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- 2026-05-16 03:41:28
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- Prescription of oral COVID-19 drugs drop to 1,800 last week
- by Kang, Shin-Kook Jun 13, 2022 05:54am
- Prescriptions of the oral COVID-19 treatments Paxlovid and Lagevrio have been rapidly decreasing in line with the decrease of confirmed COVID-19 cases in Korea. On the 10th, the Korea Disease Control and Prevention Agency announced that it had prescribed Paxlovid and Lagevrio to 1,800 patients during the past week. From 6:30 p.m. on May 3rd to 6:30 p.m. on May 9th, 1,549 courses of Paxlovid had been prescribed to patients receiving treatment from home, at residential treatment centers, and at infectious disease hospitals. In the case of Lagevrio, another oral COVID-19 treatment, 258 courses were prescribed in the same period. Compared to two months ago when prescriptions of Paxlovid amounted to 29,746 in the week of April 11th, the 1,549 prescriptions made last week is a 1/19th decrease in just two months. As a result, 469,923 courses of Paxlovid and 78,402 courses of Lagevrio remain in stock, amounting to a total of 548,325 courses of oral COVID-19 treatments available for use in Korea.
- Policy
- Novartis' new adult leukemia drug Scemblix has been approved
- by Lee, Hye-Kyung Jun 13, 2022 05:54am
- Scemblix, a treatment for Ph+ CML adult patients, has obtained domestic permission. The MFDS approved Scemblix 20mg and Scemblix 40mg applied by Novartis on the 9th. Scemblix is used in the treatment of chronic Ph+ CML adult patients who have previously been treated with two or more TKI. The efficacy was based on MMR and Cytogenetic Response. Scemblix is taken on an empty stomach and the recommended daily dose is 80 mg. Changes in dosage are determined at the discretion of the physician according to the need for patient management. Scemblix administration should continue until clinical benefits are observed or unacceptable toxicity appears. Scemblix previously treated Ph+ CML patients and T315I mutant-expressed Ph+ CML-CP patients based on MMR at the 24th week of the U.S. Food and Drug Administration (FDA) on October 29 last year. FDA approval was based on the results from the ASC4FIRST phase 3 clinical trial and NCT02081378 phase 1 clinical trial. In this study, Scemblix was found to have improved the ratio of major molecular reactions (MRR) at 24 weeks more than twice compared to the control group, Pfizer's Bosulif.
- Policy
- The risk group for COVID-19 depression was 18.5%, down
- by Lee, Jeong-Hwan Jun 13, 2022 05:54am
- The COVID-19 depression risk group surveyed in the first quarter of this year was 18.5%, down from 22.8% in March last year. It is still high compared to 3.2% in 2019, before COVID-19, and the government plans to push for COVID-19 psychological support for daily recovery. On the 3rd, the MOHW made the announcement at a regular briefing on COVID-19. According to the COVID-19 National Mental Health Survey of 2,063 adults nationwide, the depression risk group is on the decline to 18.5%. Specifically, the risk group for depression in March 2020 is decreasing to 18.5% this year, compared to 17.5% in March 2020, 22.8% in March last year, and 18.9% in December last year. However, it is still higher than 3.2% in 2019, before COVID-19. By gender, 20.3% of women were higher than 16.7% of men. In addition, 22.7% of those whose income decreased were at higher risk of depression than 16.7% of those whose income increased or did not change. The suicide rate surveyed in March this year was 11.5%, which was also on the decline, but it was still higher than 4.6% in 2019, before COVID-19. Like the depression risk group, by age, those in their 30s (15.2%), those in their 40s (13.3%), and those in their 20s (11.9%) were high, and those in their 20s (15.2%) were high. By gender, men (12.2%) were higher than women (10.9%). Based on the results of a survey on COVID-19 depression, the MOHW prepares and promotes psychological support measures for daily recovery. According to the transition of the general medical system during daily recovery, psychological support for confirmed patients is converted from existing national and regional trauma centers to local mental health welfare centers to provide comprehensive mental health services in the local community. It also provides customized services for children, adolescents, young people, women, workers, and small business owners who are vulnerable to mental health. The MOHW said, "We will continue to promote psychological support so that government ministries and local governments can restore the people's daily lives in good health and actively support anyone who needs help."
- Company
- Hanall Biopharma to expand HL161 development in earnest
- by Chon, Seung-Hyun Jun 10, 2022 05:44am
- Hanall Biopharma announced on the 9th that its U.S. partner Imunovant will expand the development of HL161 (code name IMVT-1401), which is being developed as a SC autoimmune treatment. Phase 3 clinical trials for severe work history will begin this month and the results of the top line in 2024 will be confirmed. According to Immunovant, there are estimated to be about 66,000 patients with severe work history in the United States. Clinical plans for TED, which were suspended last year, have also been unveiled. Immunovant obtained consent from the U.S. Food and Drug Administration (FDA) for phase 3 clinical trials of HL161. Phase 3 clinical trials are expected to begin in the second half of this year and confirm the results in 2025. Imunovant also unveiled a plan to further expand the indication of HL161 to provide wider treatment options for patients suffering from intractable diseases. By August, three indications, including WAIHA, will be added and phase 3 clinical trials will be launched for one of them. HL161 is the U.S. and European development name of the new antibody drug HL161, which Hanall Biopharma exported to Roivant Sciences in December 2017. It exhibits a mechanism of action to remove pathogenic autoantibodies in the body by inhibiting the 'FcRn' receptor known as the cause of autoimmune diseases. Roivant Sciences has signed a total of $52.5 million contract with Hanall Biopharma on condition that it secures exclusive rights to develop, produce, item licenses, and sell autoimmune disease HL161 in the U.K., Switzerland, the Middle East and North Africa, including the U.S. At the time of the contract, it paid $30 million in deposit (upfront fee), which was not obligated to return, and additional $20 million in research funds and $452.5 million in step-by-step milestones (technical fees). Imunovant decided to voluntarily suspend clinical trials early last year on the grounds that a rise in total cholesterol and LDL-C levels was observed in the HL161 administration group among patients participating in clinical trials 2b. Chung Seung-won, CEO of Hanall Biopharma, said, "HL161 is expected to reduce the burden of medical expenses because it is convenient for patients to take drugs on their own in the form of subcutaneous injections." "We will continue to expand the indication of HL161 to contribute to the lives of more patients," he said.
- Company
- Exports of CKD·Dong-A ST's antianemic biosimilars increase
- by Chon, Seung-Hyun Jun 10, 2022 05:43am
- The biosimilar products developed by Chong Kun Dang and Dong-A ST are starting to make their way into the overseas market, with its Nesp biosimilars starting to generate sales in earnest abroad. Although the companies’ products did not show explosive growth upon entry, the products are increasing their presence in the market. According to the Financial Supervisory Service, Chong Kun Dang’s export sales recorded ₩19.4 billion in Q1 this year, a 57.7% increase compared to sales made in the same period of the previous year. Compared to the ₩10.6 billion it had made in Q1 2020, the scale of exports increase 82.3% in two years. In the case of Chong Kun Dang, the company’s sales had been solely dependent on domestic demand. Its exports in Q1 2019 were a mere ₩6.3 billion. Chong Kun Dang’s ‘Nesbell’ is being highlighted as the driver of CKD’s recent growth in exports. New drug products being developed by Hanmi Pharmaceutical have received a total of 20 orphan drug designations from regulatory authorities in Korea and abroad. Hanmi Pharmaceutical announced on the 9th that the European Medicines Agency granted an orphan drug designation for its new triple action biologic drug LAPS Triple Agonist (HM15211) for the treatment of Idiopathic pulmonary fibrosis (IPF). Idiopathic pulmonary fibrosis is a rare condition caused by an unknown pulmonary inflammatory process and fibroblast hyperproliferation. Patients with IPF experience a rapid decline in lung function from tissue fibrosis and even death. Although it occurs in less than 100 cases per 10,000, its treatment had been rendered difficult due to the lack of efficacy in its approved treatments. LAPS Triple Agonist is a triple-action biologic drug that activates GLP-1, Glucagon, and GIP. It simultaneously targets▲ Glucagon, which inhibits fibrosis ▲ GLP-1, which facilitates insulin secretion and helps suppress appetite, and ▲ GIP, which facilitates insulin secretion and anti-inflammatory effect. Hanmi Pharmaceutical had confirmed its drug’s antiinflammatory and antifibrotic in animal models with idiopathic pulmonary fibrosis. With the designation Hanmi Pharmaceutical received a total of 20 orphan drug designations for its 10 indications in 6 pipelines (9 FDA designations, 8 EMA designations, and 3 Korea MFDS designations). LAPS Triple Agonist received a total of 6 orphan drug designations from both the FDA and EMA for the treatment of ▲primary biliary cholangitis, ▲primary sclerosing cholangitis, and ▲IPF. The FDA and EMA grant orphan drug designations to facilitate smooth development and approval of drugs that treat rare, incurable, or life-threatening diseases. In Europe, drugs that receive the designation pay reduced fees for marketing-authorization applications and may benefit from ten years of market exclusivity once they receive marketing authorization in the European Union (EU) An official from Hanmi Pharmaceutical said, “All the indications that the drug received orphan drug designation on induces fibrosis in specific tissues and has high unmet needs. LAPS Triple Agonist’s designation has meaning in that the drug's innovativeness is receiving attention from regulatory agencies in advanced countries. Nesbell is a biosimilar of the second generation anemia treatment ‘Nesp (darbepoetin-α).’ It is prescribed to treat ▲anemia in chronic kidney disease patients and ▲anemia in patients with solid cancer who receive chemotherapy. Chong Kun Dang received marketing approval from Japan's Ministry of Health, Labor, and Welfare in September 2019. The Japanese subsidiary of U.S. global pharmaceutical company Mylan N.V. is in charge of sales in Japan. Analysts believe that the continued growth of Nesbell’s sales in Japan had driven the continued growth of Chong Kun Dang’s export in Japan. Nesbell holds great significance for the company as it is the first biosimilar that it succeeded in developing. Chong Kun Dang entered the biosimilar market after securing its own platform technology in 2008. After initiating a Phase I trial on Nesbell in 2012, Chong Kun Dang succeeded in becoming the first company to commercialize a biosimilar of Nesp by receiving marketing approval for Nesbell from the Ministry of Food and Drug Safety at the end of 2018. Nesbell is also set to enter the Middle East soon. Chong Kun Dang signed an export agreement for Nesbell with an Oman company Menagene Pharmaceutical Industries in July last year. Under the agreement, Menagene Pharmaceutical Industries will be acquiring the marketing authorization and own the exclusive rights to sell Nesbell in 6 countries in the Middle East, including Oman, Saudi Arabia, Chong Kun Dang starts supplying its finished Nesbell product to United Arab Emirates, Kuwait, Qatar, and Bahrain. The drug is also increasing its presence in the Korean market. According to the market research institution IQVIA, Nesbell’s sales last year amounted to ₩4.8 billion, which was a 150.9% YoY increase. Its sales had only been ₩0.3 billion and ₩1.9 billion in the first year of its release and 2020, respectively. Its sales has risen significantly last year to increase its market share in the same ingredient market to 18.5%. Dong-A ST’s Nesp biosimilar ‘Darbepoetin-α’ is also slowly increasing its influence in the market. After conducting a Phase 1 clinical trial on’ Darbepoetin-α,’ Dong-A ST signed a licensing-out agreement on the development and sale of its drug to Sanwa Kagaku Kenkyusho (SKK). Based on a Phase III trial conducted in Japan to compare the efficacy and safety of ‘Darbepoetin-α’ to the original ‘Nesp,’ SKK received marketing approval from Japan's Ministry of Health, Labor and Welfare for the drug in September 2019 and launched the drug for sale in November of the same year. Dong-A ST exports the finished products which were produced by DM Bio, a biosimilar company under Dong-A Socio Group, to SKK, after which SKK takes charge of its local sales. Darbepoetin-α’s exports increased 13.8% YoY to record ₩3.3 billion in Q1 this year. This is a decrease from the ₩6.1 billion made in Q4 last year, but still has been making ₩3 billion in sales every quarter. Darbepoetin-α had first made ₩1 billion in the first year of its release, which increased to ₩8.8 in 2020. Its sales then exceeded ₩10 billion in annual sales for the first time last year, recording ₩12.5 billion. Darbepoetin-α’s cumulative sales totals at ₩25.6 billion.
- Company
- Sanofi & 4 other companies will participate in NIP
- by Lee, Tak-Sun Jun 10, 2022 05:42am
- Unlike the previous year, Sanofi Pasteur is expected to participate as a new business operator and Ilyang Pharmaceutical is expected to be excluded. As a result of the bidding conducted through the Nara Market of the Public Procurement Service on the 9th, Sanofi Pasteur was selected as the first choice by writing the lowest price of 14,433. The desired quantity is 2.2 million doses.The second ranking is Korea Vaccine, which participated in 16,670 won, and the desired quantity is 1.7 million doses. The third place is Boryung Bio Pharma, which spent 16,887 won, and the desired quantity is 1.8 million degrees. The fourth ranking was GC Pharma, which offered 10,700 won, and the desired quantity was 6 million doses. Ilyang Pharmaceutical has bid 10,700 won, the same as the GC Pharma, but the desired quantity is 1.9 million doses, which is less than the GC Pharma, so it is expected to be pushed back from the priority. In this bid, the bidder until the purchase quantity reaches the lowest price among the bidders at a unit price below the scheduled price shall be the successful bidder. All five companies that participated in the bidding had lower bidding prices than the scheduled price of 10,807 won. The KCDA suggested a total of 10,665,090 doses. Looking at the desired quantity in the order of the lowest price, the three companies will easily be included in the total purchase volume, with 2.2 million doses of Sanofi, 1.7 million doses of Korean vaccine, and 1.8 million doses of Boryeong Biopharma. The combined total number of these companies is 5.7 million. The remaining quantity is about 4.96 million doses, which is expected to be taken by the GC Pharma which wants 6 million doses. Ilyang Pharmaceutical has written the same price as GC Pharma, but if there are more than two bidders of the same price, it will be pushed out of the bidding range because it prioritizes bidders with high bidding volume. However, the final successful bidder is determined according to the qualification for participation in the bid and the results of the qualification examination. However, as these companies have a lot of experience in participating in the free flu vaccination project, it is expected that the successful bidder will be determined according to the results of the ticket gate unless there is an accident. Performance of Sanofi is 22.3 billion won, Korea Vaccine, 18.1 billion won, Boryung Biopharma, 19.2 billion won, and GC Pharma, 53 billion won. Compared to last year, the supply volume is the result of an increase of about 1 million doses of green cross, 400,000 doses of Korean vaccine, and 200,000 doses of Boryung Biopharma. Sanofi, which was absent last year, will be the only foreign pharmaceutical company to participate and be selected as the top priority, and will supply the second largest quantity after GC Pharma. GSK, which supplies Fluarix Tetra PFS, a quadrivalent vaccine aid, will not participate in the NIP business again this time.
- Company
- Hanmi’s new biologic receives orphan designation in Europe
- by Chon, Seung-Hyun Jun 10, 2022 05:42am
- New drug products being developed by Hanmi Pharmaceutical have received a total of 20 orphan drug designations from regulatory authorities in Korea and abroad. Hanmi Pharmaceutical announced on the 9th that the European Medicines Agency granted an orphan drug designation for its new triple action biologic drug LAPS Triple Agonist (HM15211) for the treatment of Idiopathic pulmonary fibrosis (IPF). Idiopathic pulmonary fibrosis is a rare condition caused by an unknown pulmonary inflammatory process and fibroblast hyperproliferation. Patients with IPF experience a rapid decline in lung function from tissue fibrosis and even death. Although it occurs in less than 100 cases per 10,000, its treatment had been rendered difficult due to the lack of efficacy in its approved treatments. LAPS Triple Agonist is a triple-action biologic drug that activates GLP-1, Glucagon, and GIP. It simultaneously targets▲ Glucagon, which inhibits fibrosis ▲ GLP-1, which facilitates insulin secretion and helps suppress appetite, and ▲ GIP, which facilitates insulin secretion and anti-inflammatory effect. Hanmi Pharmaceutical had confirmed its drug’s antiinflammatory and antifibrotic in animal models with idiopathic pulmonary fibrosis. With the designation Hanmi Pharmaceutical received a total of 20 orphan drug designations for its 10 indications in 6 pipelines (9 FDA designations, 8 EMA designations, and 3 Korea MFDS designations). LAPS Triple Agonist received a total of 6 orphan drug designations from both the FDA and EMA for the treatment of ▲primary biliary cholangitis, ▲primary sclerosing cholangitis, and ▲IPF. The FDA and EMA grant orphan drug designations to facilitate smooth development and approval of drugs that treat rare, incurable, or life-threatening diseases. In Europe, drugs that receive the designation pay reduced fees for marketing-authorization applications and may benefit from ten years of market exclusivity once they receive marketing authorization in the European Union (EU). An official from Hanmi Pharmaceutical said, “All the indications that the drug received orphan drug designation on induces fibrosis in specific tissues and has high unmet needs. LAPS Triple Agonist’s designation has meaning in that the drug's innovativeness is receiving attention from regulatory agencies in advanced countries.
- Company
- Jeil and Amgen agree to co-sell PCSK9 inhibitor Repatha
- by Nho, Byung Chul Jun 10, 2022 05:42am
- Noh Sang-kyung, CEO of Amgen Korea (left), and Sung Seok-je, CEO of Jeil (right), pose after signing a joint sales contract for Repatha.Jeil Pharmaceutical (CEO Seong Seok-je) and Amgen Korea (CEO Noh Sang-kyung) announced on the 7th that they signed a joint sales contract for Repatha for patients with atherosclerosis cardiovascular disease and hypercholesterolemia as of the 1st of this month. With this joint sales contract, Jeil Pharmaceutical and Amgen Korea will conduct Repatha's sales and marketing activities at hospitals, and Jeil Pharmaceutical will be in charge of sales and marketing activities for clinics. Through Repatha's joint sales cooperation, the two companies expected synergy to provide improved treatment benefits for patients with ultra-high-risk cardiovascular systems in Korea and strengthen market competitiveness. Repatha is a PCSK9 inhibitor that lowers the reuse rate of LDL-C receptors by inhibiting the activity of PCSK9 proteins that decompose LDL cholesterol (hereinafter referred to as 'LDL-C') receptors, and obtained domestic approval in April 2017 and further adaptation to treatment of ▲ atherosclerosis in August 2018, and ▲ primary hypercholesterolemia and mixed dyslipidemia In particular, Repatha showed superior LDL-C drop effects and cardiovascular risk reduction effects in patients with atherosclerosis cardiovascular disease in a large-scale three-phase global clinical trial. In addition, a 5-year follow-up study, the longest among PCSK9 inhibitors, confirmed that the consistent LDL-C drop effect of Repatha treatment was maintained in long-term treatment. Meanwhile, ESC/EAS revised the guidelines and recommended that LDL-C targets for preventing recurrence of cardiovascular events in ultra-high risk groups of cardiovascular disease be less than 55 mg/dL, and more than 50% of the base level. CEO Sung Seok-je said, "We expect that this joint sales contract will create synergy with Amgen's innovative product/clinical data and will try to provide Repatha's clinical benefits to more cardiovascular patients." He also said, "We look forward to continuously expanding and developing cooperative relations with Amgen Korea through this contract." "Repatha is a representative product of Amgen's cardiovascular disease treatment, and based on innovative mechanisms, it provides new treatment opportunities for patients who had limitations in reducing cardiovascular risk with only existing treatment options," said Noh Sang-kyung, CEO of Amgen Korea. He said, "I hope that this joint sales contract with Jeil will deliver the clinical benefits of Repatha to more ASCVD patients and medical staff in Korea, which will serve as an opportunity for Repatha to firmly settle into a new treatment standard."
- Policy
- Govt skeptical about using existing vaccines on monkeypox
- by Lee, Jeong-Hwan Jun 09, 2022 06:25am
- The government has said that the use of licensed human smallpox vaccines, antivirals, or vaccinia immune globulin intravenous (VIGIV) to prevent the domestic outbreak of monkeypox should be carefully considered in terms of efficacy and safety. In particular, the authorities explained there is a plan to study whether the 3rd generation smallpox vaccine that is being jointly developed with a Korean pharmaceutical company is effective in preventing monkeypox. The Korea Disease Control and Prevention Agency announced so in its measure to respond to monkeypox that it submitted to the National Assembly on the 8th. Cases of monkeypox are currently arising in western countries such as the United Kingdom, Portugal, Spain, Germany, the Netherlands, and the United States. However, due to the possibility of its influx the disease control and prevention authorities are working to introduce the monkeypox vaccine ‘Jynneos’ that received marketing authorization from the US Food and Drug Administration. Jynneos is a ‘third-generation smallpox vaccine,’ while other smallpox vaccines approved in Korea are classified as ‘second-generation smallpox vaccines.’ The government is skeptical about using the approved second-generation smallpox vaccines, antivirals, and VIGIVs on monkeypox. Although the second-generation smallpox vaccines are known to be 85% effective against monkeypox, KDCA explains that no proper efficacy and safety data exists and their method of administration is too complicated. Thus it is expected that the KDCA will not seriously review the use of approved second-generation smallpox vaccines and treatments until a monkeypox case arises in Korea. KDCA said, “We currently have no monkeypox treatments or vaccines in stock. The US CDC (Center for Disease Control) is guiding the use of smallpox vaccines, antivirals, and VIGIVs to control monkeypox, but recommends its use according to new drug clinical trials.” The KDCA added, “If monkeypox outbreaks in Korea, we plan to discuss the use of VIGIVs that we have in stock as treatment with experts. Also, we are monitoring the development and supply status of monkeypox antivirals in Korea and abroad for their use.” In particular, KDCA announced that a study is being planned to evaluate whether the approved second-generation smallpox vaccine and the third-generation smallpox vaccine that is being jointly developed with a domestic pharmaceutical company show effect in preventing monkeypox. The smallpox co-developer that KDCA mentioned seems to be HK Inno.N. HK Inno.N is the only Korean pharmaceutical company that manufactures a second-generation smallpox vaccine. HK Inno.N is conducting a clinical trial to confirm the preventive effect of its second-generation smallpox vaccine against monkeypox while working to develop a third-generation smallpox vaccine. Third-generation smallpox vaccines are attenuated live vaccines that are expected to improve safety and have reduced toxicity compared to second-generation smallpox vaccines. The KDCA said, “As of now, no vaccine is being developed for the prevention of monkeypox in Korea. However, there are plans to study whether the approved smallpox vaccines and the third-generation smallpox vaccine in joint development with a Korean company is effective against monkeypox.”
- Policy
- Cases for Pre-approval of Ultomiris exceeds 100
- by Lee, Tak-Sun Jun 09, 2022 06:25am
- Soliris (left) and UltomirisThe number of approved Ultomiris administered was 101 until April. Ultomiris, a treatment for paroxysmal nocturnal hemoglobinuria (PNH), has been shown to have completely replaced Soliris, the existing treatment since its benefits in June last year. Both are expensive rare drugs, and must be approved in advance by the Board of Review and Assessment before administration. According to the HIRA on the 8th, a total of 101 cases of Ultomiris were approved in advance by April for PNH patients after their benefits in June. Soliris did not have any prior approval applications for PNH patients at this time. Ultomiris has completely replaced Soliris, at least for new patients. The prospect that Ultomiris, which has improved convenience, would replace Soliris was predicted even before Ultomiris' benefits. This is because the number of Ultomiris injections is once every eight weeks, while Soliris is once every two weeks. The number of injections decreased, so the patient levy decreased compared to Soliris. Price for Ultomiris is 5,598,942 won per bottle and price for Soliris is 5,132,364 won, which is not much different. Considering the number of shots per year, Ultomiris administration is much more economical. Alexion Pharmaceuticals, the developer of the two drugs, succeeded in transforming Soliris' patent expiration crisis into an upgraded Ultomiris. Soliris' biosimilar is about to be released. The domestic vendors of Soliris and Ultomiris are Handok. The difference in the number of pre-approval cases is also reflected in the performance. Based on IQVIA, Ultomiris' sales in the first quarter of this year were 9.6 billion won, overwhelming Soliris, which recorded 2.8 billion won. PNH is a rare blood disease caused by the destruction of red blood cells by complement, which is part of the immune system. Urine color is red, and bruising or bleeding easily occurs. It is a fatal disease in which four out of ten people die within five years if not treated after diagnosis, and requires drug administration. There are about 200 patients in Korea.
