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- 2026-05-20 10:03:15
- 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.
- Opinion
- [Reporter’s View]Raising the voice of rare disease patients
- by Eo, Yun-Ho May 20, 2020 06:11am
- Seems like rare diseases put patients in utmost pain, because of its ‘rarity.’ Rare disease treatments can hardly prove cost-effectiveness and predictability with limited patient size for the reimbursement listing approval. Regardless, the Korean government is aware of the struggle. The revised drug pricing system the Ministry of Health and Welfare (MOHW) unveiled is in process of legislative preannouncement until June 11. The key revision in the new drug pricing system is to expand eligibility in pharmacoeconomic evaluation (PE) exemption and RSA. The revision would stipulate the Korean government to sign risk sharing agreement (RSA) not only with first-in-class drugs, but also with follow-on drugs. And also the revision would expand subjects for PE exemption and coverage with phase III clinical evidence in development. Even the PE exemption, previously restricted to anticancer and rare disease treatments, would be applicable on National Essential Drugs, such as tuberculosis treatment, antibiotics and emergency antidotes. However, many of the public claim rare disease treatments would still face various obstacles before receiving RSA and PE exemption benefits. In Korea, rare disease is defined as a disease with patient size less than 20,000 with difficulties in diagnosis to survey accurate number of patients. The affected patients are desperate to get access to life-saving treatment as the diseases are difficult to diagnose and treat, but many of the diseases cannot even start a clinical study with barely sufficient number of patients. Pharmaceutical companies are hesitant to develop a novel drug for rare disease, as the limited number of patients means limited marketability, while the chances of successfully proving the cost-effectiveness of the drug through PE would be thin. Many countries around the world are introducing regulatory exceptions in legislation, special approval or reimbursement listing for better access to rare disease treatments. Korea has also provided regulatory exceptions like medically essential drug management, PE exemption system and RSA in reimbursement listing or drug pricing. Regardless, the limitations to treatment access still exist. In fact, data comparing listing rate by each drug type before and after implementing RSA and PE exemption systems for bettering the access to high-cost treatments showed a significant improvement in general drug (79.6 percent to 98.6 percent) and anticancer treatment (77.1 percent to 91.7 percent), but the improvement in rare disease treatment (71.1 percent to 71.4 percent) was rather unnoticeable. As a solution to the much needed access to rare disease treatment, some argue the PE exemption eligibility should be expanded for the rare disease treatment. They say the reimbursement review system should be flexible to exempt PE or adjust the number of PE sample patients similar to the special case reimbursement standard, when a drug has no other alternative option or has been approved with placebo-controlled study results. For instance, the U.S. Food and Drug Administration’s (FDA) Breakthrough Therapy Designation (BTD) or European Medicines Agency’s (EMA) Priority Medicine (PRIME) designation could be referred as a review standard. The PE exemption system aims to provide patients the access to rare disease and anticancer treatments unable to produce PE data, while protecting the initial purpose of positive listing system. So to serve its purpose, the Korean health authority should contemplate on the flexibility of the healthcare reimbursement listing procedure. Same goes for RSA. Compared to numerous anticancer treatments that received coverage through RSA, many of rare disease treatments have failed in passing the barrier to RSA due to lack of PE data. As far as quality-adjusted life-year (QALY) goes, the majority of rare diseases results in severe physical damage in patient’s body, lowers quality of life, and shortens life expectancy. And because of extremely small number of users, rare disease treatments are inevitably high-priced and show poor cost-effectiveness. The rare disease treatments can hardly prove cost-effectiveness, when applied with incremental cost-effectiveness ratio (ICER) thresholds on par with other general drugs. The regulation stipulates the health authorities to flexibly set ICER thresholds on rare disease treatments, but the drugs are challenged with PE barriers higher than that of anticancer treatments due to their practices so far. This is why many urge more adaptable ICER thresholds should be given to rare disease treatments for their PE. When the Rare Disease Management Act came in effect in 2015, the Korean government designated May 23 as the Rare Disease Day to raise awareness and understanding of patients fighting against rare diseases. Rare diseases have a handful of treatments for a handful of patients, which is why the voice to demand their healthcare benefit is so easily lost. Hopefully in the near future, the government and pharmaceutical companies would pay a closer attention to those patients, as much as they do for cancer patients.
- 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.
- Policy
- Consult with PM from the development to post-marketing stage
- by Lee, Tak-Sun May 20, 2020 06:11am
- The MFDS (Minister Eui-kyung Lee) expanded the role of the 'product manager (PM)', which has been limited to the permitting step, from the drug development to the post-marketing cycle, in order to increase the predictability of the approval and review process and safety management expertise. Announced on the 18th that it will switch to a one-stop support and management system Accordingly, the 'Product Manager', established in 2009, will manage the entire drug lifecycle, including pre-examination at the development stage, re-examination and risk management after approval. PM is the general manager of the pharmaceutical products of the MFDS, and it manages the history of each stage, such as permits and reviews, operates communication channels between reviewers and developers, and acts as an early recognition of problems to strengthen permit efficiency and predictability. Regulatory authorities such as the United States and Europe also operate item managers and are expanding their role. PM will be managed by the headquarters of the MFDS and new and orphan drugs or high-risk items will be classified as 'Special Management Items', and designated managers with expertise and experience will be differentially managed. Pharmaceutical companies can receive the necessary consultation from the drug development stage to the post-marketing stage through the designated 'PM', and the person in charge can be found on the website of the MFDS. "The expansion of the role of PM is a policy that the MFDS is pursuing with a strong will to advance to an international level of regulatory authority, so we will try to settle early," said Minister Eui-kyung Lee, while communicating with experts such as doctors and pharmacists, we will create an environment where people can use it more safely. ”
- 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.
- Policy
- “Neglecting cost-effectiveness is dereliction of duty"
- by Kim, Jung-Ju May 19, 2020 06:07am
- Answering to the criticism that National Health Insurance (NHI) coverage enhancement initiative is toughening the barrier of pharmaceutical reimbursement listing and standard, Korean health authority officials urged the cost-effectiveness should be further reinforced. Recently appointed Director Yang Yoon Seok of the Pharmaceutical Benefits Division at Ministry of Health and Welfare (MOHW) hinted, “We want to put more filters, if possible.” The ministry officials also noted the government would pay a close attention to what pharmaceutical and bio industry, as well as patient groups, have to say, but they are planning to make policies weighing more on rationality and predictability. Regarding the listed drug reevaluation pilot program announcing last week that choline alfoscerate would be the first, the government officials stressed unlike the approval system, the cost-effectiveness comes first in listed drug reevaluation. On the questions directed to the final outcome of reevaluation—reimbursement removal or reduction, the officials shortly commented adequate actions would be taken and avoided providing further details. Director Yang elaborated during a press conference held immediately after the Health Insurance Policy Deliberation Committee (HIPDC) meeting on May 15. Appearing for the first time at an official press conference, Director Yang expressed his philosophy in insured drug policy, prospective approach, and his commitment to them. Senior Deputy Director Lee Seon-joo and Deputy Director Choi Kyung-ho, playing significant roles in the Pharmaceutical Benefits Division, also joined Director Yang during the question and answer session. (From left) Senior Deputy Director Lee Seon-joo, Director Yang Yoon Seok and Deputy Director Choi Kyung-ho ▶The Ministry of Food and Drug Safety (MFDS) is reportedly considering on reevaluating the approval standards on choline alfoscerate. Has the listed drug reevaluation been discussed with MFDS? If not, then it could cause confusion when reevaluations each conducted by MFDS and MOHW (Health Insurance Review and Assessment Service, HIRA) result in contrasting outcomes. Deputy Director Choi Kyung-ho (“Choi”) “MFDS’ approval evaluation and MOHW’s reimbursement listing evaluation are different. The previous negative listing system used to list most of the approved drugs, but the current positive listing system reviews cost-effectiveness. The listed drug reevaluation is to be introduced within the framework, and such reevaluation, specifically for the price, is nothing new.” ▶Can the listed drug reevaluation ultimately result in reimbursement standard reduction or removal? Director Yang Yoon Seok (“Yang”) “Depending on the outcome, adequate actions would be taken accordingly.” ▶The reevaluation mentioned in the first NHI Comprehensive Plan was about introducing more general drug reevaluation covering clinical efficacy, financial impact and contract compliance. While selecting choline alfoscerate for the pilot program does not exactly explain how it is covering the said factors. Is there a possibility that the pilot program could include other subject drugs during or after the first pilot program? And what is the reason behind only selecting choline alfoscerate? Yang “The lawmakers and media have raised issues over choline alfoscerate last year, and even civic health organizations have requested for an audit. As we have already promised for a reevaluation, it cannot be delayed anymore. The actual regulation would be set down based on the pilot program, but the pharmaceutical industry seems to be concerned about the [government policy] being spontaneous or arbitrary. [By understanding those concerns] the Ministry intends to enhance predictability.” Choi “A number of pharmaceutical substances were listed up as the pilot program candidates. Selecting the urgently demanded choline alfoscerate seemed appropriate. In fact, differentiating the pilot evaluation and the actual evaluation would be meaningless.” ▶According to the information from HIPDC, the pharmaceutical expenditure saved from the reevaluation would be used for listing severe and rare disease treatments. The previous director of Pharmaceutical Benefits Division mentioned about opening an account for pharmaceutical expenditure on severe disease treatment. Has it been reviewed any further? Choi “The limited resources, despite so many expenditures to cover, is our concern for the system. So basically, the talk came about as a means to accumulate resources for coverage on severe disease treatment by cutting out expenditure on drugs with weak efficacy or unnecessary reimbursement. Regardless, if the pharmaceutical expenditure can be saved, the ministry would have more resource to utilize on much needed reimbursement to cover severe disease treatments. The issue is still under review.” ▶Again, the HIPDC information explains the reason behind choosing choline alfoscerate for the pilot program, which referred to A8 external pricing reference countries. Does this mean that the existing list of A7 countries would be updated to A8 countries including Canada? Choi “[The external pricing reference countries] is set by HIRA. The A8 mentioned here is not so significant. The eight countries were picked as reasonable references. It would be better to interpreted like that.” ▶Some criticize that the financial issue of anticancer treatment reimbursement listing or expansion have been evaluated through ‘triple-filtering (Cancer Deliberation Committee, DREC and drug pricing negotiation)’ as the Cancer Committee started reinforcing financial impact management. Some even go further and say the triple-filtering is deferring deliberation on many of anticancer treatment coverage and affecting the patient’s access to treatment. Yang “They call it the ‘triple-filtering,’ but to be honest, we want more filtering if possible. For this time around, we had the applicant company to submit a financial impact management plan on their immunotherapy. Nevertheless, we would need to construct a system for the patients to receive more benefits.” Choi “It does not mean the previous evaluations were insufficiently done. Anyway, healthcare reimbursement review has to take account of cost-effectiveness at each step. “In some cases, HIRA first projects comparatively lower cost, when NHIS projects the cost higher. As a health authority, such cases should be prevented. Neglecting cost-effectiveness is as irresponsible as dereliction of duty. “Attempting to catch a mosquito with a sword would be nonsensical, but the related experts can talk about it at every step. And if each step can be a filter, we expect the next step would be able to bring even better outcome. “Pharmaceutical companies may feel these steps are excessively straining them, but demanding the health authority to review listing without the filtering would mean they are demanding us to work blindly. And in clinical scene, doctors judge the use of a drug, and these doctors are part of the committees. Financial experts are there to add more on the financial aspect. We are definitely not putting down one-fifth resource for the necessary expenditure.”
- Policy
- Reimbursement on Ibrance-Faslodex available from June
- by Lee, Hye-Kyung May 19, 2020 06:07am
- From June 1, the healthcare reimbursement would be granted on the combined use of Pfizer Pharmaceutical Korea’s HER2-negative breast cancer treatment Ibrance (palbociclib) capsule and Faslodex (fulvestrant). National Health Insurance Service (NHIS) has settled on a negotiation over an indication expansion of the already listed drug and listed Ibrance 75 mg, 100 mg and 125 mg under refund type risk sharing agreement (RSA). Each capsule would be priced at 125,900 won with the healthcare benefit. On May 15, Korea’s Ministry of Health and Welfare (MOHW) held the seventh Health Insurance Policy Deliberation Committee (HIPDC) meeting of the year. Convened for the first time in the year, the HIPDC members passed the Ibrance listing as a part of the revised list of reimbursed drugs and maximum reimbursement price. The negotiation on Ibrance was not a new drug pricing negotiation, but a reimbursement standard expansion according to the change in indication. Initially indicated to treat postmenopausal female patients with hormone receptor positive (HR+) or human epidermal growth factor receptor 2-positive (HER2+) advanced or metastatic breast cancer as an endocrine therapy, Ibrance is additionally indicated to treat, in combination with Faslodex, female patients with hormone receptor positive (HR+) or human epidermal growth factor receptor 2-positive (HER2+) advanced or metastatic breast cancer who has been treated with endocrine therapy. The indication expansion on Ibrance’ combination therapy has been demanded for over three years, as its indication was expanded to a first-line endocrine therapy combined with letrozole to treat postmenopausal women in 2017. Since Pfizer applied for the new indication to treat female patient with advanced breast cancer after endocrine therapy as a combination therapy with Faslodex on Apr. 26 last year, Health Insurance Review and Assessment Service (HIRA) has been reviewing the revised reimbursement standard. The revised reimbursement standard on Ibrance has undergone deliberations by Cancer Deliberation Committee in last September and Drug Reimbursement Evaluation Committee (DREC) in last February, and was negotiated for reimbursement pricing with NHIS from Mar. 7 to May 6. Due to the cost-effectiveness issue raised by NHIS, Pfizer has agreed to refund a set ratio of claimed cost of Ibrance to NHIS, and also to lower the reimbursed price by 10.8 percent to lessen the financial impact. The Korean health authority projected the expanded reimbursement standard on Ibrance, in effect from June 1, would additionally cost them 16.5 billion won a year.
- 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.
