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- 2026-05-16 01:14:09
- Policy
- President Yoon said he was grateful to the people
- by Lee, Jeong-Hwan May 11, 2022 05:55am
- President Yoon Seok-yeol said on the 10th, "I am deeply grateful to the medical staff for their respect and dedication to the people who have endured great pain in the process of overcoming the COVID-19 pandemic over the past two years." At the inauguration ceremony of the 20th president held in front of the main building of the National Assembly, President Yoon said, "We will rebuild the country as a country where the people are the true owners based on liberal democracy and market economy." In Yoon's inaugural address, "freedom" said a total of 35 times. President Yoon's ambition is to ensure the value of freedom as much as possible to make it a country where the people are the true owners and fulfill their responsibilities and roles in the international community. President Yoon insisted that the universal value of freedom should be shared as something to be done to resolve excessive collective conflicts between countries and within countries and to overcome the democratic crisis. "We must properly and accurately recognize the value of freedom," Yoon said. "We must rediscover the value of freedom. Looking back on human history, the place where free political rights and free markets were breathing has always been prosperous," he said. "If any individual's freedom is violated, even the freedom of all members of the community is threatened," he said. President Yoon said, "Freedom is by no means a winner-take-all. To be a citizen with freedom , a certain level of economic fundamentals and opportunities for fair education and access to culture must be guaranteed," he said, adding that he cannot be called a free citizen without such a thing. If someone's freedom is violated or fails to meet the conditions necessary to become a free citizen, all free citizens should help in solidarity," he stressed. "Science, technology and innovation will protect our liberal democracy, expand freedom, and sustain a dignified life," President Yoon said. "We should cooperate and unite with many countries that have achieved technological progress and innovation by respecting freedom and creativity." "We are in the 10th largest economy group in the world. Therefore, we should take an attitude as a global leader in actively supporting and defending universal international norms based on freedom and human rights values," he said. He added, "I will make sure to create a country where the people are the true masters, a country that is responsible and respected in the international community based on the values of freedom, human rights, fairness and solidarity."
- Company
- Kakao is throwing the hat into the healthcare business
- by Kim, Jin-Gu May 10, 2022 06:14pm
- Large domestic companies are throwing their hat into the healthcare business. In the past year, leading conglomerates such as Lotte, Kakao, Doosan, Hyundai Heavy Industries & Construction, GS, CJ, and OCI have formalized their entry into the healthcare market. Analysts say that Samsung and SK have succeeded in the pharmaceutical bio business one after another, stimulating these companies. ◆Lotte Biologics' pre-debut notice at "BioUSA" According to the pharmaceutical industry on the 9th, Lotte Group announced that it will attend the "BioUSA" in the U.S. in June. Lotte Biologics, which recently completed its trademark application, is expected to make its debut through BioUSA. In March last year, it became the second-largest shareholder by acquiring part of the stake in Enzychem. In August last year, Lotte Group's ESG Management Innovation Office established a new growth team (biological team) and a new growth team (health care team). Lotte Biologics, which is about to be officially launched, is known to be in charge of the CMO business of biopharmaceuticals. Lee Won-jik, a former executive director of Samsung Biologics, is said to be leading the new growth team, which will be the mainstay of Lotte Biologics. ◆ GS, CJ, Doosan, Hyundai Heavy Industries, Kakao, OCI In addition to Lotte, GS, CJ, Doosan, Hyundai Heavy Industries, Kakao, and OCI have visualized their entry into the healthcare business in the past year. GS acquired Hugel in August last year. A multinational consortium led by GS Group, APHRODITE ACQUISITION HOLDINGS LLC, signed a stock transfer contract to purchase a 46.9% stake in Hugel. The acquisition amount amounts to 1.724 trillion won. ▲ GS acquired Hugel, OCI acquired Bukwang, and CJ acquired ChunLab, signaling full-fledged entry into the pharmaceutical bio business OCI acquired Bukwang Pharmaceutical in February this year. OCI became the largest shareholder as it secured an 11% stake in Chairman Kim Dong-yeon, founder of Bukwang Pharmaceutical. It is interpreted as a signal that it will enter the pharmaceutical bio business in earnest. At this year's general meeting of Bukwang Pharmaceutical's shareholders, Lee Woo-hyun, vice chairman of OCI, became co-CEO of Bukwang with the existing CEO Yoo Hee-won. CJ officially launched CJ Bioscience under CJ group in January this year. CJ Bioscience selected Microbiome as its core business. To this end, it acquired ChunLab, a microbiome company, in October last year. CEO Chun Jong-sik, who led ChunLab, will continue to represent CJ Bioscience. Kakao newly established 'Kakao Healthcare' in March. Healthcare CIC, which was previously operated as an in-house independent corporation, was separated into separate corporations. Prior to this, Hwang Hee, a professor at Seoul National University Bundang Hospital, who was recruited in December 2021, was appointed. Kakao Healthcare is expected to focus on digital healthcare businesses such as AI-based medical solution development and service industry, health care by life cycle, and smart medical care. Doosan added a medical device business to its business area through the revision of its articles of association at a shareholders' meeting held in March this year. Doosan is planning to target the biopharmaceutical container market. In December last year, it invested $100 million in SiO2, a U.S. drug storage container company. At the same time, it secured exclusive business rights in Asia and Oceania for all SiO2 products. It is planning to start manufacturing in South Korea in the future. Hyundai Heavy Industries Holdings, the holding company of Hyundai Heavy Industries Group, changed its name to HD Hyundai at a shareholders' meeting in March this year and announced plans to support four future industries, including healthcare. Hyundai Heavy Industries Holdings established 'AMC' last year and is also developing new drugs. In the pharmaceutical industry, it is interpreted that the success of Samsung and SK, which entered the field first, served as a stimulus to large companies' entry into the bio business. Samsung Biologics, SK Bioscience, and SK Biopharm, affiliates of the two groups, have become leading companies in the industry before and after the Corona crisis. Large domestic companies began the pharmaceutical bio business with enthusiasm in the past, but withdrew one after another in the mid-2010s. Lotte Pharmaceutical was launched in 2002 when it acquired a subsidiary of Ilyang Pharmaceutical's health functional food. However, in 2011, Lotte Pharmaceutical was merged into Lotte Confectionery and withdrew from the market. In 2014, CJ spun off CJ Healthcare as a separate subsidiary of the pharmaceutical division, driving the pharmaceutical bio business. However, it sold its 100% stake in CJ Healthcare to Kolmar Korea for 1.31 trillion won in 2018. Hanwha established the pharmaceutical business department in 2996 and launched Dream Pharma by absorbing and merging H-PHARM in 2004. Although it made a large-scale investment to develop a biosimilar of Enbrel, a TNF alpha inhibitor through Dream Pharma, it eventually sold Dream Pharma to Alvogen in 2014 as product development was delayed and related contracts were terminated. AmorePacific sold its subsidiary Pacific Pharmaceutical Co. to Handok in 2013 to focus on its beauty business.
- Company
- Koselugo reattempts insurance benefit in neurofibromatosis
- by Eo, Yun-Ho May 10, 2022 06:07am
- The neurofibromatosis treatment Koselugo is once again making an attempt to receive insurance benefits in an area that has no available treatment options, According to industry sources, AstraZeneca has applied for the insurance reimbursement of its new neurofibromatosis drug Koselugao (selumetinib) recently. Koselugo is indicated for ‘the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in pediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and above.’ After the drug received a non-reimbursement decision by the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service in March, the company has been working to promptly prepare the supplementary data to restart listing discussions for the drug. As NF1 is a rare disease area with no available treatment option, whether Koselugao will be able to receive reimbursement approval this time remains to be seen. Until now, patients had to rely on symptomatic treatment for neurofibromatosis due to the lack of an appropriate treatment option. Neurofibromatosis is a rare disease, and 85% of the patients with neurofibromatosis have neurofibromatosis type 1 (NF1), which is caused by a mutation in the neurofibromin tumor suppressor gene located on chromosome 17. The incidence of NF1 is approximately 1 in 3,000. Its first symptom is café-au-lait spots 1 to 3 centimeters in diameter early in life. Since then, the patients experience Optic nerve gliomas (brain tumors) at age 6, and scoliosis around age 6-10. In adulthood, lisch nodules, or iris hamartomas, occur predominantly in patients with NF1. If possible, treatment includes surgical removal of affected sites or chemotherapy and radiation therapy. However, most recur even after surgery, and as the patient must undergo a major operation, its treatment puts an immense burden on both the medical staff and the patient. Recurrence is even more frequent among pediatric patients, which means the patients must live with painkillers and often suffer from speech and movement disorders even after receiving several operations. Meanwhile, Koselugo was jointly developed by AstraZeneca and MSD. The drug blocks the activation of MEK to inhibit the growth of cell lines. The Phase II SPRINT study that became the basis for Koselugo’s approval showed that Koselugo reduced tumor size by over 20% in 68% of the patients that received Koselugo and achieved its primary endpoint of ORR. Also, 82% of the patients that showed a partial response had sustained responses lasting at least 12 months. Contrary to non-treated patients, half of which experience disease progression 1.5 years after diagnosis, only 15% of patients using Koselugo showed disease progression at year 3.
- Company
- Powder-type child antipyretic analgesics have been released
- by May 10, 2022 06:07am
- Johnson & Johnson Korea (CEO Baek Joon-hyuk) announced on the 9th that it has released the first powder-type children's antipyretic painkiller Children's Tylenol powder 160 mg in Korea. Children's Tylenol powder has various effects such as headache, neuralgia, muscle pain, sprain pain, menstrual pain, toothache, and joint pain, as well as fever and pain caused by a cold, so it can be widely used for fever and labor. The new product with the unique technology of Tylenol, an original Acetaminophen product, is a fever reducer of "powder formulation" that relieves the discomfort of liquid and syrup types and improves the convenience of taking pills for consumers who are unable to swallow them. As soon as the powder touches the tongue, it melts immediately in 23 seconds, so it can be taken without water, and it is easy to carry in the form of a stick pouch. It can be eaten quickly and comfortably with a small amount, so the packaging material can be used hygienically without touching the mouth. Children's Tylenol powder has both taste and effect with its special coating. The special coating of Ethyl cellulose in children's Tylenol powder prevents the bitter taste of Acetaminophen from the tongue. Wild berries and natural berries make it easy for children who had difficulty taking medicine without feeling repulsed. Parents who had to watch their children refuse the medicine for reasons such as taste, formulation, and dosage will be able to provide new options to save them the trouble of taking the medicine. The age of taking is children aged 7 to 12 years old (can be taken by elementary school students with a weight of more than 23kg), and the recommended dose is taken directly every 4-6 hours without water. It should not be taken more than 5 times a day (75 mg/kg). It is sold at pharmacies based on 12 bags per product, and if you need to divide it separately, it is recommended to fold the pouch and divide it into small quantities such as measuring cups or spoons provided at home. "Children's Tylenol Powder is the first powder-type new product in Korea that can meet needs for young children who have difficulty swallowing pills or children who are too big to eat syrup, in the form of 15mg powder per packet," said Kim Hanna, a group manager at Johnson & Johnson's self-care division. She said, "At this point when the risk of children's COVID-19 infection continues, child Tylenol powder is expected to function as a home remedy for more convenient management of fever pains for the whole family."
- Company
- Sales of generic for Galvus are not affected
- by Kim, Jin-Gu May 10, 2022 06:07am
- A reversal occurred once again in the patent dispute for the DPP-4 inhibitor-based diabetes treatment Galvus. The original signing Novartis won the remand hearing that took place after the Supreme Court's dismissal. The pharmaceutical industry believes that the decision will not have a significant impact on sales of generic for Galvus, which was released earlier this year. This is because the material patent in question expired during the dispute. According to the pharmaceutical industry on the 4th, the Korean Intellectual Property Tribunal overturned the previous ruling in a lawsuit to invalidate the extension of the duration of the material patent of Vildagliptin and decided to win Novartis. The Galvus patent dispute has been complicated by the reversal. Ahngook and Hanmi filed a trial in 2017, claiming that some of the extended duration of material patent of Galvus was invalid. In the first trial, Generic companies won. In 2019, the Patent Tribunal ruled that 187 days of the extended duration were invalid. Novartis won the second trial. In 2020, the Patent Court ruled that 55 of 187 days were invalid. The case went to the Supreme Court on Novartis' appeal. In October last year, the Supreme Court ruled against the company and sided with the company. It was a ruling that Novartis, which won the second trial, was not eligible to appeal. The case was dealt with in the first trial. In the end, the Patent Tribunal took Novartis' side. Even 55 days recognized by the patent court did not constitute invalidity. However, the pharmaceutical industry predicts that there will be no problem with the sale and prescription of generic for Galvus even with the Korean Intellectual Property Tribunal's decision. This is because the material patent expired during the dispute. The Galvus material patent expired on March 4. Hanmi Pharmaceutical, Ahngook Pharmaceutical, Angooknewpharm, Kyongbo, Korea United Pharmaceutical, Samjin, and Shin Poong then released the generic. Hanmi Pharmaceutical, which launched Vildagle as generic for Galvus in January this year, is also determined to continue marketing and sales of its products as usual. An official from Hanmi said, "The material patent of Vildagliptin has already expired on March 4, and there is no impact on the distribution, sale, and prescription of the previously released Vildagle. We plan to appeal to continue to focus the company's capabilities for the success of Vildagle."
- Product
- Unsure efficacy of Alzheimer's drug aducanumab
- by Choi-sun May 10, 2022 06:07am
- The Korean Dementia Association has reviewed the clinical potential of aducanumab (Aduhelm), the first new drug for Alzheimer's disease to be introduced to the field in 18 years. With the efficacy of the drug under constant debate, and being barely approved for its effect in reducing surrogate biomarkers such as amyloid reduction in Korea and turned down in Europe, KDA’s position is that verification over time is required to confirm the drug’s actual effect. On the 16th, KDA held its KDA Annual Fall Conference at the Baekbeomgimgu Memorial Hall. At the event, held a panel discussion session with 4 members including KDA Chair Dong-Won Yang and KDA President Ae Young Lee. In June 2021, the US FDA granted conditional approval for aducanumab as a treatment for Alzheimer’s. Aducanumab, which is a monoclonal antibody developed to target the mechanism of Alzheimer’s Disease, had become the first new drug to be approved for Alzheimer’s since 2003. As abnormal accumulation and aggregation of beta-amyloid plaques are reported in the brains of patients with Alzheimer’s, the widely-accepted theory in the field was that these protein buildups (plaques) generate neurotoxins and gradually deteriorate the cognitive function of the brain. Aducanumab was developed to remove this plaque, and although it is not a cure, its effect in was in slowing down cognitive decline in patients was recognized. But still, there is an ongoing debate on whether the drug is ‘clinically effective’ in academia, including among FDA’s internal advisors. As the drug failed to demonstrate efficacy in the clinical trial that used the change from baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) as the scale, experts judged that it is difficult to definitively acknowledge the drug’s effect only with the surrogate endpoint that demonstrated reduced amyloid accumulation. Fully aware of such controversy during its review, the FDA had set a condition upon approval that Biogen will have to conduct post-approval studies to verify the treatment’s anticipated clinical benefit in addition to the amyloid PET results. However, the EMA refused to grant marketing authorization for the drug. Through a statement, KDA had announced, “Despite much controversy, approval of aducanumab is in itself encouraging news for patients, clinical doctors and researchers in the field,” and stressed that the association will make efforts to rigorously verify the drug’s effect with science in the future to members while sharing relevant information. The panel discussion also focused on whether the amyloid plaque removal mechanism translates to real clinical efficacy. Jae Hong Lee, Professor of Neurology at Seoul Asan Medical Center, said, “As the drug wasn’t able to reach the primary efficacy endpoint of the trial, it is difficult to readily embrace the FDA's approval result. However, I believe the FDA approved the new drug despite headwinds as the promise of a cure with new drugs in development is a long way off. Lee added, “Considering the strict standards that have been applied to new drugs for Alzheimer's disease so far, the drug was difficult to be approved. To some, the CDR-SB improvement in patients who were administered the 10mg high-dose over 14 times in the post-analysis may seem far-fetched.” “Results show only 0.1% of the patients passed the final clinical review. This is an unconventional and proactive attitude on the FDA’s part when considering FDA’s traditional approval standards. In the ENGAGE trial, the drug failed to demonstrate its clinical efficacy but demonstrated a reduction in biomarkers, therefore, whether the improvement in biomarkers will bring clinical effect needs to be seen,” said Lee, warning caution over overinterpretation of the trial results. In other words, although clinical improvement can be expected due to the reduced biomarker effects demonstrated by amyloid and tau protein, Lee believes the time is needed to verify the efficacy of the drug. KDA Chair Dong-Won Yang said, “It is quite interesting that the drug continued to reduce amyloid plaques and tau in up to 1 and 2 years after high-dose administration. We need to recognize its effect in removing amyloid plaques.” Sang-Yoon Kim, Professor of Neurology at Seoul National University Bundang Hospital said, “The drug does have an amyloid reduction effect, but its clinical effect may differ by months. Also, the tau protein reduction was observed, but due to the small number of patients, we would need to wait longer to observe its actual effect," he said. KDA President Ae Young Lee limited the drug’s utility in terms of its side effects. ARIA (amyloid-related imaging abnormalities) more commonly occurred in the aducanumab administered group (43%). In addition, ARIA-E occurred in about 50% of the 7th dose and 90% of the 12th dose of aducanumab. President Lee said, “With over 40% of patients administered the high-dose experiencing ARIA, observation according to administration period and the number of doses will be needed. As the occurrence rate differs by up to 7 times in ApoE E4 carriers, we need to play caution in using the drug for treatment.” Professor Kim said, “ Patients were recruited under very strict standards for the clinical trial, to the extent that patients with other diseases were excluded from the trial. This is very different from the characteristics of patients in the actual clinical environment. As there is a possibility of side effects in case patients have heart conditions or other diseases, a guideline for its administration needs to be set.” Kim added, “Since the effect has been confirmed in a specific patient group in the trial if the drug is introduced in Korea, we would also need to strictly select a patient group in consideration of the side effects and effects in line with the clinical trial. We need to leave the decision on whether to administer the drug at the discretion of each clinician,” However, considering the current treatment environment in which there is no suitable new drug, most HCPs have shown a positive response to ‘making an attempt’ with aducanumab. The larger issue is its price, which costs tens of millions of won. Professor Lee said, “Price of aducanumab fell from the ₩65 million early on to ₩25-30 million currently. If the price becomes more reasonable, I plan to attempt administering the drug to patients who are less likely to develop ARIA and see an effect. Chair Yang said, “I believe the drug may be of help as I've seen many patients whose condition deteriorates with amyloid accumulation. It would be great if we can use the drug in the early stages of the disease, but we need to gradually increase the dose with continuous MRI monitoring due to the possibility of ARIA."
- Company
- The diagnosis of rheumatoid arthritis has been activated
- by Eo, Yun-Ho May 09, 2022 06:04am
- The treatment environment for rheumatoid arthritis has improved significantly. As the diagnosis became accurate, it increased, and the application of the new drug developed greatly. Recently, the number of patients has been steadily increasing every year as the diagnosis of rheumatoid arthritis has been activated in Korea. The HIRA updates disease statistics last year at the end of April every year. Recently confirmed and found that the number of patients with rheumatoid arthritis in 2021 was about 131.68 million, an increase of more than 25% over five years compared to 104,354 in 2016. Rheumatoid arthritis is an autoimmune disease in which the immune system attacks joint tissue, causing inflammation and pain, causing joint damage, dysfunction, and painful swelling. Early treatment is known as a disease that can be managed by positively improving the patient's prognosis. In the past, diagnostic criteria were diagnosed as rheumatoid arthritis if more than four of the seven symptoms, such as morning stiffness or osteoarthritis of the hand. This criterion was useful as a method for diagnosing rheumatoid arthritis, which has already progressed a lot, but it was pointed out that it was not suitable for early diagnosis. However, in 2010, ACR and EULAR set a new standard for diagnosing rheumatoid arthritis if the number of joint invasion, the results of rheumatoid factors and anti-CCP antibody tests through blood tests, the increase in inflammation levels, and the duration of symptoms are scored. This was a turning point in quickly and accurately diagnosing rheumatoid arthritis. An official from the association said, "It is understood that rheumatoid arthritis is being diagnosed well compared to the past due to the recent continuous development of diagnostic methods and the increase in disease awareness. However, there are patients who do not know the disease well yet and do not receive proper treatment, or who need pain improvement even if they receive treatment," he said. In fact, since bony erosion occurs in about 60-70% of rheumatoid arthritis within two years of the outbreak, rapid diagnosis and drug treatment are important to prevent the progression of the disease. However, there are still patients with poor treatment prognosis, so more diverse treatment options are required. In an overseas meta-analysis study of about 80,000 patients with rheumatoid arthritis, the rate of achieving remission was found to be only about 20% despite biological two-year treatment. As time goes by, various drugs are introduced, creating a smooth treatment environment. The latest treatments, such as biological drugs and JAK inhibitors introduced since the 2000s, are showing effects on patients who lack treatment effects with existing treatments or have difficulty improving symptoms. Among them, the most recently introduced JAK inhibitors show significant results in clinical remission, pain, and improvement of body function. Although these drugs differ slightly, they show significant improvements compared to anti-TNF drugs in the rate of reaching various criteria. "With the recent introduction of accurate diagnostic standards and new drugs, the treatment environment for rheumatoid arthritis has been dramatically improved. As it is possible to achieve and improve pain through the introduction of continuous treatments such as JAK inhibitors, if you have symptoms of rheumatoid arthritis, please visit the rheumatoid internal medicine immediately for an accurate examination.
- Company
- “Will become a CRO specializing in cell·gene therapy”
- by Lee, Tak-Sun May 09, 2022 06:04am
- Director Eun-Kyung Sohn, HCO at Seoul CRO “I believe the cell·gene therapy market will expand the greatest among biopharmaceuticals. The number of new clinical trials entering the field increased over threefold from 2016, and the role of CROs that have strengths in conducting clinical trials for cell· gene-based therapies will further increase in the coming future.” Director Sohn explained her vision of growing the company into a cell·gene therapy specialized CRO in line with the industry trend. Director Eun-Kyung Sohn, HCO (Head of Clinical Operation·46) at Seoul CRO, joined the company in December last year. Sohn aims to find a breakthrough in the midst of the intensifying competition in the CRO market by developing Seoul CRO’s own area of expertise. In an interview held at Seoul CRO’s Gangnam office, Sohn relayed the company’s vision for growth into a cell·gene therapy specialized CRO. Director Sohn is a seasoned veteran that has over 20 years of experience accumulated in various prominent CROs in Korea, including Dream CIS and C&R Research. During her previous work at QVIS, Sohn was in charge of general project management for bioventure companies. Sohn said, “Bioventure companies are highly dependent on CRO companies due to their weak clinical infrastructure, and I was in charge of providing consulting, management, and training for our clients that contracted their research to the company.” Sohn’s career in the field fits will with Seoul CRO’s direction in attracting more cell·gene therapy venture companies for research. After joining Seoul CRO, Director Sohn has been in charge of the overall management of CRO-related clinical tasks that were by the pharmaceutical and bio company clients. Seoul CRO’s plan to become a cell·gene therapy specialized CRO reflects the company’s strategy to embrace the market situation while incorporating the company’s strengths. Sohn said, “With the number of CROs increasing recently, I believe each CRO should have a specialized area of expertise rather than cover all services. Seoul CRO aims to attract bioventures, especially those that develop cell·gene-based therapies.” Seoul CRO is part of the CHA Medical & Bio Group. The group has companies that specialize in the development of cell therapy products, including CHA Biotech. It also has hospitals that can actually conduct clinical trials for contracted cell therapy products. Seoul CRO plans to fully utilize its internal infrastructure and actively conduct clinical trials related to cell therapies. "The CHA Bundang Medical Center of the CHA Medical & Bio Group has a Global Stem Cell Clinical Trials Center that offers a one-stop service from incubation to administration for more effective cell therapy trials. We plan to utilize such strengths to attract and conduct more clinical trials.” The company is also preparing to establish a logistics system for cell·gene therapies. Sohn said, “Unlike general chemical drugs that can be transported at room temperature, logistics is a sensitive issue for cell therapies as these drugs are sensitive to temperature and have time constraints, requiring rapid transport before entering clinical trials." "This is why logistics is a sensitive and important issue from the client’s perspective, and why we are planning to set a separate department dedicated to cell and gene therapies with logistics companies." The company will also strengthen training in related areas. Seoul CRO will provide training to its employees for accurate understanding and application of relevant clinical laws and guidelines, and hold seminars in cooperation with affiliate hospitals for its external clients. Seoul CRO has accumulated a broad range of clinical experience in biopharmaceuticals, managing over 40 clinical cases including those for antibody treatments, protein drugs, vaccines, and cell therapies. The company has the most clinical experience in cell therapies, with experience accumulated from 16 cases. The company plans to further strengthen its existing strengths while specializing in cell and gene therapies. Seoul CRO also has strengths in medical devices and post-marketing clinical trials. “We plan to expand our scope to the global market in the mid-to-long term in the growing field of post-marketing clinical trials. Seoul CRO focuses on providing customer-oriented communication and service, and owns specialized vendors and the internal infrastructure to provide consulting and clinical trial-based services for the whole cycle from early stages of development to post-approval marketing strategies.” “It is important to have the expert personnel and infrastructure to conduct clinical research for cell and gene therapies. Bioventures will look for CROs that own such infrastructure and networks, which makes it ever more important for local CROs to be equipped with such competitivity." “After serving over 20 years in this field, I believe I acquired a good understanding of what is desired and needed by the clients. In essence, the mindset of taking responsibility into my own hands until the end is important. I plan to incorporate this into my work at Seoul CRO.”
- Company
- Companies reattempt to avoid Dukarb's patent in 2nd trial
- by Kim, Jin-Gu May 09, 2022 06:03am
- Companies that have failed to challenge the patent of Boryung’s antihypertensive combo drug ‘Dukarb (fimasartan+amlodipine)’ are continuing on their challenge with a second trial. As the companies are also working to invalidate the patent apart from the trial being conducted to avoid the patent, this two-track challenge on a single patent is expected to continue on for a while. According to industry sources on the 6th, Arlico Pharm, Hutex Korea Pharmaceutical, Shinpoong Pharm, and Hana Pharm filed an appeal against a ruling to the Patent Court of Korea. In other words, the four companies are taking the matter to the next trial, dissatisfied with the ruling of defeat given to them in the first trial. Around 40 companies are currently challenging Dukarb’s patent and can be divided into 4 groups: One group centered around Arlico Pharm; the DongKoo Bio&Pharma group; the Navipharm group; and the Genuone Sciences group. Since March. the four groups had filed a passive trial to confirm the scope of patent on Dukarb’s combination composition patent, one after another. Only Arlico Pharm’s group received a ruling in the first trial. The Intellectual Property Trial and Appeal Board ruled in favor of the original company, Boryung Pharmaceutical. Although the ruling hasn’t been made yet for the other generic companies, as the IPTAB conventionally makes similar rulings on the same cases, the industry forecasts defeat for the other groups as well. In this situation, the Arlico Pharm and others group has decided to continue its challenge with a second trial, forewarning a prolonged dispute. The other groups that lose their first trial in the future are now also highly likely to continue on their challenge in the second trial, just like Arlico Pharm. Apart from the trial being conducted to avoid Dukarb’s patent, the Arlico Pharm and others group is also attempting to invalidate Dukarb’s patent. In other words, the group is targeting the same patent in two ways (avoidance·invalidation). Other generic companies are also considering filing invalidation trials on Dukarb’s patent. Currently, 27 companies have filed invalidation trials against Dukarb’s patent besides Arlico Pharm. Dukarb’s patent is set to expire in August 2031. If the companies succeed in evading or invalidating the drug’s patent, generic versions of Dukarb can be released early on, as soon as Dukarb’s single-agent ingredient Kanarb’s substance patent expires in February next year. Dukarb is an antihypertensive combination drug that contains the antihypertensive ingredient fimasartan (Kanarb) which was developed by Boryung Pharmaceutical, and amlodipine. According to the market research institution UBIST, Dukarb’s prescriptions recorded ₩41.1 billion last year, a 14% increase YoY compared to the ₩36.1 billion in 2020.
- Company
- GLP-1 diabetes drugs are being released one after another
- by May 09, 2022 06:03am
- Novonodisc is expected to change the market for type 2 diabetes treatment as GLP-1 similarity products are released one after another. Novonodisc received domestic approval for Rybelsus (Semaglutide) on the 2nd following Ozempic on the 28th of last month. Ozempic is a long-lasting injection administered once a week, and Rybelsus is a drug that has changed it to an oral drug. Ozempic is expected to emerge as a strong competitive drug for Eli Lilly Trulicity, which currently dominates the GLP-1 analog market. Trulicity is a injection once a week that monopolizes the GLP-1 similarity market worth 50 billion won in Korea. According to IQVIA, a pharmaceutical market research firm, Trulicity posted 49.9 billion won in sales out of 50 billion won in the total GLP-1 similarity market. Trulicity replaced all GLP-1 analogs that had to be administered daily. Sanofi Lyxumia and AstraZeneca Byetta have been withdrawn from the market. Novonodisc's Viktoza only sold 200 million won. Unlike Trulicity, Ozempic has indications for reducing the risk of cardiovascular events. This indication is based on the SUSTAIN 6 study among Ozempic's eight SUSTAIN clinical studies. As a result of conducting clinical trials on 3,297 type 2 diabetes patients with cardiovascular disease or cardiovascular risk factors, the Ozempic group reduced the risk of major cardiovascular events (MACE) compared to the placebo group by 26%. Not only the United States but also domestic academic societies recommend GLP-1 analogs or SGLT-2 inhibitors that have confirmed cardiovascular benefits when choosing type 2 diabetes drugs, so the Ozempic's sa;es is expected to rise further. The world's first oral GLP-1 analog Rybelsus will then join, and changes are expected in the market for oral diabetes treatments such as DPP-4 inhibitors. Rybelsus can be used as a dietary and exercise supplement to improve blood sugar control in adults with insufficient control of type 2 diabetes. It is taken once a day, and there is no need to control the dosage of drugs in patients with renal or hepatic dysfunction or in the elderly. Oral drugs such as DPP-4 inhibitors and SGLT-2 inhibitors are commonly used as many patients are reluctant to inject injections such as insulin and GLP-1 analogs when treating type 2 diabetes. Based on the drug market research agency UBIST, the amount of DPP-4 inhibitor prescriptions reached 151.2 billion won last year. The prescription amount for SGLT-2 inhibitors is around 40.2 billion won. Rybelsus demonstrated superior glycemic effectiveness over SGLT-2 inhibitors and DPP-4 inhibitors through global clinical study PIONEER. In PIONEER 2, 822 patients with type 2 diabetes whose blood sugar is not controlled by metformin were compared with the SGLT-2 inhibitor Empagliflozin group. At 26 weeks, the Empagliflozin group had a 0.9% decrease in glycated hemoglobin levels, while the Rybelsus group had a 1.3% decrease. Subsequently, in a PIONEER 3 study comparing Rybelsus and DPP-4 inhibitor Sitagliptin in patients whose blood sugar is not controlled by combination administration of Metformin and Sulfonylurea, the glycated hemoglobin level in the control group decreased by only 0.8% at 26 weeks. In the Empagliflozin group, glycated hemoglobin levels decreased by 0.9% compared to the baseline, while in the Rybelsus group, they decreased by 1.3%. Subsequently, in a PIONEER 3 study comparing Rybelsus and DPP-4 inhibitor Sitagliptin in patients whose blood sugar is not controlled by combination administration of Metformin and Sulfonylurea, the glycated hemoglobin level in the control group decreased by only 0.8% at 26 weeks. Even globally, Rybelsus is emerging as an emerging competitive drug. Rybelsus, which was released in more than 20 countries starting with the U.S. in September 2019, posted sales of 867.2 billion won last year. Immediately after its launch, it slowed down due to the COVID-19 pandemic, but it quickly increased sales by aggressive marketing last year. Rybelsus is expected to change depending on the price of Rybelsus and the results of CVOT confirming the ongoing cardiovascular benefits.
