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- 2026-03-19 01:38:07
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- Alvogen Korea secures domestic rights for Seroquel
- by An, Kyung-Jin May 25, 2020 06:26am
- Alvogen Korea took over the domestic rights of the drug 'Seroquel' (Quetiapine), a treatment for schizophrenia. Alvogen Korea announced on the 21st that it has signed an exclusive distribution and marketing contract for 'Seroquel' and 'Seroquel XR' with Luye Pharma in China, and approval of the domestic license has been completed. Seroquel and Seroquel XR are atypical antipsychotic drugs with antidepressant properties. It is used alone or in combination therapy to treat schizophrenia and bipolar disorder. During the drug investigation period, the total sales of Seroquel last year were ₩12.9 billion, based on the IQVIA. Alvogen Korea has been supplying Seroquel and Seroquel XR to the domestic market since 2015 through exclusive domestic sales contracts with Astrazeneca Korea. Astrazeneca sold two products to Luye Pharma in 2018, and this agreement will allow Alvogen Korea to secure all rights to the license, exclusive distribution and marketing in Korea. Alvogen Korea plans to strengthen its position in the central nervous system (CNS) treatment market. Lee Jun-su, CEO of Alvogen Korea, expects stable and continuous growth in the market while securing expertise in the area of central nervous system treatment with this agreement. He said the company will try to contribute to improving the treatment of patients suffering from the spread of COVID-19.
- Company
- Qsymia puts a brake on Saxenda in Q1 obesity drug market
- by An, Kyung-Jin May 22, 2020 06:17am
- Product images of Saxenda (left) and Qsymia The Korean obesity treatment market has fluctuated significantly in the year. The so-called ‘Gangnam Diet Injection,’ Saxenda lost its solid market leadership and now shares the top spot with Qsymia. Saxenda’s sales has halved as soon as Qsymia entered the market and took over a significant part of it. On May 20, pharmaceutical market research firm IQVIA reported the Korean obesity treatment market in the first quarter showed noticeable changes among the top sellers. In the first quarter of 2020, Novo Nordisk’s Saxenda has generated 5.9 billion won, decreased by 44.4 percent against the same time last year. Launched in March 2018, Saxenda has made over 10 billion won in the first quarter last year and has been easily leading the market until the fourth quarter last year. But now its top spot is challenged by a new comer taking away half of its sales in a quarter. Quarterly sales performance of top selling anti-obesity treatments in Korea (Unit: KRW 1 million) Source: IQVIA Saxenda (liraglutide 3.0 mg) is the world’s first glucagon-like peptide-1 (GLP-1) receptor agonist approved as an obesity treatment. GLP-1 hormone, naturally secreted in human body after food intake, binds to receptors in the hypothalamus and reduces hunger while increasing the feeling of satiety. Saxenda shares the same substances as a treatment prescribed to patients with type 2 diabetes, Victoza (liraglutide 1.8 mg), but they differ in dose and administration method. Working in the same mechanism as GLP-1 in human body, liraglutide lessens appetite and induces weight-loss effect. Saxenda’s promising market leadership was crippled when Qsymia stepped into the Korean market in last January. In only three months, Qsymia generated 4.3 billion won in the quarter and ranked itself on the second place. The narrow sales gap between the two is 1.6 billion won. The newly launched drug sold more than double the amount of Daewoong Pharmaceutical’s Dietamin, which used to come in second after Saxenda until the fourth quarter last year. In 2017, Alvogen Korea shook hands with the U.S.-based Vivus and won the sales and marketing right over Qsymia (phentermine hydrochloride plus topiramate) in Korea. At the end of last year, Alvogen Korea also signed a co-marketing deal with Chong Kun Dang and started their first sales and marketing activity from early this year. Alvogen Korea’s rich experience in the anti-obesity medication market gained through Furing and Furimin seems to have been boosted by Chong Kun Dang’s massive sales power. Besides Qsymia, other obesity drugs generally showed stagnating performance. Except for Alvogen Korea’s Furimin, products with average quarterly sales of 1 billion won have slipped in the first quarter compared to the previous quarter. Furimin’s sales have increased by 15.7 percent in the first quarter against the same time last year by making 1.0 billion won. On the contrary, Daewoong Pharmaceutical’s Dietamin generated 2.2 billion won in the first quarter, taking 4.6 percent dip compared to the same time last year. Huons’ Hutermin (1.4 billion won) and Alvogen Korea’s Furing (1.2 billion won) have also made 0.2 percent and 3.8 percent less than the year before. The anti-obesity medication market was expecting a fierce competition as Belviq that used to make 10 billion won a year was removed from the shelf due to cancer risk. Regardless, the COVID-19 outbreak and Qsymia have put a hard brake on other products in the market.
- Company
- MOHW-KRPIA meeting canceled as confirmed COVID-19 reported
- by Eo, Yun-Ho May 22, 2020 06:16am
- A confirmed case of COVID-19 was reported from Twin City Namsan building that houses the office of Korean Research-based Pharmaceutical Industry Association (KRPIA). Accordingly, the meeting originally scheduled on May 21 to convene Ministry of Health and Welfare (MOHW) Division of Pharmaceutical Benefits officials and KRPIA and multinational pharmaceutical companies’ market access and government affair executives have been canceled. KRPIA sent back their employees home and started working from home immediately after they received the news. The recently appointed Director Yang Yoon Seok of Pharmaceutical Benefits Division was supposed to meet with KRPIA officially for the first time. Deputy Director Choi Kyung Ho was to accompany Director Yoon to hear the industry officials’ opinion and discuss prospective approach of the drug pricing policy. The industry organization official commented, “It is regrettable the meeting with MOHW official had to be canceled due to an unfortunate circumstance. KRPIA was planning to talk about recommendations on the revised risk sharing agreement (RSA) and the pricing reduction on original product undergone corporate restructuring. We have agreed to reschedule the meeting soon.” The confirmed case has reportedly came into office until May 19, but went into a self-isolation after finding out on May 20 that the individual came in contact with other confirmed case. Around 8 a.m. on the same day, the self-quarantined individual was confirmed to have contracted the disease.
- Company
- Promising shingles vaccine market halved by COVID-19
- by Chon, Seung-Hyun May 21, 2020 06:01am
- Product images of Sky Zoster (left) and Zostavax The Korean shingles prevention vaccine market has halved this year. SK Bioscience' Sky Zoster has been maintaining high growth since its launch in 2018, but the market itself plummeted recently due to the COVID-19 outbreak. According to pharmaceutical market research firm IQVIA, this year’s first quarter shingles vaccine market marked 12.2 billion won taking a 37.8-percent fall from last year’s first quarter generating 19.7 billion won. Compared to last year’s fourth quarter making 27.9 billion won, the overall shingles vaccine market shrunk by 56.1 percent. Currently, Zostavax by MSD and Sky Zoster by SK Bioscience are the only two shingles preventive vaccines in Korea. Zostavax was dominating the market initially, until Sky Zoster came about in the market in late 2017. The first quarter shingles vaccine market has hit a historic low since Sky Zoster was launched. Quarterly review on shingles vaccine market (Unit: KRW 1 million) Source: IQVIA Apparently, the spread of COVID-19 has significantly impacted the preventive vaccine market. First, the vaccine recipients refrained from visiting healthcare institutes and lowered the number of vaccination. And the fact that it was not an urgent treatment, but a preventive vaccine could have influenced the users avoiding the vaccination. After Sky Zoster was introduced, the shingles vaccine market continued to grow. The market volume skyrocketed by 16.3 percent in merely two years from 24 billion won in the fourth quarter of 2017 to 27.9 billion won in the fourth quarter of 2019. As Sky Zoster is priced about 10 percent lower than Zostavax, the market had even bigger surge in use. But the volume plunged when COVID-19 started disturbing the market. Quarterly review on Zostavax and Sky Zoster sales (Unit: KRW 1 million) Source: IQVIA The research firm reported both Zostavax and Sky Zoster took a steep fall in sales volume. Zostavax made 7.3 billion won in the first quarter, which was 39.3 percent less than last year first quarter and 56.9 percent less than the last fourth quarter. Sky Zoster made 4.9 billion won, generating 35.5 percent less than last year. From the last fourth quarter, the Korean-made vaccine took a sharp 55.0 percent dip. Taking the steep fall together, Zostavax and Sky Zoster respectively maintained about the same market share as previous quarter. Sky Zoster’s first quarter market share marked 40.3 percent, when the previous quarter marked 39.3 percent.
- Company
- Anti-smoking treatment at public health centers was stopped
- by 박상준 May 20, 2020 06:12am
- From this year, the provision of smoking cessation treatments, such as Champix, through smoking cessation clinics in public health centers will disappear. The MOHW recently removed the provision of anti-smoking treatment Bupropion and Varenicline services from smoking cessation clinics in public health centers by revising the guidelines for the '2020 Community Integrated Health Promotion Project' (Non-Smoking). This is to prevent confusion and prescription of smoking cessation drugs through hospitals and clinics. #The MOHW established a new nicotine supplement policy through smoking cessation clinics in the public health center. However, if the target patient was prescribed a non-smoking treatment drug at a health center or clinics, the prescription of nicotine supplements was restricted. It is a policy to establish a system linkage to check whether smoking treatment has been prescribed before supplements are prescribed. .An official from the Health Promotion Section ( Section chief Young-Ki Jeong) said, "The guidelines have been revised because there has been confusion about the provision of smoking cessation drugs at smoking cessation clinics and health centers registered in the hospital's smoking cessation treatment business can prescribe smoking cessation treatments by doctors." However, the number of non-smoking patients who visited medical institutions due to the COVID-19 crisis has plummeted .As a result of the Medical Times coverage, the number of patients who quit smoking in hospitals in February and March this year has dropped by nearly 40% .Of the 14,000 hospitals registered for the NHIS' smoking cessation treatment business, 18, 811 patients registered in February, and 15,683 in March .#This is a decrease of 26.2% and 39.7%, respectively, compared to 25,496 in February and 25,972 in March from the previous year (2019) The prescription of anti-smoking drugs for Bupropion and Varenicline prescribed by the hospital should be reduced .According to data released by National Assembly Auditor Seung-hee Kim of the United Future Party in September of last year, the prescription amount of 'Champix' (Varenicline, Pfizer), the absolute strongest in anti-smoking treatment, In 2016, decreased from ₩39.1 billion to ₩50.7 billion in 2017, ₩37.2 billion in 2018, and ₩9.9 billion in January-June 2019 .Combined prescription amount of 'Wellbutrin SR 150mg' (GSK, Bupropion) and 'Nicopion SR 150mg' (Hanmi, Bupropion), another cessation treatment drugs are ₩1.2 billion in 2016, ₩680 million in 2017 , ₩810 million in 2018, and ₩3.3 billion in January-June 2019 .Patches, gums, etc .were only ₩350 million in 2016, ₩280 million in 2017, ₩240 million in 2018, and ₩100 million in January-June 2019 .An official from the Insurance Benefits Division (Section chief Jung-gyu Lee) said that patients who quit smoking in hospitals have decreased due to the unexpected COVID-19 situation, and it is expected that the amount of prescription for smoking cessation treatment will also be reduced .also he added that the exact numbers will need to be calculated .The MOHW is currently in the process of researching the smoking cessation treatment business as the NHIS as research director .An official in charge of the Insurance Benefits Division added, "The research service project is struggling due to the decrease in the number of non-smoking patients .We will decide the policy direction based on the research results such as improving the success rate of smoking cessation and improving patient incentives." It is pointed out that in the medical community, in order to improve the effectiveness of the smoking cessation treatment business, the treatment consultations fee needs to be improved, and various measures should be taken, such as expanding the scope of prescriptions for anti-smoking treatments such as patches .
- Company
- Yuhan, sell anticancer drug 'Glivec' with Novartis
- by Chon, Seung-Hyun May 20, 2020 06:11am
- Yuhan jointly sells anti-cancer drug 'Glivec' with Novartis. While Glivec's patent expired seven years ago, its growth slowed, but it intends to secure stable sales and overcome its recent sluggish earnings. On the 19th, Yuhan announced that it had signed a domestic exclusive sales and joint promotion agreement for Glivec with Novartis. Glivec is an anticancer drug used to treat chronic myelogenous leukemia and gastrointestinal stromal tumors. Yuhan is responsible for joint sales of Glivec with Novartis under this agreement. Glivec had annual sales of ₩80 billion. However, since generics entered after patent expiration in 2013, sales have been somewhat reduced. Glivec Sales Trend by Year (Unit: ₩100 million, Source: IQVIA) According to drug research firm IQVIA, Glivec's sales last year recorded ₩46.9 billion. It has consistently generated sales of ₩40 billion, including ₩43.3 billion in 2015, ₩45.8 billion in 2016, ₩45.9 billion in 2017, and ₩43.3 billion in 2018. Currently, six companies including Hanmi, Chong Kun Dang, Boryung, and Dong-A ST are selling Glivec's generics. Yuhan is expected to benefit from Glivec's domestic copyright. Yuhan has recently performed poorly in the prescription market. Sales amount in the first quarter were ₩303.3 billion, down 11.3% from the previous year. The prescription drug division, which accounts for more than 60% of total sales, is showing a severe slump. In the first quarter, Yuhan's prescription drug sales fell 13.3% YoY to ₩193.7 billion. Compared to the previous quarter (₩255.3 billion), prescription drug sales fell 24.1%. It means that about a quarter of sales of prescription drugs disappeared in three months. As sales of Glivec amounted to about ₩50 billion a year, Yuhan could overcome the sluggish prescription drug sales. It is also evaluated that the sales of Glivec also provided an opportunity to accumulate anti-cancer drug sales know-how. Yuhan has some anticancer drugs, but has no experience in handling anticancer drugs with a large sales volume. Yuhan is conducting a clinical trial for commercialization of 'Lazertinib', an anticancer drug that has been transferred to Janssen. The company expects that after Yuhan boosts its anticancer drug sales capabilities, it will be able to create synergies if Lazertinib gets domestic approval.
- Company
- Daewon launches bone forming biosimilar Terrosa
- by Nho, Byung Chul May 20, 2020 06:11am
- On May 18, Daewon Pharmaceutical (CEO Baek Seung Ryel) announced the launch of a biosimilar treating patients with osteoporosis, Terrosa cartridge injection,. Richter-Helm BioTec, a joint venture between a German-based company Helm and a Hungarian-based company Gedeon Richter, has developed biosimilar Terrosa with an active ingredient teriparatide. Eli Lilly’s Forsteo (U.S. brand name Forteo) is the originator of the product. A recombinant human parathyroid hormone (PTH) drug, Terrosa is indicated to treat both postmenopausal women and men with osteoporosis in high risk of fracture. By increasing the number of osteoblasts in bones, the biosimilar forms bones and demonstrates outstanding effect of reducing risk in osteoporotic fracture. Phase 1 and 3 clinical studies conducted in Europe and Japan have confirmed the drug’s significant effect of increasing bone mineral density in lumbar, femoral neck and total hip. As a bone builder, the drug has effect of increasing bone mass superior than other bone absorption inhibitors and it received four years of post-marketing survey period after being listed as a bioequivalent biologic confirmed via bioequivalence test. The self-injected once-daily injection pen can be reused with replaceable cartridge. The sturdy aluminum body of the injection pen is intricately designed to protect the product from external damage. Daewon Pharmaceutical official stated, “Terrosa is a meaningful addition to Daewon Pharmaceutical’s line up not only as the company’s first bio drug, but also as the first teriparatide biosimilar to be released in the Korean market,” and “besides confirmed efficacy and safety, the biosimilar is expected to lessen the financial burden on patients with its competitive pricing.” With the approximate patient size of one million in Korea only, the osteoporosis treatment market in Korea is projected to be worth around 200 billion won and specifically the injectable market is worth about 70 billion won.
- Company
- Samsung Bioepis' SB11 has equivalence with Lucentis
- by Lee, Seok-Jun May 20, 2020 06:10am
- SB11 (Ranibizumab), Lucentis' Biosimilar by Samsung Bioepis has demonstrated equivalence with the original. This is a global phase III for 705 people. SB11 is Samsung Bioepis' first ophthalmic disease treatment. It is also the sixth antibody biosimilar following three autoimmune disease treatments (SB2, SB4, and SB5) and two tumor disease treatments (SB3, SB8). 'Lucentis', original for SB11 is a treatment for macular degeneration and diabetic macular edema developed by Genentech. Currently, multinational pharmaceutical companies Roche and Novartis are selling it, and last year they made a global sales of about ₩4.6 trillion. Samsung Bioepis conducted a comparative study of clinical efficacy between SB11 and Lucentis in clinical trials for a total of 705 neovascular age-related macular degeneration (nAMD) patients from March 2018 to December 2019. The primary efficacy evaluation index (primary endpoint) was set in two ways to determine whether the previously established equivalence margin was met. After the prescription, the maximum corrected visual acuity (BCVA) improvement value was measured for 8 weeks, and then the 90% confidence interval (CI) was checked. In addition, 95% confidence intervals were observed after 4 weeks of macular center thickness (CST) measurements. According to the study results, the BCVA Least Squares mean improved by 6.2 characters in SB11 and the original 7.0 characters. The 90% confidence interval interval (-1.827 ~ 0.219) of the mutual difference (-0.8) met the pre-established range of equivalence (± 3). The least square mean of the 4 week CST change was observed to be SB11 -108.4 micrometers (μm) and the original -100.1 micrometers. The 95% confidence interval interval (-19.446 ~ 2.747) of the inter-difference (-8.3) was included in the pre-established range of equivalence (± 36). Samsung Bioepis plans to start the product licensing phase by applying for sales authorization of SB11 in the US and Europe as early as this year. Samsung Bioepis is expanding the field of biopharmaceutical development with ophthalmic diseases, rare diseases, etc. along with existing autoimmune and oncology treatments based on its product portfolio expansion strategy. In addition to SB11, SB15 (Eylea’s Biosimilar, Aflibercept) is also being developed.
- Company
- Bispecific antibody by Yuhan & ABL BIO debuts at the AACR 20
- by An, Kyung-Jin May 19, 2020 06:06am
- YH32367/ABL-105, which Yuhan & ABL Bio are jointly developing, debuts on the international stage. Yuhan announced on the 15th that it will announce the results of the preclinical efficacy test of the bispecific antibodies for cancer immunotherapy 'YH32367 (ABL-105)' at the American Association of Cancer Research's 2nd online academic conference (AACR 2020). YH32367 / ABL-105 is a Pipeline drug under joint research by Yuhan & ABL Bio. By specifically binding to tumor cells and stimulating T-immune cell activation receptor 4-1BB, it increases the anticancer activity of immune cells and suppresses the growth of tumor cells. In September 2018, Yuhan Corporation secured global rights for two bispecific antibodies for cancer immunotherapy under preclinical stage through a contract with ABS Bio. The contract amount without obligation to return is ₩200 million, and the total contract size combined with milestones is up to ₩59 billion. This was achieved in one year and eight months of technology introduction. According to the abstract published on the 15th (local time) AACR website, YH32367 increased apoptosis cytokine secretion such as interferon gamma (IFN-γ) in human T-immune cells and induced tumor cell death. Animal experiments using humanized mice and human 4-1BB-expressing mice also showed superior anticancer efficacy compared to the control group. In particular, it explained that safety has been proven without identifying side effects of hepatotoxicity, which is one of the disadvantages of competitive drugs. Yuhan expects YH32367 to be effective against patients with resistance to existing anticancer drugs among a number of solid cancers such as breast cancer, stomach cancer, and lung cancer. The goal is to complete pre-clinical toxicity studies next year and start clinical trials.
- Company
- Will Hanmi also target Stivarga's patent?
- by Kim, Jin-Gu May 19, 2020 06:06am
- Hanmi's generic launch of Nexavar (Sorafenib) is imminent. Hanmi is considering internally reviewing a plan to target the patent of 'Stivarga (Legorafenib)', a secondary target treatment for liver cancer. If Hanmi succeeds in overcoming patents to Nexavar and Stivarga, it is expected that a lineup of targeted treatments for liver cancer will be established. According to the pharmaceutical industry on the 14th, Hanmi recently submitted an application of generic for Nexevar to the MFDS. Unless there is a special variable, the approval of an item for “Hanmisorafenib (tentative name)” is expected to be made soon. It is confirmed that Hanmi is already in the process of planning for the next step as the launch of Generic for Nexavar is imminent. Hanmi intends to target the patent of Stivarga, following to Nexava. Stivarga is a targeted anticancer drug that can be used as a secondary treatment for patients who fail to treat Nexavar. Bayer has a patent right. An official from Hanmi said in a call with Dailypharm, "With the imminent approval of generic for Nexavar, we are considering a new way to re-challenge the patent in the next step." In fact, Hanmi had previously tried the patents. However, the results were not good. It ended in defeat or self-dismissal. In April 2015, Hanmi, together with Huons, Yuhan, and Chong Kun Dang, requested invalidated trials for Stivarga's material patent (expired in March 2025), formulation patent (expired in August 2025), and hydrate patent (expired in September 2027). In June 2017, the Patent Tribunal sided with the original company on a trial of “partial dismissal” against the invalidation trial for a formulation patent. Subsequently, in August, domestic companies voluntarily canceled the trial for invalidating a patent. Although domestic companies seemed to have failed to acquire Stivarga's patent, Boryung requested a judgment to confirm the scope of passive rights alone in the hydrate patent. In the end, after two years of fighting, Boryung succeeded in pursuing patents in April 2019, leading to a trial. The decision was confirmed in May of the same year. Hanmi's strategy is no different from Boryung. It intends to re-challenge by raising a judgment on the passive scope of rights to Stivarga's hydrate patent. If Hanmi targets patents following Nexavar and Stivarga, it is expected to generate considerable synergy in that it will have both generics of primary targeted treatments for liver cancer. The original company, Bayer, also has the advantage of being able to perform continuous treatment and has an advantage over Lenvima. According to drug research agency IQVIA, sales of each drug amounted to ₩25.4 billion in Nexavar and 23.6 billion in Stivarga as of last year.
