectively on the first, fourth and seventh day of treatment. Lastly, the CENTERSTONE study is reviewing Xofluza’s effect on patient’s viral infectiousness. Unlike the previously mentioned post-exposure prophylaxis study, the treatment is administered not on the household members, but only on the patient. The study aims to not only confirm time to alleviation of symptoms, but also the infectiousness to household members. -Is there any other investigational drug in development at the moment? Xofluza blocks polymerase acidic endonuclease, an enzyme crucial for viral replication. Other candidate medicines inhibiting different enzymes are in R&D phase by other respective companies. If these investigational medicines have successful clinical trials, they would be commercialized as well. However, pharmaceutical companies, including Roche, have tried researching other mechanism of antivirus treatment like monoclonal antibody, but most of them have failed in clinical trial phase. Considering the challenges, release of Xofluza is particularly meaningful. The fact that Xofluza works in a novel mechanism of action, developed after twenty years, illustrates how the journey of developing an antiviral treatment is challenging and rough.
- Policy
- Chong Kun Dang's development of IMD is accelerating
- by Lee, Tak-Sun Jan 16, 2020 06:07am
- Chong Kun Dang is targeting the market for SGLT-2 inhibitors, a well-known drug for losing weight. Currently, MSD's original drug `` Steglatro '' is being jointly sold, and it is speeding up the development of other drugs such as Forxiga and Jardiance. In particular, post-development of Jardiance is avoiding the crystalline patent of the original drug alone, Chong Kun Dang is expected. The Ministry of Food and Drug Safety approved the Phase I study plan for Chong Kun Dang’s CKD-375 on the 24th of last month. This trial is a randomized, open-label, single-dose, cross-design trial to compare the pharmacokinetics and safety/tolerability of oral administration of high doses of CKD-375 and D390 in healthy adults. In a recent published study, the clinical reference is Jardiance Duo (Empagliflozin-Metformin). Accordingly, CKD-375 can be inferred as Empagliflozin, the main ingredient of Jardiance, and D390 can be inferred as Metformin. CKD-375 received approval for the Phase I clinical trial in last February. The trial at that time was also a randomized, open, single-dose, crossover study to compare pharmacokinetics and safety/tolerability with single doses of CKD-375 and D387, respectively, in healthy adult volunteers. Chong Kun Dang is accelerating a late-release drug of Jardiance because it seems to be due to the fact that PMS is scheduled to expire on August 11 this year. If applying for a permit at the end of the PMS, it will be the first applicant. Chong Kun Dang avoided the Jardiance crystalline patent (which is due to expire on December 14 2026) in last May as a domestic pharmaceutical company, so if it meets the conditions for the first applicant, it can obtain a generic exclusivity. A Generic exclusivity is expected to have a generic monopoly for nine months after March 11 2025, when Jardiance material patents expire. Chong Kun Dang is also in the process of authorizing the commercialization of CKD-387, another SGLT-2 inhibitor for Forxiga. Forxiga is reported to have already filed a permit application by many pharmaceutical companies after the PMS expired on last November 25. SGLT-2 inhibitors, which have a mechanism of selectively inhibiting SGLT-2, which is involved in glucose resorption in the renal glomerular filtration process, have a blood sugar strengthening and weight loss effect, and the size of the market is growing rapidly. On the basis of UBIST, cumulative prescription amount in the first half of 2019 exceeded ₩10 billion, which is a blockbuster, in the first half of the year, including ₩14.7 billion for Forxiga and ₩12.8 billion for Jardiance. Currently, only the original SGLT-2 products such as Forxiga, Jardiance, Suglat, Steglatro and Invokana are sold in Korea. Accordingly, domestic pharmaceutical companies are actively conducting patent challenge and product development in order to release generic drugs early.
